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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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Infrared Forehead Thermometer is intended for the intermittent measurement and monitoring of forehead temperature. The device is indicated for use by people of all ages in the home.

The Infrared Forehead Thermometer, model FR200 is a hand-held forehead thermometer and it is intended for the non-contact intermittent measurement and monitoring of forehead temperature which is based on the infrared energy emitted from the forehead. It is indicated for use by people of all ages in the home. After measurement, the temperature is directly shown on the LCD display so that the users can quickly get measurement results after properly scanning the forehead.

The provided document is a 510(k) summary for an Infrared Forehead Thermometer (Model FR200). It focuses on demonstrating substantial equivalence to a predicate device, rather than presenting a detailed study proving the device meets general acceptance criteria for a novel AI/software medical device.

Therefore, much of the requested information regarding acceptance criteria and study details for an AI/software device is not available in this document because it pertains to a different type of medical device (a thermometer) and regulatory pathway (substantial equivalence of a hardware device incorporating standard technology).

However, I can extract the information that is present and point out where the requested information is absent or not applicable given the context.

Here's a breakdown of what can be inferred or directly stated from the document:

Device Type: Infrared Forehead Thermometer (hardware device, not an AI/software image analysis device).
Regulatory Pathway: 510(k) - demonstrating substantial equivalence to a predicate device.

1. A table of acceptance criteria and the reported device performance

The document does not provide a general table of "acceptance criteria" for an AI/software device, as it is a thermometer. However, it does list performance specifications and testing standards that serve as benchmarks for this type of device.

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

• Test Set Sample Size: For the Clinical Accuracy study, the document states: "a clinical study was carried out on 160 subjects for all ages of population" (Page 7) and "consisting of 180 subjects, of which 60 subjects are infants, 60 subjects are children and the rest 60 subjects are adults" (Page 8). There is a discrepancy in the total number of subjects (160 vs 180). Assuming 60 per age group (infants, children, adults), 180 seems more consistent.
• Data Provenance: Not explicitly stated (e.g., country of origin, specific hospitals). The study is described as a "randomization, simple blind homologous control, pairing design of clinical investigation" (Page 8), indicating it was a prospective study specifically conducted for this submission.

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

Not applicable/available. This device is a thermometer. Its "ground truth" for temperature measurement is typically established by comparing readings against a reference thermometer (e.g., a rectal thermometer or other highly accurate standard) in a clinical setting, not through expert consensus on images. The document refers to meeting "acceptance criteria of the clinical study protocol" for repeatability, which would involve quantitative comparisons to a reference.

4. Adjudication method for the test set

Not applicable/available. Adjudication methods (e.g., 2+1, 3+1) are typically used for subjective assessments, like image reading, where multiple experts interpret data. For a thermometer, objective measurement comparisons are used.

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

Not applicable. This is not an AI-assisted diagnostic device. It's a standalone thermometer.

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

Yes, in essence. The device functions as a "standalone" measurement tool. Its performance is evaluated intrinsically (how accurately it measures temperature), not in conjunction with human interpretation of complex data. The clinical accuracy study assesses the device's direct measurement capability.

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

For "Clinical Accuracy," the ground truth would be established by simultaneous measurements using a recognized reference standard thermometer (e.g., a rectal thermometer, an oral thermometer, or a highly accurate laboratory-grade thermometer) according to the ASTM E1965-98 and ISO 80601-2-56 standards. The document doesn't explicitly name the reference method used within the clinical study, but these standards prescribe such methods. It's an objective, quantitative comparison rather than subjective consensus.

8. The sample size for the training set

Not applicable. This is a traditional infrared thermometer, not an AI/machine learning model that requires a "training set."

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

Not applicable. As above, no training set for an AI model.

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