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The Infrared forehead thermometer is a non-contact infrared thermometer (model BSX976) intended for the intermittent measurement of temperature from forehead at a distance of 1~3cm for people older than 2 years. The device is reusable for home use and clinical use and the safety of the device has not been established for use in neonates/infants.

BSX976 measures the body temperature through receiving the infrared energy radiation from the surface of objects. It is with forehead temperature mode, directly show on the LCD screen.

• The device is widely used for home healthcare, medical institutes, and many other occasions.
• The product is mainly composed with infrared temperature sensors, signal receiving processor, buttons, buzzer, LCD display, battery, etc.
• It focuses the infrared from the human's forehead by the Fresnel lens.

The provided document is a 510(k) summary for a non-contact infrared forehead thermometer (Model BSX976). It outlines the device's characteristics and its comparison to a predicate device to demonstrate substantial equivalence.

Here's a breakdown of the acceptance criteria and the study that proves the device meets them, based on the provided text:

Acceptance Criteria and Device Performance

The device's performance is primarily assessed against recognized international standards for medical electrical equipment and clinical thermometers. The acceptance criteria are implicitly defined by compliance with these standards, particularly regarding accuracy and safety.

Table of Acceptance Criteria and Reported Device Performance

Study Details Proving Device Meets Acceptance Criteria

The document describes both non-clinical (bench) data and clinical data collected to demonstrate product performance.

1. Sample sizes used for the test set and data provenance:

   • Clinical Data (Test Set): 150 subjects were involved in the clinical testing. 32 of these subjects were febrile.
   • Data Provenance: The document does not explicitly state the country of origin or whether the data was retrospective or prospective. Given the submitter's location (Shenzhen, China) and the nature of a 510(k) submission, it is highly probable the clinical study was conducted prospectively, but this is not explicitly confirmed.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

   • The document does not provide details on the number or qualifications of experts used to establish ground truth for the clinical test set. The clinical testing was conducted "per ISO 80601-2-56 Clause 201.102," which is a standard for clinical thermometers. This standard itself outlines methods for clinical evaluation, including comparison to reference thermometers, but the specific details of the human expertise involved in the ground truth establishment for this specific study are not described in the provided summary.

3. Adjudication method for the test set:

   • The document does not specify an adjudication method. For a clinical thermometer study, ground truth is typically established by simultaneous measurement with a highly accurate reference thermometer (e.g., a rectal thermometer) under controlled conditions, rather than by human adjudication of readings.

4. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and its effect size of how much human readers improve with AI vs without AI assistance:

   • No. This is a review of a basic medical device (a thermometer), not an AI-assisted diagnostic imaging device. Therefore, an MRMC study with human readers and AI assistance is not relevant and was not performed.

5. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:

   • Yes, indirectly. The "Clinical data" and "Bench Testing" sections describe the device's performance in isolation. The compliance with ISO 80601-2-56 and ASTM E 1965-98 specifically evaluates the thermometer's direct measurement accuracy, which is its standalone performance. This device is not an algorithm in the sense of AI; it is a physical device that performs a measurement.

6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

   • The ground truth for the clinical data (temperature measurement) is established by comparison to a reference temperature measurement method as defined by the standard ISO 80601-2-56. This standard typically involves using a highly accurate alternative method (e.g., a calibrated contact thermometer, such as a rectal or oral thermometer, serving as the "true" body temperature) against which the infrared thermometer's readings are compared. The summary does not explicitly state the exact reference method used, but compliance with the standard implies such a comparison.

7. The sample size for the training set:

   • This device is a physical thermometer, not a traditional machine learning model that undergoes a "training set" process in the AI sense. Therefore, there is no specific training set sample size as would be described for an AI/ML algorithm. Its "training" is in its design, calibration, and manufacturing processes, guided by engineering principles and adherence to standards.

8. How the ground truth for the training set was established:

   • As there is no "training set" in the AI/ML context, this question is not applicable. The device's calibration and design are based on established physics principles of infrared thermometry and validated against recognized metrology standards for temperature measurement.

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