(339 days)
ADVANTIME® synthetic absorbable surgical sutures are intended for use in general soft tissue approximation and/or ligation, but not for use cardiovascular surgery, microsurgery, ophthalmic surgery, and neurological tissue.
ADVANTIME® sutures are intended to be used in suturing and/or tissue ligation in open or laparoscopic surgery. These sutures are available with a disposable needle attachment.
ADVANTIME® is a single use, sterile, single-stranded (monofilament), synthetic bioabsorbable thread made of a poliglecaprone (a copolymer of glycolide and E- caprolactone of low tissue reactivity). Sutures are commonly used in digestive, urological, aesthetic, gynecological and intradermal surgery. To perform suturing on soft tissue wounds involves a series of precise steps. The surgeon grasps the needle, pushes it through tissue, pulls it through and repeats for continuous suturing. The same applies to double-armed needles. Further, knots are tied, excess thread is cut, and used needles are single use and safely disposed in accordance with hospital procedure.
The provided document is a 510(k) summary for a surgical suture device (ADVANTIME Absorbable Suture) and does not describe an AI/ML powered device. Therefore, the questions regarding acceptance criteria, study details, and performance measures (such as sample size for test/training sets, expert ground truth, adjudication methods, MRMC studies, or standalone performance of an algorithm) related to AI/ML devices are not applicable.
The document discusses the substantial equivalence of the ADVANTIME Absorbable Suture to a predicate device based on physical and biological performance testing for a medical device that is not an AI/ML device.
Here's the information that is relevant from the provided text regarding this medical device:
1. Acceptance Criteria and Reported Device Performance (Non-AI/ML Device)
The device was subjected to the requirements of the United States Pharmacopeia (U.S.P.) monograph for Synthetic Absorbable Sutures.
| Acceptance Criteria (USP 43) | Reported Device Performance |
|---|---|
| Diameter () | Meets USP requirements with minor variations (within FDA guidance allowance) |
| Tensile strength () | Meets USP requirements |
| Needle attachment () | Meets USP requirements |
| Length (Absorbable surgical suture) | Meets USP requirements |
| Extractable color (Absorbable surgical suture) | Meets USP requirements |
| Resorption profiles | Evaluated for each material; data provided in-vitro |
| Stability | Testing completed |
| Biocompatibility (ISO 10993-1) | All tested aspects met (Cytotoxicity, Sensitization, Irritation, Material mediated pyrogenicity, Acute Systemic Toxicity, Sub-acute/sub-chronic/chronic toxicity, Genotoxicity, Carcinogenicity, Chemical characterization and toxicological risk assessment, Implantation, Degradation, Sterilization residue testing) |
2. Sample size used for the test set and the data provenance: Not applicable as this is not an AI/ML device study. Performance was evaluated based on physical and biological tests according to USP standards and ISO 10993-1.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable as this is not an AI/ML device. Ground truth for physical properties is defined by USP standards.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable as this is not an AI/ML device. Performance is objectively measured against USP standards.
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 as 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 as this is not an AI/ML device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): For the physical characteristics, the ground truth is defined by the United States Pharmacopeia (USP) standards and test methodologies. For biological evaluation, the ground truth is established by standardized testing protocols detailed in ISO 10993-1.
8. The sample size for the training set: Not applicable as this is not an AI/ML device.
9. How the ground truth for the training set was established: Not applicable as this is not an AI/ML device.
§ 878.4493 Absorbable poly(glycolide/l-lactide) surgical suture.
(a)
Identification. An absorbable poly(glycolide/l-lactide) surgical suture (PGL suture) is an absorbable sterile, flexible strand as prepared and synthesized from homopolymers of glycolide and copolymers made from 90 percent glycolide and 10 percent l-lactide, and is indicated for use in soft tissue approximation. A PGL suture meets United States Pharmacopeia (U.S.P.) requirements as described in the U.S.P. “Monograph for Absorbable Surgical Sutures;” it may be monofilament or multifilament (braided) in form; it may be uncoated or coated; and it may be undyed or dyed with an FDA-approved 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.