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The products found in the original 510(k) K971358 Bio-Interference Screw, will use the following indications for use:

• To provide interference fixation of bone-tendon-bone and soft tissue grafts in ACL reconstruction through arthroscopy or arthrotomy.

The products found in the original 510(k) K011172 Bio-Transfix, will use the following indications for use:
. To provide ACL graft fixation in the femur in orthopedic procedures.

The products found in the original 510(k) Arthrex FASTak Suture Anchor, K971723, K000506 Arthrex Bio-FASTak, K003227 Bio-Corkscrew Suture Anchor, and K003816 Titanium Corkscrew Suture Anchor are intended to fix suture to bone, and depending on size, will use the following indications for use:

• Rotator Cuff Repairs, Bankart Repair, SLAP Lesion Repair, Biceps Shoulder. Tenodesis, Acromio-Clavicular Separation Repair, Deltoid Repair, Capsular Shift or Capsulolabral Reconstruction
• Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair, Foot/Ankle: Hallux Valgus Reconstruction, Midfoot Reconstruction, Metatarsal Ligament Repair
• Medial Collateral Ligament Repair, Lateral Collateral Ligament Knee: Repair, Patellar Tendon Repair, Posterior Oblique Ligament Repair, Illiotibial Band Tenodesis
• Biceps Tendon Reattachment, Tennis Elbow Repair, Ulnar or Elbow: Radial Collateral Ligament Reconstruction
• Hand/Wrist: Scapholunate Ligament Reconstruction, Ulnar Collateral Ligament Reconstruction, Radial Collateral Ligament Reconstruction
• Bladder Neck suspension for female urinary incontinence due to Pelvis: urethral hyper mobility or intrinsic sphincter deficiency

The products found in the original 510(k) K990340 Arthrex Tissue Tak, are intended for fixation of soft tissue to bone for reattachment of the glenoid labrum or inferior glenohumeral ligament in patients with primary or recurrent anterior dislocation or subluxation of the shoulder in association with adequate post operative immobilization.

The products found in the original 510(k) K050749 Arthrex Tak Family are intended to be used for suture or tissue fixation in the foot, ankle, knee, hand, wrist, elbow, shoulder, and in select maxillofacial applications and will use the following indications for use:
Skull: Stabilization and fixation of oral cranio-maxillofacial skeletal bone, mandible and maxillofacial bones, Lateral Canthoplasty, Repair of Nasal Vestibular Stenosis, Brow Lift, Temporomandibular Joint (TMJ) reconstruction, soft tissue attachment to the parietal temporal ridge, frontal, zygoma, and perioorbital bones of the skull
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. 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
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 products found in the original 510(k), K051726 are intended to provide soft tissue reattachment, i.e. fixation of ligament and tendon graft tissue in surgeries of the shoulder, elbow, knee, foot/ankle, and hand/wrist. This product is intended for the following indications:

• Rotator Cuff Repairs, Bankart Repair, SLAP Lesion Repair, Biceps Shoulder. Tenodesis, Acromio-Clavicular Separation Repair, Deltoid Repair, Capsular Shift or Capsulolabral Reconstruction
• Foot/Ankle: Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair. Hallux Valgus Reconstruction, Midfoot Reconstruction, Metatarsal Ligament Repair, Flexor Hallucis Longus for Achilles Tendon reconstruction, tendon transfers in the foot and ankle
• Knee: Anterior Cruciate Ligament Repair, Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, Patellar Tendon Repair, Posterior Oblique Ligament Repair, Illiotibial Band Tenodesis
• Elbow: Biceps Tendon Reattachment, Ulnar or Radial Collateral Ligament Reconstruction
• Hand/Wrist: Scapholunate Ligament Reconstruction, Ulnar Collateral Ligament Reconstruction, Radial Collateral Ligament Reconstruction, Carpometacarpal joint arthroplasty (basal thumb joint arthroplasty), Carpal Ligament Reconstructions and repairs, tendon transfer in the hand/ wrist

