(438 days)
Digital Pacifier Thermometer TM-03 is a non-sterile, reusable & battery-operated clinical electronic thermometer for use by medical professional or at home. The TM-03 is intended to measure the oral temperature of infant to children up to 5 years old.
Digital Pacifier Thermometer TM-03 is a reusable, battery-operated clinical electronic thermometer, with which a thermistor installed inside the nipple, for use by medical professional or at home. Different from the traditional electronic thermometer, our TM-03 is designed specifically for the measuring the oral temperature of baby or little child. Therefore, our TM-03 is molded as a pacifier. The patient contact portion is the thermometer's nipple which is made of medical silicon rubber. The body of TM-03 is then manufactured by ABS hard plastic. TM-03 utilizes the phenomenon of thermal conductivity changes of our selected NTC thermistor when there are changes of external environment temperature. Whenever the external temperature changed, the resistance of our thermistor changed uniformly. Then, the changes in resistance are converted to the changes of frequency of R-C oscillator circuit. This means TM-03 keep monitoring the frequency of the oscillator and the temperature can be measured accurately.
Here's a summary of the acceptance criteria and the study details for the Digital Pacifier Thermometer (Model No.: TM-03), based on the provided text:
Acceptance Criteria and Device Performance
| Acceptance Criteria (Performance) | Reported Device Performance (TM-03) |
|---|---|
| Accuracy: +/-0.2°F for 95°F – 107.6°F | Meets the requirement of +/-0.2°F for 95°F – 107.6°F |
| Not Specified | Biological evaluation of medical devices (ISO10993 sets): No evidence of delayed dermal contact sensitization, classified as non-irritant, not cytotoxic potential. |
| Not Specified | Nitrosamine content (CPG Sec. 500.450 Volatile N-Nitrosamines in Rubber Baby Bottle Nipples reference): Safe and within acceptance limit (10ppb). |
| Not Specified | Not made with BPA in accessible parts. |
| Not Specified | Electrical safety (EN60601-1, FCC Part 15, IEC60601-1-2): Complies with requirements, classified as Class B device, meets acceptance limit (40dB (uV/m)). |
Study Details
1. Sample size used for the test set and the data provenance:
- Sample Size: Not explicitly stated for the clinical test. For the independent laboratory test based on ASTME1112, the sample size is not specified.
- Data Provenance: The general nature of the studies (clinical test and independent laboratory test) suggests prospective testing of the device. The country of origin for the data is not specified, but the applicant is Cotronic Technology Limited from Hong Kong/China.
2. 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. The studies focus on device accuracy against established standards rather than expert-derived ground truth for diagnostic interpretation.
3. Adjudication method for the test set:
- Not applicable as the studies relate to temperature measurement accuracy and safety, not diagnostic interpretation requiring adjudication.
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 clinical electronic thermometer, not an AI-powered diagnostic tool that assists human readers.
5. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Yes, the performance tests conducted were standalone, evaluating the device's accuracy and safety specifications directly. The "clinical test" and independent laboratory test assessed the thermometer's ability to measure temperature accurately.
6. The type of ground truth used:
- The ground truth for the accuracy tests was comparison against established temperature references or standards, as implied by the ASTME1112 standard and the statement "meets the requirement of +/-0.2°F". For safety tests, the ground truth was adherence to international and national standards (e.g., ISO10993, EN60601-1, FCC Part 15, IEC60601-1-2, CPG Sec. 500.450).
7. The sample size for the training set:
- Not applicable. This device is a traditional electronic thermometer; it does not involve machine learning or AI models that require specific training sets.
8. How the ground truth for the training set was established:
- Not applicable, as there is no training set for this type of 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.