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The GENESYS PressFT Suture Anchor is intended to reattach soft tissue to bone in orthopedic surgical procedures. The system may be used in either arthroscopic or open surgical procedures. After the suture is anchored to the bone, it may be used to reattach soft tissue, such as ligaments, tendons, or joint capsules to the bone. The suture anchor system thereby stabilizes the damaged soft tissue, in conjunction with appropriate postoperative immobilization, throughout the healing period. Additional indications include acetabular labral repair and capsular repair in the hip.

The ConMed Linvatec GENESYS PressFT™ Suture Anchor is a device that is used to assist the surgeon in reattaching soft tissue to bone. The device includes anchors manufactured of 96L/4D copolymer + B-TCP and one (1) or two (2) Hi-Fi® sutures manufactured of ultra-high molecular weight polyethylene. The device is bioabsorbable and is available in two sizes: 1) a 2.5mm diameter x 9.8mm length suture anchor that is utilized with a 2.1mm drill bit, and 2) a 3.0mm diameter x 10.6mm length suture anchor that is utilized with a 2.6mm drill bit. A disposable inserter is included to implant the suture anchor. The disposable inserter device has a stainless steel shaft with a polycarbonate handle that is provided sterile, for single use and is removed at the end of the repair leaving behind the suture anchor construct. After the suture is anchored to the bone, it may be used to reattach soft tissue, such as ligaments, tendons, or joint capsules to the bone. The suture anchor system thereby stabilizes the damaged soft tissue, in conjunction with appropriate postoperative immobilization, throughout the healing period. Additional surgical instruments, including drill bits, guides and obturators, are Class I, non-sterile, reusable devices intended for transient use during orthopedic procedures.

This document describes the premarket notification (510(k)) for the ConMed Linvatec GENESYS PressFT™ Suture Anchor. As a 510(k) submission, the primary goal is to demonstrate substantial equivalence to a legally marketed predicate device, not necessarily to independently prove specific performance against a predefined acceptance criterion study in the same way a PMA or a de novo submission might.

Therefore, the information presented is focused on demonstrating the GENESYS PressFT™ Suture Anchor's equivalence to existing devices through various types of testing, rather than a standalone clinical study against specific acceptance criteria for a novel device.

1. Table of Acceptance Criteria and Reported Device Performance

The submission does not present a formal table of "acceptance criteria" against which a clinical performance study was conducted. Instead, it describes a series of engineering and biocompatibility tests conducted to demonstrate the safety and effectiveness of the device and its substantial equivalence to predicate devices. The "reported device performance" is essentially that the device passed these tests.

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

The document does not specify the sample sizes for the individual engineering, biocompatibility, sterilization, shelf-life, or packaging tests.

• Test Set Sample Size: Not explicitly stated for each test, but implied to be sufficient for engineering and biocompatibility evaluations. These are typically benchtop or in-vitro tests, not human clinical trials.
• Data Provenance: The data is generated from laboratory testing conducted by the manufacturer, ConMed Linvatec. This is assumed to be prospective for the purpose of this submission, though it's in vitro or ex vivo testing, not human-patient data. The country of origin of the data is not specified but is implicitly from the manufacturer's testing facilities (likely in the US given the submission to the FDA).

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

Not applicable. This is not a study requiring expert readers or ground truth establishment in the clinical diagnostic sense. The "ground truth" for these tests would be the specific pass/fail criteria for each engineering or biocompatibility test, typically defined by engineering standards, regulatory guidelines (e.g., ISO for biocompatibility), or internal company specifications derived from predicate device performance.

4. Adjudication Method for the Test Set

Not applicable. There is no adjudication method described as this is not a study involving interpretations by multiple experts. The "adjudication" is essentially the comparison of test results against predetermined engineering, biological, and functional specifications.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No. This is a medical device for orthopedic surgery (suture anchor), not an imaging or diagnostic device that would typically involve human readers interpreting cases. Therefore, an MRMC comparative effectiveness study is not relevant to this submission.

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

Not applicable. This is a physical medical device (suture anchor), not an AI algorithm.

7. The Type of Ground Truth Used

The ground truth for the "testing" section is based on:

• Engineering Standards: For fixation strength, cyclic loading, insertion, and driver strength, the "ground truth" refers to the mechanical and performance specifications derived from regulatory requirements, industry standards, and the performance characteristics of the predicate devices.
• Biocompatibility Standards: For biocompatibility, the "ground truth" conforms to recognized international standards (e.g., ISO 10993 series).
• Sterilization and Packaging Standards: For sterilization and packaging, the "ground truth" refers to validated processes and industry/regulatory standards for ensuring product sterility and integrity.

8. The Sample Size for the Training Set

Not applicable. This device does not involve machine learning or AI algorithms, thus there is no "training set."

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

Not applicable, as there is no training set for this type of device.

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