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The Corifix Ligament Anchor Soft Screw is used for anterior and posterior cruciate ligament reconstruction using hamstrings. This technique provides reduced soft-tissue morbidity and reduced post operative pain on kneeling whilst improving the cosmetic appearance for the patient. The hamstring surgical technique and the Corifix Ligament Anchor Soft Screw work together for fixation of a hamstring tendon graft, without bone block, to achieve anatomic aperture fixation of the hamstring tendon graft in the tibia or femur.

The Corifix ligament Anchor is a headless, tapered, round threaded, cannulated screw manufactured from titanium alloy (6A1 4V) which conforms to BS 7252/3 and ASTM 136/96. The screw has a 3.5mm hex drive. The Ligament Anchor Soft Screw has been on the foreign (i.e. non-US) market since January 1997, since that date approximately 1,700 screws have been implanted. The Corifix Ligament Anchor Soft Screw has a rounded thread to prevent damage to the graft, is cannulated and tapered to aid insertion, and has a 3.5mm hex drive. The Corifix Ligament Anchor Soft Screw is available in four diameters i.e 7mm, 9mm & 10 mm, for each diameter of screw four lengths of screw are available i.e. 20mm, 25mm, 30mm, & 35 mm.

Here's an analysis of the provided text regarding the acceptance criteria and study for the Corifix Ligament Anchor Soft Screw:

It's important to note that the provided text is a 510(k) summary for a medical device submitted to the FDA for market clearance, not a detailed study report. Therefore, it focuses on demonstrating substantial equivalence to a predicate device rather than presenting a comprehensive clinical or standalone performance study in the way a clinical trial or AI algorithm validation would.

Acceptance Criteria and Reported Device Performance

Study Details

1. Sample size used for the test set and the data provenance:

   • Test Set Sample Size: For the mechanical testing, the text states "Independent mechanical testing of the most popular sizes of screw determined..." It does not specify the exact number of screws or tests performed.
   • Data Provenance: The mechanical testing was described as "Independent mechanical testing," implying an external lab. The clinical experience data (1,700 implanted screws) is from the "foreign (i.e. non-US) market."

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):

   • For the mechanical testing, the "ground truth" is based on engineering standards and direct physical measurement of fixation strength. Experts would be mechanical engineers or biomechanical researchers, but their specific number or qualifications are not stated as they are not establishing subjective ground truth from data.
   • For the clinical use, no "ground truth" derived from expert consensus on a test set is described. The 1,700 implants represent real-world use, and the absence of reported issues implicitly serves as a form of "ground truth" for safety/functionality.

3. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

   • Not applicable. This type of adjudication method is used for subjective evaluations (e.g., image interpretation). Mechanical testing relies on objective measurements that do not require human adjudication in this sense.

4. 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:

   • Not applicable. This device is a surgical implant, not an AI-powered diagnostic or assistive tool.

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

   • Not applicable. This is a physical medical device, not an algorithm. However, its "standalone" performance can be considered its mechanical strength and material properties.

6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

   • Material: Conformance to established international and national standards (BS 7252/3 and ASTM 136/96).
   • Mechanical Performance: Direct physical measurements of fixation strength compared against biomechanically derived "expected clinical loads."
   • Clinical Efficacy/Safety (implicit for 510k): Real-world outcomes data from the foreign market (1,700 implants without issues) implying acceptable safety and performance. This is not a controlled outcomes study, but rather a report of post-market experience.

7. The sample size for the training set:

   • Not applicable. This is a physical device, not a machine learning algorithm that requires a "training set."

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

   • Not applicable as there is no training set.

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