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K Number
K100506
Device Name
FORCE FIBER GREEN ULTRA HIGH MOLECULAR WEIGHT POLYETHYLENE NON ABSORBABLE SUTURES MODEL:X-5000FFK, X-5001FFK, X-5002FFK
Manufacturer
TELEFLEX MEDICAL
Date Cleared
2010-03-10

(16 days)

Product Code
GAT
Regulation Number
878.5000
Type
Special
Panel
SU
Reference & Predicate Devices
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

Force Fiber® Polyethylene Non-Absorbable Surgical Sutures are indicated for use in approximation and/or ligation of soft tissues, including use in cardiovascular surgeries and the use of allograft tissue for orthopaedic surgeries.

Device Description

Force Fiber® Green Ultra High Molecular Weight Polyethylene Non-Absorbable Surgical Suture

AI/ML Overview

The provided document is an FDA 510(k) clearance letter for the "Force Fiber® Green Ultra High Molecular Weight Polyethylene Non-Absorbable Surgical Suture." This document does not contain information about acceptance criteria or a study proving the device meets those criteria in the context of AI-driven medical devices.

Instead, it's a regulatory letter confirming that the device is substantially equivalent to a predicate device, as required for traditional medical devices like sutures. The criteria discussed in the letter are related to regulatory compliance (e.g., registration, listing, manufacturing practices, labeling) and not performance metrics as would be expected for an AI/ML device.

Therefore, I cannot fulfill your request using the provided text. The document does not describe:

  1. A table of acceptance criteria and reported device performance.
  2. Sample sizes used for test sets or data provenance.
  3. Number or qualifications of experts for ground truth.
  4. Adjudication methods.
  5. MRMC comparative effectiveness studies or effect sizes.
  6. Standalone algorithm performance.
  7. Type of ground truth used (e.g., pathology, outcomes).
  8. Sample size for the training set.
  9. How ground truth for the training set was established.

§ 878.5000 Nonabsorbable poly(ethylene terephthalate) surgical suture.

(a)
Identification. Nonabsorbable poly(ethylene terephthalate) surgical suture is a multifilament, nonabsorbable, sterile, flexible thread prepared from fibers of high molecular weight, long-chain, linear polyesters having recurrent aromatic rings as an integral component and is indicated for use in soft tissue approximation. The poly(ethylene terephthalate) surgical suture meets U.S.P. requirements as described in the U.S.P. Monograph for Nonabsorbable Surgical Sutures; 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.