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The Fixone Biocomposite Small Anchor are intended to be used fixation to bone in the foot, ankle, knee, hand, wrist, elbow, shoulder, and hip.

Shoulder: Rotator Cuff Repair, Bankart Repair, SLAP Lesion Repair, Biceps Tenodesis, Acromio-Clabicular Separation Repair, Deltoid Repair, Capsular Shift or Capsulolabral Reconstruction

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 Ligament Repair, Patellar Tendon Repair, Posterior Oblique Ligament Repair, Iliotibial Band Tenodesis

Hand Wrist: Scapholunate Ligament Reconstruction, Carpal Ligament Reconstruction of collateral ligaments, Repair of Flexor and Extensor Tendons at the PP, DIP, and MCP joints for all digits, digital tendon transfers Elbow: Biceps Tendon Reattachment, Ulnar or Radial Collateral Ligament Reconstruction

Hip: Capsular repair, Acetabular Labral repair

The Fixone Biocomposite Small Anchor is intended for reattaching soft tissue to bone with sutures. It consists of Driver, Anchor, Non-absorbable suture and needle. A needle was attached to the end of the suture so that it could penetrate the damaged soft tissue to enable it to be used for OPEN surgery without arthroscopy. The anchor is manufactured from biodegradable materials (PLGA copolymer and beta-TCP). A non absorbable suture manufactured from co-braided UHMWPE and PET fibers is inserted into the anchor is implanted using a provided driver.

The provided text is a 510(k) summary for the Fixone Biocomposite Small Anchor, a medical device intended for soft tissue to bone fixation. It details the device's characteristics, intended use, and performance data used to demonstrate substantial equivalence to a legally marketed predicate device.

Here's a breakdown of the acceptance criteria and the study that proves the device meets them, based on the provided document:

Acceptance Criteria and Reported Device Performance

The acceptance criteria for the Fixone Biocomposite Small Anchor are primarily based on demonstrating substantial equivalence to a predicate device (Arthrex SutureTak Suture Anchor) through a series of bench tests and biocompatibility evaluations. The "Requirements" column in the table implicitly defines the acceptance criteria, and the "Results" column indicates whether these criteria were met.

1. Table of Acceptance Criteria and Reported Device Performance:

Study Details:

The provided document describes a bench testing and biocompatibility testing study conducted to demonstrate the substantial equivalence of the Fixone Biocomposite Small Anchor to its predicate device. This is a common approach for Class II medical devices seeking 510(k) clearance, where clinical trials are often not required if substantial equivalence can be demonstrated through non-clinical data.

2. Sample Size used for the test set and the data provenance:

   • Sample Size: The document does not explicitly state the specific number of units/samples used for each bench test (e.g., number of anchors for pull-out tests, number of extracts for chemical analysis). It simply states that "Bench test were performed." and "The tests demonstrated that the device performs in a substantially equivalent manner to the predicate device." For biocompatibility, it states "Test result" for each test, implying a sufficient number of test articles were used as per the specified ISO/ASTM standards.
   • Data Provenance: The tests were performed by AJU Pharm Co.,Ltd. in Korea, which is the manufacturer. The data is retrospective, as it's presented after the tests were conducted.

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

   • Not Applicable. This type of study (bench testing and biocompatibility) does not involve human experts establishing "ground truth" for a test set in the way an AI diagnostic study would where radiologists label images. The "ground truth" here is established by adherence to recognized international standards (ISO, ASTM, USP, OECD) and their inherent testing methodologies, which are designed to be objective and reproducible.

4. Adjudication method for the test set:

   • Not Applicable. Adjudication methods (like 2+1 or 3+1 by experts) are pertinent to studies involving human interpretation or clinical outcomes, typically in AI/diagnostic device evaluations. For bench testing and biocompatibility, the results are typically quantitative or qualitative "pass/fail" outcomes based on pre-defined standard 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:

   • No, an MRMC comparative effectiveness study was not done. This type of study is relevant for AI-powered diagnostic devices where human readers (e.g., radiologists) use the device to assist in interpretation. The Fixone Biocomposite Small Anchor is a physical implant, not a diagnostic tool.

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

   • Not Applicable. As a physical medical device (biocomposite anchor), the concept of "standalone algorithm only performance" does not apply. The device's performance is measured directly through physical and chemical properties and biological interactions, not through an algorithm.

7. The type of ground truth used:

   • The "ground truth" for this device is based on established industry standards and regulatory requirements for medical device safety and performance. This includes:
     • Biocompatibility Standards: ISO 10993 series for biological evaluation of medical devices (e.g., cytotoxicity, systemic toxicity, irritation, sensitization, genotoxicity, implantation).
     • Material and Mechanical Testing Standards: ASTM (e.g., F2502 for bioabsorbable devices, F1839 for foam testing) and USP (pharmacopeial standards).
     • Comparison to Predicate Device: The performance and safety profile of the predicate device (Arthrex SutureTak Suture Anchor) acts as a de facto "ground truth" for establishing substantial equivalence in terms of intended use, principle of operation, and general safety/performance characteristics.

8. The sample size for the training set:

   • Not Applicable. There is no "training set" in the context of this device's evaluation. This is not an AI/machine learning device that requires training data. The device's design and manufacturing processes are established based on engineering principles and regulatory guidance, not learned from data.

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

   • Not Applicable. Since there is no training set, there is no ground truth established for one.

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