(40 days)
The nylon nonabsorbable sutures, USP are indicated for use in general soft tissue approximation and/or ligation, including use in cardiovascular, ophthalmic and neurologica1 procedures.
Nylon nonabsorbable surgical sutures, USP, manufactured by R. K. Medical L. L. C. are equivalent to nylon nonabsorbable surgical sutures manufactured by Davis + Geck. The nylon sutures manufactured by R. K. Medica1 and D+G can be monofilament or braided, coated with silicone, or wax, or uncoated, dyed black or blue or undyed.
This document is a 510(k) summary for R. K. Medical L. L. C.'s Nylon Nonabsorbable Surgical Sutures. It's a regulatory submission, not a research study report, so it doesn't contain detailed information about acceptance criteria and a study in the way one would typically describe for an AI/CAD device.
However, I can extract the relevant information and structure it to answer your questions to the best of what's provided, interpreting "acceptance criteria" as meeting USP specifications and "study" as the testing performed.
Context: This device is a surgical suture, not an AI or diagnostic imaging device. Therefore, many of your questions (e.g., MRMC studies, ground truth for AI, training sets) are not applicable. I will indicate where this is the case.
Here's the breakdown of the information based on your request:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (USP XXIII Specifications) | Reported Device Performance (R. K. Medical Nylon Sutures) |
|---|---|
| Suture diameter requirements | Meets or exceeds USP specifications |
| Suture length requirements | Meets or exceeds USP specifications |
| Knot pull tensile strength requirements | Meets or exceeds USP specifications |
| Needle attachment strength requirements | Meets or exceeds USP specifications |
| Equivalency to Davis + Geck nylon sutures for the above parameters | Equivalent |
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: Not specified in the document.
- Data Provenance: Not specified, but implied to be from testing conducted during the manufacturing process by R. K. Medical L. L. C. in Danbury, CT, USA. The testing is likely prospective, as it's a part of demonstrating compliance for a new product.
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. For a surgical suture, "ground truth" is established by adherence to defined physical specifications (USP XXIII), not by expert interpretation in a clinical context. The "ground truth" is the USP standard itself.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Applicable. Adjudication methods are typically for subjective assessments or disagreements in clinical interpretations (e.g., in reading medical images). Here, objective physical measurements against established standards are performed.
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 a surgical product, not an AI or diagnostic imaging device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable. This is a surgical product, not an AI algorithm. The "standalone performance" is the suture's physical properties when tested.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Type of Ground Truth: USP XXIII (United States Pharmacopeia) specifications for nylon nonabsorbable surgical sutures. These are objective, quantitative standards for physical properties.
8. The sample size for the training set
- Not Applicable. This refers to machine learning. No training set is used for this type of device.
9. How the ground truth for the training set was established
- Not Applicable. As no training set is used, this question is irrelevant. The "ground truth" (USP standards) is established by a pharmacopeia, based on scientific testing and consensus for medical devices.
§ 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.