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The CEPTRE® Knotted UHMWPE Suture PEEK Anchor are indicated in surgical procedures for soft tissue fixation to bone in the foot, ankle, knee, hand, wrist, elbow, shoulder and hip for the following indications:

• 1. Shoulder: Rotator Cuff Repair, SLAP Lesion Repair, Biceps Tenodesis, Acromio-Clavicular Separation Repair, Deltoid Repair Capsular Shift or Capsulolabral Reconstruction.
• 2. Foot Ankle: Lateral Stabilization, Medial stabilization, Achilles Tendon repair, Hallux Valgus reconstruction, Mid-foot reconstruction, Metatarsal ligament repair, Digital tendon transfers and Bunionectomy.
• 3. Knee: Anterior Cruciate Ligament Repair, Medial Collateral ligament repair, Lateral collateral ligament repair, Patellar Tendon Repair, Posterior Oblique Ligament Repair and Iliotibial band tenodesis.
• 4. Hand/Wrist: Scapholunate ligament reconstruction, Ulnar or Radial Collateral Ligament Reconstruction, Carpal Ligament Reconstruction, Repair/Reconstruction of collateral ligaments, Repair of Flexor and Extensor Tendons at the PIP, DIP, and MCP joints for all digits, Digital tendon transfers.
• 5. Elbow: Biceps tendon reattachment, Tennis Elbow Repair, Ulnar or Radial collateral ligament reconstruction, and lateral Epicondylitis repair.
• 6. Hip: Acetabular labral repair, Capsular repair and gluteus medius repair.

The CEPTRE® Knotted UHMWPE Suture PEEK Anchors are available as Screw Anchor (threaded) & Wedge Anchor (Tap in) which are preloaded with suture(s), tape(s) or suture-tape combinations on a disposable inserter assembly. The implant is supplied sterile and ready to use.

The provided document describes a 510(k) premarket notification for a medical device called the CEPTRE® Knotted UHMWPE Suture PEEK Anchor. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than a clinical effectiveness study. Therefore, some of the requested information, such as sample size for test sets, data provenance, number of experts for ground truth, adjudication method, MRMC studies, standalone performance, and training set information, is not applicable or not provided in this specific type of regulatory document.

However, the document does contain information regarding acceptance criteria in the form of performance data and the study undertaken to demonstrate substantial equivalence.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for the CEPTRE® Knotted UHMWPE Suture PEEK Anchor are based on demonstrating mechanical performance statistically equivalent to the predicate devices. The document reports that the device successfully met these criteria.

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

• Sample Size: The document does not specify the exact sample sizes used for the mechanical tests (pull-out strength, cyclical loading, drive-in torque) or for bacterial endotoxin and packaging tests. For regulatory submissions like 510(k), it is common to use statistically significant sample sizes, but the explicit numbers are often not included in the public summary.
• Data Provenance: The studies are non-clinical, likely conducted in a laboratory setting. There is no information on country of origin for the data or whether it was retrospective or prospective, as these terms typically apply to clinical studies with human participants.

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

Not applicable. This device, being a mechanical implant, does not involve diagnostic interpretation or ground truth established by medical experts in the way a diagnostic imaging AI would. The "ground truth" for the performance tests is the objective measurement of mechanical properties and biological safety.

4. Adjudication Method for the Test Set

Not applicable. As noted above, this involves objective mechanical and biological safety testing, not subjective interpretation requiring adjudication.

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-powered diagnostic device, but a physical surgical implant. Therefore, MRMC studies and human reader improvement with AI assistance are irrelevant to this submission.

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

Not applicable. This is a physical, non-AI medical device.

7. The Type of Ground Truth Used

The "ground truth" for the device's performance is established through:

• Objective Mechanical Measurements: For pull-out strength, cyclical loading, and drive-in torque, the truth is the quantitative force, cycles, and torque measured according to established engineering and material science standards.
• Biological Safety Standards: For bacterial endotoxin, the truth is defined by the pyrogen limit specifications outlined in USP .
• Packaging Performance Standards: For packaging, the truth is established by the ability of the packaging to maintain sterility and product integrity under defined conditions.

These are all objective, measurable criteria, not subjective expert consensus or pathology.

8. The Sample Size for the Training Set

Not applicable. This is a physical product, not an AI model that requires a training set.

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

Not applicable. As this device does not use a training set, this information is not relevant.

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