(280 days)
The DemeTECH Nylon Nonabsorbable Suture is indicated for use in general soft tissue approximation and/or ligation, including use in cardiovascular and ophthalmic and neurological procedures.
The DemeTECH Nylon Nonabsorbable Suture is a single use, individually packaged, disposable nonabsorbable nylon (polyamide) surgical suture.
The provided text is related to the 510(k) submission for the DemeTECH Nylon Nonabsorbable Suture. This document focuses on demonstrating substantial equivalence to a predicate device and adherence to USP standards for a medical device (suture), not an AI/ML powered device. Therefore, many of the requested categories for AI/ML study information (e.g., sample size for test/training sets, number of experts, adjudication methods, MRMC studies, standalone performance) are not applicable or cannot be extracted from this type of regulatory submission.
However, I can provide the acceptance criteria table and the reported device performance, which is focused on equivalence and meeting safety/performance standards, as detailed in the document.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Substantial Equivalence to a legally marketed predicate device (Grams Nylon Nonabsorbable Suture - K003000). | The DemeTECH Nylon Nonabsorbable Suture has been demonstrated as equivalent to the predicate device. |
| Compliance with United States Pharmacopeia (USP) 23 and 24 requirements for Nonabsorbable Surgical Sutures. | The DemeTECH Nylon Nonabsorbable Suture meets United States Pharmacopeia (USP) 23 and 24 requirements for Nonabsorbable Surgical Sutures. |
| Intended Use: General soft tissue approximation and/or ligation, including use in cardiovascular, ophthalmic, and neurological procedures. | The device's intended use statement aligns with its established equivalence and USP compliance, supporting its use in general soft tissue approximation and/or ligation, including cardiovascular, ophthalmic, and neurological procedures. |
The following information cannot be extracted from the provided text for this medical device (suture), as these concepts typically apply to AI/ML powered devices or clinical efficacy studies that are not detailed in a 510(k) summary for a non-active medical device:
- Sample size used for the test set and the data provenance: Not applicable/not provided for a suture's physical performance testing. Testing would typically involve laboratory analysis of material properties.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for suture performance is based on standardized physical and chemical tests.
- Adjudication method for the test set: Not applicable.
- 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 a physical medical device (suture) and not an AI-powered diagnostic or assistive tool.
- If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable.
- The type of ground truth used: For a suture, ground truth is based on standardized physical and chemical properties as defined by the USP (United States Pharmacopeia) and established engineering/material science principles.
- The sample size for the training set: Not applicable. There is no "training set" in the context of a physical medical device like a suture.
- How the ground truth for the training set was established: Not applicable.
§ 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.