(21 days)
The device measures the body temperature of a patient by means of a sensor coupled with electronic signal amplification, conditioning and digital LCD (display) unit. The device is reusable and intended for oral, axillary or rectal temperature measurements for home use on people of all ages.
The device measures the body temperature of a patient by means of a sensor coupled with electronic signal amplification, conditioning and digital LCD (display) unit. The device is reusable and intended for oral, axillary or rectal temperature measurements for home use on people of all ages.
The provided text is a 510(k) clearance letter from the FDA for a Clinical Electronic Thermometer. It confirms the device is substantially equivalent to a predicate device and outlines general regulatory information. However, it does not contain the detailed information necessary to answer most of your questions about acceptance criteria and a specific study proving the device meets those criteria.
The document grants market clearance based on a determination of "substantial equivalence" to a predicate device, which implies that the new device performs as safely and effectively as a legally marketed device. This process typically involves showing that the device meets recognized standards and performs similarly to the predicate, but it doesn't usually include a detailed "stand-alone" clinical study report with the level of detail you're requesting for acceptance criteria and specific performance metrics.
I can, however, extract what little information is available:
1. A table of acceptance criteria and the reported device performance:
This information is not present in the provided document. The letter only states that the device is "substantially equivalent" to a predicate device. To get this, one would need to see the full 510(k) submission, which would likely include performance data comparing the new device to the predicate, often against recognized standards for medical thermometers (e.g., ASTM standards for accuracy).
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
This information is not present in the provided document.
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):
This information is not present in the provided document. Clinical electronic thermometers typically rely on objective measurements against a reference standard (e.g., a highly accurate laboratory thermometer), not expert consensus for "ground truth."
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
This information is not present in the provided document.
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:
This information is not present in the provided document. MRMC studies are typically for devices that assist human interpretation of diagnostic images, not for a simple electronic thermometer. "AI" assistance is not relevant for this type of device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
This information is not explicitly detailed in the provided document. For a clinical electronic thermometer, "standalone performance" refers to the accuracy and reliability of the device's measurement function itself, without human interpretation for the result. While the 510(k) implies this was assessed for substantial equivalence, the specific details of a standalone study are not included.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
For a clinical electronic thermometer, the "ground truth" would typically be established by a highly accurate, calibrated reference thermometer (e.g., a laboratory standard thermometer). This information is not explicitly stated but is implied by the nature of the device.
8. The sample size for the training set:
This information is not present in the provided document. For a traditional electronic thermometer, there isn't a "training set" in the machine learning sense. The device's calibration and accuracy are established through manufacturing and testing processes.
9. How the ground truth for the training set was established:
This information is not present in the provided document. As mentioned for #8, a "training set" is not relevant for this type of device.
In summary: The provided document is a regulatory clearance letter, not a detailed technical study report. It confirms the device's market authorization based on substantial equivalence to a predicate, but it does not contain the specific performance data, study designs, sample sizes, or expert qualifications you've requested. To obtain such information, one would typically need access to the full 510(k) submission or associated test reports that were provided to the FDA.
§ 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.