(154 days)
The device is intended for the intermittent measurement and monitoring of human body temperature. The device is indicated for use by people of all ages in the home.
The TD-1107/TD-1110 ear/skin/surface IR thermometer is characterized by measuring human body temperature and object's temperature in the ear canal and at the surface, respectively. It utilizes infrared technology to measure either infrared energy emitted from the eardrum and surrounding tissues or the surface radiation of the object when making a temperature measurement. It is able to detect skin temperature (only as a reference) when aimed at the target surface of human body. In addition, it is together with an ambient temperature sensor to monitor room temperature. A clock is integrated into the thermometer to provide what time it is.
The provided text describes a 510(k) summary for the TaiDoc TD-11 series ear/skin/surface IR thermometer. It outlines the device's intended use, comparison to a predicate device, and compliance with various consensus standards. However, it does not provide detailed information about specific acceptance criteria or the specifics of a study proving the device meets those criteria, beyond stating general compliance with standards.
Here's a breakdown of what can and cannot be extracted from the provided document based on your request:
1. Table of acceptance criteria and the reported device performance
The document states that the device conforms to consensus standards, specifically mentioning ASTM E1965-98 for infrared thermometers and IEC 60601-1 / IEC 60601-1-2 for safety. It also states: "For clinical results, differences were within clinical acceptability and repeatability was statistically and clinically acceptable."
- Acceptance Criteria (Implicit from standards cited):
- ASTM E1965-98: This standard sets specifications for infrared thermometers used for determining patient temperature. Specific numerical tolerances for accuracy and precision would be defined within this standard.
- IEC 60601-1: General requirements for safety of medical electrical equipment.
- IEC 60601-1-2: Electromagnetic compatibility requirements.
- Reported Device Performance:
- "differences were within clinical acceptability"
- "repeatability was statistically and clinically acceptable"
A table cannot be constructed with specific numerical acceptance criteria and reported device performance from the provided text, as those details are not explicitly given. The document only references compliance with general standards.
2. Sample size used for the test set and the data provenance
- Sample Size for Test Set: Not specified. The document only states "The clinical and non-clinical studies were conducted to validate the effectiveness of use."
- Data Provenance (e.g., country of origin, retrospective or prospective): Not specified.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- This information is not provided in the document. The document refers to "clinical acceptability" and "statistically and clinically acceptable repeatability" but does not detail how these were determined or what ground truth method was used.
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, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- This is not applicable as the device is an infrared thermometer, not an AI-assisted diagnostic tool requiring human reader interpretation of images or data.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- This is not applicable as the device is a physical thermometer with direct output, not an algorithm, and is intended for use by individuals (human-in-the-loop, but not as an AI interpretation). The "standalone" performance here would refer to the device's accuracy and repeatability as a measurement tool. The document implies standalone performance was evaluated through compliance with standards.
7. The type of ground truth used
- While not explicitly stated as "ground truth," for a thermometer, the "ground truth" for accuracy and repeatability studies typically involves comparison against a highly accurate reference thermometer (e.g., a calibrated laboratory standard thermometer or a rectal thermometer in clinical settings). The document mentions "clinical acceptability" and "repeatability," suggesting such comparisons were made, but it does not specify the exact methodology or reference standard used.
8. The sample size for the training set
- Not applicable/Not provided. This device is a traditional infrared thermometer where "training sets" in the AI sense are not relevant. Its performance is based on its physical design and calibration, not machine learning.
9. How the ground truth for the training set was established
- Not applicable/Not provided for the same reasons as #8.
§ 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.