(62 days)
For intermittent measurement of body temperature in patient of all ages in home environment. The device is reusable and intended for oral, axillary or rectal temperature measurements.
Not Found
This document is a 510(k) clearance letter for a digital thermometer. It does not contain the specific technical details or study results required to construct the table and answer all the questions about acceptance criteria and performance studies. The letter primarily confirms that the device is substantially equivalent to a legally marketed predicate device and can be marketed.
However, I can extract the following information that is present:
- Device Name: NPaC Digital Thermometer Models ET300, ET303, ET350, ET351 ET400, ET403, ET450, ET451 ET500, ET503, ET550, ET551
- Indications for Use: For intermittent measurement of body temperature in patients of all ages in a home environment. The device is reusable and intended for oral, axillary, or rectal temperature measurements.
- Regulatory Class: II
- Product Code: FLL
- Regulation Number: 21 CFR 880.2910 (Clinical Electronic Thermometer)
- 510(k) Number: K031907
Based on the provided text, I cannot answer most of your detailed questions regarding acceptance criteria and performance studies. This type of information is typically found in the 510(k) submission document itself, not in the FDA's clearance letter.
To fully answer your questions, I would need access to the actual 510(k) submission (K031907) which would include the performance data and testing details.
Here's what I can state based only on the provided document, addressing the questions where possible, and noting when information is absent:
1. A table of acceptance criteria and the reported device performance
- Information Absent: This document is a clearance letter, not the performance study itself. It does not contain a table of acceptance criteria or reported device performance metrics (e.g., accuracy, precision). For a digital thermometer, acceptance criteria would typically relate to accuracy (e.g., +/- 0.1°C or 0.2°F within a certain range), stability, and repeatability, as well as safety standards.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Information Absent: The clearance letter does not specify the sample size, data provenance, or the nature of the study (retrospective or prospective) used to support the substantial equivalence.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Information Absent: This is not relevant for a digital thermometer's performance study, which typically relies on comparison to a traceable reference standard (e.g., a standardized temperature bath or a clinical reference thermometer) rather than expert consensus on images.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Information Absent: Not applicable for a digital thermometer's objective performance testing against a reference standard.
5. 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
- Information Absent: Not applicable. This device is a standalone digital thermometer, not an AI-assisted diagnostic tool that involves human readers or interpretation.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Information Present & Indirectly Applicable: While not explicitly detailed, the performance study for a digital thermometer is inherently a "standalone" performance test. The device simply measures and displays temperature. There is no "human-in-the-loop" interpretation of results that would alter its measurement function. The study (which is not detailed here) would have evaluated the accuracy and precision of the device's measurements directly.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Information Absent (but inferable for a thermometer): For a digital thermometer, the ground truth would typically be established using a traceable reference standard (e.g., highly accurate laboratory thermometer, calibrated temperature bath, or a clinical reference thermometer) that is significantly more accurate than the device under test. It would not typically involve expert consensus, pathology, or outcomes data in the way these terms are used for diagnostic imaging or clinical decision support systems.
8. The sample size for the training set
- Information Absent: This device is not described as an AI/ML device that requires a training set. Its function is based on physical principles, not learned patterns from data.
9. How the ground truth for the training set was established
- Information Absent: Not applicable, as this device does not use a training set.
§ 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.