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SECULOK™ Suture Anchor is for fixation or reattachment of soft tissue including ligament and tendon to bone especially with below indications.

• Shoulder:
  Bankart repair, SLAP lesion repair, Acromio-Clavicular separation repair, Rotator Cuff repair, Capsular shift or Capsulolabral reconstruction, Biceps tenodesis, Deltoid repair.

• Foot/Ankle:
  Medial or lateral stabilization, Achilles tendon repair.

• Elbow/Wrist/Hand:
  Ulnar or Radial collateral ligament reconstruction, Lateral epicondylitis repair, Biceps tendon reattachment.

• Knee:
  Extra-capsular repairs: Medial/lateral ligament repair, posterior oblique ligament repair, Iliotibial band tenodesis Patellar realignment and tendon repairs : Vastus medialis obliquous advancement

The SECULOK™ Suture Anchor consists of two types, Suture Anchor and Knotless Anchor.

The Suture Anchor is an implant used for fixation of sutures into bone. The implant is made of PEEK (ASTM F2026) and works with preloaded 1 ~ 3 USP#2 size sutures (Ultra High Molecular Weight Polyethylene(UHMWPE, ASTM F2848)). The Suture Anchor is provided sterile as single package including the implant and inserter for users to use without additional process of sterilization in hospitals.

The Knotless Anchor is an implant used for fixation of sutures into bone. The implant is made of PEEK (implant body) and Titanium alloy (tip, ASTM F136) and fixate the USP #2 sutures without knotting. The Knotless Anchor is provided sterile as single package including the implant and inserter for users to use without additional process of sterilization in hospitals.

The SECULOK™ Suture Anchor comes preloaded on a disposable inserter made from surgical grade stainless steel and ABS plastic. The entire product is packaged in a box with a Tyvek® lid, and blister the finished product is sterilized by ethylene oxide. Both the implant, suture and inserter are designed for single use only and supplied non-pyrogenic.

Based on the provided text, the document describes a 510(k) premarket notification for the SECULOK™ Suture Anchor, demonstrating its substantial equivalence to predicate devices through performance testing.

Here's the breakdown of the acceptance criteria and the study that proves the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance:

The document indicates that the acceptance criteria for performance testing were developed using data from the primary predicate devices: CrossFT BC Suture Anchor (K101100) and PushLock™ (K101679). The reported device performance is that "The all tests met all acceptance criteria and that verifies performance of the SECULOK™ Suture Anchor is substantially equivalent to predicate devices."

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

The document refers to "non clinical setting (bench testing)" for performance testing. It does not explicitly state the sample size used for each specific test or the "test set" in terms of data provenance (e.g., country of origin, retrospective/prospective). This information is typically detailed in the full test reports that support the 510(k) submission, but it's not present in this summary.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts:

This section is not applicable to this type of submission. The performance testing described is bench testing of the physical device's mechanical properties, not a clinical study involving human or animal subjects where expert ground truth would be established for diagnoses or assessments. The "ground truth" for these tests is based on established engineering standards (ASTM, USP) and mechanical properties of predicate devices.

4. Adjudication Method for the Test Set:

This section is not applicable. Since the testing is bench testing of mechanical properties, no adjudication by human experts is involved. The results are quantitative measurements against defined criteria.

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:

This section is not applicable. The SECULOK™ Suture Anchor is a physical medical device (suture anchor), not an AI-powered diagnostic or assistive technology. Therefore, an MRMC study related to AI assistance for human readers would not be relevant.

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

This section is not applicable. As explained above, the SECULOK™ Suture Anchor is a physical medical device, not an algorithm or AI system.

7. The Type of Ground Truth Used:

For the performance testing, the "ground truth" is established by:

• Established engineering standards: ASTM F543-17 for torsional properties and driving torque, USP 29 for suture tensile strength.
• FDA guidance documents: Premarket Notification (510(k)) Submissions for Bone Anchors Draft Guidance (January 3, 2017) for axial pullout strength and fatigue tests.
• Mechanical performance data of legally marketed predicate devices: CrossFT BC Suture Anchor (K101100) and PushLock™ (K101679). The acceptance criteria were specifically "developed using the data of the primary predicate."

8. The Sample Size for the Training Set:

This section is not applicable. There is no "training set" in the context of this device and the described performance testing. Training sets are typically associated with machine learning or AI algorithm development, which is not relevant here.

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

This section is not applicable for the same reasons as point 8.

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