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ScarEase Sheets and Gel are indicated for use in the management of hypertrophic and keloid scars. ScarEase Sheets and Gel may prevent hypertrophic and keloid scarring.

ScarEase is a non-invasive medical device that reduces hypertrophic and keloid scars resulting from surgical procedures and traumatic events. ScarEase may soften, smooth and/or flatten scars. ScarEase Sheets will be individually packaged rectangular-shaped sheets (.0055 to .040″ thickness, by 1.5″ wide, by 4.0″ long) heat-sealed in polyethylene tubing, enclosed in a fold-over (labeled) outer covering with descriptive product information, enclosed with a package insert and sealed with shrinkwrap. ScarEase Gel will be available in 4 and 15 gram tamper-evident, labeled tubes. Each tube will be appropriately labeled to provide size, instructions for use and warnings. Each tube is generally placed into a descriptive display box stating product information and enclosed with a package insert. ScarEase sheets are made from Applied Silicone's calendared silicone sheeting material, durometer 50, shore A. ScarEase Gel is an amorphous clear gel made with Nusil Technology's MED 4210 4211 infused with polydimethysiloxane and silicone dioxide.

The provided text is a 510(k) summary for the device "ScarEase Sheets and ScarEase Gel," which describes the product, its intended use, and its substantial equivalence to predicate devices. However, this document does not contain any information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, or multi-reader multi-case (MRMC) studies.

The purpose of a 510(k) summary is to demonstrate that a new device is "substantially equivalent" to a legally marketed predicate device. This typically involves demonstrating similar technological characteristics and intended use, rather than presenting a detailed clinical study with performance metrics against pre-defined acceptance criteria.

Therefore, I cannot fulfill your request for the specific information regarding acceptance criteria and study details based on the provided text. The document focuses on demonstrating equivalence to existing devices based on materials and intended use.

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• ScarEase is indicated for use in the management of hypertrophic and keloid scars.
• ScarEase is effective in the management of hypertrophic and keloid scars. .
• Consistent use of ScarEase can reduce hypertrophic and keloid scarring. .
• lf used following surgical procedures, ScarEase may prevent hypertrophic . and keloid scarring.

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I am sorry, but the provided text does not contain the information required to describe the acceptance criteria and the study that proves the device meets the acceptance criteria. The document is an FDA 510(k) clearance letter for the ScarEase and ScarEase Adhesive Gel, indicating that the device is substantially equivalent to legally marketed predicate devices.

The letter mentions:

• Trade Name: ScarEase and ScarEase Adhesive Gel
• Regulatory Class: Unclassified
• Product Code: MDA
• Indications for Use: Management of hypertrophic and keloid scars; reduction of hypertrophic and keloid scarring with consistent use; prevention of hypertrophic and keloid scarring if used following surgical procedures.

However, the document does not include any details about:

1. A table of acceptance criteria or reported device performance.
2. Sample sizes for test sets, data provenance, or retrospective/prospective study design.
3. Number or qualifications of experts for ground truth establishment.
4. Adjudication methods.
5. Multi-reader multi-case (MRMC) comparative effectiveness studies or effect sizes.
6. Standalone (algorithm-only) performance studies.
7. Type of ground truth used (e.g., pathology, outcomes data).
8. Sample size for the training set.
9. How ground truth for the training set was established.

Therefore, I cannot fulfill your request based on the provided text.

Ask a specific question about this device