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The 2.5mm Arthrex Mini Bio-PushLock is intended to be used for suture or tissue fixation in the foot, ankle, knee, hand, wrist, elbow, shoulder, and hip. Specific indications are listed below:

Elbow: Biceps Tendon Reattachment, Ulnar or Radial Collateral Ligament Reconstruction

Shoulder: Rotator Cuff Repairs, Bankart Repair, Biceps Tenodesis, Acromio-Clavicular Separation Repair, Deltoid Repair, Capsular Shift or Capsulolabral Reconstruction

Hand/Wrist: Scapholunate Ligament Reconstruction, Carpal Ligament Reconstructions, Repair/Reconstruction of collateral ligaments, Repair of Flexor and Extensor Tendons at the PIP, DIP, and MCP joints for all digits, Digital Tendon Transfers

Foot/Ankle: Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair, Metatarsal Ligament Repair, Hallux Valgus reconstruction, Digital Tendon Transfers, Mid-foot Reconstruction

Knee: Medial Collateral Ligament Repair, Lateral Ligament Repair, Patellar Tendon Repair, Posterior Oblique Ligament Repair, Iliotibial Band Tenodesis

The 2.9mm BioComposite PushLock is intended to be used for suture or tissue fixation in the foot, ankle, knee, hand, wrist, elbow, shoulder, and hip. Specific indications are listed below:

Elbow: Bicens Tendon Reattachment, Tennis Elbow Repair.Unar or Radial Collateral Ligament Reconstruction, Lateral Epicondylitis Repair

Shoulder: Rotator Cuff Repair, Bankart Repair, SLAP Lesion Repair, Biceps Tenodesis, Acromio-Clavicular Separation Repair, Deltoid Repair, Capsular Shift or Capsulolabral Reconstruction

Hand/Wrist: Scapholunate Ligament Reconstruction, Ulnar or Radial Collateral Ligament Reconstruction

Foot/Ankle: Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair, Metatarsal Ligament Repair, Hallux Valgus reconstruction, Digital Tendon Transfers, Mid-foot Reconstruction, Bunionectomy

Knee: Medial Collateral Ligament Repair, Lateral Ligament Repair, Patellar Tendon Repair, Posterior Oblique Ligament Repair, Iliotibial Band Tenodesis

Hip: Capsular Repair, Acetabular Labral repair

The Arthrex PushLock is a two piece "push-in" suture anchor device comprising a biodegradable anchor body manufactured from either PLLA or PLDLA/betaTCP with a polyetheretherketone (PEEK) eyelet pre-loaded on a disposable inserter. The anchor body ranges in diameter from 2.5mm to 2.9mm and 8mm to 15.5mm in length.

Here's a breakdown of the acceptance criteria and study information based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not explicitly state a sample size for a "test set" in the context of validating a device for its intended use or performance against a specific clinical outcome. The testing mentioned (inherent viscosity, peak load, bacterial endotoxin) is related to material properties and safety rather than a clinical performance test.

• Sample Size: Not explicitly stated for a "test set" in the traditional sense of clinical or performance validation. It refers to the number of units tested for material properties and shelf-life.
• Data Provenance: The testing was performed after four years on the shelf, indicating a controlled laboratory environment. No country of origin for the data is specified, but the submission is from Arthrex Inc. in Naples, Florida, USA, implying U.S. based testing or standards. The testing is retrospective in the sense that it evaluates the effects of storage over time.

3. Number of Experts Used to Establish Ground Truth and Qualifications

Not applicable. This device is a surgical implant (suture anchor), and the submitted data pertains to material properties, shelf-life, and biocompatibility, not a diagnostic or AI-driven device requiring expert-established ground truth from images or clinical assessments.

4. Adjudication Method for the Test Set

Not applicable. There was no "test set" in the context of diagnostic performance requiring adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No. This is a surgical implant, not a diagnostic device that would typically undergo an MRMC study.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

Not applicable. This is a surgical implant, not a software algorithm.

7. The Type of Ground Truth Used

The "ground truth" for the tests performed relates to:

• Material Specifications: Established limits for inherent viscosity and minimum peak load for the biodegradable materials (PLLA, PLDLA/βTCP) to ensure structural integrity and proper degradation over time.
• Regulatory Standards: Pyrogen limit specifications as defined by EP 2.6.14/USP for bacterial endotoxin.

8. The Sample Size for the Training Set

Not applicable. This is a physical medical device, not a machine learning model, so there is no "training set."

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

Not applicable. There is no training set for this type of device.

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The Arthrex Graft-Anchor is intended to be used for suture or tissue fixation in the foot/ankle, knee, hand/wrist, elbow, and shoulder. Specific indications are listed below:

Elbow: Biceps Tendon Reattachment, Ulnar or Radial Collateral Ligament Reconstruction
Shoulder: Rotator Cuff Repair, Bankart Repair, SLAP Lesion Repair, Biceps Tenodesis, Acromio-Clavicular Separation Repair, Deltoid Repair, Capsular Shift or Capsulolabral Reconstruction
Hand/Wrist: Scapholunate 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, Carpal Ligament Reconstruction and Carpometacarpal joint arthroplasty (basal thumb joint arthroplasty)
Foot/Ankle: Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair, Metatarsal Ligament Repair, Hallux Valgus reconstruction, digital tendon transfers, Mid-foot reconstruction
Knee: Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, Patellar Tendon Repair, Posterior Oblique Ligament Repair, Iliotibial Band Tenodesis

The Arthrex Graft-Anchor is a one-piece titanium “push-in” anchor and comes pre-loaded on a driver.

This is a 510(k) summary for a medical device called the Arthrex Graft-Anchor, which is a bone fixation screw. This type of submission relies on demonstrating substantial equivalence to a legally marketed predicate device rather than conducting new clinical trials to prove efficacy or deriving acceptance criteria from such trials. Therefore, the information requested regarding acceptance criteria and studies demonstrating that the device meets those criteria, as typically understood for AI/diagnostic devices, is not directly applicable in the same way.

However, based on the provided text, I can infer and extract information relevant to the substantial equivalence argument, which serves a similar function to demonstrating device performance.

Here's an analysis based on your questions:

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

The acceptance criteria in this context are tied to the concept of substantial equivalence to the predicate device (K063479: Arthrex Mini PushLock). The primary performance characteristic used for comparison is pull-out strength.

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 for Test Set: Not specified in the provided document. The "test set" here refers to the number of Arthrex Graft-Anchors used in the mechanical testing.
• Data Provenance: Not specified, but given it's mechanical testing by the manufacturer (Arthrex, Inc., based in Naples, FL, USA), it's highly likely to be internal, prospective mechanical testing conducted in the USA.

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. For a mechanical device like a bone fixation screw, the "ground truth" for performance is established through physical mechanical testing according to recognized standards, not by expert consensus or interpretation of clinical data in the same way an AI diagnostic would be. There are no experts in this context establishing "ground truth" for device performance.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. Adjudication methods are relevant for subjective interpretations (e.g., image reading). Mechanical testing results are objective measurements.

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 (bone fixation screw), not an AI diagnostic algorithm or an assistive technology for human readers.

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

Not applicable. This is a physical medical device, not an algorithm.

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

The "ground truth" for the performance claim (pull-out strength) is established through physical mechanical testing and measurement. This typically involves laboratory setups designed to apply controlled forces and measure the point at which the anchor fails or dislodges from a surrogate material (e.g., synthetic bone).

8. The sample size for the training set

Not applicable. This is a physical medical device, not a machine learning model that requires a "training set."

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

Not applicable. As above, this device does not involve a training set.

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