(221 days)
AxyaFlex™ polyester suture is indicated for use in general soft tissue approximation and/or ligation, including use in cardiovascular, ophthalmic and neurological procedures.
AxyaFlex™ polyester suture is a nonabsorbable, braided, sterile, surgical suture composed of poly(ethylene terephthalate co-isophthalate). It is prepared from fibers of high molecular weight, long-chain, linear polyesters having recurrent aromatic rings as an integral component. AxyaFlex™ sutures are braided for optimal handling properties.
The provided text is a 510(k) summary for a surgical suture and does not contain information about the acceptance criteria or a study that proves the device meets specific performance criteria in the context of an AI/ML-based device. Instead, it focuses on demonstrating substantial equivalence to predicate devices through physical and chemical properties and biocompatibility.
Therefore, many of the requested categories for AI/ML device evaluation are not applicable or cannot be extracted from this document.
Here's an attempt to answer the questions based on the provided text, while noting where information is missing or not relevant to AI/ML devices:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (from USP & FDA Guidance) | Reported Device Performance |
|---|---|
| Suture Diameter requirements | Satisfied USP requirements |
| Suture Length requirements | Satisfied USP requirements |
| Knot Tensile Strength requirements | Satisfied USP requirements |
| Biocompatibility | Equivalent to predicate polyester material |
| Chemical Analyses | Equivalent to predicate polyester material |
| Sterilization Process | Equivalent to predicate suture manufacturers' process |
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 for Test Set: Not specified. The document mentions "summaries of studies" but does not detail the sample sizes for the tests conducted to evaluate suture diameter, length, and knot tensile strength.
- Data Provenance: Not specified.
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 is a medical device (suture), not an AI/ML diagnostic or prognostic tool requiring expert-established ground truth for performance evaluation in the clinical sense. The "ground truth" here would be objective measurements against established standards (USP).
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
- Not applicable. (See #3)
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 not an AI/ML device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This is not an AI/ML device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- The "ground truth" implicitly used for the physical and mechanical properties (diameter, length, knot tensile strength) would be the United States Pharmacopeia (USP) standards and FDA Guidance Document entitled "Class II Special Controls Guidance Document: Surgical Sutures." For biocompatibility and chemical analyses, the ground truth would be established scientific and regulatory benchmarks for safety and equivalence to predicate materials.
8. The sample size for the training set
- Not applicable. This is not an AI/ML device with a training set.
9. How the ground truth for the training set was established
- Not applicable. This is not an AI/ML device.
§ 878.5000 Nonabsorbable poly(ethylene terephthalate) surgical suture.
(a)
Identification. Nonabsorbable poly(ethylene terephthalate) surgical suture is a multifilament, nonabsorbable, sterile, flexible thread prepared from fibers of high molecular weight, long-chain, linear polyesters having recurrent aromatic rings as an integral component and is indicated for use in soft tissue approximation. The poly(ethylene terephthalate) surgical suture meets U.S.P. requirements as described in the U.S.P. Monograph for Nonabsorbable Surgical Sutures; it may be provided uncoated or coated; and it may be undyed or dyed with an appropriate FDA listed 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.