(15 days)
Infrared Thermometer Model: DT-8806H/DT-8806 Non-contact body infrared thermometer is designed for body surface and forehead temperature measurement for infants and adults without contact to human body. The Digital Infrared Ear Thermometer Model: DT-886 can provide a stable, hear –interference ~free reading with each measurement, The digital Infrared Thermometer is intended for the periodic measurement and monitoring of human body temperature, It is intended for use on people of all ages. The Infrared Thermometer can be used by consumers in household environment. It is manufactured in accordance with the ASTM E1965-1998 Standard specification for Infrared Thermometers for Intermittent Determination of Patient Temperature.
Infrared Thermometer Model: DT-8806H/DT-8806/DT-886 is medical instruments, used as an assistant device by normal people to evaluate, by the result of measurement, their decision for the next clinical step in order to protect human's health. The function for measuring human body's temperature with precision helps detect and observe human states of health, in case of any possible illness.
Infrared Thermometer Model: DT-8806H/DT-8806 is a hand-held, non-sterile, reusable medical device, Use and alcohol swab or cotton tissue moistened with alcohol(70% Isopropyl) to clean, the Digital Infrared Ear thermometer(DT-886) casing and the measuring probe contact body. supplied by internal power. It is used for human beings, and it belongs personal use monitoring device.
Infrared Thermometer Model:DT-8806/DT-8806H/DT-886 is hand-held, reusable, battery operated.The device that can measures human body temperature by ways:
- on forehead,the skin temperature on one's forehead(DT-8806H/DT-8806); 2.In ear.The tympanic temperature in one's ear(DT-886).
The operation principle is based on Infrared Sensor technology.IR Sensor can putout different signal when measuring different object temperature or in different ambient temperature. An ASIC can turn the signal from IR Sensor to a digital Value and display it by LCD.
The provided text describes an Infrared Thermometer (Models: DT-8806H/DT-8806/DT-886) and its 510(k) submission. However, the document does not contain a detailed study proving the device meets specific acceptance criteria in the format typically seen for advanced AI/ML medical devices. The information available focuses on compliance with existing standards and comparison to a predicate device.
Based on the provided text, here's an analysis of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state acceptance criteria in a structured table or provide specific performance metrics beyond compliance with standards. It states that the device conforms to "applicable standards" and that "tests in this submission provide demonstration these small differences [from the predicate device] do not raise any new question of safety or effectiveness."
Common performance metrics for thermometers include accuracy (e.g., within ±0.2°C or ±0.4°F) and repeatability. While these are implied by compliance with ASTM E1965-98, the specific numerical acceptance criteria and the device's reported performance against them are not detailed in this summary.
| Acceptance Criteria (Implied by Standards) | Reported Device Performance |
|---|---|
| Specific Accuracy Requirements (e.g., ±0.2°C within a certain range) (Implied by ASTM E1965-98) | Not explicitly stated in numerical terms within the provided text. |
| Intermittent determination of patient temperature (ASTM E1965-98) | Conforms to ASTM E1965-98 (2003) |
| Electrical safety (IEC60601-1) | Conforms to IEC60601-1 |
| Electromagnetic compatibility (IEC60601-1-2) | Conforms to IEC60601-1-2 |
| Risk management (ISO14971) | Conforms to ISO14971 |
| Biocompatibility (EN ISO10993-5, EN ISO10993-10 - for DT-886) | Conforms to EN ISO10993-5, EN ISO10993-10 |
| Clinical thermometers - Part 5: Performance of infrared ear thermometers (EN12470-5 - for DT-886) | Conforms to EN12470-5 |
2. Sample size used for the test set and the data provenance
The document does not provide details on the sample size used for any specific test set, nor does it mention the data provenance (e.g., country of origin, retrospective or prospective nature of data collection). It broadly states "Valid scientific evidence of product testing reports, software verification, and substantial equivalence are provided," but does not give specifics.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not available in the provided text. The submission focuses on device compliance with standards and comparison to a predicate, not on a study involving human expert judgment for ground truth establishment.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not available. Adjudication methods are typically relevant for studies where multiple human readers interpret data, which is not described here.
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
An MRMC comparative effectiveness study was not conducted. This device is a standalone infrared thermometer and does not involve AI assistance for human readers.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Yes, a standalone performance assessment was effectively done, as the device itself is a measurement tool. The "Performance Summary" lists the standards to which the device conforms, which inherently involves testing the device's performance directly against those standards without human intervention in the temperature measurement process itself. The "tests in this submission" would be demonstrating the device's accuracy and other specifications.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
For a thermometer, the "ground truth" would typically be established using a calibrated reference thermometer or a precisely controlled temperature bath. The device's measurements are compared against these known, highly accurate temperature sources to determine its accuracy and precision. The document doesn't explicitly state "calibrated reference thermometer," but compliance with standards like ASTM E1965-98 would necessitate such a method.
8. The sample size for the training set
This device does not appear to involve machine learning or AI models that would require a "training set" in the conventional sense. Therefore, this information is not applicable/not provided.
9. How the ground truth for the training set was established
As there is no indication of a training set for an AI/ML model, this information is not applicable/not provided.
§ 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.