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K Number
K080507
Device Name
AOC POROUS POLYETHYLENE, AOC POROUS HDPE, AOC POROUS POLYETHYLENE SURGICAL IMPLANT
Manufacturer
CEREMED, INC.
Date Cleared
2008-04-21

(56 days)

Product Code
KKY
Regulation Number
878.3500
Type
Traditional
Panel
SU
Reference & Predicate Devices
K043133,K040364
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

AOC™ Porous Polyethylene Surgical Implants are intended for the augmentation or reconstruction of the craniomaxillofacial skeleton.

Device Description

AOC™ Porous Polyethylene Surgical Implants are provided as blocks, sheets, and anatomical shapes, and are manufactured of porous high-density polyethylene (HDPE), a material that has been used in craniofacial reconstruction for over 25 years. The implants are manufactured with the option of a coating with a water-soluble alkylene oxide copolymer blend and/or the option of embedded titanium mesh. AOC Porous Polyethylene Implants are provided sterile by irradiation and must not be resterilized.

AI/ML Overview

The provided text describes a 510(k) submission for the Ceremed, Inc. AOC Porous Polyethylene surgical implants. This type of submission is for demonstrating substantial equivalence to a legally marketed predicate device, rather than proving safety and efficacy through clinical studies with specific acceptance criteria and performance metrics.

Therefore, the document does not contain the following information:

  • A table of acceptance criteria and reported device performance.
  • Details about a study to prove the device meets acceptance criteria (as this is not required for a 510(k) submission in the same way it would be for a PMA).
  • Sample size used for a test set or its data provenance.
  • Number and qualifications of experts used to establish ground truth.
  • Adjudication method.
  • Multi-reader multi-case (MRMC) comparative effectiveness study or its effect size.
  • Standalone (algorithm only) performance.
  • Type of ground truth used.
  • Sample size for the training set.
  • How ground truth for the training set was established.

Instead, the document focuses on:

  • Device Description: AOC™ Porous Polyethylene Surgical Implants are made of porous high-density polyethylene (HDPE), used for craniofacial reconstruction. They can be coated with an alkylene oxide copolymer blend and/or have embedded titanium mesh. They are provided sterile by irradiation.
  • Intended Use: Augmentation or reconstruction of the craniomaxillofacial skeleton.
  • Substantial Equivalence: The device is deemed substantially equivalent to predicate devices (Ceremed, Inc. AOC™ Porous Polyethylene Surgical Implants K043133 and Porex Surgical Inc. MEDPOR® Craniofacial Implants with embedded Titanium Mesh K040364) based on:
    • Same intended use and indications for use.
    • Biocompatibility of the alkylene oxide copolymer blend in accordance with ISO-10993.
    • Mechanical properties being substantially equivalent to predicate devices, with minor differences raising no new issues of safety and efficacy.

Conclusion:

This document is a 510(k) summary, which inherently focuses on demonstrating "substantial equivalence" to existing predicate devices rather than establishing de novo performance against acceptance criteria in the manner of a clinical trial. As such, the information requested in your prompt (specific acceptance criteria, study details, expert involvement for ground truth, AI performance metrics, etc.) is not applicable to or present in this type of regulatory submission.

§ 878.3500 Polytetrafluoroethylene with carbon fibers composite implant material.

(a)
Identification. A polytetrafluoroethylene with carbon fibers composite implant material is a porous device material intended to be implanted during surgery of the chin, jaw, nose, or bones or tissue near the eye or ear. The device material serves as a space-occupying substance and is shaped and formed by the surgeon to conform to the patient's need.(b)
Classification. Class II.