(25 days)
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.
§ 878.5000 Nonabsorbable poly(ethylene terephthalate) surgical suture.
(a)
Identification. Nonabsorbable poly(ethylene terephthalate) surgical suture is a multifilament, nonabsorbable, sterile, flexible thread prepared from fibers of high molecular weight, long-chain, linear polyesters having recurrent aromatic rings as an integral component and is indicated for use in soft tissue approximation. The poly(ethylene terephthalate) surgical suture meets U.S.P. requirements as described in the U.S.P. Monograph for Nonabsorbable Surgical Sutures; it may be provided uncoated or coated; and it may be undyed or dyed with an appropriate FDA listed color additive. Also, the suture may be provided with or without a standard needle attached.(b)
Classification. Class II (special controls). The special control for this device is FDA's “Class II Special Controls Guidance Document: Surgical Sutures; Guidance for Industry and FDA.” See § 878.1(e) for the availability of this guidance document.