(48 days)
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No
The summary describes a physical implant material and does not mention any software, algorithms, or data processing that would indicate AI/ML.
Yes
The device is described as "Facial restoration and augmentation" using a synthetic material for implantation, which aligns with the definition of a therapeutic device designed to treat or correct a medical condition or aesthetic concern.
No
Explanation: The device description indicates it is a synthetic material used for facial restoration and augmentation, implying a treatment or reconstructive purpose rather than diagnosing a condition.
No
The device description clearly states it is a synthetic form of hydroxylapatite in a woven sheet form, which is a physical material, 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 implant ("synthetic form of hydroxylapatite") designed to be placed within the body for structural support and augmentation.
- Lack of IVD Characteristics: IVD devices are used to examine specimens (like blood, urine, or tissue) outside of the body to provide information about a person's health. The description of PermaRidge does not involve any such testing of specimens.
Therefore, PermaRidge 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
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Device Description
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.
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.)
Not Found
Predicate Device(s)
MEDPOR® Surgical Implant OsteoGraf/D-700 (Originally OsteoGraf/AR)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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
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.