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The device is a clinical electronic thermometer using an infrared sensor to detect body temperature from the auditory canal in the neonatal, pediatric and adult population used in the home setting.

The device TT-001 is an electronic thermometer using an infrared sensor to detect body temperature from the auditory canal. Its operation is based in the measuring the natural thermalradiation emanating from the tympanic membrane and the adjacent tissue. The tympanic membrane (eardrum) is thin and flooded with blood at the core temperature. The waveguide, usually a cylindrical pipe with a highly reflective inner surface for confining the radiation, is adaptive to the outer without contacting the eardrum. When inserting the probe into the ear canal, the radiation fluxes transfer among the tympanum membrane (eardrum), the IR sensor, and the inner surface of the waveguide. The ambient sensor is packed with the IR sensor to monitor the ambient temperature of the IR sensor. To measure core temperature, an ear thermometer is inserted into a patient's outer ear canal. An activation button is pressed to start the measurement through the radiation exchanges. The electrical signal readouts form the IR sensor and the ambient temperature sensor are fed to the circuit for amplification, digitization and calculation. The measured temperature then appears on the LCD. The total operation takes one second.

The provided submission, K101322, for the Joinsoon Electronics Mfg. Co., Ltd. Infrared Ear Thermometer, Model TT-001, primarily focuses on demonstrating substantial equivalence to a predicate device (TempTeller - Infrared Ear Thermometer, Models CT-31/32DX/32/32DX, K030299) rather than detailing a specific clinical study with acceptance criteria.

The submission states that "bench testing contained in this submission supplied demonstrate that any differences in their characteristics do not raise any new questions of safety or effectiveness." This implies that the performance was evaluated against established standards and internal testing, rather than a clinical trial directly measuring accuracy against a ground truth from human experts.

Therefore, much of the requested information regarding acceptance criteria, study design, and expert involvement is not explicitly available in the provided 510(k) summary.

However, based on the information provided, here's what can be inferred and stated:

Acceptance Criteria and Device Performance

The submission indicates compliance with ASTM E1965-98 for evaluating infrared thermometers. This standard sets the clinical accuracy requirements for such devices. While the specific numerical acceptance criteria from ASTM E1965-98 are not detailed in the summary, they would typically involve limits on the difference between the device's reading and a reference temperature.

The submission does not report specific numerical device performance metrics (e.g., mean difference, standard deviation of differences, clinical accuracy within a certain range). It only states that the device's characteristics "do not raise any new questions of safety or effectiveness," implying it met the relevant performance standards.

Study Details (Based on available information)

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

   • The 510(k) summary mentions "bench testing" but does not provide details on test set sample sizes or data provenance (e.g., country of origin, retrospective or prospective). This type of information would typically be in the full submission, but not in the summary. For thermometer evaluations against ASTM E1965, a specific number of subjects are usually required for clinical accuracy testing, often involving multiple readings.

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

   • Not applicable as this was a bench/laboratory performance study against a reference standard, not a study requiring expert interpretation of medical images or conditions. The "ground truth" for thermometer accuracy assessment is typically a highly accurate reference thermometer measurement, not an expert medical opinion.

3. Adjudication method for the test set:

   • Not applicable. Adjudication methods like 2+1 or 3+1 are used for resolving discrepancies in expert interpretations (e.g., radiology studies). For thermometer calibration and accuracy testing, a comparison is made to a calibrated reference temperature source.

4. 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. This device is an infrared ear thermometer, not an AI-assisted diagnostic tool involving human readers.

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

   • Yes, implicitly. The performance evaluation against ASTM E1965-98 would be a standalone evaluation of the device's accuracy without a "human-in-the-loop" in the context of interpretation. The human uses the device, but the device's measurement is assessed independently.

6. The type of ground truth used:

   • Calibrated reference temperature or blackbody source, as per international standards like ASTM E1965-98. This standard includes sections for both laboratory and clinical accuracy testing. Clinical accuracy would involve comparison to a "standard clinical thermometer" (e.g., rectal thermometer in a controlled setting) or a highly accurate core body temperature measurement.

7. The sample size for the training set:

   • Not applicable. Infrared ear thermometers are typically calibrated during manufacturing rather than "trained" with a dataset in the AI sense. Their operation is based on fundamental physical principles (infrared radiation detection) and algorithms converting raw sensor data to a temperature reading.

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

   • Not applicable. (See point 7). Calibration during manufacturing would involve highly accurate reference temperature sources.

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