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The CWAS 100 is a non-invasive, multi-modality physiologic monitoring device. The device measures several physiologic signals, and its software generates a report.

The CWAS 100 measures the following physiologic signals:

• Bilateral differences in surface EMG along the spine
• Heart Rate
• Skin temperature
• Galvanic Skin Resistance
• Body fat percentage in subjects eighteen years and older

The CWAS 100 is a non-invasive, multi-modality physiologic monitoring device. The CWAS 100 contains the following five sensor types: (1) surface EMG, (2) IR Plethsmograph, (3), Skin temperature, (4) Galvanic Skin Resistance and (5) IR Body Composition Analyzer.

Hardware: The CWAS 100 hardware consists of an instrument console and five different sensor types. All five sensor types plug directly into the front panel of the CWAS 100 Instrument Console. The CWAS 100 Console is powered via a UL2601 listed power supply. The Instrument Console is connected to a personal computer (IBM compatible) via an isolated USB port connection.

Software: The CWAS 100 software displays real-time surface EMG, heart rate, skin temperature, Galvanic Skin Resistance, and Body Composition, allowing the user to ensure that readings are stable prior to data collection. The CWAS 100 software allows the user to: (1) enter patient information, (2) record surface EMG, heart rate, skin temperature, Galvanic Skin Resistance, and Body Composition, and (3) print out a data report which summarizes the results of the above sensors as well as blood pressure, vital lung capacity, and chest, leg and back strength, which are data provided by the user.

This document describes the CWAS 100 electromyograph, a multi-modality physiologic monitoring device. The provided text outlines the device's indications for use, description, and a comparison to predicate devices, but does not contain information about a specific study or acceptance criteria demonstration for the CWAS 100 itself.

The document is primarily a 510(k) summary, which focuses on demonstrating substantial equivalence to previously cleared predicate devices. The performance specifications listed are for the CWAS 100's components and are largely presented as equivalent to or derived from the predicate devices. There is no section detailing a study to prove these specifications are met for the CWAS 100.

Therefore, many of the requested details about acceptance criteria, study design, sample sizes, ground truth establishment, expert involvement, and MRMC studies cannot be extracted from the provided text for the CWAS 100. The provided information is limited to the device's stated specifications and equivalence claims based on predicate devices.

Based on the provided text, the following information can be extracted or inferred:

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

The "Reported Device Performance" for the CWAS 100 in this table is based on its stated specifications and the claim of substantial equivalence to predicate devices, rather than results from an independent performance study specifically for the CWAS 100 that is detailed in the provided text. The submission focuses on demonstrating equivalence to predicate devices which have presumably already met their performance criteria.

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

Not provided. The document describes device specifications and predicate comparisons but does not detail a study with a test set of data.

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)

Not provided. No study with a test set and associated ground truth establishment by experts is described.

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

Not provided. No study with a test set is described.

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

Not done / Not applicable. The CWAS 100 is a physiologic monitoring device, not an AI-powered diagnostic tool requiring human reader interpretation in the context of an MRMC study. The document does not describe any AI component or any study involving human readers.

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

Not done / Not applicable. The CWAS 100 is a hardware-based physiologic monitoring device with software to display and report data. It does not rely on an "algorithm only" performance in the sense of an AI diagnostic tool. Its performance is linked to the accuracy and range of its sensors, which are claimed to be substantially equivalent to predicate devices. No standalone performance study details are provided.

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

Not provided / Not applicable. No study requiring external ground truth for performance evaluation is described for the CWAS 100. The device's performance relies on its physical measurements and their accuracy, which are presented as specifications rather than being evaluated against a "ground truth" derived from patient data. For the IR Body Composition Analyzer, the predicate device Futrex 6100/XL likely established its accuracy against a gold standard for body fat measurement, but this specific detail for this submission is not provided.

8. The sample size for the training set

Not provided. No training set for an algorithm is mentioned as the device is not described as an AI/ML-based system.

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

Not provided. No training set for an algorithm is mentioned.

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