(317 days)
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:
| Acceptance Criterion (Inferred from Predicate/Standards) | Reported Device Performance (Temp Pal) |
|---|---|
| Measurement Accuracy: ±0.09°F (0.05°C), range 95 | ±0.09°F (0.05°C) (Reported for Temp Pal, implying it meets or exceeds the predicate's more stringent range) |
| Measurement Range: 77-113°F (25-45°C) | 77-113°F (25-45°C) |
| Electrical Safety | Verified and met pre-defined criteria (Compliance with IEC/EN 60601-1, IEC/EN 60601-1-11) |
| Electromagnetic Compatibility (EMC) | Verified and met pre-defined criteria (Compliance with EN 60601-1-2, 47 CFR FCC Part 15 Subpart B, 47 CFR FCC Part 15 Subpart C) |
| Biocompatibility | Verified and validated (Compliance with EN ISO 10993-5, ISO 10993-10, ISO 10993-12, ISO 10993-1) |
| Software Validation | In compliance with FDA Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices and ISO 14971 |
| Human Factors (Usability) | In compliance with EN 60601-1-6 and EN 62366 |
| Lifetime and Shelf Life | Validation up to 13 months for subject device and supporting battery cell cycle life test |
| Cleaning Validation | Tested by microorganisms and supported total organic carbon |
| Performance (General) | Compliance with EN 12470-4, ASTM E1112, and ISO 80601-2-56 |
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.
§ 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.