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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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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.

The Super Quick Anchor Plus is intended as an upgrade of the current Super QuickAnchor. The new system includes enhanced ergonomics, and improved visualization. The product will be offered with both Ethibond and Panacryl suture. The ergonomics are improved by allowing a single-handed operation. In addition, the visualization of the anchor is improved by increasing the length of the inserter shafts. The Super QuickAnchor is a metallic (6Al-4V ELI Titanium base and NiTi Titanium Alloy arcs) anchor and is used to assist in the reattachment of soft tissue to bone. The anchor is identical to the currently marketed Mitek SuperAnchor QuickAnchor (K930893).

This document is a 510(k) summary for a medical device called "Super QuickAnchor Plus." It is a premarket notification to the FDA to demonstrate substantial equivalence to a legally marketed predicate device. This type of submission does not typically include detailed studies proving acceptance criteria in the same way a new, high-risk device might. Instead, it focuses on demonstrating that the new device is as safe and effective as an existing one.

Based on the provided text, here's an analysis against your requested information:

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

The document does not explicitly present a table of acceptance criteria with corresponding performance data in the traditional sense of a clinical trial or performance study for a novel device. Instead, the core "acceptance criteria" here is demonstrating substantial equivalence to a predicate device.

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

• Sample size: Not applicable in the context of this 510(k) submission. This document does not describe a clinical performance study using a "test set" of patients or cases. The biocompatibility studies would typically involve in-vitro or in-vivo testing on material samples, not a patient "test set". The document does not specify their sample sizes.
• Data provenance: Not applicable for a clinical test set. The biocompatibility studies' provenance is not detailed (e.g., country of origin, retrospective/prospective). These are typically laboratory studies.

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

• This information is not present. A clinical ground truth for a test set is not established in this type of submission.

4. Adjudication method for the test set

• This information is not present, as no clinical test set is described.

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

• This information is not present. This device is a bone fixation anchor, not an AI-powered diagnostic tool. Therefore, an MRMC study related to AI assistance is irrelevant and not conducted.

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

• This information is not present. This device is a surgical implant and delivery system, not an algorithm or software. Therefore, standalone algorithm performance is irrelevant.

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

• For the core claim of "substantial equivalence," the "ground truth" is established by the existing, legally marketed predicate device (Mitek SuperAnchor QuickAnchor K980893 and K930893). The new device is compared against the characteristics and performance of this predicate.
• For biocompatibility, the "ground truth" would be established by standard biological safety testing methods to determine non-toxicity, non-irritation, and non-cytotoxicity, as per ISO 10993 or equivalent standards. The results of these tests (stated as having "demonstrated" the device is safe) are the ground truth for that specific safety aspect.

8. The sample size for the training set

• This information is not present. There is no "training set" in the context of this medical device submission, as it is a physical implant and not a machine learning model.

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

• This information is not present, as there is no "training set" for this device.

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