(253 days)
The Checkme Pro Health Monitor is intended to be used for measuring, reviewing and storing of ECG (adults only), oxygen saturation and pulse rate (adults only for continuous data collection and recording, adults and pediatrics for spot checking) and temperature in the home or in healthcare facilities.
This device is not intended to subspital diagnostic ECG device and also not to be used on patients with implanted cardiac devices, such as pacemakers and/or implanted cardio-defibrillators (ICDs).
The Checkme Pro Health Monitor is a lightweight, portable health monitor for use in the home or health care facility. The Checkme Pro Health Monitor is used for measuring, displaying, reviewing and storing of multiple physiological parameters including ECG, pulse oxygen saturation (SpO2), pulse rate and temperature. This device is not intended to substitute for a hospital diagnostic ECG device. The device is capable of measuring and storing data for up to twelve users.
The provided text describes the regulatory clearance for the Viatom Checkme Pro Health Monitor, which includes functionalities for ECG, oxygen saturation (SpO2), pulse rate, and temperature measurement. The document details performance testing for each function against recognized standards.
Here's a breakdown of the requested information based on the provided text, focusing on the ECG, SpO2, and Thermometer functionalities as these are the core medical measurements. The Pedometer function is also listed but does not have detailed acceptance criteria or performance study information similar to the medical functions within this document.
1. Table of Acceptance Criteria and Reported Device Performance
| Function | Parameter | Acceptance Criteria (Standard Reference) | Reported Device Performance |
|---|---|---|---|
| ECG | ECG algorithm | IEC 60601-2-47: Medical electrical equipment Part 2: Particular requirements for the basic safety and essential performance of ambulatory electrocardiographic systems. | The ECG algorithm used in the Checkme Pro Health Monitor has been tested according to the requirements of IEC 60601-2-47. (Implies compliance) |
| Heart Rate Range | Predicate K062894 (InstantCheck RTD-ECG Monitor): 45 to 180 bpm | Subject Device (Checkme Pro): 30~250 bpm, ±2 bpm or ±2% whichever is larger. This indicates the Checkme Pro has a wider range with a specified accuracy. | |
| SpO2 | Accuracy (Integrated Sensor) | ISO 80601-2-61: Medical electrical equipment - Part 2-61: Particular requirements for basic safety and essential performance of pulse oximeter equipment. | The Checkme Pro Health Monitor has been tested and shown to comply with the requirements of ISO 80601-2-61. (Implies compliance). Specific accuracy stated as: 70%-100%: ± 3% (Arms:2.11) with further breakdown: 70-80%: ± 3%, 80-90%: ± 3%, 90-100%: ± 2%. 0% - 69% not defined. This is compared to the predicate's (K131762's external sensor) 70%-100%: ± 2% (Arms:1.88) with 70-80%: ± 3%, 80-90%: ± 2%, 90-100%: ± 2%. While slightly different, the subject device's performance is listed and implicitly accepted through the substantial equivalence claim. |
| Accuracy (External Sensor) | ISO 80601-2-61: Medical electrical equipment - Part 2-61: Particular requirements for basic safety and essential performance of pulse oximeter equipment. Additional predicate (K131762) has an accuracy of 70% - 100%: ± 2% (0% - 69% not defined). | Same compliance as above. Specific accuracy stated as: 70%-100%: ± 2% (Arms:1.88) with further breakdown: 70-80%: ± 3%, 80-90%: ± 2%, 90-100%: ± 2%. 0% - 69% not defined. This meets the predicate's overall accuracy for 70-100%. | |
| PR Accuracy | Predicate K131762: 25-250 BPM, ± 1 bpm or ± 2% whichever is larger. | Subject Device (Checkme Pro): 30-250 BPM, ± 2 bpm or ± 2% whichever is larger. While the predicate has slightly better absolute bpm accuracy, the overall accuracy within 2% is similar. | |
| Thermometer | Body Mode Accuracy | ISO 80601-2-56:2009: Medical electrical equipment - Part 2-56: Particular requirements for basic safety and essential performance of clinical thermometers for body temperature measurement. | The Checkme Pro has been tested and shown to comply with the requirements of ISO 80601-2-56:2009. (Implies compliance). Specific accuracy stated as: ±0.4°F. This is compared to the predicate's (K100953) 36°C to 39°C (96.8°F to 102.2°F): +/- 0.2°C / 0.4°F, and 34.0°C to 35.9°C (93.2°F to 96.6°F), 39.1°C to 42.2°C (102.4°F to 108.0°F): +/- 0.3°C/0.5°F. The subject device's +/- 0.4°F falls within the predicate's accuracy range for its primary operating range. |
2. Sample size used for the test set and the data provenance
The document does not provide specific sample sizes (number of patients/cases) for the clinical performance tests (ECG, SpO2, Temperature). It only states that the device was tested according to relevant IEC and ISO standards. These standards typically involve specific test methodologies, which may include human subjects or simulations, but the details of the sample size or whether the data was retrospective or prospective, or country of origin are not disclosed in this summary.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not provided in the document. The performance claims are based on compliance with international standards, which would outline how ground truth is established within their testing protocols, but the specifics (e.g., number of expert clinicians, their qualifications) are not detailed here.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
The adjudication method for establishing ground truth within the test sets is not specified in this document.
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
There is no mention of a multi-reader multi-case (MRMC) comparative effectiveness study, nor any evaluation of human reader improvement with AI assistance. The device is a monitor that provides measurements and waveforms, not an AI-assisted diagnostic tool that interprets complex medical images or data requiring human reader assessment of improvement.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
The performance testing described (ECG algorithm testing, SpO2 compliance, Thermometer compliance) assesses the device's inherent function, which is a standalone performance of the algorithms and sensors. For instance, the ECG algorithm's compliance with IEC 60601-2-47 means its performance in calculating heart rate and waveform display meets the standard without human intervention for results generation. Similarly for SpO2 and temperature, the listed accuracies are for the device's direct measurements.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The document does not explicitly state the type of ground truth used for each test. However, for devices like these, ground truth would typically be established by:
- ECG: Reference highly accurate diagnostic ECG devices or expert interpretation of standard 12-lead ECGs for heart rate and morphology analysis (as per IEC 60601-2-47).
- SpO2: Co-oximetry for blood oxygen saturation levels for absolute accuracy, or a calibrated reference pulse oximeter for comparative accuracy (as per ISO 80601-2-61).
- Temperature: Calibrated reference thermometers (e.g., rectal thermometers for core body temperature, as per ISO 80601-2-56).
8. The sample size for the training set
The document does not mention any training set size. This device appears to be primarily a physiological monitor with direct measurement capabilities rather than a complex machine learning model that requires explicit training data in the context of this regulatory submission. The "ECG algorithm" mentioned would likely refer to signal processing algorithms for heart rate detection and waveform filtering, which are typically designed and validated through engineering methods rather than machine learning training sets in the same sense.
9. How the ground truth for the training set was established
Since no training set is mentioned in the context of machine learning, this information is not applicable and therefore not provided in the document.
§ 870.2300 Cardiac monitor (including cardiotachometer and rate alarm).
(a)
Identification. A cardiac monitor (including cardiotachometer and rate alarm) is a device used to measure the heart rate from an analog signal produced by an electrocardiograph, vectorcardiograph, or blood pressure monitor. This device may sound an alarm when the heart rate falls outside preset upper and lower limits.(b)
Classification. Class II (performance standards).