SOZO

The SOZO® system utilizes multi-frequency bioimpedance spectroscopy to non-invasively measure electrical properties of the human body, aiding clinicians in assessing protein-calorie malnutrition risk and tracking detailed body composition parameters. Its methodology involves applying a low-level electrical current across a wide range of frequencies through hand and footplate electrodes, with algorithms then converting the measured impedance data into clinically relevant metrics like fluid volumes, fat mass, and muscle mass.

The SOZO® system is a bioimpedance spectroscopy device designed to aid clinicians in assessing patients at risk of protein-calorie malnutrition by serving as an adjunct to Subjective Global Assessment tools. It also estimates and tracks various body composition parameters over time, including fat mass, fat-free mass, total body water (differentiating intracellular and extracellular fluid), and skeletal muscle mass. The system operates by having a patient make contact with stainless steel electrodes on a connected hand and footplate. A small electrical current (200μA RMS) is applied across 256 frequencies (3kHz to 1000kHz), and the device measures the resulting voltage and phase angle to calculate impedance, resistance, and reactance. These bioimpedance measurements (current, voltage, phase angle, resistance, reactance, impedance) are then processed by established algorithms within the SOZOapp on a paired Android tablet. The system provides outputs such as Body Mass Index, basal metabolic rate, and protein/mineral content (dry lean mass), in addition to the primary body composition parameters. Data is stored and managed via the SOZOhub database. Performance testing confirmed the device's electrical safety, biocompatibility, software validity, and functional reliability. Clinical studies have supported the applicability of its bioimpedance spectroscopy technology for body composition assessment, and comparative testing showed strong correlation with a predicate device.

AI Regulatory Concerns

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Jev reads the full FDA letter and returns calibrated concern probabilities per regulatory category. These are AI estimates, not regulatory advice.

• Q1. What is the specific accuracy and precision of the SOZO system in differentiating between intracellular and extracellular fluid compared to gold-standard methods like dilution techniques across diverse patient populations (e.g., varying hydration states, renal patients)?; How do the "established algorithms" used by SOZO account for variations in body geometry, ethnicity, and age, and what is the evidence supporting their validity across these demographics for each reported parameter?; For its use as an adjunct in assessing protein-calorie malnutrition risk, what is the quantitative impact or added diagnostic value of SOZO measurements when combined with SGA tools, particularly in early detection or severity grading of PCM?; Given the wide frequency range (3kHz to 1000kHz), how does the SOZO system specifically utilize data from different parts of this spectrum to derive distinct body composition parameters, and are there specific frequencies critical for certain estimations like skeletal muscle mass?; How does the system's performance, particularly the stability and reproducibility of measurements, vary with repeated use over its intended life, especially concerning electrode integrity and calibration requirements in a clinical setting?