(11 days)
Quill™ Self-Retaining System (SRS) comprised of PDO are 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 in USP Sizes 3-0. 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 Quill™ 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 QuillTM Self-Retaining System (SRS) comprised of PDO breaks, the remaining suture passes will hold the wound edges in approximation.
This document is a 510(k) premarket notification for a medical device, the Quill™ Self-Retaining System (SRS) comprised of PDO. It asserts substantial equivalence to predicate devices but does not describe a study proving the device meets acceptance criteria.
Therefore, most of the requested information cannot be extracted from the provided text. The document primarily focuses on demonstrating that the new device is substantially equivalent to existing, legally marketed predicate devices, rather than presenting a performance study with acceptance criteria.
Here's a breakdown of what can and cannot be provided based on the input:
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A table of acceptance criteria and the reported device performance:
- Cannot be provided. The document does not specify performance acceptance criteria or report performance statistics from a study. It states that the device modification (decreased barb spacing) is intended "to increase tissue holding strength," but no quantitative data or specific acceptance criteria are presented to demonstrate this improvement or equivalence.
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Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Cannot be provided. No test set or an associated study is described.
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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):
- Cannot be provided. No test set or ground truth establishment process is described.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Cannot be provided. No test set or adjudication method is described.
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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:
- Cannot be provided. This document is for a surgical suture, not an AI-assisted diagnostic device. Therefore, an MRMC study is not applicable and not mentioned.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Cannot be provided. This document is for a surgical suture, not an algorithm.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- Cannot be provided. No ground truth is described as no study demonstrating performance against specific criteria is presented.
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The sample size for the training set:
- Cannot be provided. No training set is described.
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How the ground truth for the training set was established:
- Cannot be provided. No training set or ground truth establishment process is described.
Summary of what the document does provide regarding "acceptance criteria" and "study":
The document's primary argument for acceptance is substantial equivalence to predicate devices, not the fulfillment of specific performance acceptance criteria from a new study.
- Implied Acceptance Criteria (Substantial Equivalence): The "acceptance criteria" in this context are implicitly that the new device (Quill™ Self-Retaining System (SRS) comprised of PDO with decreased barb spacing) is as safe and effective as the predicate devices, despite a modification. The document asserts this equivalence through a comparison table (
Characteristics of the device in comparison to those of the predicate device(s) 6.). - "Study" (Comparison and Assertion): The "study" here is essentially the comparison presented in the table, demonstrating that all key characteristics (product code, suture characteristic, intended use, technique of deployment, technological characteristic, material, sterilization, packaging) are "Identical" to the predicate devices, with the only specified modification being the decreased spacing between barbs to "increase tissue holding strength" (a functional claim, but not backed by a performance study in this document). The conclusion is a statement of belief in substantial equivalence rather than a report of study results against quantifiable acceptance criteria.
Key takeaway: This document represents a 510(k) submission where substantial equivalence is demonstrated through comparison to predicates, not through detailed performance studies against defined acceptance criteria.
§ 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.