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The Auxilock Draw Tight Suture-Based Anchor is indicated for attachment of soft tissue to bone. This product is intended for the following indications:

Shoulder: Rotator Cuff Repair, Acromioclavicular Separation Repair, Bankart Lesion Repair, Biceps Tenodesis, Capsular Shift or Capsulolabral Reconstruction, Deltoid Repair, Superior Labrum, Anterior to Posterior Lesion Repair.

Knee: Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, Posterior Oblique Ligament Repair, Extra Capsular Reconstruction, Iliotibial Band Tenodesis, Patellar Ligament and Tendon Avulsion Repair.

Foot/Ankle: Lateral Stabilization, Medial Stabilization, Midfoot Reconstruction, Achilles Tendon Repair, Hallux Valgus Reconstruction, Metatarsal Ligament Repair.

Elbow: Tennis Elbow Repair, Biceps Tendon Reattachment.

Hand/Wrist: Scapholunate Ligament Reconstruction, Ulnar or Radial Collateral Ligament Reconstruction, Triangular Fibrocartilage Complex Tear.

AUXILOCK® Draw tight anchor is made with UHMWPE suture anchor body and PEEK OPTIMA eyelet tip. The Auxilock Draw Tight Anchors are designed for use in attachment of soft tissue to bone. The construct of the Draw Tight Anchors is such that when inserted into the bone and deployed via the included suture, a suture ball is created in the prepared socket that provides the necessary fixation. The Draw Tight Anchors are designed to accommodate both sliding and fixed sutures to be used for soft tissue fixation. The anchor is designed to deliver efficiency and promote ease of use. The anchor can be used for rotator cuff repair surgeries. The AUXILOCK® Draw tight suture based anchor provides a small footprint and also asserts subcortical fixation for anchor insertion. The Draw tight anchor is available in 1.8mm and 3.2mm diameter with various combination of BioBraid and suture tapes. The drill guide and anchor driver combination is well-designed to improve the performance and reliability. The Auxilock Draw Tight Suture-Based Anchor consists of the following types of implants:

• AUXILOCK® 1.8mm Draw Tight Suture-Based Anchor with One #2 BioBraid: White/Blue .
• AUXILOCK® 1.8mm Draw Tight Suture-Based Anchor with One 1.6mm Suture Tape: ● White/Blue
• AUXILOCK® 3.2mm Draw Tight Suture-Based Anchor with Two #2 BioBraid: White/Blue & ● White/Black
• AUXILOCK® 3.2mm Draw Tight Suture-Based Anchor with One #2 BioBraid And One 1.6mm Suture tape: White/Black & White/Blue
  The Auxilock Suture is a dyed or non-dyed braided suture construct made of UHMWPE. The proposed suture is braided flat with round ends, and is available in precut lengths in straight and loop configurations, and with or without needles. Suture ends are stiffened with cyanoacrylate. The Suture constructs meet USP standards for suture. The Suture is available in straight and loop configurations; and sizes #2 for suture, and 1.6mm (width) for tape.

AUXILOCK® BioBraid Suture

AUXILOCK® BioBraid Sutures are braided sterile sutures prepared from Ultra High Molecular Weight Polyethylene (UHMWPE). Sutures are non-absorbable and do not impose any significant changes in tensile strength retention known to occur in vivo. BioBraid sutures are available in a variety of colour combinations for easy suture management in complicated repairs.

Suture color additives

The UHMWPE sutures when made up of tracers can be with blue polypropylene (pigment ß-Cuphthalocyanine blue) or polyamide black (pigment hematein).

The color additive FD&C Blue 2, color additive Black logwood and color additive phtalocyanine are according to FDA and it is approved for use in medical applications (§74.3102 - FDA), (§73.1410 –FDA) and (§74.3045 – FDA) respectively.

AUXILOCK® BioBraid Suture Tape

AUXILOCK® BioBraid Suture Tape made from UHMPWE has a width of 1.6mm. The suture tape design accommodates the tape in the centre with a suture on the either sides of the tape.

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

Surgical instrumentation is included in Auxilock Draw Tight Suture-Based Anchor to allow the placement and attachment of the Anchors with bone. Various drill, anchor driver, Awl, Threading device, Tray, Containers and other components are included with the Auxilock Draw Tight Suture-Based Anchor. These Instruments are made from Stainless steel (SS 304) Material.

The provided text is a 510(k) summary for a medical device (Auxilock Draw Tight Suture-Based Anchor), which is a premarket notification to the FDA for a device that is substantially equivalent to a legally marketed predicate device. This type of submission relies on demonstrating similarity to existing devices and does not involve an AI/ML component or clinical studies meeting the criteria outlined in your request (e.g., multi-reader multi-case studies, expert consensus ground truth for image data, training/test sets for an algorithm).

Therefore, I cannot provide the specific information requested about acceptance criteria and study proving a device meets them, especially pertaining to AI/ML performance. The document focuses on demonstrating substantial equivalence through:

• Material Standards: Conformance to ASTM F2026-17 (PEEK) and ASTM F2848-17 (UHMWPE) for the anchor and suture, respectively, and ASTM F899-12 (Stainless Steel) for instruments.
• Biocompatibility: Evaluation according to ISO 10993.
• Performance Standards: Bench testing (static and fatigue loading) of pull-out strength, with results compared side-by-side to the predicate device. The document explicitly states "no significant differences."
• Sterilization, Shelf-life, and Packaging: Conformance to various ISO and ASTM standards related to EO sterilization, microbial methods, packaging integrity, and accelerated aging for a 5-year shelf life.
• Bacterial Endotoxin: Testing performed according to USP and .

In summary, the provided text describes a submission for a physical medical device (suture-based anchor) that is not an AI/ML-driven diagnostic or assistive technology. Consequently, there are no details about AI/ML acceptance criteria, test set characteristics (sample size, provenance), expert ground truth, adjudication methods, MRMC studies, standalone algorithm performance, or training set details as you've requested.

The "performance standards" mentioned relate to the physical and mechanical properties of the anchor itself, not the diagnostic performance of an AI algorithm.

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