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K Number
K020901
Device Name
SERRALSILK
Manufacturer
SERRAL, S.A. DE C.V.
Date Cleared
2002-04-26

(37 days)

Product Code
GAP
Regulation Number
878.5030
Type
Traditional
Panel
SU
Reference & Predicate Devices
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

SERRALSILK™ sutures are indicated for use in general soft tissue approximation and/or ligation, including use in cardiovascular, ophthalmic and neurological procedures.

Device Description

Not Found

AI/ML Overview

This document is a 510(k) clearance letter from the FDA for surgical sutures, not a study report for an AI/ML device. Therefore, it does not contain the information requested in the prompt regarding acceptance criteria and a study proving device performance for an AI/ML product.

Specifically, the document discusses:

  • Trade/Device Name: Serralsilk™, Non-absorbable Surgical Sutures
  • Regulation Number: 21 CFR 878.5030 (Natural nonabsorbable silk surgical suture)
  • Regulatory Class: II
  • Product Code: GAP
  • Indications for Use: General soft tissue approximation and/or ligation, including use in cardiovascular, ophthalmic and neurological procedures.

There is no mention of AI/ML, algorithms, performance metrics like sensitivity/specificity, sample sizes for test/training sets, expert readers, ground truth establishment, or any other elements related to the evaluation of an AI-powered diagnostic or assistive device.

Therefore, I cannot provide the requested table or information because this document is entirely unrelated to the study of an AI/ML device.

§ 878.5030 Natural nonabsorbable silk surgical suture.

(a)
Identification. Natural nonabsorbable silk surgical suture is a nonabsorbable, sterile, flexible multifilament thread composed of an organic protein called fibroin. This protein is derived from the domesticated speciesBombyx mori (B. mori ) of the familyBombycidae. Natural nonabsorbable silk surgical suture is indicated for use in soft tissue approximation. Natural nonabsorbable silk surgical suture meets the United States Pharmacopeia (U.S.P.) monograph requirements for Nonabsorbable Surgical Suture (class I). Natural nonabsorbable silk surgical suture may be braided or twisted; it may be provided uncoated or coated; and it may be undyed or dyed with an FDA listed color additive.(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.