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The Covidien Sports Surgery AS Meniscal Repair Device is Intended for use for approximation of soft tissue such as the repair of meniscal tear injuries

The Covidien Sports Surgery AS Meniscal Repair Device is a sterile single use device for the approximation of soft tissue such as for the repair of meniscal tears. The disposable single use Device is comprised of a suture-passing needle mechanism which is pre-loaded with a strand of Size 2/0 nonabsorbable polyethylene terephthalate surgical suture (TiCron™) which includes a pre-tied knot.

The provided text is a 510(k) summary for the Covidien Sports Surgery AS Meniscal Repair Device. It describes the device, its intended use, and its substantial equivalence to predicate devices based on material and performance data. However, it does not contain acceptance criteria or a detailed description of any study that proves the device meets specific performance criteria.

Here's a breakdown of why the requested information cannot be extracted from the provided text:

• No acceptance criteria: The document states "Performance testing was conducted to verify that the Meniscal Repair Device is safe and effective and performs as intended," but it does not specify what those performance criteria were (e.g., tensile strength, knot security, deployment force).
• No detailed study information: While performance testing is mentioned, there are no details about the study design, sample sizes, data provenance, ground truth establishment, expert involvement, or any quantitative results.
• No direct comparison to acceptance criteria: Without specific acceptance criteria, a table showing reported device performance against those criteria cannot be created.

Therefore, most of the requested information cannot be provided based on the given document.

What can be extracted or inferred:

• Device Type: Meniscal Repair Device (surgical tool for soft tissue approximation).
• Intended Use: To approximate soft tissue, such as during the repair of meniscal tear injuries.
• Predicate Devices: Confirmed in the document (TiCron™ surgical suture, Smith & Nephew Ultra Fast-Fix Meniscal Repair System, Stryker Mini-Mender Meniscal Repair System).
• Testing Conducted: Performance testing and material compliance testing (ISO Standard 10993-1 for biocompatibility).
• Regulatory Decision: The FDA found the device substantially equivalent to predicate devices, indicating that the performance data (though not detailed here) was sufficient to demonstrate this equivalence.

In summary, the provided text from the 510(k) summary is a high-level overview and does not delve into the detailed technical specifications and study results required to answer your specific questions about acceptance criteria and study data.

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