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The Bio-Anchor is a bioabsorbable device used for soft tissue to bone fixation in orthopedic applications except for anterior or posterior cruciate ligament repair or reconstruction.

Shoulder:

1. Bankart lesion repairs
2. SLAP lesion repairs
3. Acromio-clavicular separation repairs
4. Rotator cuff tear repairs
5. Capsular shift or capsulolabral reconstructions
6. Biceps tenodesis
7. Deltoid repairs

Foot and Ankle:

1. Hallux Valgus repairs
2. Medial or lateral instability repairs/reconstructions
3. Achilles tendon repairs/reconstructions
4. Midfoot reconstructions

Elbow, Wrist and Hand:

1. Scapholunate ligament reconstructions
2. Ulnar or radial collateral ligament reconstructions
3. Tennis elbow repair
4. Biceps tendon reattachment

Knee:

1. Extra-capsular repairs and reattachments of:
   a. medial collateral ligament
   b. lateral collateral ligament
   c. posterior oblique ligament or joint capsule to tibia
   d. joint capsule closure to anterior proximal tibia
2. Extracapsular reconstruction, iliotibial band tenodesis
3. Patellar realignment and tendon repairs

The Bio-Anchor is a PLLA suture anchoring device. The device is cylindrical in shape with three circular ribs perpendicular to the long axis. The first and second ribs are the same size, with the proximal, third rib wider to allow for a centrally located eyelet running perpendicular to the long axis of the device. Freely passing suture is then threaded onto the Bio-Anchor by the surgeon. The lack of permanent attachment of the suture to the Bio-Anchor allows the use of sliding knots. Once the Bio-Anchor is implanted, the ends of the suture are passed through the soft tissue and tied for reattachment. Synthetic non-absorbable, polyester USP #0, #1, or #2 suture is recommended for use with this device.

The material used for this device is:

Anchor - Poly (L-lactic) acid (PLLA)

The provided text is a 510(k) Summary of Safety and Effectiveness for the Linvatec Bio-Anchor™ Absorbable Suture Anchor. It primarily focuses on demonstrating substantial equivalence to a predicate device rather than detailing specific acceptance criteria and a performance study with quantitative results.

Therefore, many of the requested categories regarding acceptance criteria, study design, sample sizes, ground truth establishment, and MRMC studies cannot be answered directly from the provided document. The document describes the device, its intended use, and its similarities and dissimilarities to predicate devices. It refers to a "chart of similarities and dissimilarities" to demonstrate substantial equivalence, which is a qualitative comparison rather than a formal performance study with acceptance criteria.

Below is an attempt to address your request based only on the information provided in the input, with many fields explicitly marked as "Not provided in the document."

Acceptance Criteria and Device Performance

Since this is a 510(k) submission primarily focused on substantial equivalence, specific numeric acceptance criteria for performance are not explicitly stated in the provided text. The "performance" demonstrated is typically compliance with mechanical and material properties similar to the predicate device. The table below represents a qualitative comparison used for substantial equivalence rather than quantitative acceptance criteria.

Study Details

1. Sample size used for the test set and the data provenance: Not provided in the document. The document describes a comparison to predicate devices for substantial equivalence, not a performance study with a defined test set.
2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable/Not provided. Ground truth establishment for a clinical test set is not described as part of this 510(k) submission.
3. Adjudication method for the test set: Not applicable/Not provided.
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: Not applicable. This document is for a medical device (suture anchor), not an AI-assisted diagnostic or therapeutic tool.
5. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable. This is not an algorithm.
6. The type of ground truth used: Not applicable/Not provided. The basis for approval is substantial equivalence to a legally marketed predicate device, primarily based on design, materials, and intended use, rather than a clinical performance study with "ground truth" as typically understood in diagnostic device evaluation.
7. The sample size for the training set: Not applicable/Not provided. This is a medical device, not an AI model requiring a training set.
8. How the ground truth for the training set was established: Not applicable/Not provided.

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