(30 days)
Optilene Nonabsorbable Polypropylene Polyethylene Surgical sutures are indicated for use in all types of general soft tissue approximation and/or ligation, including use in cardiovascular, ophthalmic, microsurgery and neural tissue.
Optilene is a nonabsorbable monofilament surgical suture which is supplied sterile. Optilene is composed of 95% polypropylene and 5% polyethylene. The Optilene suture is offered dyed with the FDA approved colorant [Phthalacyaninato(2-)] copper in accordance with Title 21 CFR, §74.3045. The Optilene suture previously ranged in diameters from USP size 10-0 through 0 in lengths ranging from 8 cm to 150 cm. The Optilene suture is offered with or without needles attached. The Optilene sutures are also offered with or without pledgets composed of 100% polytetrafluorothylene (PTFE). The pledgets are available separately packaged six per pouch.
The purpose of this submission is to seek clearance for a line extension to the Optilene Nonabsorbable Surgical Suture (K133890). This submission proposes two additional USP sizes, size 1 and 2 and to extend the length range to 240 cm.
The provided document is a 510(k) premarket notification for a medical device, specifically a surgical suture. Such documents focus on demonstrating "substantial equivalence" to a predicate device rather than presenting a standalone study with acceptance criteria in the traditional sense of a clinical trial for an AI-powered diagnostic or therapeutic device.
Therefore, the information requested in your prompt (acceptance criteria, details of a study with sample sizes, expert ground truth, MRMC, standalone performance, training set details) is not applicable to this type of regulatory submission.
This document describes a line extension for an existing nonabsorbable surgical suture (Aesculap Optilene Nonabsorbable Suture). The purpose of the submission is to introduce additional USP sizes (size 1 and 2) and to extend the length range (up to 240 cm) for an already cleared device.
Instead of a clinical study demonstrating AI performance, the manufacturer performed non-clinical laboratory performance testing to show that the new sizes and lengths of the suture meet the established standards for nonabsorbable surgical sutures.
Here's how the information aligns with your request, despite the different context:
1. A table of acceptance criteria and the reported device performance
The "acceptance criteria" here are the requirements set forth by the USP (United States Pharmacopeia) Monograph for Nonabsorbable Surgical Sutures and the FDA's Class II Special Controls Guidance Document: Surgical Sutures, Issued June 3, 2003.
| Acceptance Criteria (Standards Met) | Reported Device Performance (Compliance) |
|---|---|
| USP 40 Monograph for Nonabsorbable Surgical Sutures (as applicable) | Complied |
| USP40 Sutures - Diameter | Complied |
| USP 40 Tensile Strength | Complied |
| USP 40 Sutures - Needle Attachment | Complied |
| ISO 10993-1 (Materials evaluation) | Complied |
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 document. For non-clinical performance testing of physical devices, specific sample sizes for various tests (e.g., tensile strength, diameter measurements) would be defined in testing protocols, but these details are typically not included in the summary provided in the 510(k).
- Data Provenance: Not explicitly stated, but derived from non-clinical laboratory testing performed by the manufacturer (Aesculap, Inc.) to verify compliance with U.S. and international standards.
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. This pertains to a physical medical device (suture), not an AI device requiring expert-established ground truth for diagnostic or prognostic purposes. The "ground truth" is defined by the objective physical and chemical standards of the USP monograph.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. This refers to adjudication of expert opinions for ground truth in AI studies.
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 non-AI surgical suture.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Not applicable. This is a non-AI physical device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- The "ground truth" for this device's performance is based on objective, quantifiable physical and material specifications defined by established standards:
- United States Pharmacopeia (USP) Monograph for Nonabsorbable Surgical Sutures.
- ISO 10993-1 for biocompatibility of materials.
8. The sample size for the training set
- Not applicable. There is no "training set" as this is not an AI/machine learning device.
9. How the ground truth for the training set was established
- Not applicable.
In summary, this 510(k) premarket notification is for a conventional medical device line extension. The "study" mentioned refers to non-clinical laboratory testing demonstrating compliance with established physical standards for surgical sutures. The concepts of AI acceptance criteria, expert ground truth, training sets, and MRMC studies are not relevant to this specific device and its regulatory submission path.
§ 878.5010 Nonabsorbable polypropylene surgical suture.
(a)
Identification. Nonabsorbable polypropylene surgical suture is a monofilament, nonabsorbable, sterile, flexible thread prepared from long-chain polyolefin polymer known as polypropylene and is indicated for use in soft tissue approximation. The polypropylene surgical suture meets United States Pharmacopeia (U.S.P.) requirements as described in the U.S.P. Monograph for Nonabsorbable Surgical Sutures; it may be undyed or dyed with an FDA approved color additive; and 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.