(268 days)
CROWNJUN Nylon Suture is intended to join the edges of soft-tissue wound or incision to ligate soft tissues.
The CROWNJUN Nylon Suture is a sterile nonabsorbable polyamide surgical suture. The CROWNJUN Nylon Suture is composed of long-chain aliphatic polymers polyamide 6,6 which is available undyed or dyed black using logwood extract (Hematein) per 21 CFR 73.1410. The CROWNJUN Nylon Suture is offered in diameters ranging from USP size 12-0 through USP 0 and available in various lengths from 2.5 cm to 90 cm with pre-attached needles. The needle is composed of 300 series stainless steel of various types of tip shapes, curvatures, and sizes. The product meets all requirements established by the United States Pharmacopeia (USP) for nonabsorbable surgical sutures.
This document is a 510(k) Pre-Market Notification from the FDA regarding the "CROWNJUN Nylon Suture." It describes the device, its intended use, and a comparison with a predicate device to establish substantial equivalence.
Based on the provided text, the device is a surgical suture, not an AI/ML powered device, therefore most of the requested information (such as sample sizes for test/training sets, expert qualifications, adjudication methods, MRMC studies, and standalone algorithm performance) is not applicable or unavailable.
However, I can extract the acceptance criteria and reported device performance related to this specific medical device from the non-clinical tests section:
1. Table of Acceptance Criteria and Reported Device Performance
For this specific device (CROWNJUN Nylon Suture), the "acceptance criteria" are generally derived from established standards for surgical sutures. The reported "device performance" indicates that the device conforms to or meets these requirements.
| Acceptance Criteria (Standard / Test) | Reported Device Performance |
|---|---|
| USP (United States Pharmacopeia) for synthetic nonabsorbable suture requirements (specifically USP 41 , , ) | The product meets all requirements established by the USP for nonabsorbable surgical sutures. |
| Suture Material meets or exceeds the performance requirements defined in: USP 41 , USP 41 , USP 41 | |
| ISO 10993-1 (Biocompatibility) | Biocompatibility testing in accordance with ISO 10993-1 was conducted, demonstrating substantial equivalence to the predicate device. Specific tests included: Cytotoxicity, Sensitization, Intracutaneous Irritation, Systemic and Muscle Implantation (12-week), Genotoxicity, Subchronic System Toxicity, Hemolysis, and Pyrogenicity. |
| Physical Properties & Functionality (Diameter, Length, Extractable Color, Sterility) | Testing assured that the device conformed with suture diameter and suture length, extractable color and sterility to methods outlined in USP. |
| Ethylene Oxide (EO) Sterilization Validation | The device is sterilized by Ethylene Oxide (EO). (Compliance implicitly demonstrated through meeting general controls and manufacturing practices). |
| FDA's Special Control Guidance Document: Surgical Sutures | Non-clinical testing was conducted per this document to prove conformance. |
The remaining sections of your request are explicitly related to studies involving AI/ML devices, which this document does not describe. Therefore, the information is largely not applicable.
2. Sample size used for the test set and the data provenance: Not Applicable (not an AI/ML device)
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not Applicable (not an AI/ML device)
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not Applicable (not an AI/ML device)
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: No (not an AI/ML device)
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: No (not an AI/ML device)
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): For this non-AI/ML device, the "ground truth" is established by the compliance with recognized standards (USP, ISO, FDA Guidance) through laboratory testing, material characterization, and manufacturing controls.
8. The sample size for the training set: Not Applicable (not an AI/ML device)
9. How the ground truth for the training set was established: Not Applicable (not an AI/ML device)
§ 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.