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For Plastic and Reconstructive Surgery

The Surgiform Technology Ltd.'s S.F.A.M. implant is intended for augmentation or repair of the soft tissues of the facial area. The product is available in sheets or strands of the following sizes: Sheets: Length 5-100mm, Width 5-100mm, Thickness 0.2-0.4mm. Strands: 5-15cm, OD-1.0-4.0mm.

I am sorry, but the provided text is a 510(k) premarket notification letter from the FDA to a medical device manufacturer, indicating that their device (Surgiform Augmentation Material) has been found substantially equivalent to a legally marketed predicate device.

This document does not contain any information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert involvement. It is a regulatory approval letter, not a scientific study report. Therefore, I cannot extract the requested information from this text.

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Surgical Technology Laboratories, Inc. Standard Chin implants are intended to be used to augment or reconstruct the anterior of the mandible for cosmetic or reconstructive surgery.

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This is an FDA 510(k) clearance letter for the "Standard Chin" device from 1998. It is a premarket notification for a medical device that determines substantial equivalence to a legally marketed predicate device, rather than requiring extensive clinical trials to prove efficacy and safety in the way a PMA (Premarket Approval) would.

Therefore, the document does not contain the kind of detailed information about acceptance criteria, study design, sample sizes, ground truth establishment, or AI performance metrics that you are requesting. This type of information is typically found in clinical study reports, scientific publications, or more recent 510(k) submissions for AI/ML-driven devices.

Here's why your requested information isn't in this document:

• Device Type: The "Standard Chin" is an implant intended for cosmetic or reconstructive surgery of the mandible. This is a physical, passive medical device, not an AI/ML diagnostic or prognostic tool.
• Regulatory Pathway (510(k) in 1998): At the time, a 510(k) for devices like this primarily focused on demonstrating that the new device is "substantially equivalent" to a device already on the market (a predicate device). This generally involves comparing materials, design features, and intended use, often supported by bench testing and sometimes limited clinical data to assess safety. It does not typically involve the rigorous performance evaluation studies (like standalone performance or MRMC studies) associated with AI-driven diagnostic tools today.
• AI/ML was not a factor: Artificial intelligence and machine learning in medical devices were not a significant part of the regulatory landscape in 1998, especially for physical implants.

Therefore, I cannot provide the requested information based on the provided text. The document simply states the FDA has reviewed the 510(k) notification and determined the device is substantially equivalent, allowing it to be marketed.

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Surgiform Anatomical Malar implants can be used by surgeons in a unique surgical procedure designed to restore or enhance a patients facial appearance. The implants can be used for aesthetic or reconstructive procedures. The implants can be inserted into a "pocket" created by means of a standard intraoral surgical incision. The implants can elevate and reposition sagging skin and can also fill the hollows and depressions caused by gravity and time. The implants can also be used by surgeons to restore a patients natural appearance as a result of severe facial trauma.

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I am sorry, but the provided text does not contain the necessary information to answer your questions regarding acceptance criteria and study details for the Surgiform Anatomical Malar device. The document is a 510(k) clearance letter from the FDA, which confirms that the device is substantially equivalent to a legally marketed predicate device. It specifies general information about regulatory approval, but it does not include details about device performance studies, acceptance criteria, sample sizes, expert qualifications, or ground truth establishment.

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Surgical Technology Laboratories, Inc. Nasal Dorsal Series implants are intended to be used to augment or reconstruct the nose in rhinoplasty.

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I am sorry, but the provided text is a 510(k) clearance letter from the FDA to Surgical Technology Laboratories, Inc. for their "Nasal Dorsal Series" device. This letter indicates that the device has been found substantially equivalent to a legally marketed predicate device.

However, the letter does not contain any information regarding acceptance criteria, device performance studies, sample sizes, ground truth establishment, expert qualifications, or details about the clinical studies requested in your prompt.

Therefore, I cannot provide the requested table and study information based on the given document.

Ask a specific question about this device

Ask a specific question about this device