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The Mitek Super QUICKANCHOR Anchor Plus is intended for fixation of USP size #2 through #5 suture to bone for the indications listed below.

Shoulder: Rotator cuff repair; capsular repair; biceps repair; deltoid repair.

Ankle: Achilles tendon repair/reconstruction.

Knee: Extra capsular repairs; Reattachment of: medial collateral ligament, lateral collateral ligament, posterior oblique ligament or joint capsule to tibia and joint capsule closure to anterior proximal tibia; extra capsular reconstruction, ITB tenodesis; patellar ligament and tendon avulsions.

Super Quickanchor Plus (with ORTHOCORD) is a preloaded, metallic disposable suture anchor/ inserter assembly designed to allow soft tissue repair to bone. The metal anchor is an identical anchor as that of the Super Quickanchor Plus in design, configuration and dimensions. The anchor system may be sold with Ethibond Suture (NDA 17-804 and 17-809), Panacryl Suture (K964345), or Orthocord Suture (K040004 and K043298).

The provided text describes the "Super Quickanchor Plus" device and its 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device. This document is a premarket notification for a medical device and therefore does not contain the kind of detailed study information (e.g., acceptance criteria, test set sample sizes, expert qualifications, HR/AI performance improvement, training set details) associated with demonstrating the performance of a device against specific acceptance criteria.

The document primarily states that the determination of substantial equivalence was based on:

• Detailed device description
• Conformance to consensus and voluntary standards
• Bench testing: This bench testing "demonstrated that the ORTHOCORD suture conformed to the USP monograph for absorbable sutures, and the suture compatibility and deployment met predetermined acceptance criteria."

Therefore, it's impossible to fill out most of the requested table and answer the study-specific questions based on the provided text. The text confirms that some acceptance criteria related to suture conformity, compatibility, and deployment were met through bench testing, but it does not specify what those criteria were or the details of the study.

Here's what can be extracted and what cannot:

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

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

• Sample Size: Not specified.
• Data Provenance: Not specified, but generally, bench testing for 510(k) submissions would be laboratory-based rather than patient data.

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)

• Not applicable. This was bench testing, not a clinical study involving expert interpretations of data.

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

• Not applicable. This was bench testing.

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 a medical device (surgical anchor), not an AI diagnostic or interpretive tool.

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

• Not applicable. This is a medical device (surgical anchor).

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

• For the bench testing described, the "ground truth" would be objective measurements and adherence to technical specifications and standards (e.g., USP monograph specifications, engineering performance metrics for deployment forces, mechanical integrity).

8. The sample size for the training set

• Not applicable. This is a medical device, not an AI/machine learning model that undergoes "training."

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

• Not applicable.

Summary of what the document does communicate regarding device performance:

The document states that the Super Quickanchor Plus (with ORTHOCORD) was found to be substantially equivalent to its predicate device (Super Quickanchor Plus, K041116). This determination was supported by bench testing that confirmed:

• The ORTHOCORD suture conformed to the USP monograph for absorbable sutures.
• The suture compatibility and deployment met predetermined acceptance criteria.

These statements confirm that certain performance standards were met, but the specific numerical values of the acceptance criteria and the detailed results of the bench testing are not included in this 510(k) summary.

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