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The Surgiform Saf-T-Vac® Smoke and Fluid Evacuator is an add-on device used to provide an air suction path for the reduction of gases, body fluids, and smoke associated with the use of most electro-cauterization systems that are not designed with integrated smoke evacuation capabilities. The Saf-T-Vac® is intended to be used with currently designed and distributed electro-cauterization systems, and most standard operating room suction systems.

The Surgiform Saf-T-Vac® Smoke and Fluid Evacuator is an add-on device used to provide an air suction path for the reduction of gases, body fluids, and smoke associated with the use of most electro-cauterization systems that are not designed with integrated smoke evacuation capabilities.

I am sorry, but based on the provided document, I cannot answer your request. The document is a 510(k) clearance letter from the FDA for a medical device called the "Saf-T-Vac Smoke and Fluid Evacuator." It primarily discusses the regulatory approval process, substantial equivalence, and general controls for the device.

The document does not contain any information regarding:

• Acceptance criteria or reported device performance in a table format.
• Details of any study conducted to prove the device meets acceptance criteria.
• Sample sizes, data provenance, ground truth establishment, expert qualifications, or adjudication methods for any test or training sets.
• Whether a multi-reader multi-case (MRMC) comparative effectiveness study or a standalone algorithm performance study was done.
• The type of ground truth used for any studies.

Therefore, I cannot extract the information you requested from the provided text.

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PureForm ePTFE Facial Implants are indicated for use in facial plastic and reconstructive surgery.

The PureForm ePTFE Facial Implants are threedimensional facial prosthesis (Nasal, Chin, and Malar) that are made from expanded Polytetraflouroethylene (ePTFE). The device is offered sterile in multiple sizes.

I am sorry, but based on the provided text, there is no information available about acceptance criteria or a study proving the device meets those criteria.

The document is a 510(k) summary for a medical device (PureForm ePTFE Facial Implants). This type of submission focuses on demonstrating substantial equivalence to predicate devices already on the market, rather than presenting a performance study with defined acceptance criteria.

The key points of the provided text are:

• Identification of the device: PureForm ePTFE Facial Implants (Nasal, Chin, Malar)
• Applicant: Surgical Technology Laboratories, Inc.
• Date Prepared: April 8, 2009
• Predicate Devices: Several existing facial implants.
• Conclusion: The device is deemed substantially equivalent to the predicate devices based on indications, intended use, material, design, and biocompatibility. This is a regulatory finding, not a demonstration of performance against specific, quantitative acceptance criteria through a study.
• FDA Letter: The FDA letter confirms the substantial equivalence determination but does not mention any performance studies or acceptance criteria met by the device.

Therefore, I cannot populate the requested table or answer the specific questions about sample size, expert qualifications, ground truth, or study types because the provided text does not contain this information.

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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. Nasal Dorsal Series implants are intended to be used to augment or reconstruct the nose in rhinoplasty.

Not Found

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.

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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.

Not Found

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.

Not Found

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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Ask a specific question about this device