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The Mitek GII Anchor (QUICKANCHOR) is intended for fixation of USP size #2 suture to bone for the indications listed below.

Shoulder: Bankart repair, SLAP lesion repair, acromio-clavicular separation, rotator cuff repair, capsule shift/capsulo-labral reconstruction, biceps tenodesis, deltoid repair.

Ankle: Lateral instability, medial instability, achilles tendon repair/reconstruction, midfoot reconstruction.

Foot: Hallux valgus reconstruction.

Wrist: Scapholunate ligament.

Hand: Ulnar or lateral collateral ligament reconstruction.

Elbow: Tennis elbow repair, biceps tendon reattachment.

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.

GII 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 GII 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 GII Quickanchor Plus is a medical device designed for soft tissue repair to bone using a preloaded, metallic disposable suture anchor/inserter assembly. The following details the acceptance criteria and the study that demonstrates the device meets these criteria.

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size Used for the Test Set and Data Provenance

The provided document does not specify a distinct "test set" for the GII Quickanchor Plus separate from the general bench testing. The evaluation was based on conformance to consensus and voluntary standards and bench testing. Therefore, details regarding sample size for a specific test set, country of origin, or retrospective/prospective nature of the data are not provided.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications

This information is not provided in the document. The evaluation relies on "conformance to consensus and voluntary standards" and "bench testing" rather than expert-established ground truth on case data.

4. Adjudication Method for the Test Set

This information is not provided. Given the nature of the testing described (bench testing for material conformance and system deployment), an adjudication method as typically applied to clinical or imaging datasets is not applicable or described.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No MRMC comparative effectiveness study is mentioned. The submission is for a medical device (suture anchor), not an AI diagnostic tool that would typically involve human reader performance evaluation.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

This is not applicable as the GII Quickanchor Plus is a physical medical device, not an algorithm or AI system. The "standalone" performance refers to the device's ability to meet its functional specifications during bench testing. The bench testing demonstrated that the Orthocord suture, suture compatibility, and deployment met predetermined acceptance criteria.

7. Type of Ground Truth Used

The ground truth used was based on:

• USP monograph for absorbable sutures: This serves as a standardized, objective benchmark for material properties.
• Predetermined acceptance criteria for suture compatibility and deployment: These are internal engineering specifications established to ensure the device functions as intended.

8. Sample Size for the Training Set

This information is not applicable. The device is a physical medical implant, not an AI model that requires a training set of data.

9. How the Ground Truth for the Training Set Was Established

This information is not applicable, as there is no training set mentioned for this device.

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The Mitek GII Anchor (QUICKANCHOR) is intended for fixation of USP size #2 suture to bone for the indications listed below.
Shoulder: Bankart repair, SLAP lesion repair, acromio-clavicular separation, rotator cuff repair, capsule shift/capsulo-labral reconstruction, biceps tenodesis, deltoid repair.
Ankle: Lateral instability, medial instability, achilles tendon repair/reconstruction, midfoot reconstruction.
Foot: Hallux valgus reconstruction.
Wrist: Scapholunate ligament.
Hand: Ulnar or lateral collateral ligament reconstruction.
Elbow: Tennis elbow repair, biceps tendon reattachment.
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 GII QuickAnchor Plus is intended as an upgrade of the current GII Anchor. While retaining the current GII Anchor design, 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 GII Anchor is a metallic (6A1-4V ELI Titanium base and NiTi Titanium Alloy arcs) and is used to assist in the reattachment of soft tissue to bone. The anchor is identical to the currently marketed Mitek GII Anchor (K915889).

The provided text is a 510(k) summary for the GII QuickAnchor Plus device, which is a bone fixation staple. The primary purpose of a 510(k) submission is to demonstrate that a new device is "substantially equivalent" to a legally marketed predicate device, not necessarily to prove it meets specific performance criteria through a detailed clinical study with acceptance criteria.

Based on the provided text, there is no detailed information regarding acceptance criteria or specific studies proving the device meets them in the format requested. The submission focuses on demonstrating substantial equivalence to a predicate device (Mitek GII Anchor, K915889).

Here's an analysis of why the requested information isn't available in this document:

• Type of Device: The GII QuickAnchor Plus is a bone fixation staple. For this type of device, substantial equivalence often relies on material equivalence, design similarity, and biomechanical testing (demonstrating equivalent strength, pull-out force, etc.), rather than complex clinical studies with human participants and AI assistance.
• 510(k) Process: A 510(k) notification is a premarket submission made to FDA to demonstrate that the device to be marketed is at least as safe and effective as a legally marketed device (predicate device). It generally doesn't require new clinical data unless the technological characteristics differ significantly and raise new questions of safety or effectiveness.
• Content of the Document: The document explicitly states: "Based on the type of changes being made and the fact that the GII QuickAnchor Plus represents the same fundamental scientific technology as the existing GII Anchor; Mitek believes the GII QuickAnchor Plus is substantially equivalent to Mitek's existing GII Anchor (K915889)." It also mentions "Biocompatibility studies have demonstrated the GII QuickAnchor Plus Safety to be non-toxic, non-irritating, and non-cytotoxic." This paragraph serves as the equivalent of "proving acceptance criteria" for this type of submission.

Therefore, I cannot populate the table or answer most of the questions as the information is not present in the provided document.

However, I can extract the following relevant information:

• Device Type: Staple, Fixation, Bone (21 CFR 888.3030)
• Predicate Device: Mitek GII Anchor (K915889)
• Basis for Equivalence: Same fundamental scientific technology, design updates for ergonomics and visualization, identical metallic anchor components.
• Safety Testing Mentioned: Biocompatibility studies demonstrated the GII QuickAnchor Plus to be non-toxic, non-irritating, and non-cytotoxic.

Regarding the specific questions, here's what can be inferred or stated as not applicable/provided:

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

   • Acceptance Criteria: Not explicitly stated as quantitative performance metrics for a study. The primary "acceptance criterion" for a 510(k) is substantial equivalence to the predicate device in terms of safety and effectiveness.
   • Reported Device Performance: The document highlights improvements in ergonomics (single-handed operation) and visualization (increased inserter shaft length) over the predicate, but these are design features, not performance metrics like accuracy, sensitivity, or specificity. Biocompatibility is mentioned as demonstrating non-toxicity, non-irritation, and non-cytotoxicity.

2. Sample size used for the test set and the data provenance: Not applicable. This document does not describe a test set or clinical study of that nature.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No test set or ground truth establishment described for diagnostic performance.

4. Adjudication method for the test set: Not applicable.

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 not an AI-assisted diagnostic device.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an AI algorithm.

7. The type of ground truth used: Not applicable in the context of diagnostic device ground truth. For the biocompatibility studies, the "ground truth" would be the biological response (e.g., cell viability, irritation levels) measured against established safety thresholds.

8. The sample size for the training set: Not applicable. This is not an AI algorithm.

9. How the ground truth for the training set was established: Not applicable.

In summary, the provided document is a 510(k) summary for a medical device (bone fixation staple). It aims to demonstrate substantial equivalence to a predicate device, focusing on material, design, and basic safety (biocompatibility), rather than presenting a performance study with acceptance criteria often associated with diagnostic or AI-powered devices.

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