(55 days)
Seare Biomedical Malar Implants are intended to be used to augment or reconstruct the maxilla for cosmetic or reconstructive surgery.
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 Searc Biomedical Malar Implants 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.
The provided text is a 510(k) summary for the Seare Biomedical Malar Implants. It details the device's description, indications for use, and a comparison to a predicate device. However, it explicitly states "Clinical Tests: None" and "Adverse S&E Information: None."
Therefore, based on the information provided, there are no acceptance criteria or studies detailed that prove the device meets acceptance criteria.
The 510(k) submission relies on demonstrating substantial equivalence to a legally marketed predicate device (Allied Biomedical Malar Implants) rather than presenting new clinical performance data for this specific device.
To answer your questions based only on the provided text:
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A table of acceptance criteria and the reported device performance
- Acceptance Criteria: Not specified in the document. The submission focuses on substantial equivalence to a predicate device.
- Reported Device Performance: Not reported as no clinical tests were performed for this device in this submission.
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Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not applicable. No clinical tests were performed.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not applicable. No clinical tests were performed.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. No clinical tests were performed.
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If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- Not applicable. No clinical tests were performed, and this device is not an AI-assisted diagnostic tool.
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If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Not applicable. No clinical tests were performed, and this device is not an algorithm.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not applicable. No clinical tests were performed involving ground truth establishment for this device. The "ground truth" for demonstrating regulatory acceptance was demonstrating substantial equivalence to the predicate device.
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The sample size for the training set
- Not applicable. This device is a physical implant, not a machine learning model requiring training data.
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How the ground truth for the training set was established
- Not applicable. This device is a physical implant, not a machine learning model.
§ 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.