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The Modified NeoTract Anchor System is intended for the approximation of tissue in open surgical procedures.

The Modified NeoTract Anchor System is used for the approximation of soft tissue in open surgical procedures. It consists of a single use delivery device that delivers the permanently implanted Suture Anchor. The delivery system is comprised of a polycarbonate handle and trigger assembly connected to a stainless steel shaft.

The provided text describes a 510(k) summary for the "Modified NeoTract Anchor System." However, it does not contain information about acceptance criteria, device performance metrics, sample sizes for test/training sets, expert qualifications, ground truth establishment, or multi-reader multi-case studies.

The document is a premarket notification to the FDA, focusing on substantial equivalence to predicate devices, and mentions in-vitro testing only in a very general sense. It states:

"In-vitro testing has been performed and all components, subassemblies, and/or full devices met the required specifications for the completed tests."

This statement confirms that some testing was done and met specifications, but it does not provide any details about:

1. Specific Acceptance Criteria: What "required specifications" were, e.g., tensile strength, knot security, degradation rate.
2. Reported Device Performance: The actual numerical results of the tests.
3. Study Design: What kind of study was conducted (sample size, data provenance, etc.).
4. Clinical Performance: There is no mention of studies involving human or animal subjects to assess clinical performance.

Therefore, I cannot fulfill the request to describe acceptance criteria and the study that proves the device meets them because that information is not present in the provided text. The document is primarily a regulatory submission for substantial equivalence.

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