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The Auxilock Titanium Screw-In Suture Anchor is intended to be used with #2 Biobraid suture with white, blue, black colors for use for the reattachment of soft tissue to bone for the following indications:

Shoulder:
Bankart lesion repairs, SLAP lesion repairs, Acromiolavicular separation repairs, Rotator cuff tear repairs, Capsular shift or Capsutolabral reconstructions, Biceps tenodesis, and Deltoid Repairs, Anterior Shoulder Instability Repair.

Foot and Ankle:
Hallux valgus reconstruction, Medial or Lateral instability repairs/reconstructions, Achilles tendon repair/reconstructions, Mid-foot reconstruction, Metatarsal ligament/tendon repairs/reconstructions, Bunionectomy.

Elbow, Wrist and Hand:
Scapholunate ligament reconstruction, Unar or radial collateral ligament reconstructions, Lateral epicondylitis repair, Biceps tendon reattachment, Tennis elbow repair.

Knee:
Extra-capsular repairs: Medial collateral ligament repair. Lateral ligament repair. Posterior oblique ligament. Iliotibial band tenodesis, Patellar tendon repair - Vastus medialis obliquous advancement.

Hip:
Capsular repair, Acetabular labral repair.

The Titanium Screw-In Suture Anchor is a threaded, tapered fastener for use in attachment of soft tissue to bone. The self-tapping AUXILOCK® Titanium screw-in suture anchor is mostly used as a medial row anchor in rotator cuff repair surgery, Bankart or SLAP surgeries. It is recommended for use in small and large-joint repairs without the need for tapping or drilling. AUXILOCK® Titanium screw-in anchors are available in diameter of 2.8mm, 3.5mm, 5.0mm and 6.5mm. The anchor design incorporates a cancellous thread with a tiny core diameter to maximize pull-out strength in cancellous or osteoporotic bone. The AUXILOCK® Titanium screw-in anchor is designed for ultimate mechanical properties (pull-out strength, tensile strength, etc.) and ease-of-use. The anchor design incorporates a cortical thread with a small core diameter to maximize pull-out strength in a cortical or hard bone. The drill guide and drill bit are provided in the instrument set for the accurate placement of the anchor. It in turn minimizes the anchor slippage or breakage during the surgery.

All of the Auxein's Non-Absorbable Suture Anchors are provided sterile, for single use only. All Non-Absorbable Suture Anchors are preassembled onto an inserter, sized appropriately to accommodate the indicated procedures. Auxein's Non-Absorbable Suture Anchors come in various configurations, including: with attached non-absorbable suture(s). In certain configurations, the Non-Absorbable Suture Anchors are packaged with a guide and awl. All configurations of the Non-Absorbable Suture Anchors are identical to the identified predicate devices.

The device is made from a Titanium alloy, Ti-6Al-4V (ASTM F136) as per grade 5.

Note: The #2 Biobraid Suture is not to be used as a stand-alone. It should be used only with the assembled implant.

These implants are sold in sterile conditions (Ethylene Oxide Sterilization). The system is indicated for use in adult patients only. All implants are for single use only.

The provided text is a 510(k) premarket notification for a medical device called "Auxilock Titanium Screw-In Suture Anchor." It details the device's characteristics, intended use, and a comparison to predicate devices to demonstrate substantial equivalence.

However, this document does not contain information about acceptance criteria and a study that proves the device meets those criteria, specifically concerning an AI/ML-based medical device performance study. The document focuses on demonstrating substantial equivalence for a physical implantable device based on material standards, sterilization, mechanical performance (insertion, pull-out tensile static/fatigue), dimensional verification, shelf-life, and biocompatibility.

Therefore, I cannot fulfill your request to describe acceptance criteria and a study proving device performance for an AI/ML device, as the provided text pertains to a traditional medical implant and lacks any mention of AI/ML components or associated performance studies.

The document instead describes:

• Device Type: Auxilock Titanium Screw-In Suture Anchor (a physical implant).
• Performance Tests per document:
  • Material Standards (ASTM F136, ASTM F2848-17, ASTM F899-20)
  • Biocompatibility (ISO 10993-3)
  • Mechanical Performance (Insertion Test, Pull-Out Tensile Static Test, Pull-Out Tensile Fatigue Test)
  • Sterilization (ETO Sterilization, ISO 11135, ISO 17665, ISO 11140-1, ISO 11737-1, ISO 11737-2)
  • Packaging integrity (ISO 11607-1, ISO 11607-2, ASTM F1980, ASTM F88/F88M, ASTM F1929)
  • Shelf-life (5 years based on stability study)
  • Bacterial Endotoxin testing (USP , USP , ANSI/AAMI ST72:2019)

None of these tests align with the detailed questions regarding AI/ML device performance (like MRMC studies, standalone algorithm performance, ground truth establishment for training/test sets, or expert adjudication).

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