(30 days)
RiverLon Suture is intended to be used in general soft tissue approximation and/or ligation, including use in cardiovascular, ophthalmic, and neurological procedures.
The Riverpoint Medical RiverLon Nylon Sutures are inert, non-absorbable, sterile surgical sutures composed of the long-chain aliphatic polymers Nylon 6 and Nylon 6/6. RiverLon sutures are available in common sizes and length with or without pre-attached needles.
The provided text does not contain a study that proves the device meets specific acceptance criteria in the format requested. The document is a 510(k) summary for Riverpoint Medical's RiverLon Nylon Suture, focusing on demonstrating substantial equivalence to a predicate device rather than presenting a performance study with detailed acceptance criteria and results.
However, it does mention some general performance requirements and tests performed. Here's a breakdown of the available information:
1. A table of acceptance criteria and the reported device performance
The document broadly states that the RiverLon Sutures meet requirements established by the United States Pharmacopeia (USP). Specific acceptance criteria (e.g., minimum tensile strength values, diameter ranges) are not provided, nor are the precise reported device performance metrics beyond the general statement of compliance.
| Acceptance Criteria (Not explicitly stated with values, implied by USP) | Reported Device Performance |
|---|---|
| USP performance requirements for needle attachment | Meets USP requirements |
| USP performance requirements for diameter | Meets USP requirements |
| USP performance requirements for tensile strength | Meets USP requirements |
| Biological Evaluation (per ISO 10993-1:2009) | Materials evaluated per ISO 10993-1:2009 |
2. Sample size used for the test set and the data provenance
- Sample Size: Not specified.
- Data Provenance: Not specified. The document only mentions that the sutures are "tested" per USP requirements. No information on country of origin or whether the data is retrospective or prospective is present.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not applicable and not provided. The testing relates to physical and chemical properties of the suture, primarily against pharmacopeial standards (USP), not clinical or expert-reviewed interpretative data.
4. Adjudication method for the test set
Not applicable. The testing is against defined physical/chemical standards, not interpretive data requiring adjudication.
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 device is a surgical suture, not an AI-powered diagnostic or assistive technology.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is a surgical suture, not an algorithm.
7. The type of ground truth used
The "ground truth" for the device's technical characteristics is compliance with the United States Pharmacopeia (USP) performance requirements for surgical sutures, as well as biological evaluation standards like ISO 10993-1:2009. These are often established through standardized testing methodologies and specifications.
8. The sample size for the training set
Not applicable. This is a physical medical device, not an algorithm that requires a training set.
9. How the ground truth for the training set was established
Not applicable.
Summary of the Study Mentioned:
The document describes a "Performance Data" section stating that:
- "The Riverpoint Medical RiverLon Sutures meet requirements established by the United States Pharmacopeia."
- "The RiverLon Sutures are tested per USP performance requirements for needle attachment, diameter, and tensile strength."
- "FDA Guidance 'Class II Special Controls Guidance Document: Surgical Sutures; Guidance for Industry and FDA' was followed during the preparation of this submission."
- "Materials used were evaluated per ISO 10993-1:2009 -Biological Evaluation of Medical Devices."
This indicates that standard pharmacopeial and international standards testing was performed to demonstrate the device's compliance. However, the specific details of these tests (e.g., number of samples, exact values of acceptance criteria, detailed results, specific test methods used beyond "per USP") are not provided in this 510(k) summary. The purpose of this document is primarily to establish substantial equivalence to a predicate device (K100006 – Riverpoint Medical RiverLon (Nylon)) based on similar materials, manufacturing processes, intended use, and meeting established performance standards.
§ 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.