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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.

Study Details (Based on provided text)

1. 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.

2. 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.

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

   • This information is not applicable/provided for this type of device.

4. 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.

5. 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.

6. 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.

7. 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.

8. 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.

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The 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 over two years old. The device is for home healthcare used by the layperson.

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 and transmitting measured results to authorized caregivers via a real-time cloud service.

Here's an analysis of the acceptance criteria and study information for the Temp Pal device, based on the provided FDA 510(k) summary:

1. Table of Acceptance Criteria and Reported Device Performance

The document explicitly states compliance with various standards rather than presenting a direct side-by-side comparison of specific numerical acceptance criteria and performance for all aspects. However, based on the "Differences and Equivalences" table and the "Non-clinical Testing Summary," we can infer the primary performance acceptance criterion:

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

The document states: "A series of verification and validation activities were conducted on the subject device as below, and no clinical testing is performed to support the decision of substantial equivalence." This indicates that the performance evaluation relied on non-clinical (bench) testing and comparison against established standards and a predicate device.

Therefore:

• Sample size for the test set: Not explicitly stated as this was non-clinical testing. The "sample" would refer to the physical devices and components tested.
• Data provenance: Non-clinical (bench) testing, likely conducted in a lab environment. Origin, if outside the manufacturer's own facilities, is not specified. It is inherently retrospective in the sense that the device's performance was evaluated against pre-defined criteria and standards.

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

Since no clinical testing was performed and the evaluation was based on non-clinical performance and compliance with standards, the concept of "experts" establishing ground truth for a clinical test set doesn't directly apply in this context. The "ground truth" for non-clinical performance is defined by the technical specifications of the standards (e.g., ASTM E1112 for thermometer accuracy) and the design requirements. Expert roles would be in the interpretation and application of these standards, typically by qualified engineers and quality assurance personnel.

4. Adjudication Method for the Test Set

Not applicable as there was no expert-adjudicated clinical test set.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No, an MRMC comparative effectiveness study was not done. The document explicitly states "no clinical testing is performed." This type of study would involve human readers (e.g., clinicians) evaluating cases, which is not applicable here as the device is a thermometer, and its performance is assessed via direct measurement accuracy and adherence to technical standards.

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

The device is a physical electronic thermometer, not an AI or algorithm-only device in the diagnostic sense. Its standalone performance refers to its ability to accurately measure temperature according to specified standards. All the non-clinical testing described (accuracy, electrical safety, EMC, biocompatibility, etc.) can be considered standalone (device-only) performance evaluations as they assess the device's inherent characteristics without direct human intervention as part of the measurement process itself, beyond operating the device.

7. The Type of Ground Truth Used

The ground truth used for evaluating the device's performance is primarily:

• Standard Specifications: Requirements outlined in international and national standards such as EN 12470-4, ASTM E1112, ISO 80601-2-56 for performance, and EN ISO 10993 series for biocompatibility, IEC/EN 60601 series for electrical safety and EMC.
• Predicate Device Specifications: The performance characteristics of the legally marketed predicate device (Wireless Thermometer, Model WT701, K132761) served as a benchmark for comparison to establish substantial equivalence.

8. The Sample Size for the Training Set

The concept of a "training set" is typically applicable to machine learning or AI models. Since the Temp Pal is an electronic thermometer and not an AI device in this context, there is no training set in the machine learning sense. The device's design and calibration would be based on engineering principles and validated through the non-clinical testing mentioned.

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

Not applicable, as there is no training set for this type of medical device.

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