(76 days)
COROLENE® sutures are intended for use in general soft tissue approximation and/or ligation, including use in cardiovascular and vascular surgery, in ophthalmic surgery, in plastic surgery and in neurological surgery.
COROLENE® is a monofilament synthetic non-absorbable surgical suture composed of polypropylene. The suture is available undyed or blue dyed with an FDA approved color additive: Phtalocyanine-copper (CI 74160), to enhance visibility. The suture may be provided with or without a standard needle attached.
The provided text describes a 510(k) summary for a new surgical suture called COROLENE®. The submission aims to demonstrate substantial equivalence to a predicate device, PROLENE™.
Here's an analysis of the acceptance criteria and study information:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Conformance to USP Monographs for non-absorbable surgical sutures | The device complied with the USP monographs. |
| Conformance to EP Monographs for non-absorbable surgical sutures | The device complied with the EP monographs. |
| Biocompatibility of Polypropylene material | The polypropylene material used for both medical devices is commonly used in surgical applications and has been proven to be biocompatible. |
| Intended Use | COROLENE® has the same intended use as the predicate device PROLENE®. |
| Technological Characteristics | COROLENE® has similar technological characteristics as the predicate device PROLENE® (monofilament synthetic non-absorbable surgical suture, sterile, undyed or blue dyed). |
2. Sample size used for the test set and the data provenance
The document does not specify a "test set" in the context of clinical or performance testing on a specific sample size of devices, nor does it provide information on data provenance (e.g., country of origin, retrospective/prospective). The performance data cited are related to compliance with established industry standards (USP and EP monographs).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. The ground truth for this type of device (surgical suture) is established through adherence to recognized pharmacopoeia standards (USP, EP) rather than expert consensus on a test set in the way one might evaluate an AI diagnostic tool.
4. Adjudication method for the test set
Not applicable, as there isn't a "test set" requiring adjudication by experts.
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 device is a surgical suture, not an AI-assisted diagnostic or therapeutic tool that would involve human readers or AI assistance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is a surgical suture, not an algorithm or AI system.
7. The type of ground truth used
The "ground truth" for this device's performance is its conformance to the specifications and requirements outlined in the United States Pharmacopoeia (USP) Monographs and the European Pharmacopoeia (EP) Monographs for non-absorbable surgical sutures. This includes material properties, sterility, dimensions, tensile strength, and biocompatibility.
8. The sample size for the training set
Not applicable. This is not an AI/ML device that requires a training set. The "device" is a physical surgical suture.
9. How the ground truth for the training set was established
Not applicable, as there is no training set for this type of device.
§ 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.