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The FORA IR22 Ear Thermometer is an electronic thermometer using an infrared sensor to detect human body temperature from the ear canal. The device is indicated for use by people of all ages. It is also available to detect object's surface temperature including human skin.

The FORA IR22 Ear Thermometer is an electronic thermometer using an infrared sensor to detect human body temperature from the ear canal.

The provided document is an FDA 510(k) clearance letter for the FORA IR22 Ear Thermometer. It confirms that the device is substantially equivalent to a legally marketed predicate device. However, this document does not contain the detailed study information, acceptance criteria, or performance data that would be found in the 510(k) submission itself or the supporting technical documentation.

Therefore, I cannot extract the information required to populate all sections of your request. The FDA clearance letter only indicates that performance data was submitted and found acceptable for substantial equivalence, but it doesn't present the data itself.

Based on the provided document, here is what can be inferred or explicitly stated:

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

   • N/A. This information is not present in the FDA clearance letter. Performance data and acceptance criteria would be detailed in the 510(k) submission document, which is not provided here.

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):

   • N/A. This information is not present in the FDA clearance letter.

3. 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):

   • N/A. This information is not present in the FDA clearance letter.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

   • N/A. This information is not present in the FDA clearance letter.

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:

   • N/A. This device is an ear thermometer, not an AI-assisted diagnostic tool for human readers. Therefore, an MRMC study is not applicable.

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

   • Yes, implicitly. A thermometer operates in a standalone manner, providing a direct measurement. Its performance is evaluated on its accuracy and precision against a reference standard. The FDA clearance implies that such standalone performance (i.e., the device itself providing accurate temperature readings) was demonstrated. Specific metrics are not available in this letter.

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

   • Clinical reference thermometers/standards. For a clinical thermometer, the ground truth would typically be established by highly accurate, calibrated reference thermometers or other established temperature measurement methods in a clinical setting.
   • N/A (specific details). The exact type of reference instrument or gold standard used is not detailed in this clearance letter.

8. The sample size for the training set:

   • N/A. Thermometers typically do not use "training sets" in the machine learning sense. Their accuracy is based on physical principles and calibration, not learned from data in the same way an AI algorithm would be. Performance is verified through clinical validation studies.

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

   • N/A. (See point 8).

Summary of what the document does tell us about the device:

• Device Name: FORA IR22 Ear Thermometer
• Regulation Number: 21 CFR 880.2910
• Regulation Name: Clinical Electronic Thermometer
• Regulatory Class: II
• Product Code: FLL
• Indications for Use:
  • Electronic thermometer using an infrared sensor to detect human body temperature from the ear canal.
  • Indicated for use by people of all ages.
  • Available to detect object's surface temperature including human skin.
• Usage: Over the Counter Use
• Clearance Date: February 8, 2009 (Received February 5, 2009)
• Basis for Clearance: Substantial Equivalence to a legally marketed predicate device. This means the FDA reviewed performance data (accuracy, precision, etc.) and found it to be comparable to known safe and effective thermometers on the market.

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