(292 days)
Infrared Forehead Thermometer is intended for the intermittent measurement and monitoring of forehead temperature. The device is indicated for use by people of all ages in the home.
The Infrared Forehead Thermometer, model FR200 is a hand-held forehead thermometer and it is intended for the non-contact intermittent measurement and monitoring of forehead temperature which is based on the infrared energy emitted from the forehead. It is indicated for use by people of all ages in the home. After measurement, the temperature is directly shown on the LCD display so that the users can quickly get measurement results after properly scanning the forehead.
The provided document is a 510(k) summary for an Infrared Forehead Thermometer (Model FR200). It focuses on demonstrating substantial equivalence to a predicate device, rather than presenting a detailed study proving the device meets general acceptance criteria for a novel AI/software medical device.
Therefore, much of the requested information regarding acceptance criteria and study details for an AI/software device is not available in this document because it pertains to a different type of medical device (a thermometer) and regulatory pathway (substantial equivalence of a hardware device incorporating standard technology).
However, I can extract the information that is present and point out where the requested information is absent or not applicable given the context.
Here's a breakdown of what can be inferred or directly stated from the document:
Device Type: Infrared Forehead Thermometer (hardware device, not an AI/software image analysis device).
Regulatory Pathway: 510(k) - demonstrating substantial equivalence to a predicate device.
1. A table of acceptance criteria and the reported device performance
The document does not provide a general table of "acceptance criteria" for an AI/software device, as it is a thermometer. However, it does list performance specifications and testing standards that serve as benchmarks for this type of device.
| Acceptance Criteria (Performance Specifications/Standards) | Reported Device Performance (Compliance) |
|---|---|
| Measurement Accuracy: | Subject Device (K202741): |
| - $±0.2°C: 34.0°C \sim 43.0°C$ | $±0.2°C (±0.4°F): 34.0°C \sim 43.0°C (93.2°F \sim 109.4°F)$ |
| (Note 1 states the difference in accuracy with the predicate does not affect performance/accuracy evaluated by ISO 80601-2-56 and ASTM E1965-98) | (Complies based on evaluation) |
| Measurement Range: | $34.0°C \sim 43.0°C (93.2°F \sim 109.4°F)$ |
| Display Resolution: | $0.1°C (0.1°F)$ |
| Electromagnetic Compatibility & Electrical Safety: | Passed IEC 60601-1, IEC 60601-1-2, IEC 60601-1-11 |
| Biocompatibility: | Passed ISO 10993-5, ISO 10993-10 |
| Performance Test-Bench: | Passed ISO 80601-2-56, ASTM E1965-98 |
| Clinical Accuracy (Repeatability): | Met the acceptance criteria of the clinical study protocol. (Specific numerical criteria for repeatability are not provided in this summary, but are stated as met). |
2. Sample size used for the test set and the data provenance
- Test Set Sample Size: For the Clinical Accuracy study, the document states: "a clinical study was carried out on 160 subjects for all ages of population" (Page 7) and "consisting of 180 subjects, of which 60 subjects are infants, 60 subjects are children and the rest 60 subjects are adults" (Page 8). There is a discrepancy in the total number of subjects (160 vs 180). Assuming 60 per age group (infants, children, adults), 180 seems more consistent.
- Data Provenance: Not explicitly stated (e.g., country of origin, specific hospitals). The study is described as a "randomization, simple blind homologous control, pairing design of clinical investigation" (Page 8), indicating it was a prospective study specifically conducted for this submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable/available. This device is a thermometer. Its "ground truth" for temperature measurement is typically established by comparing readings against a reference thermometer (e.g., a rectal thermometer or other highly accurate standard) in a clinical setting, not through expert consensus on images. The document refers to meeting "acceptance criteria of the clinical study protocol" for repeatability, which would involve quantitative comparisons to a reference.
4. Adjudication method for the test set
Not applicable/available. Adjudication methods (e.g., 2+1, 3+1) are typically used for subjective assessments, like image reading, where multiple experts interpret data. For a thermometer, objective measurement comparisons are used.
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
Not applicable. This is not an AI-assisted diagnostic device. It's a standalone thermometer.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Yes, in essence. The device functions as a "standalone" measurement tool. Its performance is evaluated intrinsically (how accurately it measures temperature), not in conjunction with human interpretation of complex data. The clinical accuracy study assesses the device's direct measurement capability.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
For "Clinical Accuracy," the ground truth would be established by simultaneous measurements using a recognized reference standard thermometer (e.g., a rectal thermometer, an oral thermometer, or a highly accurate laboratory-grade thermometer) according to the ASTM E1965-98 and ISO 80601-2-56 standards. The document doesn't explicitly name the reference method used within the clinical study, but these standards prescribe such methods. It's an objective, quantitative comparison rather than subjective consensus.
8. The sample size for the training set
Not applicable. This is a traditional infrared thermometer, not an AI/machine learning model that requires a "training set."
9. How the ground truth for the training set was established
Not applicable. As above, no training set for an AI model.
§ 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.