(175 days)
Temp Pal is a battery-operated electronic device with intended use of measuring and monitoring human armpit temperature continuously via wireless signal transmission of the measuring result. This system is reusable and intended for armpit temperature monitoring for persons of all age. The temperature data of device is not intended to replace the advice, diagnosis, nor treatment recommendations of doctor. Temp Pal can be used at home and healthcare center.
The Temp Pal is designed for the following: A comprehensive Android and iOS App are provided to access Temp Pal from a smart device. It is used for measuring and monitoring armpit temperature in real-time continuously and remotely via Bluetooth to smart device.
- The subject device could measure and monitor temperature in real-time continuously and remotely via Bluetooth to smart phone.
- The Temp Pal is the combination device of thermometer and Bluetooth communication unit intended to be worn at axilla to monitor the armpit temperature continuously. The subject device is a direct mode clinical thermometer where the output temperature is not adjusted. For the monitoring operation, switch the thermometer on and stick the thermometer in the user's axilla. The thermometer will make a Bluetooth connection between the thermometer and the receiver automatically (User should setup Bluetooth properly on receiver). Then the thermometer starts to measure the body temperature. The wireless thermometer uses a rechargeable battery for operation. When the battery is low, internal circuit will detect the low battery condition automatically and send "low battery" signal through Bluetooth communication unit to receiver.
- power source Rechargeable Battery 3.7V/10mAh
- operation mode Direct mode
- measuring results display method The measuring results are transmitted to smart phone and display by APP.
- data communication method Wireless 2.4G Bluetooth BLE.
The provided text describes the Temp Pal (Smart Thermometer Patch) and its substantial equivalence determination to a predicate device. However, it does not explicitly detail a "study that proves the device meets the acceptance criteria" in a format that would include the specific data points requested for a typical AI/ML-based device study (e.g., sample size for test set, expert qualifications, effect size for human readers with AI assistance).
The document focuses on non-clinical testing to demonstrate that the device meets various safety and performance standards for a clinical electronic thermometer. It compares the subject device to a predicate device and addresses how differences do not raise new safety and effectiveness questions.
Here's an attempt to extract and present the information based on the provided text, acknowledging that some requested fields might not be explicitly present for this type of medical device submission.
Acceptance Criteria and Device Performance (Clinical Electronic Thermometer)
The device's performance is gauged against established standards for clinical electronic thermometers. The primary acceptance criterion related to performance is accuracy.
| Acceptance Criteria (Performance) | Reported Device Performance |
|---|---|
| Accuracy (as per standards like EN 12470-4, ASTM E1112, ISO 80601-2-56) | 0.09 °F (± 0.05 °C) |
| Display Resolution | 0.01 °F (± 0.01 °C) |
| Max Continuous Measuring Time | 24 hours |
| Response Time | Requires up to 5 minutes to reach stable reading |
| Measurement Range | 77-113°F (25-45°C) |
| Shelf Life | 24 months (improved from 13 months of predicate) |
| Biocompatibility | In compliance with ISO 10993-5, ISO 10993-10, ISO 10993-12, and ISO 10993-1. |
| Electrical Safety & EMC | In compliance with IEC/EN 60601-1, EN 60601-1-2, 47 CFR FCC Part 15 Subpart B and C, and IEC/EN 60601-1-11. |
| Software Compliance | In compliance with IEC 62304. |
| Usability | In compliance with EN 60601-1-6 and EN 62366. |
Study Details (Based on provided text)
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Sample size used for the test set and the data provenance:
- The document mentions "Performance test," including "Continuous measurement," "Intermittent Determination," and "Direct clinical thermometer measure." However, specific sample sizes for these performance tests are not provided in this summary.
- Data provenance: Not explicitly stated (e.g., country of origin, retrospective/prospective). The tests listed are general performance and safety tests, not clinical trials with human subjects for efficacy in the same way an AI/ML diagnostic might be reported. The "Indication for Use" mentions use for "persons of all age," and the subject device expands the patient population to include children under 2 years old, implying broader testing than the predicate.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This information is not applicable/provided in the context of this device's regulatory submission, as it's a direct measuring thermometer, not an AI/ML diagnostic device requiring expert interpretation for ground truth.
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Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- This information is not applicable/provided for this type of device.
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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 done. This device is a standalone thermometer, not an AI-assisted diagnostic tool that would involve human readers.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Yes, the performance tests mentioned (continuous measurement, intermittent determination, direct clinical thermometer measure) assess the device's standalone accuracy and other performance metrics against established standards. The device itself is the "algorithm only" in the sense that it measures and transmits temperature.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For the accuracy measurements, the ground truth would typically be established by highly accurate reference thermometers or calibration standards as defined by the relevant ISO and ASTM standards (e.g., ISO 80601-2-56, ASTM E1112). This is standard for clinical electronic thermometers.
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The sample size for the training set:
- This information is not applicable/provided. This device is a traditional electronic thermometer, not an AI/ML model that requires a training set.
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How the ground truth for the training set was established:
- This information is not applicable/provided as there is no training set for an AI/ML model for this device.
§ 880.2910 Clinical electronic thermometer.
(a)
Identification. A clinical electronic thermometer is a device used to measure the body temperature of a patient by means of a transducer coupled with an electronic signal amplification, conditioning, and display unit. The transducer may be in a detachable probe with or without a disposable cover.(b)
Classification. Class II (performance standards). The device is exempt from the premarket notification procedures in part 807, subpart E of this chapter, subject to the limitations in § 880.9 and the following conditions for exemption:(1) Device is not a clinical thermometer with telethermographic functions;
(2) Device is not a clinical thermometer with continuous temperature measurement functions; and
(3) Appropriate analysis and testing (such as that outlined in the currently FDA-recognized editions, as appropriate, of ISO 80601-2-56, “Medical electrical equipment—Part 2-56: Particular requirements for basic safety and essential performance of clinical thermometers for body temperature measurement,” or ASTM E1965, “Standard Specification for Infrared Thermometers for Intermittent Determination of Patient Temperature,” or ASTM E1112, “Standard Specification for Electronic Thermometer for Intermittent Determination of Patient Temperature,” or ASTM E1104, “Standard Specification for Clinical Thermometer Probe Covers and Sheaths”) must validate specifications and performance of the device.