(140 days)
The Wireless thermometers are battery-operated electronic devices with intended use of measuring human body temperature precisely. The devices are single-use and intended for armpit temperature measurement for persons of all ages.
TempTraq is a single-use device used to monitor temperature. The type of temperature that can be taken by the TempTraq patch is axillary only. The TempTraq temperature patches consist of a flexible circuit board that is positioned between two pieces of foam. The TempTraq temperature sensor patch is applied to the patient via foam that is backed with a biocompatible adhesive and transmits body temperature data via low energy Bluetooth transmission to a smart device running a TempTraq application. The patch is worn on the underarm and senses, processes, stores, and transmits temperature data to a smart device running a compatible TempTrag application using Bluetooth LE.
The provided text describes the regulatory filing for the TempTraq thermometer, focusing on its substantial equivalence to a previously cleared predicate device. However, it does not contain specific acceptance criteria, test set sample sizes, expert qualifications, or detailed study results (like MRMC studies) for algorithm performance as would typically be found for an AI/ML powered medical device.
The document focuses on demonstrating that the new TempTraq models (TT-100, TT-200, TT-300) are substantially equivalent to the predicate TempTraq TT-100. The testing performed is primarily focused on confirming the hardware and software functionality, safety, and performance of the thermometer itself, rather than an AI/ML algorithm's diagnostic performance.
Therefore, I cannot fulfill your request for the specific details regarding AI/ML acceptance criteria and study results from this document. The information typically found in 510(k) summaries for AI-powered devices (e.g., AUC, sensitivity, specificity, expert reads, etc.) is not present here because this device is a thermometer, not an AI diagnostic tool.
The closest information related to "acceptance criteria" is under the "Accuracy" row in the comparison table, which states "+/- 0.1 °C (0.2 °F) between 30 °C ~ 42.4 °C (86 °F ~ 108.3 °F)". This is a performance specification for the thermometer's accuracy, not for an AI algorithm's diagnostic performance.
Please note: The document describes a thermometer, not a device powered by AI/ML that would require the typical acceptance criteria and study types requested in your prompt.
If you have a document describing an AI/ML device, please provide that, and I can attempt to extract the requested information.
§ 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.