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The Parcus Knotless PEEK and PEEK CF Push-In Suture Anchors are indicated for attachment of soft tissue to bone. This product is intended for the following indications:
Shoulder Rotator Cuff Repair, Acromioclavicular Separation Repair, Bankart Lesion Repair, Biceps Tenodesis, Capsular Shift or Capsulolabral Reconstruction, Deltoid Repair, SLAP Lesion Repair.
Knee Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, Posterior Oblique Ligament Repair, Extra Capsular Reconstruction, lliotibial Band Tenodesis, Patellar Ligament and Tendon Avulsion Repair.
Foot/Ankle Lateral Stabilization. Medial Stabilization. Midfoot Reconstruction. Achilles Tendon Repair, Hallux Valgus Reconstruction, Metatarsal Ligament Repair.
Elbow Tennis Elbow Repair, Biceps Tendon Reattachment.
Hand/Wrist Scapholunate Ligament Reconstruction, Ulnar or Radial Collateral Ligament Reconstruction, TFCC.
Hip Acetabular Labral Repair

The Parcus Knotless PEEK and PEEK CF Push-In Suture Anchors are tapered fasteners with an eyelet at the distal tip and circumferential barbs used to secure the implant in bone and provide suture fixation without the need for knot tying. After passing through the target tissue, sutures are passed through the distal eyelet of the anchor, it is pounded into place which secures both the anchor and the suture in place. This is the same design and insertion technique as the predicate Knotless PEEK CF Push-In Suture Anchors. The predicate device was originally provided in 3.5mm and 4.5mm diameters and this 510(k) will expand that size range to include 2.8mm and 5.5mm options. The Knotless PEEK Push-In Suture Anchor is made from polyetheretherketone (PEEK) and the Knotless PEEK CF Push-In Suture Anchors are made from carbon fiber polyetheretherketone (PEEK CF). The Parcus predicate device is comprised of carbon fiber polyetheretherketone (PEEK CF). The Parcus reference devices consist of devices comprised of either PEEK or PEEK CF. The Parcus Knotless PEEK and PEEK CF Push-In Suture Anchors are provided sterile with a single use suture passer and either with or without a single use inserter.

This document describes the Parcus Knotless PEEK and PEEK CF Push-In Suture Anchors. The provided text is a 510(k) summary for a medical device and, as such, does not contain information about acceptance criteria or a detailed study proving the device meets those criteria in the context of diagnostic performance or AI model evaluation.

The "Summary Performance Data" section briefly mentions that the device was evaluated for "strength and elongation under cycle loading and ultimate failure conditions" and that "Results were compared with test data for the predicate device and demonstrated substantial equivalency." This indicates mechanical testing was performed to demonstrate that the new device performs comparably to an existing, legally marketed device (the predicate).

However, the document does not provide specific numerical acceptance criteria for these mechanical tests, nor does it detail the specific results. It also does not involve any AI, image analysis, or human reader performance evaluation, and therefore, many of the requested points are not applicable.

Below is an attempt to address the request based only on the provided text.

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample size used for the test set and the data provenance
The document does not specify the sample size for the mechanical performance tests. The data provenance is not explicitly stated in terms of country of origin, but it is implied to be from internal testing conducted by Parcus Medical, LLC. The testing is for a new device attempting to prove substantial equivalence to a predicate, so it is a prospective evaluation of the new device's performance against existing data or concurrent testing of the predicate.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. This is a mechanical device performance study, not a study requiring expert interpretation of diagnostic data.

4. Adjudication method for the test set
Not applicable. This is a mechanical device performance study.

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 document pertains to a physical medical device (suture anchors) and does not involve AI, image analysis, or human reader studies.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This document pertains to a physical medical device.

7. The type of ground truth used
For the mechanical tests, the "ground truth" (or reference) was the performance data of the predicate device (Parcus Knotless PEEK CF Suture Anchors, K113730) for "strength and elongation under cycle loading and ultimate failure conditions." For biocompatibility, the ground truth was based on the known materials and manufacturing processes of the predicate and reference devices. For pyrogenicity, it was an endotoxin limit specification.

8. The sample size for the training set
Not applicable. This document describes the testing of a physical medical device and does not involve a "training set" in the context of machine learning or AI.

9. How the ground truth for the training set was established
Not applicable. This document describes the testing of a physical medical device and does not involve a "training set" in the context of machine learning or AI.

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