(258 days)
The HCK - 2000 (health station) is an automated system intended to be used by the general adult public, in public environments, so that the user can measure his/her own health parameters such as blood pressure, heart rate, Body Mass Index (BMI) and body weight. It is not a diagnostic device and only furnishes data so that users can consult their personal physicians or other healthcare professional. For personal reference purposes, the user can also choose to print or store their data on the HealthChek network's database.
The HealthChek Network Health Station, Model HCK - 2000 is a kiosk designed for use by the general adult public in public locations to measure the user's health parameters such as blood pressure, heart rate, Body Mass Index (BMI) and body weight. The HealthChek Network Health Station kiosk is not a diagnostic device. It does not introduce any novel modes of operational theory.
The HealthChek Network Health Station, Model HCK-2000, is an automated system intended for use by the general adult public in public environments to measure health parameters such as blood pressure, heart rate, Body Mass Index (BMI), and body weight. It is not a diagnostic device and only provides data for users to consult with their personal physicians or other healthcare professionals.
1. Table of Acceptance Criteria and Reported Device Performance
The provided document does not explicitly state acceptance criteria in a quantitative table format with corresponding device performance for each metric. Instead, it relies on a Substantial Equivalence Comparison to a predicate device (StayHealthy HealthCENTER Biometric Screening Kiosk) and compliance with recognized consensus standards.
However, based on the information provided, particularly for the regulated component (Noninvasive Blood Pressure Measurement System), the device's performance is expected to meet the requirements of relevant standards.
Implicit Acceptance Criteria (based on standards compliance and predicate comparison):
| Feature/Parameter | Acceptance Criteria (Implicit) | Reported Device Performance/Compliance |
|---|---|---|
| Blood Pressure | Accuracy and safety as per IEC 80601-2-30 and AAMI/ANSI/ISO 81060-1 | Compliant with IEC 80601-2-30:2009. Uses the SunTech Advantage Model 2 module (same as predicate). Capable of recording blood pressures from +40 to +260 mmHg Systolic and +20 to +200 mmHg Diastolic. |
| Heart Rate | Accuracy and safety as per relevant standards | Calculated via the BP module, capable of recording rates from 30 to 220 beats per minute. |
| Body Weight | Measurement up to 440 lbs / 200 kg with reasonable accuracy. | Tested at 440 lbs / 200 kg. Measured via a load cell imbedded in an ADA compliant seat (similar to predicate). |
| BMI | Calculation accuracy using NIH's algorithms. | Calculated using NIH's algorithms from user-entered height and measured weight. |
| Electrical Safety | Compliance with IEC 60601-1 and IEC 60601-1-2. | Compliant with IEC 60601-1:2005 3rd edition and IEC 60601-1-2:2007 3rd edition (with immunity testing to IEC 60601-1-2:2014 4th edition). |
| Quality Management System | Compliance with 21 CFR Part 820 & ISO 13485:2003. | Compliant with 21 CFR 820 and ISO 13485:2003. |
| Risk Management | Compliance with ISO 14971:2007. | Compliant with ISO 14971:2007. |
2. Sample Size Used for the Test Set and Data Provenance
The document explicitly states: "Because of the long-established use of health monitoring kiosks, no clinical trial was performed." (Page 4). Therefore, there is no specific sample size for a test set involving human subjects for performance evaluation mentioned in this submission. The evaluation relies on bench testing and comparison to a predicate device.
The data provenance for the bench testing is not specified beyond "Bench Testing was conducted on a unit...". It's implied this was conducted in a laboratory setting by the manufacturer (GMI Solutions) or a testing facility working with them.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
Since no clinical trial or test set involving human subjects for performance evaluation was conducted, there are no experts mentioned as establishing ground truth in this context. The "ground truth" for the device's technical specifications and safety is derived from compliance with recognized international and national standards.
4. Adjudication Method for the Test Set
Not applicable, as no clinical test set requiring adjudication was performed.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No. The document states "no clinical trial was performed." Therefore, there was no MRMC comparative effectiveness study to assess improvement with or without AI assistance. The device is a "health station" for self-measurement, not an AI-assisted diagnostic tool for human readers.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
The document describes the device as an "automated system" for self-measurement, which inherently functions in a standalone capacity without "human-in-the-loop" performance as typically understood in AI/imaging diagnostics. Its performance is demonstrated through compliance with technical standards and equivalence to a predicate device, rather than a standalone performance study as would be conducted for a diagnostic algorithm.
7. Type of Ground Truth Used
The "ground truth" for the device's acceptable performance is established through:
- Compliance with recognized consensus standards: (e.g., IEC 80601-2-30 for non-invasive sphygmomanometers, IEC 60601-1 for electrical safety).
- Bench testing: Verifying the device's technical specifications against these standards.
- Substantial equivalence to a legally marketed predicate device: Demonstrating that its design, intended use, and technological characteristics are similar to a device already cleared by the FDA.
8. Sample Size for the Training Set
Not applicable. This device is a measurement kiosk and does not involve AI or machine learning algorithms that require a "training set" in the context of diagnostic image analysis or similar applications. The BMI calculation uses "NIH's algorithms," which are established formulas, not a learned model requiring a training set.
9. How the Ground Truth for the Training Set was Established
Not applicable, as there is no training set for the reasons stated above.
§ 870.1130 Noninvasive blood pressure measurement system.
(a)
Identification. A noninvasive blood pressure measurement system is a device that provides a signal from which systolic, diastolic, mean, or any combination of the three pressures can be derived through the use of tranducers placed on the surface of the body.(b)
Classification. Class II (performance standards).