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The MectaFix CL Fixation Button with Continuous Loop is indicated for use in reconstructive treatment and extracortical femoral fixation of an implanted anterior cruciate ligament reconstruction.

The MectaFix CL Fixation Button with Continuous Loop is an implantable fixation button with a continuous loop used for the femoral fixation of the anterior cruciate ligament (ACL) graft by means of an extra-cortical suspensory fixation. It consists of a metal elongated button (Ti6AI4V ELI), a continuous loop (UHMWPE) ranging in length from 15 mm to 60 mm to be coupled with the graft, and a pulling suture (UHMWPE) to pull the construct through the prepared bone tunnel and to subsequently flip the button after passing the femoral lateral cortex. The MectaFix CL Fixation Button with Continuous Loop implants are provided sterile and are provided in single-use packages.

Here's a breakdown of the acceptance criteria and study information for the MectaFix CL Fixation Button with Continuous Loop, based on the provided FDA 510(k) summary:

1. Table of Acceptance Criteria and Reported Device Performance

Important Note: The provided 510(k) summary only states that "Testing was conducted according to written protocols with acceptance criteria that were based on standards." It does not provide the specific quantitative acceptance criteria or the detailed reported performance results for the mechanical tests (cyclic loading, tensile strength, cadaver testing). These details would be contained within the full 510(k) submission but are not summarized here. For pyrogenicity, it mentions the tests performed and the absence of a "non-pyrogenic" label, implying the tests confirmed acceptable pyrogen levels without claiming complete absence.

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

The document does not explicitly state the sample sizes for the "worst-case implants" used in the non-clinical studies. It also doesn't specify data provenance (country of origin, retrospective/prospective) for any of the test data. These are non-clinical (mechanical and sterility) studies, so clinical data provenance is not applicable here.

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

This information is not applicable. The studies described are non-clinical (mechanical, sterilization, shelf-life, pyrogenicity) and do not involve human subjects or expert assessment for ground truth.

4. Adjudication Method for the Test Set

This information is not applicable. The studies are non-clinical and do not involve adjudication by experts.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size

No, an MRMC comparative effectiveness study was not done. This is a submission for a mechanical fixation device, not an imaging or diagnostic AI device.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

No, a standalone algorithm performance study was not done. This device is a physical implant, not an algorithm.

7. The Type of Ground Truth Used

The "ground truth" for these tests is based on engineering standards and established scientific methods. For example:

• Mechanical properties: Defined by ASTM standards (e.g., ASTM D2256/D2256M-10 for tensile strength).
• Sterilization: Defined by recognized sterilization standards and validation protocols.
• Pyrogenicity: Defined by pharmacopoeial monographs (e.g., European Pharmacopoeia §2.6.14, USP , USP ).
• Cadaver testing: Likely involves biomechanical evaluation against established performance benchmarks for ACL fixation.

8. The Sample Size for the Training Set

This information is not applicable as this is not an AI/machine learning device. The non-clinical tests do not involve training sets.

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

This information is not applicable as this is not an AI/machine learning device.

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