(465 days)
The NIR is non-sterile non-invasive infrared thermometer intended for the intermittent calculation of human body temperature of people of all ages for home and professional use.
The device is built of one or more infrared thermopile sensors that is/are designed to measure a temperature above the artery on the skin. Each of the sensor/s is mounted on a reflector which is used to reduce the sensor field of view. In order to minimize distance effects on the readouts the device is equipped with a distance measurement sensor. Each of the thermopile/s has its own thermistor which is used for calculating the self temperature of each sensor. In addition there is another external thermistor which is used for measuring the ambient temperature and to asses the thermal condition of the thermal equilibrium of the device and to correct the result according to its value and the difference between the external sensor and the internal termistors readout.
Here's a breakdown of the acceptance criteria and study information for the Medisim Ltd. NIR Electrical Thermometer, based on the provided text:
Acceptance Criteria and Reported Device Performance
Acceptance Criteria | Reported Device Performance |
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Accuracy | Below 0.3°C |
Study Details
Due to the nature of this submission (510(k) for a non-invasive infrared thermometer), the study design is focused on demonstrating substantial equivalence to a predicate device and adherence to industry standards, rather than proving efficacy through a typical clinical trial comparing intervention vs. control.
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Sample sizes used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):
- Test Set Sample Size: Not explicitly stated in the provided text. The submission mentions "comparative testing with market-cleared devices," and "clinical and bench tests." However, the exact number of participants or measurements in these tests is not quantified.
- Data Provenance: Not explicitly stated. The manufacturer is Medisim Ltd. in Israel, and the Israeli Institute of Standards was involved in safety validation. It's reasonable to infer that testing occurred in Israel, but this is not definitively stated for the clinical performance. The submission refers to "clinical and bench tests," which implies prospective data collection for the purpose of this submission.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience):
- This information is not provided in the text. For a thermometer, "ground truth" would typically refer to a highly accurate reference thermometer (e.g., a rectal thermometer or a laboratory-grade temperature measurement device), not expert consensus.
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Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- This concept of "adjudication" is not applicable to the type of device and study described. Adjudication methods like 2+1 or 3+1 are typically used in studies where subjective interpretation (e.g., of medical images) requires multiple experts to reach a consensus for ground truth. For a thermometer, objective measurements against a reference are performed.
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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:
- Not applicable. The NIR Electrical Thermometer is a direct measurement device; it does not involve "human readers" or "AI assistance" in the interpretation of complex data in the way an MRMC study would apply (e.g., for diagnostic imaging). The device provides a direct temperature reading.
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If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Yes, implicitly. The device itself is a standalone system that measures and displays temperature. The "clinical and bench tests" would have evaluated the device's accuracy in isolation, independent of human interpretation beyond recording the displayed temperature.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- The ground truth would have been established using reference temperature measurements from highly accurate and calibrated thermometers, either in a controlled laboratory ("bench tests") or clinical setting. This is implied by the nature of temperature measurement device testing and the reference to ASTM E1965-98, which outlines standards for infrared thermometers, including accuracy testing against known temperatures.
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The sample size for the training set:
- Not applicable/Not provided. The NIR thermometer is not described as a device that uses machine learning or AI that requires a "training set" in the conventional sense. Its function is based on established physical principles of infrared thermometry. Any internal calibration or algorithm development would fall under engineering validation rather than an AI training set.
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How the ground truth for the training set was established:
- Not applicable. As stated above, there is no "training set" for an AI or machine learning algorithm described for this device.
§ 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.