(17 days)
Quill™ 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 suture available in various suture lengths and needle configurations in USP Sizes 3-0 and 4-0. Each suture has bi-directional barbs along the long axis of the suture strand. Barbs allow for tissue approximation without the need to tie surgical knots.
Quill™ SRS is comprised of dyed (D&C Violet No. 2 per 21 CFR 74.3602) polyester [poly (p-dioxanone)], the empirical molecular formula of which is (C4H6O3)x. Polydioxanone polymer has been found to be nonantigenic, nonpyrogenic and elicits only a slight tissue reaction during absorption.
As with interrupted sutures, if the Quill™ Self-Retaining System (SRS) comprised of PDO breaks, the remaining suture passes will hold the wound edges in approximation.
The provided document is a 510(k) premarket notification for a medical device (Quill™ Self-Retaining System (SRS) comprised of PDO, a surgical suture). This type of submission focuses on demonstrating substantial equivalence to legally marketed predicate devices, rather than presenting a detailed study proving the device meets specific acceptance criteria in the way a new, high-risk device might.
The document does not include information about acceptance criteria or a study that rigorously proves the device meets specific performance criteria in the context of AI/ML or a novel technology requiring extensive clinical trials with statistical endpoints. Instead, it relies on demonstrating equivalence to existing, approved devices.
Therefore, I cannot directly extract most of the requested information, which pertains to a different type of device evaluation study (e.g., AI/MRMC study, standalone performance, ground truth establishment, training set size).
However, I can provide the limited information available from the document:
1. A table of acceptance criteria and the reported device performance
The document does not specify "acceptance criteria" in a quantitative, statistical sense for this device. Instead, it argues for "substantial equivalence" based on qualitative comparisons and an animal study. The "performance" is implicitly deemed equivalent to the predicate devices.
| Characteristic | Quill™ SRS comprised of PDO (Reported Performance/Characteristic) | Predicate Devices (Implied Acceptance) |
|---|---|---|
| Suture Characteristic | Synthetic Absorbable PDO | Identical (Synthetic Absorbable PDO) |
| Indication for Use | Soft tissue approximation | Identical (Soft tissue approximation) |
| Technique of Deployment | Attached needles | Identical (Attached needles) |
| Technological Characteristic | Bi-directional barbs along the long axis of the suture monofilament | Identical (for Quill® Predicate), Different (for PDS II Predicate) |
| Material | PDO | Identical (PDO) |
| Sterilization | EtO | Identical (EtO) |
| Packaging | Device wound onto inner support card, within a foil pouch within a poly/tyvek pouch | Identical (for Quill® Predicate), Similar (for PDS II Predicate) |
| Functional Equivalence | Capabilities of the barbs to maintain wound approximation (animal study) | Capabilities of barbs/knots to maintain wound approximation (predicates) |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document mentions "animal studies" to assess the capabilities of the barbs.
- Sample Size: Not specified.
- Data Provenance: "Animal studies." No country of origin or retrospective/prospective nature is specified, but animal studies are typically prospective.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Not applicable. The document describes animal studies, not human-read diagnostic studies involving experts for ground truth.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. This type of adjudication pertains to human expert interpretation of data, which is not described.
5. 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
Not applicable. This is not an AI/ML device, and no MRMC study is mentioned.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an AI/ML algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the animal studies, the "ground truth" would be the observed wound approximation over time, likely assessed directly by the researchers or veterinary professionals involved in the study.
8. The sample size for the training set
Not applicable. This is not an AI/ML device that requires a training set.
9. How the ground truth for the training set was established
Not applicable.
§ 878.4840 Absorbable polydioxanone surgical suture.
(a)
Identification. An absorbable polydioxanone surgical suture is an absorbable, flexible, sterile, monofilament thread prepared from polyester polymer poly (p-dioxanone) and is intended for use in soft tissue approximation, including pediatric cardiovascular tissue where growth is expected to occur, and ophthalmic surgery. It may be coated or uncoated, undyed or dyed, and with or without a standard needle attached.(b)
Classification. Class II (special controls). The special control for the 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.