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1. The Arthrex Bi-Cortical Bio-Post™ and Washers device is intended as an anchor device for suture or to secure soft tissue directly to bone in the shoulder, foot/ankle, knee, hand/wrist, and elbow in the following procedures:

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

Foot/Ankle: Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair, Reconstruction, Midfoot Reconstruction.

Knee: Anterior Cruciate Ligament Repair, Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, Patellar Tendon Repair, Posterior Oblique Ligament Repair, and Illiotibial Band Tenodesis.

Hand/Wrist: Scaphaolunate Ligament Reconstruction, Ulnar Collateral Ligament Radial Collateral Ligament Reconstruction.

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

2. The Arthrex Bi-Cortical Bio-Post™ and Washers device is intended for the maintenance of alignment, reduction, and fixation of fractures, osteotomies or arthrodesis of the upper extremity, ankle and foot.

Fusions/fracture of Phalangeal, Metacarpal, and Carpal Wrist arthrodesis Fractures of Distal radius, Olecranon, Radial head, Humeral condylar, Cancellous Osteotomies Malleolus, Ankle fractures, Metatarsal Correction of hallux valgus

The Arthrex Bi-Cortical Bio-Post™ and Washers device is a PLLA 6.5 mm diameter x 70 mm length post screw with a hybrid thread and two 16mm washers in two configurations, smooth and spiked.

This 510(k) premarket notification for the Arthrex Bi-Cortical Bio-Post™ and Washers describes a medical device, not a diagnostic AI system or software; therefore, the traditional acceptance criteria and study designs relevant to AI/ML performance (e.g., sensitivity, specificity, AUC, sample sizes for training/test sets, expert adjudication of ground truth, MRMC studies) are not applicable.

Instead, the submission focuses on demonstrating substantial equivalence to predicate devices. This means that the manufacturer asserts the new device is as safe and effective as a legally marketed device that is not subject to premarket approval.

Here's an analysis based on the provided document, addressing the spirit of your request where applicable to medical devices:

Acceptance Criteria and Device Performance (Substantial Equivalence)

For medical devices, the "acceptance criteria" for 510(k) clearance is typically that the device is shown to be substantially equivalent to a predicate device. This involves demonstrating that the new device has:

• The same intended use as a legally marketed predicate device.
• The same technological characteristics as the predicate device; OR
• Different technological characteristics, but the information submitted to FDA does not raise new questions of safety and effectiveness, and the device is as safe and effective as the legally marketed device.

In this case, the Arthrex Bi-Cortical Bio-Post™ and Washers, comprised of a PLLA 6.5 mm diameter x 70 mm length post screw with a hybrid thread and two 16mm washers, is deemed substantially equivalent to the following predicate devices:

Reported Device Performance (as per Substantial Equivalence Claim):
The document states: "The Arthrex Bi-Cortical Bio-Post™ and Washers device is substantially equivalent to the predicate devices where basic features and intended uses are the same. Any differences between the Arthrex Bi-Cortical Bio-Post™ and Washers and the predicate devices are considered minor and do not raise questions concerning safety and effectiveness. Based on the information submitted, Arthrex, Inc. has determined that the Bi-Cortical Bio-Post™ and Washers are substantially equivalent to the currently marketed predicated no r os cleared for the expanded indications."

This implies that the device performs similarly to these predicate devices in terms of its mechanical properties, biocompatibility (PLLA is a known biodegradable material), and ability to serve as a bone fixation appliance for the stated indications. Specific quantitative performance metrics (e.g., tensile strength, degradation rates) would have been submitted to the FDA as part of the supporting data for substantial equivalence, but are not detailed in this summary.

Study-Specific Information (Not Applicable to this 510(k) Summary)

The questions below are primarily relevant to performance studies for software as a medical device (SaMD) or AI/ML-based systems, which is not the nature of this submission. Thus, most of these fields will be marked as "Not Applicable".

1. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)

   • Not Applicable. This 510(k) summary does not describe a clinical performance study with a test set in the context of an AI/ML device. It's a submission for a mechanical implant. Safety and effectiveness are typically demonstrated through comparison to predicates, material testing, and sometimes bench testing, not through retrospective/prospective clinical data for a "test set" in the AI sense.

2. 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. No ground truth establishment by experts for a test set is described in this 510(k) summary. The "ground truth" for a mechanical device largely revolves around material properties, mechanical integrity, and biocompatibility, which are assessed through laboratory testing and established standards or comparison to predicates, rather than expert judgment on clinical data.

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

   • Not Applicable. No adjudication method is described.

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 is not an AI-assisted diagnostic device.

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

   • Not Applicable. This is a physical implant, not an algorithm.

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

   • Not Applicable. For this type of device, "ground truth" would be established through engineering specifications, material science testing (e.g., mechanical properties, biocompatibility per ISO standards), and clinical outcomes from predicate devices. These are not explicitly detailed as "ground truth" methods in this summary but are the underlying data types for substantial equivalence.

7. The sample size for the training set

   • Not Applicable. No training set is used as this is not an AI/ML device.

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

   • Not Applicable. No training set is used.

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