(305 days)
The FEMON Banana Thermometer is a battery operated electronic device with intended use of measuring human body temperature. This device is intended for armpit temperature measurement from ages 29 days and older.
The FEMON Banana Thermometer is a thermometer composed of a body patch to be directly attached to the patient's skin on armpit. The temperature information is then to be retrieved from the patch to the mobile phone application via Bluetooth.
The FEMON Banana Thermometer is intended for armpit temperature measurement for patients aged 29 days and older.
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Accuracy (°C): ±0.1°C between 35°C and 42°C | ±0.1°C: 35~42°C |
Important Note: The provided document states that the subject device's accuracy criteria are ±0.1°C for the entire range of 35-42°C, which is different and stricter than the predicate device's accuracy criteria (±0.1°C for 37-39°C and ±0.2°C for 35-37°C and 39-42°C). However, the document does not explicitly state an "acceptance criteria" but rather reports the device's performance. For the purpose of this table, the reported device performance for accuracy is assumed to be the acceptance criterion it aims to meet.
2. Sample size used for the test set and the data provenance:
The document states that "Clinical Accuracy Performance Testing (per ISO80601-2-56)" was performed. However, it does not specify the sample size used for this test set or the data provenance (e.g., country of origin, retrospective or prospective).
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 for the clinical accuracy testing.
4. Adjudication method for the test set:
This information is not provided in the document for the clinical accuracy testing.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done:
No, an MRMC comparative effectiveness study is not mentioned in the provided document. The study performed was a clinical accuracy performance test for the device itself against a standard, not a comparison of human readers with and without AI assistance.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
Yes, a standalone performance study was done in the form of "Clinical Accuracy Performance Testing (per ISO80601-2-56)." This tests the device's accuracy in measuring temperature directly, without human interpretation or intervention in the measurement process itself.
7. The type of ground truth used:
The ground truth for the clinical accuracy performance testing was established by following the "ISO80601-2-56" standard. This standard typically dictates methods for determining the true or reference temperature, often involving a reference thermometer or a calibrated temperature bath to provide the gold standard for comparison.
8. The sample size for the training set:
This information is not applicable or not provided. The FEMON Banana Thermometer is an electronic thermometer, not an AI/machine learning algorithm that requires a training set in the conventional sense. Its performance is validated through direct measurement accuracy testing.
9. How the ground truth for the training set was established:
This information is not applicable as there is no training set for an electronic thermometer in the context of an AI/ML algorithm.
§ 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.