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K Number
K040364
Device Name
MEDPOR CRANIOFACIAL IMPLANTS WITH EMBEDDED TITANIUM MESH
Manufacturer
POREX SURGICAL, INC.
Date Cleared
2004-06-30

(138 days)

Product Code
FTM,FTL
Regulation Number
878.3300
Type
Traditional
Panel
SU
Reference & Predicate Devices
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

MEDPOR Biomaterial with Embedded Titanium Mesh Implants are intended for non-weight bearing applications of craniofacial reconstruction/cosmetic surgery and repair of craniofacial trauma.

Device Description

This device is a MEDPOR/titanium mesh craniofacial implant available in three configurations: (1) A titanium mesh encapsulated within a thin coating of solid high density polyethylene. (2) A titanium mesh encapsulated within a MEDPOR Biomaterial porous polyethylene sheet with a nonporous barrier on one side. (3) A titanium mesh encapsulated within a MEDPOR Biomaterial porous polyethylene sheet.

AI/ML Overview

The provided text is a 510(k) summary for the MEDPOR Craniofacial Implants with Embedded Titanium Mesh. This document focuses on establishing substantial equivalence to previously marketed predicate devices, rather than detailed performance studies against specific acceptance criteria. Therefore, the document does not contain the requested information about acceptance criteria, device performance, validation study details, or AI-related metrics.

Specifically, the document includes:

  • Device Description: A description of the implant configurations (titanium mesh encapsulated in various MEDPOR biomaterials).
  • Indications for Use: Non-weight bearing applications of craniofacial reconstruction/cosmetic surgery and repair of craniofacial trauma.
  • Predicate Devices: A list of devices to which the new device is considered substantially equivalent.

The document does NOT provide:

  1. A table of acceptance criteria and reported device performance.
  2. Sample sizes or data provenance for a test set.
  3. Information on experts used to establish ground truth or adjudication methods.
  4. Any mention of a multi-reader multi-case (MRMC) comparative effectiveness study or AI assistance.
  5. Information about standalone algorithm performance.
  6. The type of ground truth used in any study.
  7. Sample size for a training set.
  8. How ground truth for a training set was established.

This is typical for 510(k) summaries which primarily aim to demonstrate substantial equivalence based on existing predicate device performance and material characteristics, rather than new comprehensive clinical or engineering validation studies against predefined acceptance criteria for novel performance claims.

§ 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.