(124 days)
The Infrared Forehead Thermometer, FS-300&301 is intended for intermittent measurement of human body temperature in people of all ages.
The Infrared Forehead Thermometer, Modelfype FS-300&301 is an electronic thermometer using an infrared i sensor (thermopile) to measure forehead temperature, then get a reading and display it on the LCD. Its operation is based on measuring the natural thermal radiation emanating from the forehead and the adjacent surfaces. This product is an Infrared Forehead Thermometer with measuring room temperature and relative humidity.
The provided 510(k) summary for "The Infrared Forehead Thermometer, FS-300&301" does not contain detailed information regarding specific acceptance criteria, a dedicated clinical study with defined performance metrics, or the other requested points (sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, or training set details).
The summary primarily focuses on:
- Substantial Equivalence: Stating that "The performance tests demonstrated that The Infrared Forehead Thermometer. FS-3008301 is as safe, as effective and performs in a substantially equivalent manner to the predicate device."
- Compliance with Standards: Mentioning compliance with IEC 60601-1 and IEC 60601-1-2 for safety and electromagnetic compatibility.
- Technological Characteristics: Describing how it measures temperature (5,000 times in one second, displays highest temperature, scans forehead to temple).
Without specific acceptance criteria and detailed study results in the provided document, the requested table and information cannot be fully populated.
However, based on the provided text, here's what can be extracted and inferred:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Inferred from regulatory context) | Reported Device Performance (from summary) |
|---|---|
| Safety Requirements | Manufactured and tested to meet the safety requirements of IEC (IEC 60601-1 and IEC 60601-1-2). |
| Effectiveness/Accuracy | Performs in a substantially equivalent manner to the predicate device, Sensor touch (K011291). Body temperature is measured 5,000 times in one second instantly and displays highest temperature on the LCD. Searches the highest temperature from the forehead to the temple. |
| Electromagnetic Compatibility | Complies with IEC 60601-1-2:2001. |
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 provided in the summary. The summary refers to "performance tests" in a general sense without detailing the specifics of these tests, including sample size or data provenance.
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 provided. The summary does not mention any expert involvement for establishing ground truth. For a thermometer, "ground truth" would typically refer to a consensus reference temperature measurement (e.g., from a rectal or oral thermometer), not expert interpretation.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- This information is not provided. Adjudication methods are typically relevant for subjective assessments, which are not applicable to measuring temperature with a device like this.
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
- No. This is not applicable. The device is a standalone temperature measurement device, not an AI-assisted diagnostic tool that would involve human readers or image interpretation.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Yes, implicitly. As a clinical electronic thermometer, its "performance" is inherently standalone. The summary states "The Infrared Forehead Thermometer... has been manufactured and tested to meet the safety requirements of IEC" and "The performance tests demonstrated that The Infrared Forehead Thermometer... is as safe, as effective and performs in a substantially equivalent manner to the predicate device." This implies standalone testing of the device's accuracy and safety without human interpretation of its readings, beyond simply taking the measurement.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
- This information is not explicitly stated, but for a clinical thermometer, the ground truth for performance testing would typically be established by comparison to a highly accurate reference thermometer (e.g., a calibrated mercury-in-glass thermometer or a highly precise electronic rectal/oral thermometer).
8. The sample size for the training set
- This information is not provided. This device is a traditional electronic thermometer, not an AI/ML device, so the concept of a "training set" in the context of machine learning does not apply.
9. How the ground truth for the training set was established
- This information is not provided and is not applicable, as this is not an AI/ML device requiring 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.