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The devices may be used in either arthroscopic or open surgical procedures. After suture is anchored to the bone, it may be used to reattach soft tissue, such as ligaments, tendons, or joint capsules to the suture anchor system thereby stabilizes the damaged soft tissue, in conjunction with appropriate immobilizations, throughout the healing period.

Device Description

The CONMED Y-Knot® OneStep™ Anchors are manufactured from High Strength Flat Braided Suture and threaded with either one or two #2 (5 metric) Hi-Fi® suture strands or suture ribbon. Y-Knot® OneStep anchors are provided single-use, sterile, and preloaded onto a disposable inserter. The anchors, sutures and disposable inserter are EO Sterilized.

AI/ML Overview

This is a 510(k) premarket notification for a medical device called the Y-Knot® OneStep™ Anchor, which is intended for reattaching soft tissue to bone in orthopedic surgical procedures. The document establishes substantial equivalence to a predicate device, the Y-Knot® Flex All-Suture Anchor.

Here's an analysis of the acceptance criteria and the study proving the device meets them, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't explicitly present a table of acceptance criteria with specific quantitative thresholds. Instead, it describes a series of tests conducted to demonstrate that the proposed device performs as intended and is substantially equivalent to the predicate device. The performance is assessed by comparing the device's characteristics and the results of various verification and validation tests to those of the predicate.

Acceptance Criterion (Implicit)	Reported Device Performance
Similarity in Design, Materials, Intended Use, Principles of Operation, and Technical Characteristics to Predicate Device	The Y-Knot® OneStep™ Anchor is manufactured from High Strength Flat Braided Suture and threaded with either one or two #2 (5 metric) Hi-Fi® suture strands or suture ribbon. It is provided single-use, sterile, and preloaded onto a disposable inserter. The anchors, sutures, and disposable inserter are EO Sterilized. The intended use and indications for use are nearly identical to the predicate device, focusing on reattaching soft tissue to bone in orthopedic surgical procedures (arthroscopic or open) to stabilize damaged soft tissue during healing. The contraindications and components (All-Suture Anchor, Disposable Inserter, Suture) are also the same. Technologically, both are flat-braid suture anchors, with expandable design, and flexible inserters. Both are single-use and sterilized by EtO to a Sterility Assurance Level (SAL) of 10-6. Biocompatibility materials met ISO 10993-1 and FDA Guidance requirements. The primary difference noted is the inclusion of "suture ribbon" option for the proposed device and "one or two #2 sutures or ribbon" compared to "two #2 sutures" for the predicate, and a longer shelf life for the predicate (5 years) vs. the proposed device (18 months); however, the overall conclusion states these differences present no new issues of safety and efficacy.
Performance as Intended	Testing has been completed to demonstrate that the Y-Knot® OneStep™ Anchor performs as intended. Specific tests conducted include: - Verification Testing: Reliability, Fixation/Pull Out, Displacement, Cyclic, Sterilization, Pyrogen, Biocompatibility, Shelf-life, Transportation, Post Aging Functional Testing, MR Safety Testing. - Validation Testing: User Validation, Packaging And Labeling. Bacterial endotoxin testing was conducted and met endotoxin limits. The document concludes that based on the performance testing findings, the device is substantially equivalent to the predicate.
Safety and Efficacy (Implicit through Substantial Equivalence)	The document explicitly states: "Based upon the findings of our performance testing, the differences present no new issues of safety and efficacy, and the Y-Knot® OneStep™ Anchor is substantially equivalent to the Y-Knot® Flex All-Suture Anchor (K131035)." This implies that the device achieved performance levels comparable to a legally marketed device known to be safe and effective for its indicated use.

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

The document does not provide details on the sample sizes used for the various tests (e.g., Reliability, Fixation/Pull Out, Displacement, Cyclic, etc.) nor does it specify the data provenance (e.g., country of origin, retrospective or prospective). These tests are typically conducted in a laboratory setting on device prototypes or manufactured units rather than on patient data.

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

This information is not provided in the document. For a physical device like a suture anchor, "ground truth" is typically established through adherence to engineering specifications, validated test methods, and comparison against established performance benchmarks (often derived from predicate devices or industry standards), rather than expert medical opinion on a specific "test set" of cases in the way it would be for an AI diagnostic device. The "User Validation" mentioned under validation testing might involve experts, but no details are given.

4. Adjudication Method for the Test Set:

This information is not provided and is generally not applicable to the type of performance testing described for a mechanical medical device. Adjudication methods like 2+1 or 3+1 are relevant for clinical studies or studies establishing ground truth for diagnostic devices, particularly with ambiguous cases.

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

No MRMC comparative effectiveness study was mentioned or performed. This type of study is relevant for diagnostic devices, particularly those involving interpretation of medical images or data by human readers, and comparing their performance with and without AI assistance. The Y-Knot® OneStep™ Anchor is a surgical implant.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:

This concept is not applicable to the Y-Knot® OneStep™ Anchor, as it is a physical medical device and not an algorithm or AI system.

7. The Type of Ground Truth Used:

For this device, the "ground truth" for the performance tests would be established by:

Engineering Specifications: The device met pre-defined mechanical and material properties.
Validated Test Methods: Performance tests (e.g., pull-out strength, displacement, cyclic loading) were conducted according to established, validated protocols.
Predicate Device Performance: The results from the new device's tests were compared against the known performance characteristics of the legally marketed predicate device to demonstrate substantial equivalence.
Regulatory Standards: Biocompatibility testing met ISO 10993-1 and FDA Guidance, and sterilization achieved a SAL of 10-6.

8. The Sample Size for the Training Set:

This information is not applicable as there is no "training set" in the context of a physical medical device like a suture anchor. Training sets are used in machine learning for AI algorithms.

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

This information is not applicable for the same reason as point 8.

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