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The Fixone Hybrid Knotless Anchor is intended for fixation of suture (soft tissue) to bone in the shoulder, foot/ankle, knee and elbow in the following procedures:

Shoulder: Rotor Cuff Repair, Bankart Repair, Biceps Tenodesis, Acromio-Clavicular Separation Repair, Deltoid Repair, Capsular Shift or Capsulolabral Reconstruction;

Foot/Ankle: Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair;

Knee: Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, Posterior Oblique Ligament Repair, lliotibial Band Tenodesis;

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

The Fixone Hybrid Knotless Anchor is intended for reattaching soft tissue to bone with sutures. The anchor is manufactured from biodegradable materials (PLGA copolymer and β-TCP) and nonabsorbable PEEK tip. A nonabsorbable suture manufactured from cobraided UHMWPE and PET fibers is inserted into the anchor. The anchor is implanted using a provided driver.

This device is could used with instrument that manufactured by Aju Pharm Co.,Ltd. It is consist of 11 models. It provide non-sterile (user must sterilization before use).

Here's a summary of the acceptance criteria and the study that proves the device meets them, based on the provided FDA 510(k) summary for the Fixone Hybrid Knotless Anchor.

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size for the Test Set and Data Provenance

The document describes bench testing for mechanical and biocompatibility properties. It doesn't specify a "test set" in the context of patient data or clinical images. The tests were performed on the device components themselves.

• Sample Size: Not explicitly stated as a single number across all tests. Each test (e.g., tensile strength, insertion torque, various biocompatibility tests) would have its own sample size, which is not detailed but assumed to be sufficient for the relevant standards (e.g., ASTM, ISO, USP). For tensile strength, it mentions "measuring 10 suture threads."
• Data Provenance: The studies were bench tests conducted by the manufacturer, AJU Pharm Co., Ltd., which is located in Korea. The details provided do not indicate the use of retrospective or prospective patient data, as this is a physical device rather than a diagnostic or AI-driven system.

3. Number of Experts Used to Establish Ground Truth and Qualifications

This information is not applicable to this type of medical device submission. The Fixone Hybrid Knotless Anchor is a physical surgical implant, not a device that generates or interprets diagnostic images or data requiring expert review for ground truth. The "ground truth" here is established through adherence to recognized international and national standards (e.g., ISO, ASTM, USP) for mechanical properties, material properties, and biocompatibility.

4. Adjudication Method for the Test Set

This is not applicable as there is no "test set" in the clinical imaging or diagnostic sense requiring expert adjudication. The performance is assessed against predefined quantitative and qualitative criteria in bench testing.

5. Multi Reader Multi Case (MRMC) Comparative Effectiveness Study

This is not applicable. The device is a surgical anchor, not an AI-assisted diagnostic tool or a system that involves human readers interpreting output. Therefore, there is no concept of improving human reader performance with or without AI assistance in this context.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

This is not applicable. The Fixone Hybrid Knotless Anchor is a physical medical device, not a software algorithm or an AI system.

7. Type of Ground Truth Used

The "ground truth" in this submission is established through:

• International Standards: Adherence to widely recognized standards from organizations like ISO (e.g., ISO 10993 for biocompatibility, ISO 11135 for sterilization, ISO 11607 for packaging), ASTM (e.g., ASTM F2502, F1839, F1980-02 for mechanical and aging tests), and USP (e.g., USP<28> for material properties, USP39<151> for pyrogen, USP 43 <85> for endotoxin).
• Predicate Device Comparison: The primary method for proving substantial equivalence is demonstrating that the test results of the Fixone Hybrid Knotless Anchor are comparable to a legally marketed predicate device (Fixone Biocomposite Anchor, K192484) and meet relevant performance benchmarks. The new device is substantially similar, with the only noted difference being the material of the tip (PEEK in the new device versus PLGA + β-TCP in the predicate).

8. Sample Size for the Training Set

This is not applicable. There is no "training set" as this is not a machine learning or artificial intelligence device.

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

This is not applicable for the reasons mentioned above.

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