(10 days)
Quill™ Self-Retaining System (SRS) comprised of MONODERM™ is indicated for soft tissue approximation where use of an absorbable suture is appropriate.
The Quill™ Self-Retaining System (SRS) comprised of MONODERM™ is a synthetic absorbable monofilament suture prepared from a copolymer of glycolide and e-caprolactone (per 21 CFR 878.4493). 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 in USP Sizes 0, 2-0 and 3-0. Each suture has bi-directional barbs along the long axis of the suture monofilament.
The Quill™ Self-Retaining System (SRS) comprised of MONODERMIM 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 MONODERM™ pass provides the security of an interrupted suture strand without the added bulk of a knot. As with interrupted sutures, if the Quill™ Self-Retaining System (SRS) comprised of MONODERM™ breaks, the remaining suture passes will hold the wound edges in approximation.
The provided text describes a 510(k) premarket notification for the Quill™ Self-Retaining System (SRS) comprised of MONODERM™ sutures. This document focuses on demonstrating substantial equivalence to predicate devices, rather than presenting a study with acceptance criteria and measured performance metrics in the way one would for a new clinical device or AI algorithm.
Therefore, many of the requested sections (e.g., sample size for test set, number of experts, adjudication method, MRMC study, standalone performance, training set details) are not applicable or not available in this type of regulatory submission.
Here's an analysis based on the information provided:
Acceptance Criteria and Device Performance (Not applicable in the traditional sense for this 510(k))
This 510(k) submission does not establish performance acceptance criteria in the form of specific quantitative metrics (e.g., sensitivity, specificity, accuracy) that the device must meet, nor does it report device performance as such. Instead, the "acceptance criteria" for a 510(k) are met by demonstrating substantial equivalence to legally marketed predicate devices in terms of intended use, technological characteristics, safety, and effectiveness.
The study referenced is an animal study comparing the Quill™ Self-Retaining System (SRS) comprised of MONODERM™ to MONOCRYL sutures to assess the capabilities of barbs to knots in maintaining wound approximation. However, the document does not provide specific performance data or statistical analysis from this study. It only states that the study was conducted to "assess the capabilities."
Table of "Acceptance Criteria" (Substantial Equivalence Factors) and "Reported Device Performance" (Comparison to Predicates):
| Factor for Substantial Equivalence | Predicate Device (MONODERM™ / MONOCRYL) Characteristic | Quill™ SRS comprised of MONODERM™ Characteristic / "Performance" |
|---|---|---|
| Intended Use | Soft tissue approximation where absorbable suture is appropriate | Identical |
| Technological Characteristic | Utilizes knots to secure the suture (MONOCRYL) | Bi-directional barbs along the long axis of the suture monofilament |
| (Implied: Provides wound approximation) | The animal study was conducted to "maintain wound approximation" using barbs vs. knots (details not provided) | |
| Material | Polyglycolide/l-lactide (MONODERM) / Poliglecaprone 25 (MONOCRYL) | PGA-PCL (copolymer of glycolide and e-caprolactone) - Identical to MONODERM, Similar to MONOCRYL |
| Sterilization | EO | Identical |
| Packaging | Device wound onto inner support card, within a foil pouch, within a poly/tyvek pouch | Identical |
| Safety and Effectiveness | Safe and effective (as legally marketed predicates) | Stated that differences do not raise questions regarding safety and effectiveness; device is as safe and effective as predicates. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size: Not specified in the provided document. The submission mentions "animal studies" comparing the device to MONOCRYL, but does not provide details on the number of animals or specific experimental groups.
- Data Provenance: Not specified. The animal studies would typically be prospective, but the location of the study is not mentioned.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not Applicable. This type of information is generally relevant for studies involving qualitative assessments or diagnostic accuracy by human readers, often in medical imaging or pathology. This 510(k) submission describes a physical medical device (suture) and relies on animal studies for performance, not expert ground truth for a diagnostic task.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Applicable. Adjudication methods are typically used when multiple human experts provide assessments that need to be reconciled, which is not the case for an animal study of suture performance as described here.
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 a 510(k) submission for a surgical suture, not an AI algorithm or a diagnostic tool that involves human readers.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Not Applicable. This is a 510(k) submission for a surgical suture, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- The "ground truth" in the context of the animal studies would likely relate to objective measures of wound approximation/healing, tensile strength retention, or inflammatory response, as assessed by veterinary pathologists or other scientific measures in an animal model. Specific methods are not detailed in this submission.
8. The sample size for the training set
- Not Applicable. This is a 510(k) submission for a physical medical device (suture), not an algorithm that requires a training set.
9. How the ground truth for the training set was established
- Not Applicable. This is a 510(k) submission for a physical medical device (suture), not an algorithm that requires a training set.
§ 878.4493 Absorbable poly(glycolide/l-lactide) surgical suture.
(a)
Identification. An absorbable poly(glycolide/l-lactide) surgical suture (PGL suture) is an absorbable sterile, flexible strand as prepared and synthesized from homopolymers of glycolide and copolymers made from 90 percent glycolide and 10 percent l-lactide, and is indicated for use in soft tissue approximation. A PGL suture meets United States Pharmacopeia (U.S.P.) requirements as described in the U.S.P. “Monograph for Absorbable Surgical Sutures;” it may be monofilament or multifilament (braided) in form; it may be uncoated or coated; and it may be undyed or dyed with an FDA-approved 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.