(30 days)
Thermofocus 0800, 0900, 01500, 0700 Series are infrared thermometers intended for the intermittent measurement of human body temperature in people of all ages.
Thermofocus devices belonging to the 0800, 0900, 01500, 0700 series are hand-held and battery-operated thermometers. They take skin temperature mainly in the middle of the forehead, on the navel, neck or under the armpit. The Thermofocus devices use the principle of surveying the natural emission of infrared thermal radiation from all objects, including the human body. Thermofocus thermometers take temperature at distance, without any contact with the patient.
The provided text describes a 510(k) submission for new models of the Thermofocus infrared thermometer, which are updates to previously cleared devices. It states that "Performance tests were not required as the modified devices are essentially equivalent to previously cleared predicate devices." However, it does mention that "Certain performance tests were conducted as part of the risk analysis and demonstrated acceptable results for devices safety and effectiveness." It also indicates that "Both devices meet the ASTM E1965-98 Standard for Infrared Thermometer for Intermittent Determination of Patient Temperature, as far as this standard applies to them."
Based on the provided information, a full study (as commonly understood for AI/ML devices) demonstrating device performance against specific acceptance criteria is not detailed because the submission focuses on equivalence to a predicate device and adherence to a recognized standard.
Here's an attempt to fill in the requested information based on the provided text, with explicit notes about what is not available:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not provide a specific table of acceptance criteria with corresponding performance metrics from a dedicated study. Instead, it relies on conformance to the ASTM standard and equivalence to predicate devices.
| Acceptance Criteria (Inferred from ASTM E1965-98) | Reported Device Performance |
|---|---|
| Conformance to ASTM E1965-98 Standard | Meets ASTM E1965-98 Standard (as far as applicable) |
| Device Safety and Effectiveness | Acceptable results from performance tests conducted as part of risk analysis |
2. Sample Size for the Test Set and Data Provenance
- Sample Size: Not specified. The document states that "Performance tests were not required as the modified devices are essentially equivalent to previously cleared predicate devices." "Certain performance tests were conducted as part of the risk analysis," but the sample size for these tests is not mentioned.
- Data Provenance: Not specified. The manufacturer is Tecnimed srl, Italy, which could imply European testing standards, but details are absent.
- Retrospective/Prospective: Not specified.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
- Number of Experts: Not applicable/not specified. The device is a thermometer, and "ground truth" for temperature measurement typically refers to calibrated reference thermometers, not expert human assessment in the way it's used for diagnostic imaging.
- Qualifications of Experts: Not applicable/not specified.
4. Adjudication Method for the Test Set
- Adjudication Method: Not applicable/not specified. This concept is typically relevant for studies involving human interpretation or subjective assessments, which is not the primary focus for a thermometer's performance evaluation.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- MRMC Study Done: No. This type of study assesses how AI impacts human reader performance, which is not relevant for a standalone temperature measurement device.
- Effect Size: Not applicable.
6. Standalone (Algorithm only without Human-in-the-loop performance) Study
- Standalone Study Done: Yes, in principle. A thermometer's performance is inherently standalone. The document states, "Certain performance tests were conducted as part of the risk analysis and demonstrated acceptable results for devices safety and effectiveness." and "Both devices meet the ASTM E1965-98 Standard for Infrared Thermometer for Intermittent Determination of Patient Temperature, as far as this standard applies to them." These statements imply standalone performance evaluations against established standards.
7. Type of Ground Truth Used
- Type of Ground Truth: For a thermometer, the "ground truth" would be established by a highly accurate and calibrated reference thermometer. The document implies adherence to the ASTM E1965-98 standard, which would define the methods and reference standards for temperature measurement accuracy. Specific details of the reference thermometer used are not provided in this excerpt.
8. Sample Size for the Training Set
- Sample Size for Training Set: Not applicable. This device is an infrared thermometer, not an AI/ML device that requires a "training set" in the computational sense. Its function is based on physical principles of infrared radiation, calibrated during manufacturing, rather than learned from a dataset.
9. How Ground Truth for the Training Set Was Established
- How Ground Truth for Training Set Was Established: Not applicable, as there is no "training set" in the AI/ML context for this device. The device is calibrated during manufacturing against physical standards to ensure accurate temperature readings, which is a different process than establishing ground truth for machine learning.
§ 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.