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The non-absorbable suture anchors are intended to reattach soft tissue to bone in orthopedic surgical procedures. The Fixone All Suture Anchors may be used in either arthroscopic or open surgical procedures. After the suture strands are anchored to the bone, they may be used to reattach soft tissue, such as ligaments, tendons, or joint capsules to the bone. In conjunction with appropriate postoperative immobilization throughout the healing period, the suture anchor systems stabilize the damaged soft tissue.

Fixone All suture anchor consists of one "fix Suture" and one,two or three non-absorbable Sutures. The nonabsorbable suture is manufactured from UHMWPE. They are pre-loaded on a handled insertion device. This device is provided sterile, for single use only. This device is medical device. Prescription use only.

The color additive copper-phthalocyanine blue, color additive D&C green 6, color additive D&C violet 2 and color additive D&C black 4 are according to FDA regulations and it is approved for use in medical applications (§74.3045 – FDA), (§74.3206 –FDA), (§74.1602 –FDA) and (§74.3054 – FDA) respectively.

The provided document is a 510(k) premarket notification for a medical device called "Fixone All Suture Anchor." This document primarily deals with the substantial equivalence of a new version of the suture anchor to previously cleared predicate devices. It focuses on engineering and biocompatibility testing rather than clinical study data involving AI or human readers evaluating image-based diagnostics.

Therefore, the information required to answer the prompt regarding acceptance criteria and study that proves the device meets the acceptance criteria, specifically related to AI in a clinical setting (e.g., sample size for test set, data provenance, expert ground truth, MRMC study, standalone performance, training set details), is not present in the provided text.

The document discusses acceptance criteria and proof of mechanical performance and biocompatibility for the suture anchor. Here's what can be extracted based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance (Mechanical & Biocompatibility)

Please note that the acceptance criteria are generally implied by the "Requirements" column and "Pass" result, indicating the device met those requirements. Specific numerical requirements are given where applicable.

Anchor Performance

Suture Performance (USP 0, UHMWPE)

Suture Performance (USP 2, UHMWPE)

Suture Performance (USP 0, USP 2, UHMWPE)

Biocompatibility (UHMWPE + PET)

Biocompatibility (Only UHMWPE)

(Same tests and results as UHMWPE + PET table, excluding PET interaction)

Sterilization/Endotoxin

2. Sample size used for the test set and the data provenance:
This information is not provided in the context of an AI/image-based diagnostic test set. The document refers to "bench tests" performed on physical samples of the anchors and sutures. The number of samples for each mechanical test is not specified, only that "each anchor" or "the test article" was evaluated. The data provenance is implied to be from AJU Pharm Co., Ltd.'s internal testing, likely at their facility or a contracted lab. No country of origin for this specific testing data is given, but the company address is in South Korea (A-207, 697, Pangyo-ro, Seongnam-si, Gyeonggi-do, Korea). The data is retrospective of the device design.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
Not applicable for this type of device (mechanical and biocompatibility testing). Ground truth is established by objective physical measurements and standardized biological assays.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
Not applicable for this type of device.

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. This is not an AI-assisted diagnostic device.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. This is not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
For mechanical tests: Physical measurements against engineering specifications (e.g., tensile strength, length, diameter, pull-out force).
For biocompatibility tests: Standardized laboratory assays with pass/fail criteria based on ISO standards.
For sterilization/endotoxin: Standardized laboratory assays (e.g., LAL test) with pass/fail criteria.

8. The sample size for the training set:
Not applicable. This is not a machine learning/AI device.

9. How the ground truth for the training set was established:
Not applicable.

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The CuffLink Implant System is intended to reattach soft tissue to bone in orthopedic surgical procedures.

The Implant 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 suture anchor system thereby stabilizes the damaged soft tissue, in conjunction with appropriative immobilization, throughout the healing period.

The CuffLink™ Implant System consists of six kits that will be provided sterile, for singleuse only. Each kit will contain four suture anchors, one disposable broaching punch, and one suture passing loop assembled in a single PETG tray, and sealed in a Tyvek pouch. The tray is subsequently placed in a folding carton.

The provided document is a 510(k) premarket notification from the FDA to CONMED Corporation regarding their CuffLink Implant System. It primarily focuses on demonstrating substantial equivalence to a predicate device, rather than providing detailed clinical study data with acceptance criteria for device performance.

Therefore, many of the requested details about acceptance criteria, study design, expert involvement, and ground truth establishment cannot be found in this document. The document focuses on showing the new device is as safe and effective as a previously approved one, often through non-clinical testing.

Here's what can be extracted from the document:

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

The document does not provide specific quantitative acceptance criteria or detailed reported performance data for the CuffLink Implant System in the way one would expect for a clinical study evaluating diagnostic accuracy or a specific functional outcome. It states that "Testing has been completed to demonstrate that the Cufflink Implant System performs as intended and is substantially equivalent to the predicate device."

It lists categories of completed test data:

2. Sample size used for the test set and the data provenance

The document does not specify sample sizes for any of the performance testing categories. It also does not mention clinical test sets or data provenance (e.g., country of origin, retrospective/prospective) because the submission focuses on non-clinical performance and a comparison to a predicate device for substantial equivalence, not a clinical outcomes study.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. This type of submission relies on engineering and laboratory testing for device performance characteristics, not expert consensus on clinical data.

4. Adjudication method for the test set

Not applicable. There is no mention of a test set requiring adjudication in the context of this submission.

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. This is a medical device for reattaching soft tissue to bone (suture anchors), not an AI-powered diagnostic or assistive tool for human readers.

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

Not applicable. This is not an algorithmic device.

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

For the non-clinical tests mentioned (biocompatibility, pyrogenicity, shelf-life, etc.), the "ground truth" would be established by validated test methods and industry standards (e.g., ISO standards for biocompatibility, specific microbial limits for pyrogenicity). No clinical or expert consensus ground truth is described in this document.

8. The sample size for the training set

Not applicable. This is not an AI/ML device that requires a training set.

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

Not applicable.

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