(55 days)
MEDPOR® Surgical Implant OsteoGraf/D-700 (Originally OsteoGraf/AR)
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No
The device description focuses on the material composition and physical form of the implant, with no mention of software, algorithms, or data processing that would indicate AI/ML. The "Mentions AI, DNN, or ML" field is explicitly "Not Found".
No.
The intended use of the device is for "facial restoration and augmentation," which are aesthetic or reconstructive purposes rather than directly treating a disease, injury, or medical condition.
No
The device description and intended use indicate it is an implant for "facial restoration and augmentation," not for diagnosing conditions.
No
The device description clearly states it is a synthetic form of hydroxylapatite produced as a woven sheet, indicating it is a physical implant, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "Facial restoration and augmentation." This describes a surgical procedure performed directly on the patient's body.
- Device Description: The device is a synthetic material (hydroxylapatite) in a woven sheet form, intended for implantation. This is a medical device used in vivo (within the living body).
- Lack of IVD Characteristics: IVD devices are used to examine specimens (like blood, urine, or tissue) in vitro (outside the living body) to provide information about a patient's health. The description of PermaMesh does not involve any such testing of specimens.
Therefore, PermaMesh is a medical device intended for surgical implantation, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
Facial restoration and augmentation.
Product codes (comma separated list FDA assigned to the subject device)
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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.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
MEDPOR® Surgical Implant OsteoGraf/D-700 (Originally OsteoGraf/AR)
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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§ 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.
0
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.
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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: 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.
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- 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.