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The Bodyport Cardiac Scale is intended for use, under the direction of a physician, for the non-invasive monitoring and management of patients with fluid management related health conditions. The device is intended to be used to measure and track body weight, peripheral impedance, pulse rate, and center of pressure. The device is intended to be used in the home or clinic environment.

Intended users are people over 21 years of age who can stand for the measurement and weigh less than 180 kg (397 lbs).

The device does not generate any real-time alarms for consideration by the user at home or by a healthcare professional. Data from the device should be used in the context of all clinical data to make determinations of a patient's status.

The Bodyport Cardiac Scale is a non-invasive cardiovascular monitor and body weight scale that measures body weight, peripheral impedance, pulse rate, and center of pressure through the feet of a user standing on its surface. The device is powered by four (4) AA alkaline batteries.

The device is comprised of a physical platform on which the user stands with bare feet. Four electrodes located on the top surface of the platform are used to measure of the user's lower body (foot-to-foot). The impedance signal is obtained by applying a small, safe battery-generated current (

The provided text is a 510(k) summary for the Bodyport Cardiac Scale. It outlines the device's intended use, technological characteristics, and performance data used to demonstrate substantial equivalence to a predicate device. However, it does not provide explicit acceptance criteria in a table format or detailed results from a study proving that the device meets specific performance criteria for AI/algorithm-driven features.

The document states:

• "Performance Bench Testing: Measurement accuracy and linearity of the Bodyport Cardiac Scale were compared to the predicate device to determine substantial equivalence."
• "Clinical Data: Pulse Rate: Clinical testing demonstrated the accuracy of the pulse rate measurement from the Bodyport Cardiac Scale compared to a reference single lead ECG heart rate measurement. For this study, adult subjects, with a range of peripheral impedances and pulse rates, were analyzed. Peripheral Impedance: Analysis of clinical data demonstrated the clinical utility of peripheral impedance in the monitoring of patients with fluid management conditions. This analysis included clinical data from patients with heart failure, as an example patient population with fluid management related health conditions, and healthy subjects, as a control population. Additional testing demonstrated the correlation between impedances measured through hand-to-foot and foot-to-foot body segments. For this study, adult subjects, with a range of peripheral impedances, were analyzed."

Without access to the specific study reports referenced, it's not possible to populate all the requested information about acceptance criteria and study details. The document provides a high-level summary of the types of tests performed but lacks the granular data required.

Here's an attempt to answer the questions based only on the provided text, highlighting what is not available:

1. A table of acceptance criteria and the reported device performance

The document does not explicitly present acceptance criteria in a table or precise reported performance metrics for the device's measurements (body weight, peripheral impedance, pulse rate, center of pressure) against specific numerical targets. It generally states that "Measurement accuracy and linearity... were compared to the predicate device to determine substantial equivalence." and "Clinical testing demonstrated the accuracy of the pulse rate measurement...".

2. Sample sizes used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Sample Size for Pulse Rate Study: "adult subjects, with a range of peripheral impedances and pulse rates, were analyzed." (Specific number of subjects not provided).
• Sample Size for Peripheral Impedance Utility Study: "patients with heart failure, as an example patient population with fluid management related health conditions, and healthy subjects, as a control population." (Specific numbers not provided).
• Sample Size for Peripheral Impedance Correlation Study: "adult subjects, with a range of peripheral impedances, were analyzed." (Specific number not provided).
• Data Provenance: Not specified (e.g., country of origin, retrospective or prospective). The context of a 510(k) submission for a US device often implies US-based studies, but it is not explicitly stated.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

• The document mentions "reference single lead ECG heart rate measurement" for pulse rate, implying a gold standard measurement, not subjective expert opinion.
• For peripheral impedance, "clinical utility" and "correlation" were analyzed. It does not mention experts establishing ground truth or their qualifications.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

• This concept is not relevant as the "ground truth" for the measured parameters (pulse rate, impedance, weight, center of pressure) would typically be established by validated reference instruments or objective clinical data, not expert consensus or adjudication in this context.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

• No, an MRMC comparative effectiveness study involving human readers with and without AI assistance was not performed or described. The device is a "Cardiac Scale" that measures physiological parameters; it is not an AI-driven diagnostic imaging interpretation tool where human-in-the-loop performance would typically be evaluated in an MRMC study. The device's role is to provide data for physicians to use in context.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

• Yes, the performance data presented (accuracy of pulse rate, utility/correlation of impedance, accuracy/linearity of weight/center of pressure) would represent the standalone performance of the device's measurement algorithms. It measures the parameters directly.

