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The SOZO Pro has the following uses:

For adult human patients at risk of lymphedema:

A bioimpedance spectroscopy device for use on adult human patients, utilizing impedance ratios that are displayed as an L-Dex ratio that supports the measurement of extracellular volume differences between the limbs and is presented to the clinician on an L-Dex scale as an aid to their clinical assessment of lymphedema.

The use of the device to obtain an L-Dex score is only indicated for patients who will have or who have had lymph nodes, from the axillary and/or pelvic regions, either removed, damaged or irradiated.

The SOZO Pro is intended for adult patients living with heart failure.

This device is intended for use, under the direction of a physician, for the monitoring of patients with fluid management problems suffering from heart failure. Data from the device should be considered in conjunction with other clinical data.

The SOZO Pro may be used as an adjunct to existing methods by aiding clinicians who are using Subjective Global Assessment (SGA) tools to assess patients at risk of protein-calorie malnutrition (PCM).

The SOZO Pro may be further used to estimate the following body composition parameters in humans to track clinically relevant body composition parameters over time:

• Fat mass

• Fat-free mass

• Total body water

• Intracellular fluid

• Extracellular fluid

• Skeletal muscle mass

• The following outputs are also presented:

• Body Mass Index (BMI)

• Basal metabolic rate (BMR; based on Mifflin St. Jeor's algorithm) displayed in calories per day

• Protein and mineral (also known as 'dry lean mass') represents the content of a body that is not fat or fluid; calculated by subtracting total body water weight from fat-free mass weight.

The SOZO Pro device measures current (I), voltage (V) and phase angle (Phi), and from these values calculates resistance (R), reactance (Xc), and impedance (Z), which are used to estimate the above body composition parameters. The device' software will also display the Cole plot, subject height, weight, age and sex.

The SOZO Pro system consists of a connected hand and footplate with built-in stainless-steel electrodes, paired with an Android tablet over Bluetooth connection. An app ("SOZOapp"), supplied with the tablet, controls the functionality of the hardware, and supplies the bioimpedance measurement data to a database ("MySOZO") managed on an external cloud- hosted database. Patient weight is measured with load cells located in the SOZO Pro foot unit or can be hand entered.

Bioimpedance measurements require the patient's weight to be measured by a scale embedded in the base of the system or for the weight of the patient to be entered manually. Following the collection of the patient weight, the patient contacts the SOZO Pro with their bare hands and feet on stainless steel electrodes. The impedance measurement takes about 30 seconds, during which the SOZO Pro® system applies small levels of electrical energy (200μA RMS) to the body across 256 frequencies spaced from 3kHz to 1000kHz and measures the resulting voltage levels.

The provided text describes the SOZO Pro device, a bioimpedance spectroscopy device, and its 510(k) submission to the FDA. However, it does not contain the specific details about acceptance criteria, a comparative study with a human-in-the-loop, the exact sample sizes for test and training sets, the number and qualifications of experts for ground truth, or adjudication methods for all the stated indications for use.

Based on the information available, here's what can be extracted and inferred:

1. Table of Acceptance Criteria and Reported Device Performance

The document states that the device went through "appropriate testing per design controls to confirm functionality and performance of the indications." While specific numerical acceptance criteria (e.g., accuracy percentages, thresholds) are not explicitly provided in this document, the general categories of testing and the reported outcomes are:

2. Sample Sizes Used for the Test Set and Data Provenance

• Test Set Sample Size: Not explicitly stated for any of the performance tests. The document mentions "fixed loads" for functional performance, implying a controlled, non-patient-specific test, and "a variety of pacemakers" for compatibility. For the software V&V, it states the software was "verified and validated," which implies testing, but sample size is not quantified.
• Data Provenance: Not explicitly stated. The document is a 510(k) summary for a device manufactured by ImpediMed Limited in Australia. The testing is likely conducted by the manufacturer, but the origin of the data used for performance comparison (e.g., patient data) is not specified. It does not indicate if it was retrospective or prospective.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Experts

• Not explicitly stated. The document focuses on technical performance and validation against engineering standards and a predicate device, rather than diagnostic accuracy studies involving expert human readers and a ground truth derived from clinical experts.

4. Adjudication Method for the Test Set

• Not applicable/Not explicitly stated. Since there's no mention of a human-in-the-loop diagnostic study or expert consensus for ground truth establishment, adjudication methods are not detailed.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

• No, not explicitly stated or implied. The submission emphasizes substantial equivalence to a predicate device primarily through technical and functional comparisons, not through a comparative effectiveness study showing improvement in human reader performance with AI assistance. The document states, "The SOZO Pro is intended for use, under the direction of a physician, for the monitoring of patients with fluid management problems suffering from heart failure. Data from the device should be considered in conjunction with other clinical data." This indicates it's an aid, not a standalone diagnostic that would typically undergo such a comparative study for its primary clearance.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

• Yes, implied. The "Functional performance" section, where it states "performance testing was undertaken using fixed loads and comparing modified SOZO Pro to predicate SOZO measurements to demonstrate that outputs remained consistently accurate and precise," suggests standalone performance evaluation. The device measures impedance, resistance, reactance, and then calculates body composition parameters. The validation of these calculations against a known standard (fixed loads, predicate device performance) represents a standalone performance assessment.

7. The Type of Ground Truth Used

• Reference to Predicate Device and Engineering Standards: For most of the performance claims, the ground truth appears to be:

  • The performance of the predicate SOZO device (K203473).
  • Compliance with IEC 60601 (Electrical Safety/EMC), ISO 62304 (Software V&V), ISO 10993 (Biocompatibility), NIST Handbook 44 and EU Directive 2014/31/EU (Weight Scale).
  • Fixed loads for functional performance testing.
  • ISO 14117 for pacemaker/ICD compatibility.

  There is no mention of "expert consensus," "pathology," or "outcomes data" as ground truth for the device's diagnostic or monitoring capabilities beyond aiding clinical assessment.

8. The Sample Size for the Training Set

• Not applicable/Not stated. This device does not appear to be an AI/ML device that requires a distinct "training set" in the conventional sense for a deep learning model. It's a bioimpedance spectroscopy device that measures physical parameters and applies algorithms (e.g., Mifflin St. Jeor for BMR). The "software updates were included to integrate the scale and weight measurement capabilities," but this doesn't imply a self-learning algorithm that would require a training dataset.

9. How the Ground Truth for the Training Set Was Established

• Not applicable. As it does not appear to be an AI/ML device with a training set, this information is not relevant or provided. The algorithms it uses (e.g., for body composition) are likely fixed formulas validated against general physiological principles and existing scientific literature.

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