The Arthrex metal and polymer implants are manufactured from titanium alloy conforming to ASTM F136, and medical grade polymers (PLLA and PLDLA). These implant families are made up of previous cleared devices. The screws, anchors, suture taks, and buttons are threaded or smooth, fully cannulated, partially cannulated, or non-cannulated, and offered with or without suture. Most of these implants are offered for sale with specific instruments and accessories.
The Arthrex implants described above will now be sold sterile by VHP or Vaporized Hydrogen Peroxide. This method of sterilization does not compromise the integrity of the materials used in the construction of the Arthrex implants. The method of VHP sterilization has been validated to an SAL 10°.

The provided 510(k) summary (K053338) for Arthrex Titanium and Bio-Degradable (polymer) Implants does not contain details directly related to acceptance criteria and performance of an AI/ML powered device, nor does it describe a study like those typically conducted for such devices (e.g., comparative effectiveness, standalone performance).

Instead, this submission focuses on demonstrating substantial equivalence to predicate devices for sterilization processing of existing implants. The "device" in this context is the physical implants themselves, and the "study" described is verification testing related to the change in sterilization method.

Therefore, many of the requested categories for AI/ML device studies are not applicable to this 510(k) submission. Below, I will address the relevant information from the provided document and explicitly state where information is not available or not applicable.

Acceptance Criteria and Device Performance (for sterilization method)

Study Details (for sterilization method as described in the 510(k))

1. Sample size used for the test set and the data provenance:

   • Sample Size: Not explicitly stated in the provided document.
   • Data Provenance: Not explicitly stated. The testing activities (Pull testing, shelf life, sterilization validation, microbiological testing) would have been conducted by Arthrex, Inc. or a contracted lab. The document does not specify country of origin for the data or if it was retrospective or prospective, though sterilization validation is inherently prospective.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

   • Not Applicable. For a sterilization validation and material integrity assessment, "ground truth" is typically established through standardized physical, chemical, and microbiological testing protocols rather than expert consensus on interpretation. The qualification of individuals conducting these tests would be in areas like microbiology, materials science, and engineering, but specific numbers and qualifications are not provided.

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

   • Not Applicable. Adjudication methods like 2+1 or 3+1 are used for human interpretation of medical images or data where there might be disagreement. For sterilization validation and non-clinical material testing, the results are typically quantitative and objective, following predefined pass/fail criteria.

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 type of study is specifically for AI/ML devices involving human readers and interpretation. The current submission is for physical implants with a new sterilization method.

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

   • Not Applicable. This is not an AI/ML algorithm. The "device performance" refers to the physical implants and the effectiveness of their sterilization.

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

   • For sterilization validation: The ground truth is objective, typically defined by established standards for sterility (e.g., SAL 10⁻⁶) and material integrity (e.g., meeting predefined physical and chemical specifications post-sterilization).
   • For non-clinical testing (pull testing, shelf life, microbiological testing): Ground truth is based on quantitative measurements against pre-established specifications and industry standards (e.g., ASTM F136 for titanium alloy).

7. The sample size for the training set:

   • Not Applicable. This submission does not involve an AI/ML model that requires a training set.

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

   • Not Applicable. No training set for an AI/ML model is involved.

Summary of the K053338 Submission:

The K053338 submission is concerned with a change in the sterilization method (from previous methods to Vaporized Hydrogen Peroxide - VHP) for existing Arthrex titanium and bio-degradable implants. The acceptance criteria and "study" are focused on demonstrating that this new sterilization method renders the devices sterile to an acceptable level (SAL 10⁻⁶) and does not negatively impact the material integrity or performance of the implants.

The submission claims substantial equivalence to predicate devices (Smith & Nephew products) that also utilize VHP sterilization for their implants, further supporting the safety and effectiveness of the proposed sterilization method for these types of materials. The non-clinical testing performed includes pull testing, shelf life testing, sterilization validation, and microbiological testing to verify these aspects.

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