K Number
K113205
Manufacturer
Date Cleared
2012-06-11

(224 days)

Product Code
Regulation Number
878.3300
Panel
OB
Reference & Predicate Devices
Predicate For
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

ARTISYN™ Y-Shaped Mesh is indicated for use as a bridging material for sacrocolposuspension/sacrocolpopexy (laparatomy or laparoscopic approach) where surgical treatment for vaginal vault prolapse is warranted.

Device Description

ARTISYN™ Y-Shaped Mesh consists of two pieces of partially absorbable mesh provided in a Y shape: a vaginal section with anterior/posterior flaps and a sacral section. The anterior and posterior flaps are for anterior and posterior vaginal attachment, and the sacral flap for attachment to the sacral promontory. The mesh consists of non-absorbable undyed and dyed polypropylene and absorbable undyed poliglecaprone-25 monofilament. The vaginal and sacral sections are sewn together using polypropylene monofilament. Blue polypropylene monofilaments have been incorporated in the mesh material to produce contrast striping. The vertical stripes on the sacral flap and the horizontal stripes on the anterior and posterior vaginal flaps help aid in positioning, trimming and suturing the mesh.

AI/ML Overview

The document you provided is a 510(k) summary for a surgical mesh device, ARTISYN™ Y-Shaped Mesh. This type of submission is for demonstrating substantial equivalence to a legally marketed predicate device, rather than proving that a device meets specific clinical performance acceptance criteria through a study with defined endpoints like sensitivity and specificity.

Therefore, many of the requested categories are not applicable or cannot be extracted from this specific document, as it focuses on demonstrating material and design equivalence rather than performance equivalence in the way a diagnostic AI device would.

Here's a breakdown based on the information provided:

1. Table of Acceptance Criteria and Reported Device Performance

This document does not specify quantitative acceptance criteria (e.g., sensitivity, specificity, accuracy) like those found for diagnostic or AI devices. The "acceptance criteria" here are implicitly related to demonstrating substantial equivalence in material properties and mechanical performance compared to predicate surgical meshes.

Acceptance Criterion (Implied)Reported Device Performance
Material Equivalence- ARTISYN™ Y-Shaped Mesh is composed of the same partially absorbable mesh material used in the predicate device, GYNECARE GYNEMESH M® Partially Absorbable Mesh.
  • The mesh material has been subjected to mechanical testing and is identical to GYNECARE GYNEMESH M® Partially Absorbable Mesh and substantially equivalent to BARD ALYTE™ Y-Mesh Graft. |
    | Design/Configuration Equivalence | - The design is a Y-configuration with a similar shape and similar dimensions as the predicate devices, BARD ALYTE™ Y-Mesh Graft and Mpathy MEDICAL RESTORELLE® Y.
  • ARTISYN™ Y-Shaped Mesh, BARD ALYTE® Y-Mesh Graft and Mpathy MEDICAL RESTORELLE® Y are the same shape and same approximate dimensions. |
    | Mechanical Performance Equivalence | - The finished ARTISYN™ Y-Shaped Mesh device was subjected to mechanical testing and is substantially equivalent to the predicate devices, BARD ALYTE™ Y-Mesh Graft and Mpathy MEDICAL RESTORELLE® Y.
  • Bench testing was performed in accordance with "FDA Guidance for the Preparation of a Premarket Notification Application for a Surgical Mesh, March 22, 1999."
  • Results show that all four devices provide similar performance. |
    | Intended Use Equivalence | - The device has the same intended use as the predicate devices (bridging material for sacrocolposuspension/sacrocolpopexy where surgical treatment for vaginal vault prolapse is warranted).
  • All four devices have the same intended use, fundamental technology, and principle of operation. They are surgical mesh intended to support organs in the pelvic floor to address pelvic organ prolapse. |

2. Sample size used for the test set and the data provenance

Not Applicable. The study described is bench testing (mechanical testing) of the mesh material and the finished device, and a comparison to predicate devices, not a clinical study on a patient test set.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not Applicable. This is a bench testing and equivalence study, not a study involving expert assessment of images or patient data to establish ground truth.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not Applicable. This is a bench testing and equivalence study.

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 is a surgical mesh device, not an AI-assisted diagnostic device.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

Not Applicable. This is a surgical mesh device, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

For the mechanical testing, the "ground truth" would be the measured physical and mechanical properties of the mesh materials and finished devices as determined by standardized laboratory tests and comparison to established specifications or the properties of the predicate devices.

8. The sample size for the training set

Not Applicable. There is no "training set" as this is not an AI/algorithm-based device.

9. How the ground truth for the training set was established

Not Applicable. There is no "training set" or "ground truth" in the context of an algorithm for this type of device.

§ 878.3300 Surgical mesh.

(a)
Identification. Surgical mesh is a metallic or polymeric screen intended to be implanted to reinforce soft tissue or bone where weakness exists. Examples of surgical mesh are metallic and polymeric mesh for hernia repair, and acetabular and cement restrictor mesh used during orthopedic surgery.(b)
Classification. Class II.