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Infrared Forehead Thermometer, model: HS-9802D 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.

Infrared Forehead Thermometer, model: HS-9802D is a hand-held, battery powered, infrared thermometer that measures human body temperature from forehead. The reference body site is oral. The device measures temperature from center of the forehead.

The provided document is an FDA 510(k) Premarket Notification for an Infrared Forehead Thermometer, model: HS-9802D. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than proving de novo safety and effectiveness through extensive clinical trials for new technologies.

Therefore, the information requested in your prompt related to AI/ML device performance, expert adjudication, MRMC studies, and detailed ground truth establishment for training sets (which would be typical for an AI/ML device) is not present in this document because this is a traditional medical device submission for a thermometer, not an AI/ML diagnostic tool.

The "acceptance criteria" for this device are its ability to accurately measure temperature within specified tolerances, which is demonstrated through non-clinical performance testing and clinical accuracy testing as per established standards for thermometers.

Here's a breakdown of the information that is available in the document, framed as close as possible to your prompt, along with explanations for the missing information:

Acceptance Criteria and Reported Device Performance

1. Table of Acceptance Criteria and Reported Device Performance:

The document refers to the acceptance criteria as compliance with recognized consensus standards. The performance of the device is assessed against these standards.

• For the operating range of the device, the clinical accuracy should be within specified limits (e.g., ±0.2 °C or ±0.3 °C for certain temperature ranges, or specific deviations from reference oral temperature). Specific values are in the standard, not explicitly detailed here for criteria, but the "Measuring accuracy" in the comparison table gives inferred criteria for this device's claimed accuracy. | Measuring Accuracy (as per 6. Summary of technological characteristics):
  ±0.3°C (0.5°F): 34.0 to 42.0 °C (93.2 to 107.6 °F).

Study Conclusion: "The test data showed the clinical accuracy of the subject device complied with the requirements of ASTM E1965-98 (2016)." |
| Material Biocompatibility | ISO 10993-5, ISO 10993-10 | ISO 10993-5 (cytotoxicity) and ISO 10993-10 (irritation and skin sensitization) compliance. | "The proposed device has been validated for cytotoxicity per ISO 10993- 5 and Irritation as well as Sensitization per ISO 10993-10." |
| Electrical Safety | ANSI AAMI ES60601-1 | Compliance with the general requirements for basic safety and essential performance of medical electrical equipment. | "Meets ANSI AAMI ES60601-1" |
| Electromagnetic Compatibility| IEC 60601-1-2 | Compliance with requirements for electromagnetic disturbances. | "Meets IEC 60601-1-2" |
| Software (if applicable) | IEC 62304, FDA Guidance for Software (2005) | Compliance with medical device software life cycle processes and FDA guidance for software in medical devices. | "IEC 62304 are complied."
"Software verification and validation was performed for the subject device in accordance with Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices -Guidance for Industry and FDA Staff, May 2005." |
| General Requirements | IEC 60601-1-11 | Compliance with general requirements for basic safety and essential performance, specifically for home healthcare environment. | "The subject device complies the standard IEC 60601-1-11." |
| Packaging/Transport | ISTA 2A | Not explicitly stated, but compliance implies the device can withstand typical transport conditions. | "The operating condition of subject device has passed the tests... ISTA 2A." |

Study Proving Device Meets Acceptance Criteria

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

• Sample Size: "The clinical accuracy testing evaluated 105 of subjects."
• Data Provenance: Not explicitly stated regarding country of origin. The test is described as "clinical accuracy testing" and is presumably prospective as it involves "subjects" undergoing measurement. It's safe to assume this was a prospective study conducted for the purpose of this submission.
• Retrospective/Prospective: Implied prospective as it "evaluated 105 subjects."

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

• Not Applicable in the traditional sense for a thermometer. Ground truth for temperature measurement is established by a reference thermometer (or method) that is itself calibrated and adheres to metrological standards. The document states:
  • "Summary of reference equipment: Digital Thermometer, Model KFT-03, Manufacturer Kangfu Medical Equipment Factory, K Number K182652."
  • This Digital Thermometer serves as the ground truth. It is a legally marketed device likely calibrated to national/international temperature standards.
• There were no "experts" establishing qualitative ground truth through image review or similar tasks as would be seen for an AI/ML diagnostic device.

4. Adjudication method for the test set:

• None. Adjudication is not relevant for direct temperature measurement, where the ground truth is a quantitative reading from a reference device.

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:

• No. This is not an AI/ML diagnostic device and does not involve human readers interpreting AI output. It is a standalone measurement device.

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

• Yes, implicitly. The device is an "Infrared Forehead Thermometer." Its performance is inherently "standalone" in that it takes a measurement directly. There's no separate "algorithm" being evaluated beyond the device's internal measurement and calculation process as a whole. The clinical accuracy study assesses the device's output against a reference standard without human interpretative input.

7. The type of ground truth used:

• Reference Device Measurement: The "ground truth" for body temperature was established by simultaneously measuring the subjects' temperatures using a "Digital Thermometer, Model KFT-03," which is a legally marketed and presumably well-calibrated device. This is analogous to using a gold-standard measurement tool.

8. The sample size for the training set:

• Not Applicable. This is a traditional medical device (thermometer), not an AI/ML model that requires a "training set." The device's internal algorithms are based on physics and calibration, not machine learning from a large dataset.

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

• Not Applicable. As there is no training set (as in AI/ML), there is no ground truth established for one. The device is designed, manufactured, and calibrated according to established engineering principles for infrared thermometry. Calibration occurs at the factory using known temperature references.

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