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The Y-Knot™ All-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.

The Y-Knot™ All-Suture Anchor is a soft-tissue fixation device with an expandable push-in design, provided preloaded on a disposable inserter device. This suture anchor is constructed of a flat suture that is interlaced longitudinally along its central width by one suture strand. The flat suture and the single suture strand are folded back on themselves at the distal end of the disposable inserter. The disposable inserter device has a forked shaped distal end, stainless steel shaft, with an ABS handle, that is provided sterile, for single use and is removed at the end of the repair leaving behind an all suture 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 all-suture anchor system thereby stabilizes the damaged soft tissue, in conjunction with appropriate postoperative immobilization, throughout the healing period.

The suture anchor configuration is supplied sterile, single use, preloaded onto a disposable driver. The disposable driver is composed of a 300 series surgical grade stainless-steel shaft with an ABS handle. Additional surgical instruments, including a drill bit and drill guides, are Class I, sterile, single-use devices intended for transient use during orthopedic procedures.

The provided text describes a medical device, the Y-Knot™ All-Suture Anchor, and its substantial equivalence to predicate devices, but does not contain information about acceptance criteria or a study proving the device meets those criteria, as typically understood in the context of device performance metrics and clinical or analytical evaluations.

Instead, the document focuses on:

• 510(k) Summary: A regulatory submission outlining the device's characteristics and its equivalence to already marketed devices.
• Device Description: What the device is made of and how it works.
• Testing: A general list of testing performed (fixation strength, pull-out, cyclic loading, insertion, biocompatibility, sterilization, shelf-life, packaging/transportation, and side-by-side comparator qualifications), but no specific results or acceptance criteria are reported here.
• Intended Use/Indications: For what medical purpose the device is designed.
• Substantial Equivalence: The FDA's basis for clearing the device, comparing it to existing, legally marketed devices.

Therefore, I cannot provide the requested information from the given text. The text does not include:

1. A table of acceptance criteria and the reported device performance: No specific performance metrics or acceptance criteria (e.g., minimum pull-out strength, maximum displacement under cyclic loading) are quantified.
2. Sample size used for the test set and the data provenance: Not mentioned.
3. Number of experts used to establish the ground truth for the test set and their qualifications: Not applicable, as this is related to a cognitive assessment or diagnostic device, not a mechanical fixation device.
4. Adjudication method: Not applicable.
5. Multi Reader Multi Case (MRMC) comparative effectiveness study: Not applicable.
6. Standalone (algorithm only) performance: Not applicable.
7. Type of ground truth used: Not applicable in the context of performance metrics for a mechanical device. The ground truth for this device would be its physical behavior under stress, not a diagnostic finding.
8. Sample size for the training set: Not applicable, as this device does not involve a "training set" in the machine learning sense.
9. How the ground truth for the training set was established: Not applicable.

The "Testing" section broadly mentions various tests performed, such as "fixation strength" and "pull-out," which are likely mechanical tests to ensure the device performs as expected. However, the document provided is a summary of the 510(k) submission, and typically does not contain the detailed results, acceptance criteria, and methodologies of these tests. These details would be in the full submission, not in this public summary.

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