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K Number
K960354
Device Name
PERMAMESH-D HYDROXYLAPATITE MATRIX
Manufacturer
CERAMED CORP.
Date Cleared
1996-03-20

(55 days)

Product Code
LZK
Regulation Number
878.3550
Type
Traditional
Panel
General & Plastic Surgery
Reference & Predicate Devices
N/A
Predicate For
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

Facial (malar) restoration and augmentation

Device Description

PermaMesh-D is a synthetic form of hydroxylapatite, the major mineral component of tooth enamel and bone, produced in the form of a woven sheet. It is manufactured as high purity, radiopaque, rounded particles sized at 1000 microns diameter and organized into a flat, flexible clothlike form by means of absorbable suture.

AI/ML Overview

The provided text describes a medical device (PermaMesh-D Hydroxylapatite Matrix) and its intended use, but it does not contain information about acceptance criteria, device performance studies, or AI/software components.

Therefore, I cannot fulfill the request to describe the acceptance criteria and the study that proves the device meets them, as the necessary information is absent from the input.

The document is a 510(k) summary from 1996 for a physical implant, not a software or AI-powered diagnostic/analysis device. The questions in your prompt are geared towards evaluating AI/machine learning medical devices.

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K960354
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510(k) SUMMARY

January 22, 1996

MAR 2 0 1996

This 510(k) summary of safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990.

    1. Submitter: CeraMed Corporation 12860 West Cedar Drive Lakewood, CO 80228 (303) 985-0800 Contact Person: Barbara A. Watson
    1. Device Name: PermaMesh-D Hydroxylapatite Matrix, 1000 microns Classification Name: Malar implant
    1. Predicate Device: MEDPOR® Surgical Implant
    1. Device Description: PermaMesh-D is a synthetic form of hydroxylapatite, the major mineral component of tooth enamel and bone, produced in the form of a woven sheet. It is manufactured as high purity, radiopaque, rounded particles sized at 1000 microns diameter and organized into a flat, flexible clothlike form by means of absorbable suture.
    1. Intended Use: Facial (malar) restoration and augmentation,
    1. Comparison of Product Characteristics: PermaMesh-D consists of 100% synthetic hydroxylapatite beads strung on absorbable suture.

X-ray diffraction shows PermaMesh-D beads to be 100% HA. The hydroxylapatite component of PermaMesh-D conforms to ASTM Standard # F1185, "Standard Specification for Composition of Ceramic Hydroxylapatite for Surgical Implants", for trace elements. Typical calcium to phosphorus mole ratio is 1.69.

§ 878.3550 Chin prosthesis.

(a)
Identification. A chin prosthesis is a silicone rubber solid device intended to be implanted to augment or reconstruct the chin.(b)
Classification. Class II.