(55 days)
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No
The device description focuses on the material and manufacturing process of silicone implants, 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 device is used for augmentation or reconstruction, which falls under cosmetic or reconstructive surgery, not therapeutic treatment of a disease or condition.
No
The device, Seare Biomedical Malar Implants, is described as crescent-shaped convex silicone elastomer rubber implants used to augment or reconstruct the maxilla. Its intended use is for cosmetic or reconstructive surgery. There is no mention of it being used to detect, diagnose, or monitor a disease or condition; rather, it is a physical implant.
No
The device description clearly states it is a physical implant made of silicone elastomer rubber, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health. These tests are performed outside of the body (in vitro).
- Device Description: The Seare Biomedical Malar Implants are physical implants made of silicone elastomer rubber. They are surgically placed inside the body to augment or reconstruct the maxilla.
- Intended Use: The intended use is for cosmetic or reconstructive surgery, which involves physically altering the body, not performing diagnostic tests on samples.
The description clearly indicates a surgically implanted device, not a device used for laboratory testing of biological samples.
N/A
Intended Use / Indications for Use
Seare Biomedical Malar Implants are intended to be used to augment or reconstruct the maxilla for cosmetic or reconstructive surgery.
Product codes
LZK
Device Description
Seare Biomedical Malar implants are crescent shaped convex silicone elastomer rubber implants made from specially formulated silicone elastomers designed for implantation. They are manufactured in pairs with a mirror image left and right. Surface characteristics will varying degrees of texturing and porosity. Seare Biomedical Malar Implants are intended to be used to augment or reconstruct the maxilla for cosmetic or reconstructive surgery. The Seare Biomedical Malar Implants will be produced using standard manufacturing molding techniques. The Seare Biomedical Malars will be available in many sizes and styles, all of which are very similar - differing only by a few millimeters in length and projection. The Searc Biomedical Malar Implants will be provided sterile and nonsterile.
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
maxilla
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
Clinical Tests: None
Key Metrics
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Predicate Device(s)
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Reference Device(s)
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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