(48 days)
Facial restoration and augmentation.
PermaRidge 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.
This document is a 510(k) summary for a medical device called "PermaRidge Hydroxylapatite Matrix". It is a pre-market notification to the FDA to demonstrate that the device is substantially equivalent to a legally marketed predicate device.
The provided text does not contain any information about acceptance criteria or a study proving the device meets acceptance criteria.
The 510(k) summary focuses on:
- Device Identification: Submitter, device name (PermaRidge Hydroxylapatite Matrix, 1000 microns), classification name (Chin implant).
- Predicate Device: MEDPOR® Surgical Implant OsteoGraf/D-700.
- Device Description: Synthetic hydroxylapatite in the form of a woven sheet with rounded particles (1000 microns diameter) organized by absorbable suture. It's radiopaque.
- Intended Use: Facial restoration and augmentation.
- Comparison of Product Characteristics: States PermaRidge is 100% synthetic hydroxylapatite beads on absorbable suture, shows 100% HA by X-ray diffraction, and conforms to ASTM Standard # F1185 for trace elements and Ca:P ratio.
Therefore, I cannot provide the requested table or answer the questions related to studies, sample sizes, ground truth, or expert involvement because this information is not present in the provided 510(k) summary.
In regulatory submissions like 510(k)s, "acceptance criteria" and "device performance" usually refer to the results of non-clinical (e.g., sterilization validation, biocompatibility, mechanical testing) or clinical (if applicable and necessary for substantial equivalence) studies that demonstrate safety and effectiveness. The provided text only describes the composition of the device and its compliance with an ASTM standard for material composition, not performance data from a specific study.
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M-K 13 1996
ા ર્વા
510(k) SUMMARY
January 22, 1996
This 510(k) summary of safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990.
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- Submitter: CeraMed Corporation 12860 West Cedar Drive Lakewood, CO 80228 (303) 985-0800 Contact Person: Barbara A. Watson
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- Device Name: PermaRidge Hydroxylapatite Matrix, 1000 microns Classification Name: Chin implant
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- Predicate Device: MEDPOR® Surgical Implant OsteoGraf/D-700 (Originally OsteoGraf/AR)
Device Description: 4.
PermaRidge 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.
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- Intended Use: Facial restoration and augmentation.
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- Comparison of Product Characteristics: PermaRidge consists of 100% synthetic hydroxylapatite beads strung on absorbable suture.
X-ray diffraction shows PermaRidge beads to be 100% HA. The hydroxylapatite component of PermaRidge 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.