(182 days)
The Thermotocus series 0800, 01500 and 0700 are infrared thermometers intended for the intermittent measurement of human body temperature of people of all ages
Thermofocus devices belonging to the 0800, 0900, 01500, 0700 series are hand-held and battery-operated, taking skin temperature mainly in the middle of the forehead. In case of difficult to take the temperature on this area it is also possible to take the temperature on the navel 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. Thanks to an exclusive optic aiming system, the peculiarity of Thermofocus thermometers is to take the temperature at distance, without any contact with the patient.
The provided document is a 510(k) summary for the Tecnimed Thermofocus series of infrared thermometers. It describes the device, its intended use, and provides a summary of performance testing.
Here's an analysis of the acceptance criteria and study information contained within:
1. Table of Acceptance Criteria and Reported Device Performance
| Performance Test | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Accuracy tests | Pass | Pass |
| Repetability tests | Pass | Pass |
| °F vs °C tests | Pass | Pass |
| Error messages tests | Pass | Pass |
| Display limits tests | Pass | Pass |
| DFU evaluation | Pass | Pass |
| Current leakage tests | Pass | Pass |
| Variable voltage tests | Pass | Pass |
| EMC tests | Pass | Pass |
| Clinical Performance | Substantial equivalence to predicate (Sensortouch) | Substantial equivalence demonstrated |
Note: The document states "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." This ASTM standard would contain specific quantitative acceptance criteria for parameters like accuracy and repeatability, but these specific values are not explicitly detailed in this 510(k) summary.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: The document states that "The numerous tests conducted in our laboratories and also in hospital and clinics, on several subjects..." but does not specify the exact sample size for subjects or cases used in the clinical performance testing.
- Data Provenance: The tests were conducted in "our laboratories" and "hospital and clinics." This indicates prospective data collection through internal testing and clinical sites. The country of origin for Tecnimed srl is Italy.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not provided in the document. The clinical performance testing focused on demonstrating "substantial equivalence between Thermofocus and the predicate Sensortouch," implying a comparison to the predicate device's readings rather than a separate expert-established ground truth.
4. Adjudication Method for the Test Set
This information is not provided in the document.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance
This section is not applicable. The device is an infrared thermometer, not an AI-powered diagnostic tool requiring human reader interpretation or improvement.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done
The device is a standalone thermometer (algorithm-only in its functional sense, as it autonomously measures and displays temperature). The document implicitly describes standalone performance testing as part of the "Summary of non-clinical Performance Testing" (e.g., accuracy, repeatability) and the comparative clinical testing against the predicate.
7. The Type of Ground Truth Used
For the clinical performance testing, the ground truth was based on comparison to a legally marketed predicate device (TemporalScanner thermometer, formerly known as SensorTouch). The study aimed to demonstrate "substantial equivalence" to this predicate. For the non-clinical performance tests (accuracy, repeatability, etc.), the ground truth would typically be established against calibrated reference standards or methods as defined by the ASTM E1965-98 standard, though not explicitly stated here.
8. The Sample Size for the Training Set
This information is not applicable/not provided. The Thermofocus is a physical electronic device that measures infrared radiation; it does not explicitly use a "training set" in the machine learning sense to develop an algorithm. Its "algorithm" is likely embedded mathematical adjustments based on physics and sensor readings, not learned from a dataset.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable/not provided for the reasons stated above (no training set in the machine learning context).
§ 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.