(125 days)
The Artelon™ Surgical Suture is intended for use in general soft tissue approximation and/or ligation.
Artelon™ Surgical Suture is a nonabsorbable braided surgical suture, which is supplied sterile. It is composed of Artelon™, a polycaprolactone based poly(urethane urea), in multifilament form. The Artelon™ Surgical Suture will be offered uncoated and undyed and without needle.
The product meets all requirements established by the United States Pharmacopoeia (U.S.P) for nonabsorbable surgical sutures.
This document describes the Artelon™ Surgical Suture and its substantial equivalence to predicate devices, rather than a study proving the device meets specific acceptance criteria in the context of AI/ML performance. Therefore, many of the requested fields are not applicable. However, I can extract the relevant information regarding performance testing that was conducted.
Here's the information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria (Set by regulatory standards) | Reported Device Performance |
|---|---|
| ISO 10993 standards (Biocompatibility) | Successfully completed |
| USP 26 (Diameter, Tensile Strength, Properties) | Successfully completed |
| Guidance for surgical suture (August 10, 2000) | Successfully completed |
| Class II Special Control Guidance, Surgical Suture; Guidance for Industry and FDA (June 3, 2003) | Successfully completed |
2. Sample size used for the test set and the data provenance:
- Not applicable (N/A). This document does not detail a clinical study with a test set of data. The "performance testing" refers to in-vitro and material characteristic tests rather than performance against a clinical dataset.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- N/A. Ground truth is not established in the context of clinical data for this type of device submission. Performance is measured against established physical and biological standards.
4. Adjudication method for the test set:
- N/A. No adjudication method for a test set of data is mentioned as this is not a clinical study.
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:
- N/A. No MRMC study was conducted, as this device (surgical suture) is not an AI/ML-powered diagnostic or assistive tool for human readers.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- N/A. Not an AI/ML device.
7. The type of ground truth used:
- For biocompatibility: ISO 10993 standards.
- For physical characteristics (diameter, tensile strength, pliability, handling): USP 26 requirements.
- For regulatory compliance: Guidance for surgical suture documents.
8. The sample size for the training set:
- N/A. This device does not involve machine learning; therefore, no training set or sample size for training is relevant.
9. How the ground truth for the training set was established:
- N/A. No training set for machine learning. The "ground truth" for the device's performance is established by recognized international and national standards (ISO, USP, FDA guidance).
§ 878.5020 Nonabsorbable polyamide surgical suture.
(a)
Identification. Nonabsorbable polyamide surgical suture is a nonabsorbable, sterile, flexible thread prepared from long-chain aliphatic polymers Nylon 6 and Nylon 6,6 and is indicated for use in soft tissue approximation. The polyamide 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 monofilament or multifilament in form; 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.