(556 days)
Omega V L comprised of PDO is indicated for use in soft tissue approximation where use of absorbable sutures is appropriate.
This device is made of polydioxanone and has bi-directional barbs along the long axis of the suture monofilament without needle attachment
The provided text describes a 510(k) premarket notification for a medical device called "Omega V L," an absorbable polydioxanone surgical suture. This document focuses on demonstrating substantial equivalence to a predicate device, rather than presenting a study to prove the device meets specific performance acceptance criteria for a new medical device. The information required in the prompt is not fully available in the provided text.
Here's an analysis of the available information in relation to your questions, and what is not provided:
1. A table of acceptance criteria and the reported device performance
- Not provided in this document directly as acceptance criteria for this device. The document states that the device is "substantially equivalent" to the predicate device in its "performance properties." It lists non-clinical studies (biocompatibility and bench testing) but does not present specific acceptance criteria values the Omega V L device needed to meet, nor does it provide a table of measured performance values for the Omega V L device against such criteria. Instead, it implies that by performing these tests, the device's performance is comparable to the predicate.
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
- Not provided. The document lists types of tests (e.g., Biocompatibility, USP Sutures—Diameter, USP Tensile Strength, Barb Holding Strength, In Vitro Resorption Rate Test, In Vitro Tensile Strength Test) but does not specify the sample sizes used for these tests. Data provenance details are also not mentioned.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable / Not provided. For a surgical suture, the "ground truth" for performance is typically established through direct physical and chemical measurements (e.g., tensile strength, diameter, absorption rate) rather than expert consensus on interpretation, as might be the case for an imaging AI device. Therefore, a "ground truth" established by experts in the sense of adjudicating findings is not relevant here, and no such information is provided.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
- Not applicable / Not provided. As mentioned above, performance of a suture is determined by objective measurements, not by expert adjudication of interpretations.
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-powered diagnostic or assistive tool. Therefore, an MRMC study related to human readers and AI assistance is not relevant.
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.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- For the non-clinical studies listed, the "ground truth" would be the objective measurements obtained from physical, chemical, and biological testing as per ISO and USP standards (e.g., measured diameter, tensile strength, cytotoxicity, irritation, etc.). There is no mention of expert consensus, pathology, or outcomes data being used to establish a ground truth for the performance parameters.
8. The sample size for the training set
- Not applicable / Not provided. This is a physical medical device (suture), not an AI algorithm that requires a training set.
9. How the ground truth for the training set was established
- Not applicable / Not provided. As above, no training set for an algorithm is involved.
In summary of what is available:
The document focuses on demonstrating substantial equivalence of the Omega V L suture to a legally marketed predicate device (K130191 MINT). The basis for this equivalence is stated to be:
- Identical indications for use.
- Similar technological characteristics (material, sterilization, suture type, deployment technique, barbs, absorbability, patient contact duration, color additive, suture diameters, tensile strength).
- Non-clinical studies (biocompatibility and bench performance tests) conducted according to established international standards (ISO 10993 series) and U.S. Pharmacopeia (USP) standards to ensure safety and performance comparable to the predicate.
The specific numerical acceptance criteria and reported performance values against those criteria for the Omega V L are not explicitly presented as a table in this summary document. The assumption is that successful completion of the listed tests implies performance within an acceptable range, demonstrating equivalence to the predicate.
§ 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.