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)

• Pulse Rate: "reference single lead ECG heart rate measurement." This is an objective, instrumental ground truth.
• Peripheral Impedance: For utility, it involved "patients with heart failure... and healthy subjects" which implies clinical diagnoses/outcomes as context for utility. For correlation, it involved comparison between "hand-to-foot and foot-to-foot body segments," likely referring to an instrumental comparison.
• Body Weight & Center of Pressure: Not specified beyond "compared to the predicate device to determine substantial equivalence," which implies a reference standard or validated measurement.

8. The sample size for the training set

• The document does not describe any specific training set for an AI/ML model. It describes "clinical testing" and "analysis of clinical data" but does not differentiate between training and test sets in the context of a machine learning pipeline. The device's function appears to be direct measurement and calculation, not an AI model trained on a large dataset to make a diagnosis or prediction.

9. How the ground truth for the training set was established

• Not applicable, as no explicit training set for an AI/ML model is described. The device's functionalities (measuring impedance, pulse rate, weight, center of pressure) are based on established physiological principles and signal processing, not explicitly a supervised machine learning model requiring a ground-truthed training set in the typical AI/ML sense.

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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 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 ("SOZOhub") contained within the hospital/facility network.

Measurements require the patient to make contact with bare hands and feet on stainless steel electrodes. The measurement takes about 30 seconds, during which the SOZO™ system applies small levels of electrical energy (200µA RMS) to the body across 256 frequencies spaced logarithmically from 3kHz to 1000kHz and measures the resulting voltage levels. Established algorithms are used to analyze data and calculate extracellular fluid impedance levels for left and right limbs, and present the impedance ratio as an L-Dex® score for the clinician to review. This score facilitates their clinical assessment of lymphedema in adult human patients.

The SOZO® device is a bioimpedance spectroscopy device intended for adult human patients at risk of lymphedema. It uses impedance ratios to display an L-Dex ratio, aiding clinicians in assessing lymphedema by measuring extracellular volume differences between limbs.

Here's an overview of the acceptance criteria and the study proving the device meets them:

1. Acceptance Criteria and Reported Device Performance:

2. Sample Size Used for the Test Set and Data Provenance:

The document does not explicitly state a specific sample size for the "clinical testing" mentioned, nor does it detail the provenance (country of origin, retrospective or prospective) of the data used for establishing the strong correlation of extracellular fluid levels. For the "comparative performance vs. predicate device" test, the "test set" consisted of a test fixture creating "multiple fixed impedance loads representing different 'humans'".

3. Number of Experts and Qualifications:

The document does not specify the number or qualifications of experts used to establish ground truth for any of the tests. For "clinical testing," it refers to "studies" that identified the applicability of the BIS technology, implying clinical expertise was involved in those studies, but no details are provided here.

4. Adjudication Method:

The document does not mention any adjudication method for establishing ground truth within the context of the provided performance data.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

The document does not describe an MRMC comparative effectiveness study involving human readers with and without AI assistance. The device is presented as an "aid to their clinical assessment," suggesting a human-in-the-loop scenario, but no comparative effectiveness study of this nature is detailed.

6. Standalone (Algorithm Only) Performance Study:

A standalone performance study was conducted for the device. The comparative performance against the predicate device using a test fixture and the "clinical testing" demonstrating correlation of extracellular fluid levels support the algorithm's standalone performance in producing the L-Dex ratio.

7. Type of Ground Truth Used:

• For Electrical Safety/EMC, Software V&V, Biocompatibility, and Functional Performance, the ground truth was based on adherence to international standards and internal design specifications/requirements.
• For Clinical Performance, the ground truth seems to be implicitly derived from established clinical understanding of lymphedema and extracellular fluid levels, as evidenced by "studies (that) have identified the applicability of ImpediMed's BIS technology." While not explicitly stated as "expert consensus," the nature of clinical assessment of lymphedema often relies on expert judgment integrated with objective measures.
• For Comparative Performance vs. Predicate Device, the ground truth was established by comparing the SOZO system's outputs against the outputs of already established predicate devices (ImpediMed U400 and SFB7) when presented with the same "fixed impedance loads." This implies the predicate devices' outputs served as the reference or "ground truth" for correlation.

8. Sample Size for the Training Set:

The document does not explicitly mention a separate "training set" or its sample size. The "Established algorithms are used to analyze data" implies algorithms were developed and likely trained, but details about the training process are not provided in this summary.

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

This information is not provided in the document.

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