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The Allofix™ Anchor is indicated for use in the attachment of soft . tissue to bone in orthopedic procedures.
The Allofix™ Anchor is indicated for use in soft tissue approximation and/or ligation of orthopaedic procedure.

The anchor, suture, and inserter are all packaged together. The kit contains one allograft anchor, loaded with two strands of #2 polyethylene suture, blue, and one strand of white. The anchor and suture are housed in an inserter. The anchor resides at the tip of the tube while the bulk of the suture resides within the inserter handle.

The inserter, with the loaded anchor, et al, delivers the product to the site. The inserter is composed of a plastic body and a stainless steel tube with two #2 sutures. A drill or punch is provided to create a hole to deliver the anchor. The inserter contents are housed within a plastic tray. All components are single use and sterile.

Here's a summary of the acceptance criteria and study information for the Allofix™ Anchor, based on the provided text:

Acceptance Criteria and Device Performance

The provided document does not explicitly state quantitative acceptance criteria or a direct comparison table for the Allofix™ Anchor. Instead, it refers to the device meeting "design input requirements for strength" and exceeding values of "metal and polymeric devices used for similar types of fixation."

Inferred Acceptance Criteria based on "Summary of Studies (P)":

Study Details

The provided text describes "Biomechanical testing" as the study performed.

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

   • Sample Size: Not specified in the provided text.
   • Data Provenance: Not explicitly stated, however, the testing was conducted to investigate design requirements, implying it was likely a laboratory-based biomechanical study. There is no information regarding the country of origin of data or whether it was retrospective or prospective in the context of patient data.

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

   • Not applicable. This was a biomechanical study, not a study involving expert review or ground truth establishment by medical professionals. The "ground truth" would be the measured physical properties (strength, dimensions, repeatability) of the anchor itself against engineering specifications.

3. Adjudication method for the test set:

   • Not applicable. This was a biomechanical study.

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:

   • No, an MRMC comparative effectiveness study was not done. The device is a bone anchor, not an AI-assisted diagnostic or imaging device.

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

   • Not applicable. This is a physical medical device, not an algorithm. The "standalone" performance here refers to the device's physical properties as measured in the biomechanical tests.

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

   • The "ground truth" for this biomechanical study refers to the engineering specifications and performance benchmarks set for device strength, dimensions, and insertion repeatability. The device's performance was measured against these predefined physical and mechanical properties.

7. The sample size for the training set:

   • Not applicable. This is not a machine learning or AI device that requires a training set.

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

   • Not applicable, as there is no training set for this type of device.

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