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The non-absorbable suture anchor is intended to reattach soft tissue to bone in orthopedic surgical procedures.

The device 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 ioint 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 Anchors are soft-tissue fixation devices with an expandable push-in design, provided preloaded on a flexible disposable inserter for the Y1802 (double-loaded). This suture anchor is constructed of a flat suture that is interlaced longitudinally along its central width by two suture strands. The flat suture and the double loaded suture strands are folded back on themselves at the distal end of the disposable inserter. The disposable, flexible inserter has a stainless steel shaft supporting the forked shaped tip, with ABS handle, and is provided sterile, for single use. The disposable inserter device is removed at the end of the repair leaving behind an all suture construct. This device differs from the predicate in terms of the number of sutures threaded through its center (two) and in terms of the use of a flexible driver to implant the anchor.

The provided text is a 510(k) Summary for a medical device called the "Y-Knot Flex All-Suture Anchor." This document describes the device, its intended use, and the testing performed to demonstrate its substantial equivalence to a predicate device.

However, the request asks for "acceptance criteria and the study that proves the device meets the acceptance criteria" specifically in the context of a device that uses AI. The provided document describes a physical medical device (a surgical suture anchor) and its associated testing, which are standard for mechanical medical devices (fixation strength, cyclic loading, insertion, biocompatibility, sterilization, shelf-life, and packaging/transportation).

This document does not contain information about an AI-powered device, nor does it address AI-specific acceptance criteria, a test set, ground truth established by experts, MRMC studies, or standalone algorithm performance, as requested in the prompt.

Therefore, I cannot fulfill most of the detailed requirements of your request based on the provided text.

I can, however, extract the information relevant to the testing performed for this specific non-AI device, which is analogous to a "study" for this type of product:

1. A table of acceptance criteria and the reported device performance:

The document states testing was performed but does not provide a specific table of acceptance criteria with corresponding performance values. It simply lists the types of tests conducted to demonstrate equivalence to the predicate device.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):

The document does not specify sample sizes for the tests nor the provenance of any data.

3. 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):

Not applicable, as this is a mechanical device and "ground truth" in the context of expert consensus (e.g., for image interpretation) is not relevant.

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

Not applicable.

5. 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, as this is not an AI device.

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

Not applicable, as this is not an AI device.

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

For a mechanical device, "ground truth" would be established by engineering specifications, material properties, and biomechanical standards (e.g., pull-out strength measured against a predefined threshold). The document lists the types of tests done (fixation strength/pull-out, cyclic loading, insertion, biocompatibility, sterilization, shelf-life, and packaging/transportation), implying these engineering and material standards serve as the "ground truth" or acceptance criteria.

8. The sample size for the training set:

Not applicable, as this is not an AI device and there is no "training set."

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

Not applicable.

Summary of what can be extracted for this mechanical device:

• Device Name: Y-Knot Flex All-Suture Anchor, w/ Two #2 (5 Metric) Hi-Fi Sutures, 1.8mm
• Predicate Device: Y-Knot™ All-Suture Anchor (K111779)
• Purpose of Testing: To demonstrate substantial equivalence to the predicate device.
• Types of Testing Performed (analogous to "study"):
  • Fixation strength / pull-out
  • Cyclic loading
  • Insertion
  • Biocompatibility
  • Sterilization
  • Shelf-life
  • Packaging/transportation

The document does not provide quantitative acceptance criteria or detailed performance data for these tests, nor does it involve AI, expert consensus for ground truth, or MRMC studies.

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