Search Results

The Covidien Sports Surgery AS Meniscal Repair Device with High Strength Suture is intended for use for approximation of soft tissue such as the repair of meniscal tear infuries

The Covidien Sports Surgery AS Meniscal Repair Device with High Strength Suture is a sterile single use device for the approximation of soft tissue such as the repair of meniscal tears. The disposable single use Device is comprised of a suture-passing needle mechanism which is pre-loaded with Size 2/0 Force Fiber Ultra High Molecular Weight (UHMW) Non Absorbable Polyethylene suture (K040472), inclusive of a pre-tied knot. The distal end of the device will be offered in various angular configurations to enable access to areas of the meniscal anatomy, and to allow for user preference.

The provided text is a 510(k) summary for the Covidien Sports Surgery AS Meniscal Repair Device with High Strength Suture. It describes the device, its intended use, and states that performance testing was conducted. However, it does not provide specific details about the acceptance criteria, the study design, or the results of the performance testing.

Therefore, I cannot fulfill your request for:

• A table of acceptance criteria and the reported device performance.
• Sample size used for the test set and the data provenance.
• Number of experts used to establish the ground truth for the test set and their qualifications.
• Adjudication method for the test set.
• If a multi-reader multi-case (MRMC) comparative effectiveness study was done, or its effect size.
• If a standalone performance study was done.
• The type of ground truth used.
• Sample size for the training set.
• How the ground truth for the training set was established.

The document only states that:

• Performance testing was conducted to verify that the Meniscal Repair Device with High Strength Suture is safe and effective and performs as intended. (Under "PERFORMANCE DATA")
• All components...are comprised of materials which are evaluated in accordance with ISO Standard 10993-1. (Under "MATERIALS")

This 510(k) summary focuses on demonstrating substantial equivalence to a predicate device based on technological characteristics and materials, rather than providing detailed performance study results that would typically be associated with software or AI-driven diagnostic devices. For mechanical devices like this meniscal repair device, performance testing usually involves bench testing for mechanical properties (e.g., tensile strength, knot security) and biocompatibility testing, rather than studies involving human readers or expert consensus on diagnostic outcomes.

Ask a specific question about this device

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.

Ask a specific question about this device