(195 days)
PG-IRT1601 Infrared Ear Thermometer is intended to measure human body temperature by measuring ear canal. PG-IRT1602 Infrared Forehead Thermometer is intended to measure human body temperature by measuring forehead. PG-IRT1603 Infrared Ear/Forehead Thermometer is intended to measure human body temperature by measuring ear canal or forehead.
The device can be used on people of all ages.
The proposed device includes 3 models, which are PG-IRT1602 and PG-IRT1603. It includes infrared thermometers and is intended for people of all age.
The proposed device, Infrared Ear Thermometers, Model PG-IRT1601, is hand-held, reusable, battery powered device, which is intended to measure human body temperature by measuring ear canal.
The proposed device, Infrared Skin Thermometers, Model PG-IRT1602, is hand-held, reusable, battery powered device, which is intended to measure human body temperature by measuring forehead. The distance of the measurement is 3cm~5cm.
The proposed device, Infrared Ear/Forehead Thermometer, Model PG-IRT1603, is hand-held, reusable, battery powered device, which is intended to measure human body temperature by measuring ear canal or forehead. The distance of the measurement is 3~5cm while measuring the forehead temperature.
The provided document is a 510(k) Summary for an Infrared Thermometer. It describes the device's indications for use, design, and the testing conducted to demonstrate its substantial equivalence to predicate devices. However, this document does not contain the detailed acceptance criteria and study results in the format requested. Specifically, it talks about clinical and non-clinical tests verifying compliance with standards like ASTM E1965-98, but it does not provide:
- A table of specific numerical acceptance criteria for performance metrics (e.g., accuracy +/- X degrees C) and the reported device performance against those specific criteria.
- The exact sample size used for the test set in the clinical study (it states 130 subjects for each clinical study, implying 3 studies for the 3 models, but doesn't break down by test set vs. training set or specific age groups for overall "clinical study" rather than a dedicated "test set").
- Data provenance beyond "clinical trial results."
- Details on expert involvement, ground truth establishment methods (beyond "clinical validation"), or adjudication methods.
- Any information regarding MRMC studies, standalone AI performance, or training set details.
The document focuses on demonstrating compliance with recognized standards and similarity to predicate devices, rather than providing raw performance data against predefined acceptance criteria for a novel AI/algorithm. This is typical for a 510(k) submission for a non-AI medical device like a thermometer, where compliance with performance standards and safety is key for substantial equivalence.
Therefore, I cannot provide the information in the requested format based on the text provided. The document is a regulatory submission for a simple medical device (infrared thermometer), not an AI algorithm.
If this were a submission for an AI/ML device, the content would have to include the specific details you've asked for because the performance evaluation of AI is very different from that of a basic electronic thermometer.
§ 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.