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The HealthGuard-15 is a non-invasive screening device intended for use in corporate wellness facilities and in health/fitness clubs. It is not for use in medical facilities such as hospitals or doctor's offices. This device measures systolic and diastolic blood pressure, heart rate, percent body fat and weight. It is operated by the client supplied PC computer. The device is intended for users eighteen years and older.

The HealthGuard-15 is a portable health kiosk that provides a means for measuring and tracking an individual's systolic and diastolic blood pressure, heart rate, percent body fat and weight. The HG-15 integrates two FDA market cleared devices ---- the Omron HEM-7200-Z [BP742] (K121932) for measurement of blood pressure and heart rate, and the FUTREX-6100/XL (K963271) for the estimation of the percent body fat --into a health kiosk with similar performance as the Health Check Kiosk (K063008). The HG-15 kiosk can typically be installed in corporate offices, lunch rooms or other community places so that employees can be measured as part of a corporate wellness program to track changes over time. It is not for use in hospitals or in other health care facilities. The HG-15 is delivered without the necessary PC computer. The client supplies the computer and Futrex supplies not only the HealthGuard-15 "kiosk" but also supplies the software that will be driven by the client's computer. In addition to making the measurements, the HealthGuard-15 also provides the recognized norms for systolic and diastolic blood pressure and weight. It provides a direct comparison of the user's measurements to these established norms, thereby providing education and motivation to the user. The computer/s monitor also warns the user not to start any exercise or diet program without first discussing it with their healthcare professional.

This document is a 510(k) Summary for the HealthGuard-15 device, which is a non-invasive screening device measuring blood pressure, heart rate, percent body fat, and weight. The information below is extracted from the provided text.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are not explicitly stated as distinct numerical targets but are based on achieving "substantially equivalent" performance to the predicate devices. The reported device performance is compared to these predicate devices.

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

The document does not specify a separate "test set" with a defined sample size for directly evaluating the HealthGuard-15's performance against ground truth in a clinical setting. Instead, the study relies on bench performance tests to demonstrate that modifications to integrated predicate devices (Omron Hem-7200-Z and FUTREX-6100/XL) did not affect their established accuracy or precision.

• Sample Size: Not explicitly stated for specific measurements or a general test set. The evaluation focuses on bench testing of the integrated components rather than a new clinical study with a patient cohort.
• Data Provenance: The study does not mention country of origin or whether it was retrospective or prospective, as it primarily involves bench testing of components.

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

Not applicable. The study primarily uses bench performance tests and comparison to established predicate device specifications, not a ground truth established by medical experts for a new clinical test set. The predicate devices themselves would have undergone such validation during their original clearance.

4. Adjudication Method for the Test Set

Not applicable, as no clinical test set requiring expert adjudication is described in the provided summary.

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

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. The device is a "screening device" that provides direct measurements (blood pressure, heart rate, body fat, weight) and does not involve human readers interpreting output that would then be compared to AI-assisted human reading.

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

The device itself is essentially a standalone system for taking measurements. There is no explicit mention of an "algorithm only" study in the context of comparative performance against a human or a gold standard separate from the integrated predicate devices. The device's performance is demonstrated by its components (Omron BP742 for BP/HR and FUTREX-6100/XL for body fat) which are themselves standalone measurement instruments integrated into the kiosk.

7. The Type of Ground Truth Used

The "ground truth" for the HealthGuard-15's performance is established by:

• Predicate Device Specifications: The primary method is to demonstrate that the HealthGuard-15 (or its modified internal components) maintains the accuracy and precision reported for the original, legally marketed predicate devices (Omron HEM-7200-Z for blood pressure/heart rate, FUTREX-6100/XL for percent body fat).
• Established Methods: For percent body fat, the accuracy is stated as "Equal to official method of hydrostatic weighing," which serves as a commonly accepted gold standard for body composition.
• Bench Performance Tests: These tests confirmed that minor physical and software modifications to the integrated predicate devices did not diminish their original accuracy or precision.

8. The Sample Size for the Training Set

The document does not describe a separate "training set" for the HealthGuard-15. The device integrates pre-existing, FDA-cleared technologies (Omron HEM-7200-Z and FUTREX-6100/XL). These predicate devices would have had their own validation studies and, if they included machine learning components, their own training sets, but details for these are not provided for the HealthGuard-15's submission.

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

Not applicable, as there is no described training set for the HealthGuard-15 itself in this summary. Any training data for the internal components would have been part of their original development and clearance, and is not detailed here.

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