PERMAMESH HYDROXYLAPATITE MATRIX

• K Number: K960362
• Device Name: PERMAMESH 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

Intended Use

Facial restoration and augmentation.

Device Description

PermaMesh 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

This document is a 510(k) summary for a medical device called "PermaMesh Hydroxylapatite Matrix," submitted in 1996. It describes the device, its intended use, and compares it to predicate devices.

However, the provided text does not contain any information about acceptance criteria or a study proving the device meets those criteria. The document focuses on the physical characteristics and composition of the device, its classification, and comparison to existing products. It does not mention any performance metrics, clinical trials, or validation studies in the context of effectiveness or safety in a patient population.

Therefore, I cannot fulfill your request for the tables and details regarding acceptance criteria and study design based on the input text. The information required for those points (performance data, sample sizes, expert involvement, ground truth methods, MRMC studies, standalone performance, training set details) is entirely absent from this 510(k) summary excerpt.

Summary

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510(k) SUMMARY MAR 2 0 1996

January 22, 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 [phone] Contact Person: Barbara A. Watson
• 2. Device Name: PermaMesh Hydroxylapatite Matrix, 1000 microns Classification Name: Malar implant
• Predicate Device: 3. MEDPOR® Surgical Implant OsteoGraf/D-700 (Originally OsteoGraf/AR)

4. Device Description:

PermaMesh 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.

• 5. Intended Use: Facial restoration and augmentation.
• б. Comparison of Product Characteristics: PermaMesh consists of 100% synthetic hydroxylapatite beads strung on absorbable suture.

X-ray diffraction shows PermaMesh beads to be 100% HA. The hydroxylapatite component of PermaMesh 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.

Regulation Number and Section

§ 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.