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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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The NICaS 2004 Slim is intended for use in monitoring hemodynamic parameters (including stroke volume, stroke index, heart rate, cardiac index, cardiac output, and total peripheral resistance), in males and females needing cardiac output assessment, including patients with cardiac disorders, patients undergoing cardiac catheterization, cardiac surgery patients and patients in intensive and cardiac care units and rehabilitation.

The NICaS (non-invasive cardiac system) is a CD-ROM shaped device which replaces the actual CD-Rom of a laptop computer. It is used for noninvasive cardiac diagnostic purposes.

The NICaS (non-invasive cardiac system) SLIM 2004 is an impedance device which is unique in its use of a laptop computer as part of a technology for non-invasively measuring the cardiac output and its derivatives. The NICaS is also unique in that it is the only method of impedance cardiography (ICG) which utilizes only two pairs of impedance electrodes, placed on two limbs, preferably one pair on the wrist, and the other on the contra-lateral ankle. This type of electrical surveillance is called regional ICG, or RIC.

The NICaS is a tetrapolar apparatus which operates by an alternating current of 1.4 mA and 32 kHZ.

The principle of this technology is based on the fact that the electrical conductance of the blood is higher than that of the surrounding tissue structures. Consequently, with each arterial systolic expansion (pulsation), an increase in the electrical conductance (or reduction in the electrical resistance) of the body is measured. This systolic resistance (impedance) change is termed OR, and the baseline body resistance is R (0).

The analog resistance signals are received by the device, where they are amplified and filtered. These signals are then transmitted to a microprocessor. where they are digitized and analyzed via mathematical algorithms.

Here's a breakdown of the acceptance criteria and study information for the NICaS 2004 Slim Bioimpedance Cardiac Analyzing Measuring System, based on the provided text:

Acceptance Criteria and Device Performance

The provided text does not explicitly state specific numerical acceptance criteria for the NICaS 2004 Slim. Instead, it describes a non-clinical and clinical testing approach to demonstrate substantial equivalence to its predicate device, the NICaS 2001, and to illustrate its improved performance. The core "acceptance" appears to be based on demonstrating superior or at least equivalent performance to the predicate device in relevant measurements.

However, based on the provided text, we can infer a form of acceptance criteria related to its improved readings.

Study Details

1. Sample size used for the test set and the data provenance:

   • Test Set Sample Size: 163 patients for the clinical study. Additionally, 50 readings were taken on a simulator for non-clinical testing.
   • Data Provenance: Not explicitly stated (e.g., country of origin, retrospective/prospective). However, the device manufacturer is N. I. Medical, Ltd. in Israel, suggesting the study may have been conducted there or internationally. Given a 510(k) summary, it's typically a summary of completed studies rather than a prospective study design being presented.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

   • Clinical Ground Truth: The ground truth for the clinical test set was established by thermodilution. This is an invasive, established method for measuring cardiac output, often considered a gold standard. No "experts" in the human sense were explicitly mentioned for interpreting the thermodilution data, as the method itself directly provides the reference measurement.
   • Non-Clinical Ground Truth: For the non-clinical testing, a "simulator" was used. The ground truth would be the known, controlled parameters set by the simulator itself.

3. Adjudication method for the test set:

   • No adjudication method (e.g., 2+1, 3+1) is mentioned in the provided text, as the comparison was made against objective measurements (thermodilution for clinical, simulator output for non-clinical).

4. 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 was not conducted or described. The NICaS 2004 Slim is a device that directly measures parameters (though using sophisticated algorithms), not one that assists human readers in interpreting complex images or data in a diagnostic context that would typically require MRMC studies.

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

   • Yes, the performance described is primarily a standalone algorithm-only performance. The device takes measurements, processes them with its "improved algorithm," and provides hemodynamic parameters. While a human clinician interprets these parameters, the measurement and calculation process itself is automated.

6. The type of ground truth used:

   • Clinical: Thermodilution (a recognized clinical standard/gold standard for cardiac output measurement).
   • Non-Clinical: Simulator output (controlled, known values).

7. The sample size for the training set:

   • The document does not specify a separate "training set" sample size. The focus is on the performance of the device and its algorithm rather than the development of a trained AI model in the modern sense. The "improved algorithm" is mentioned as providing greater mathematical precision, implying refinement, but no details on training data are provided.

8. How the ground truth for the training set was established:

   • Not applicable, as a distinct training set and its ground truth establishment are not discussed in the summary. The "improved algorithm" development process, which might be analogous to training, is not detailed in terms of specific data provenance or ground truth methods.

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