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The Cayenne Medical, Inc. Ventix™ Link Knotless Anchors are intended to be used for the reattachment of soft tissue to bone for the following indications:

Shoulder

• Acromioclavicular separation repairs ●
• Deltoid repairs
• Rotator cuff repairs
• Biceps tenodesis

Knee

• Extra-capsular repairs ●
• o Medial collateral ligament
• o Lateral collateral ligament
• Posterior oblique ligament O
• Patellar realignment and tendon repairs
• Illiotibial band tenodesis ●
• Supplementary fixation when used in conjunction with a primary fixation device in ACL repair and reconstruction surgical procedures requiring graft fixation.

Foot and Ankle

• Medial or lateral instability repairs/reconstructions
• Achilles tendon repairs/reconstructions

The Ventix™ Link Knotless Anchor is a sterile, manually operated, single procedure anchor device for reattachment of soft tissue to bone. The anchor is preloaded on a disposable inserter. The Ventix™ Link Knotless Anchor incorporates design features that facilitate anchor placement under arthroscopic, open or limited access conditions in soft tissue to bone reattachment procedures. The Ventix™ Link Knotless Anchor is offered in two sizes, 4.75mm and 5.5mm, and can receive up to six suture ends. The anchor is made out of PolyEtherEtherKetone (PEEK). Zimmer Biomet TRU-LINK™, MaxBraid™ and/or MaxBraid™ BroadBand™ Tape, or Force Fiber® USP #1 or #2 sutures are to be only used with the Ventix™ Link Knotless Anchors.

The disposable inserter has a working shaft length (from handle to distal tip of anchor) of 6.1 in (155 mm) with an outer shaft diameter of 0.1875 in (4.76 mm). The inserter shaft is made out of surgical grade stainless steel and the handle is made out of ABS plastic. The inserter facilitates the placement of the implant into a hole prepared in the bone.

This document is a 510(k) premarket notification for a medical device called the "Ventix Link Knotless Anchor with Inserter."

Here's an analysis of the provided text in relation to your request about acceptance criteria and a study proving the device meets them:

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

Based on the provided text, there isn't a specific table of "acceptance criteria" from a performance study that directly compares against the reported device performance in a quantitative manner. The document states that "Non-clinical testing data...demonstrated that the functionality and safety of the Ventix™ Link Knotless Anchor are adequate for its intended use and determination of substantial equivalence to the predicate device."

The non-clinical testing performed included:

• Mechanical testing: Specifically, "pull-out strength."
• Biocompatibility assessment
• Pyrogenicity assessment
• Shelf-life assessment
• MRI safety assessment

While these are the types of tests conducted, the document does not report the specific quantitative acceptance criteria or the actual measured performance values for these tests. It only states that the results "demonstrated that the functionality and safety... are adequate."

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

The document mentions "non-clinical testing data" for mechanical testing, biocompatibility, pyrogenicity, shelf-life, and MRI safety. However:

• Sample size: The specific sample sizes used for these non-clinical tests are not provided in this document.
• Data provenance: The country of origin of the data is not specified. Given that the manufacturer is "Cayenne Medical, Inc." based in "Scottsdale, Arizona," it's likely the testing was conducted in the US or by a lab contracted by a US company, but this is not explicitly stated. The tests are non-clinical, so the terms "retrospective" or "prospective" are not applicable in the same way they would be for clinical trials.

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)

This question is geared towards studies involving human interpretation or clinical expertise to establish a "ground truth" (e.g., in AI/diagnostic device studies).

• Not Applicable: The studies conducted for this device were non-clinical (mechanical, biocompatibility, etc.). Therefore, there were no human "experts" in the sense of clinicians establishing a "ground truth" for diagnostic or predictive purposes related to the device's function. The "ground truth" in these engineering and material science tests would be established by validated test methods and material specifications, interpreted by qualified engineers/scientists, but these are not explicitly identified as "experts" for ground truth establishment in this context.

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

• Not Applicable: As mentioned above, the studies were non-clinical and did not involve human interpretation requiring adjudication methods.

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 device is a surgical implant (suture anchor). It is not an AI diagnostic or assistive device that would involve human "readers" or benefit from AI assistance in its direct use. Therefore, no MRMC comparative effectiveness study was done.

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

• Not Applicable: This device is a physical medical implant, not an algorithm or software. Therefore, the concept of "standalone (algorithm only)" performance is not relevant.

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

For the non-clinical tests:

• Mechanical Testing (Pull-out strength): The "ground truth" would be established by engineering standards and specifications (e.g., a certain force in Newtons/pounds the anchor must withstand) as determined by the device design and potentially industry standards. The test results would then be compared against these predefined physical requirements.
• Biocompatibility, Pyrogenicity, Shelf-life, MRI Safety: The "ground truth" for these tests is compliance with established international standards (e.g., ISO, ASTM) and regulatory guidelines for material safety, sterility, stability, and compatibility.

The document does not explicitly detail these "ground truths" but implies that the tests confirmed "adequacy" against such standards.

8. The sample size for the training set

• Not Applicable: This device is not an AI/machine learning product and therefore does not have a "training set" in that context. The "training" for a physical device happens during its design and manufacturing process, using engineering principles and material science.

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

• Not Applicable: As per point 8, there is no "training set" in the context of an AI/machine learning device. The design and manufacturing processes are validated against engineering and regulatory standards, but this isn't analogous to establishing "ground truth" for a training set in AI.

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