(268 days)
The Infrared Thermometer (Model: PC808) is intermittent measurement of ear and forehead temperature at home. It can be used for anybody, e.g. for new-born, for children and for adults. The thermometer is touch for the forehead measurement site.
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I am sorry, but the provided text does not contain detailed information about the acceptance criteria, specific test results, sample sizes, expert qualifications, or study methodologies for a device's performance. The document is an FDA 510(k) clearance letter for an Infrared Thermometer, model: PC808, stating that the device is substantially equivalent to legally marketed predicate devices.
The document discusses:
- The FDA's review of the premarket notification.
- The device name and model.
- The regulation number and name for clinical electronic thermometers.
- The regulatory class (Class II).
- Indications for Use: intermittent measurement of ear and forehead temperature at home for anybody (newborn, children, adults), with touch for forehead measurement.
- Type of Use: Over-The-Counter Use.
- General controls provisions of the Act that the manufacturer must comply with.
However, it does not include:
- A table of acceptance criteria and reported device performance.
- Sample sizes for test sets or data provenance.
- Information about experts used to establish ground truth.
- Adjudication methods.
- Whether a multi-reader multi-case (MRMC) comparative effectiveness study was done.
- Standalone algorithm performance.
- The type of ground truth used.
- Sample size for the training set.
- How ground truth for the training set was established.
This type of detailed performance data is typically found in the full 510(k) submission, not in the clearance letter itself.
§ 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.