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K Number
K020902
Device Name
SERRALESTER
Manufacturer
SERRAL, S.A. DE C.V.
Date Cleared
2002-05-20

(61 days)

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

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

Device Description

SERRALESTER™ Surgical Suture

AI/ML Overview

The provided text is a 510(k) clearance letter from the FDA for a surgical suture. It declares the device, SERRALESTER™ Surgical Suture, substantially equivalent to legally marketed predicate devices.

This type of document does not typically contain detailed information about acceptance criteria or specific studies proving a device meets these criteria in the way that a clinical trial report or a performance study summary would.

Therefore, based only on the provided text, I cannot extract the requested information. The document is an administrative clearance, not a scientific study report.

Here's why each of your requested points cannot be addressed by the provided text:

  1. A table of acceptance criteria and the reported device performance: This document states the device is "substantially equivalent" to predicate devices, but it does not define specific performance acceptance criteria for the new device nor report its performance against such criteria.
  2. Sample sized used for the test set and the data provenance: Not mentioned.
  3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not mentioned.
  4. Adjudication method for the test set: Not mentioned.
  5. If a multi reader multi case (MRMC) comparative effectiveness study was done: Not mentioned. Such studies are more common for diagnostic imaging AI than for surgical sutures.
  6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable to a surgical suture.
  7. The type of ground truth used: Not applicable/mentioned. For sutures, "ground truth" might refer to material properties or in vivo performance, but specific metrics are not in this document.
  8. The sample size for the training set: Not applicable/mentioned. This refers to AI algorithms, not a physical medical device like a suture.
  9. How the ground truth for the training set was established: Not applicable/mentioned.

In summary, the provided FDA 510(k) letter confirms regulatory clearance but does not detail the technical studies, acceptance criteria, or performance data that would have been submitted to the FDA as part of the clearance process.

§ 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.