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QuillTM Self-Retaining System (SRS) comprised of PDO is indicated for soft tissue approximation where use of an absorbable suture is appropriate.

The Quill™ Self-Retaining System (SRS) comprised of PDO is a synthetic absorbable monofilament suture comprised of polyester [poly (p-dioxanone)] per 21 CFR 878.4840. It is available sterile, dyed violet (D&C Violet No. 2 per 21 CFR 74.3602) or undyed (beige) in various suture lengths and needle configurations. Each suture has bi-directional barbs along the long axis of the suture monofilament. The Quill™ Self-Retaining System (SRS) comprised of PDO approximates tissue 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 QuillTM Self-Retaining System (SRS) comprised of PDO pass provides the security of an interrupted suture strand without the added bulk of a knot. As with interrupted sutures, if the QuilITM Self-Retaining System (SRS) comprised of PDO breaks, the remaining suture passes will hold the wound edges in approximation.

Here's an analysis of the provided text regarding the acceptance criteria and study for the Quill™ Self-Retaining System (SRS) comprised of PDO, based on the requested information.

Important Note: The provided document is a 510(k) summary for a medical device. These summaries typically focus on demonstrating substantial equivalence to predicate devices rather than providing detailed acceptance criteria and standalone performance studies in the way you might expect for a novel AI device. Therefore, much of the requested information, particularly regarding specific numerical acceptance criteria, detailed study designs for performance, sample sizes for test/training sets, expert qualifications, and AI-specific metrics (like MRMC studies or effect sizes for AI assistance), is not present in this type of regulatory submission.

The device discussed is a surgical suture, not an AI or imaging device. The "study" here refers to the comparisons made to predicate devices to demonstrate substantial equivalence, rather than a clinical trial proving specific performance metrics against a defined standard.

Acceptance Criteria and Reported Device Performance

Study Details (Based on available information)

1. Sample size used for the test set and the data provenance:

   • Sample Size: Not specified in the provided document. The submission relies on a comparison to predicate devices, not an independent test set in the typical sense for performance evaluation in an AI context.
   • Data Provenance: Not applicable in the context of an AI device. For this surgical suture, the "data" would be the characteristics and performance data of the predicate devices already approved by the FDA, and possibly internal testing data for the modified barb design, which is not detailed here. It's implicitly retrospective as it compares to existing, approved devices.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

   • Number of Experts & Qualifications: Not applicable. Ground truth, in the AI sense, is not established for this device. The regulatory decision is based on assessing the device's design, materials, and intended use against established standards and predicate devices.

3. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

   • Adjudication method: Not applicable. There is no expert adjudication process described for a "test set" in this context.

4. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

   • MRMC Study: No, this is not an AI device, so an MRMC study is not relevant.

5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

   • Standalone Performance: Not applicable. This is a physical surgical suture, not an algorithm.

6. The type of ground truth used (expert consensus, pathology, outcomes data, etc):

   • Type of Ground Truth: Not applicable in the AI sense. The "ground truth" for this regulatory submission is the established safety and effectiveness of the predicate devices, and the demonstration that the new device shares fundamental characteristics and performs equivalently or better in its specific modification.

7. The sample size for the training set:

   • Training Set Sample Size: Not applicable.

8. How the ground truth for the training set was established:

   • Training Set Ground Truth: Not applicable.

Summary of 510(k) Approach for K080985:

The K080985 submission for the Quill™ Self-Retaining System (SRS) comprised of PDO is a Special 510(k). This type of submission is typically used when a modification to an existing device (for which the manufacturer already holds a 510(k) clearance) does not raise new questions of safety and effectiveness.

The core of the "study" demonstrating the device meets "acceptance criteria" (which are implicitly the characteristics and performance of the predicate devices) is a comparison to predicate devices. The document highlights that the new device is:

• Identical in Product Code, Suture Characteristics, Intended Use, Technique of Deployment, Technological Characteristic (overall barbed design), Material, Sterilization, and Packaging to its predicate devices.
• The only described modification is a decrease in spacing between barbs to increase tissue holding strength. The implication is that this modification improves a key performance aspect without altering the fundamental safety or effectiveness profile, thus maintaining substantial equivalence.
• The "acceptance criteria" are, therefore, the characteristics and performance standards already established and approved for the predicate Quill SRS devices (K051609, K071989, K080680). The device "meets" these by being substantially equivalent in all critical aspects, and implicitly improving upon one.
• No specific clinical trials or studies with explicit numerical performance targets (e.g., tensile strength, degradation rates) are detailed in this summary, as is common for a Special 510(k) where the focus is on demonstrating that the change does not impact safety or effectiveness such that a new predicate comparison is needed.

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