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Reinforcement of an endodontically involved tooth

Retention of Core and or Core Material

FIBREKOR POST SYSTEM ™

This appears to be a 510(k) clearance letter from the FDA for the "FIBREKOR POST SYSTEM ™". The letter itself does not contain the detailed information about acceptance criteria, study design, or performance metrics that would be present in the actual 510(k) submission.

Since the provided text is only the FDA's clearance letter and not the original submission, it does not include the specific details of the acceptance criteria or the study used to demonstrate substantial equivalence. The letter merely states that the device is "substantially equivalent" to predicate devices.

Therefore, I cannot provide the requested information based solely on the text provided. The information typically required for FDA clearance (and thus, to answer your questions) would be found in the 510(k) submission itself, which is not included here.

Here's what I can tell you based on the provided letter, and what would be missing to answer your questions fully:

Information NOT available in the provided text:

• A table of acceptance criteria and the reported device performance: This would be in the detailed testing results section of the 510(k) submission.
• Sample sizes used for the test set and the data provenance: Not mentioned.
• Number of experts used to establish the ground truth for the test set and their qualifications: Not mentioned.
• Adjudication method for the test set: Not mentioned.
• If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and its effect size: Not mentioned. This type of study is more common for diagnostic imaging AI than for a dental post system.
• If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable for a physical medical device like a dental post.
• The type of ground truth used: Not applicable or mentioned.
• The sample size for the training set: Not applicable for this type of device.
• How the ground truth for the training set was established: Not applicable for this type of device.

What the letter does indicate:

• Device Name: FIBREKOR POST SYSTEM ™
• Indications For Use:
  • Reinforcement of an endodontically involved tooth
  • Retention of Core and or Core Material
• Regulatory Class: I
• Product Code: ELR
• Type of Submission: 510(k) notification, indicating substantial equivalence to a predicate device. This means the device was determined to be as safe and effective as a legally marketed device that was on the market prior to May 28, 1976, or has been subsequently reclassified. For Class I devices, the general controls provisions of the Act apply.

To obtain the specific details you're asking about, one would typically need to review the full 510(k) submission for K983266, which is usually publicly available on the FDA website (though finding very old submissions might be challenging, or they may only contain a summary).

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