(112 days)
Caregiver professional Clinical Thermometer is an infrared thermometer intended for the measurement of human body temperature in people of all ages without contact to the body and may be used by medical professionals or by consumers in a home environment.
Caregiver Professional Clinical Thermometer (Model PRO-TF300) is characterized by measuring human body temperature from the surface of human skin. It utilizes infrared technology to measure infrared energy emitted from the skin surface when making a temperature measurement.
The provided text describes the 510(k) summary for the Caregiver Professional Clinical Thermometer (Model PRO-TF300). Here's a breakdown of the acceptance criteria and study information:
Acceptance Criteria and Reported Device Performance
The device's performance was validated according to ASTM E1965-98. The specific acceptance criteria are not explicitly detailed as numerical thresholds in this document, but the tests performed and their outputs are listed.
| Item | Standard Complied | Data Presentation |
|---|---|---|
| Laboratory accuracy | ASTM E1965-98 | Measurement error |
| Clinical accuracy | ASTM E1965-98 | Clinical bias |
| Clinical repeatability | ||
| Storage stability | ASTM E1965-98 | Measurement error |
| Shock | ASTM E1965-98 | Measurement error |
| Cleaning procedure | ASTM E1965-98 | Measurement error |
| Safety | IEC 60601-1 | Evaluated by SGS |
| Electromagnetic | IEC 60601-1-2 | Evaluated by SGS |
| compatibility (EMC) |
Study Details
Due to the nature of the device (a clinical thermometer), many typical AI/ML study components (like expert consensus, adjudication, MRMC studies, or training/test set provenance) are not directly applicable or documented in this type of 510(k) submission.
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Sample size used for the test set and the data provenance:
- Specific sample sizes for the clinical accuracy and laboratory accuracy tests are not provided in this summary.
- The data provenance (country of origin, retrospective/prospective) is not specified in this summary.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- For a clinical thermometer, "ground truth" would typically refer to a reference temperature measurement (e.g., from a rectal thermometer or an accredited blackbody calibrator). The document does not specify the number or qualifications of experts involved in establishing this reference.
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Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Adjudication methods are generally used for subjective assessments (like image interpretation). For objective measurements like temperature, adjudication as typically understood for AI models is not applicable and therefore not mentioned.
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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 a standalone diagnostic device, not an AI-assisted interpretation tool for human readers. Therefore, an MRMC comparative effectiveness study is not applicable and was not performed.
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If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Yes, the performance tests (laboratory accuracy, clinical accuracy) described were for the device in a standalone capacity, meaning its performance was evaluated inherently. The device itself is a measurement tool, not an AI algorithm in the contemporary sense.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For laboratory accuracy, the ground truth would typically be an accredited blackbody calibrator or similar highly accurate reference thermometer.
- For clinical accuracy, the ground truth would typically be core body temperature measured by a reference method (e.g., rectal thermometer). The document does not explicitly state the reference method used.
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The sample size for the training set:
- This device is a traditional infrared thermometer and does not involve AI/ML requiring a training set. Therefore, this concept is not applicable.
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How the ground truth for the training set was established:
- As there is no training set for an AI/ML algorithm involved, this question is not applicable.
§ 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.