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Gelzone is indicated for use in the management of keloid and hypertrophic scars. Gelzone may also be used prophylactically to help retard the formation of such scars.

Gelzone is a soft, semi-occlusive, slightly adhesive silicone gel backed by a polyester hook and loop fabric.

The provided 510(k) summary for the Implantech Associates Inc. "Gelzone" device does not contain a study that proves the device meets specific acceptance criteria in the manner of a performance study. This is a premarket notification where substantial equivalence to a predicate device is claimed, not a study demonstrating efficacy against defined metrics.

Therefore, most of the requested information (acceptance criteria table, sample sizes, expert involvement, adjudication, MRMC studies, standalone performance, ground truth details, training set size, and ground truth establishment for training set) cannot be extracted from this document as no such study is presented.

The summary states:

"Efficacy
Gelzone's silicone layer is manufactured with silicone gel. This silicone layer is the same material used in the current Implantech Gel Sheeting and Conform Sheeting products. The manufacturer of the gel has an FDA Master File which includes information on their formulation, on manufacturing methods, testing, and toxicology information."

This indicates that the efficacy is primarily supported by the known properties of the silicone gel material and its prior use in substantially equivalent devices, rather than a new clinical study with specific acceptance criteria for the Gelzone product itself.

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Conform Sheeting is indicated for use in the management of keloid and hypertrophic Scars. Conform Sheeting may also be used prophylactically to help retard the formation of such scars.

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This document is an FDA 510(k) clearance letter for a medical device called "Conform Sheeting, Model IGEL." It is a regulatory document addressing the substantial equivalence of the device to legally marketed predicate devices.

This document DOES NOT contain information about acceptance criteria, device performance specifications, study details (sample sizes, data provenance, expert qualifications, adjudication methods), multi-reader multi-case studies, standalone algorithm performance, or ground truth establishment relevant to the request.

The letter is focused on the regulatory approval process and states that the device is substantially equivalent for its intended use, which is in the management and prevention of keloid and hypertrophic scars. It does not provide any technical performance data or a study description of the kind requested.

Therefore, I cannot fulfill the request using only the provided text.

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The Implantech Conform™ Combined Submalar® Implant is indicated for implantation to augment or reconstruct the underdeveloped or traumatized malar region of the face. The soft, flexible Conform Combined Submalar Implant is designed to easily conform to the facial skeleton in the malar area.

The soft, flexible Conform Combined Submalar Implant is designed to easily conform to the facial skeleton in the malar area.

This document does not contain information about acceptance criteria or a study proving that a device meets those criteria. The provided text is a 510(k) clearance letter from the FDA for a medical device (Implantech Conform™ Binder Submalar® Implant), indicating that the device has been found substantially equivalent to a legally marketed predicate device. This letter allows the device to be marketed, subject to general controls and other regulations.

The letter explicitly states that the FDA "reviewed your Section 510(k) notification of intent to market the device ... and we have determined the device is substantially equivalent..." This is a regulatory clearance based on equivalence, not a performance study demonstrating specific acceptance criteria.

Therefore, I cannot provide the requested information, including:

1. A table of acceptance criteria and reported device performance.
2. Sample size and data provenance for a test set.
3. Number and qualifications of experts for ground truth.
4. Adjudication method.
5. MRMC comparative effectiveness study results.
6. Standalone algorithm performance.
7. Type of ground truth used.
8. Sample size for the training set.
9. How ground truth for the training set was established.

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