(109 days)
The CapSew™ Plication System is intended for use in placement of suture through soft tissue in arthroscopic and open surgical procedures including shoulder capsule tightening.
The CapSew"" Plication System is a sterile hand-held, manually operated, single procedure suture placement system for shoulder capsule tightening (plication) procedures. The CapSew Plication System includes one CapSew Plication Device (consisting of a Plication Handle with mounted Suture Cartridge) and one additional CapSew" Suture Cartridge.
The provided text describes a 510(k) premarket notification for the CapSew™ Plication System, a medical device for placing sutures. However, it does not contain the detailed acceptance criteria and study information typically found in a clinical trial report or a performance validation study for a device.
The document primarily focuses on:
- Administrative Information: Manufacturer, contact, device name, classification, and intended use.
- Device Description: A brief physical description of the CapSew™ Plication System.
- Performance Testing: A high-level statement that "Mechanical testing has been conducted and data was submitted to demonstrate that the performance of the CapSew™ Plication System is equivalent to that of predicate devices."
- Equivalence to Marketed Product: Listing of predicate devices to which the CapSew™ Plication System is considered substantially equivalent.
- FDA Communication: The FDA's substantial equivalence letter, confirming the device can be marketed.
- Indications for Use: The approved indications for the device.
Based on the provided text, I cannot extract the specific information requested in your prompt regarding acceptance criteria, reported device performance, sample sizes, ground truth establishment, expert qualifications, or comparative effectiveness studies.
The submission is a 510(k) for a Class II device, which often relies on demonstrating substantial equivalence to a predicate device through mechanical testing and comparison of design principles, rather than extensive clinical trials with detailed performance metrics against predefined acceptance criteria. The statement about "Mechanical testing" suggests that performance was evaluated against engineering specifications related to the device's function (e.g., suture placement strength, device durability), but the specific criteria and results are not included in this summary.
Therefore, I cannot populate the table or answer the specific questions because the necessary details are not present in the provided document.
§ 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.