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510(k) Data Aggregation
(27 days)
QUILL NONABSORBABLE POLYPROPYLENE BARBED SUTURE
Quill® Nonabsorbable Polypropylene Barbed Sutures are indicated for use in soft tissue approximation excluding closure of the epidermis.
The Quill® Nonabsorbable Polypropylene Barbed Suture is a monofilament, flexible thread prepared from long chain polyolefin polymer. It is available sterile, dyed blue [Phthalocyaninato(2-)] copper (and also undyed) in various suture diameters, lengths and needle configurations. Each suture has bidirectional barbs along the long axis of the suture monofilament.
The Quill® Nonabsorbable Polypropylene Barbed Sutures approximate tissues by using the opposing barbs on the suture surface to imbed in the tissues after the surgeon precisely places the suture within the tissues. Each Quill® Nonabsorbable Polypropylene Barbed Suture pass provides the security of an interrupted suture strand without the added bulk of a knot. As with interrupted sutures, if the Quill® Nonabsorbable Polypropylene Barbed Suture breaks, the remaining suture passes will hold the wound edges in approximation.
The provided document is a 510(k) summary for the Quill® Nonabsorbable Polypropylene Barbed Suture. This type of regulatory submission aims to demonstrate substantial equivalence to a predicate device, rather than proving safety and effectiveness through clinical trials with defined acceptance criteria and study designs as would be expected for a novel device or a Premarket Approval (PMA) application.
Therefore, the document does not contain the detailed information requested in the prompt regarding acceptance criteria, study performance, sample sizes, expert ground truth establishment, adjudication methods, MRMC studies, or standalone algorithm performance.
Here's why the requested information is absent:
- Acceptance Criteria and Reported Device Performance: Instead of performance metrics, the document focuses on comparing the new device's characteristics (materials, technology, intended use) to those of a legally marketed predicate device to establish substantial equivalence.
- Sample Size, Data Provenance, Experts, Adjudication, MRMC, Standalone Performance, Ground Truth Type & Training Set Details: These are all elements of a clinical effectiveness study or an AI/software performance study. A 510(k) summary for a medical device like this suture typically relies on non-clinical testing (e.g., tensile strength, biocompatibility), material safety, and comparison to a predicate, not clinical trials.
The document does, however, discuss:
- Predicate Devices: The Quill® Nonabsorbable Polypropylene Barbed Suture claims equivalence to:
- Intended Use: Soft tissue approximation, excluding closure of the epidermis.
- Basis for Equivalence:
- Indication for Use: Equivalent to the Quill® Synthetic Absorbable Barbed Suture.
- Material and Technology: Equivalent to the Contour Midface Opposing Unidirectional Threads™ in product code (GAW), technique of deployment (attached needles), technological characteristic (bi-directional barbs), material (polypropylene, cleared per K904906), sterilization (EO), and packaging.
- Safety and Performance Rationale: The document states, "The difference between the Quill® Nonabsorbable Polypropylene Barbed Suture and the above mentioned predicate devices do not raise any questions regarding the safety and effectiveness of the barbed suture... The device, as designed, is as safe and effective as its predicate devices."
In summary, the provided text does not describe a study with acceptance criteria in the manner requested because it is a 510(k) premarket notification, which relies on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting novel clinical performance data against pre-defined acceptance criteria.
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