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SKIN 2 forté Silicone Sheeting is indicated for the management of hypertrophic and keloid scars. Consistent use of SKIN 2 forte can reduce hypertrophic and keloid scars.

SKIN 2 forté may be useful as a prophylaxis after surgical or traumatic dermal injury to aid in the prevention of hypertrophic and keloid scars. SKIN 2 forté may be used as soon as the wound is closed, dry and the sutures or staples have been removed.

Device Description

Skin 2 forté Silicone Sheeting is a non-surgical, medically proven product that can help reduce your old scars and prevent new scars from developing. Skin 2 forté softens, smoothes and flattens scar tissue and restores a more normal skin color and texture. Consistent use of the SKIN 2 forté system can reduce hypertrophic and keloid scars.

AI/ML Overview

The provided text describes the biocompatibility testing and substantial equivalence determination for the "SKIN 2 forté Silicone Sheeting" device. It does not contain information about a study proving the device meets acceptance criteria in the context of an AI-powered diagnostic or similar system, nor does it provide details about acceptance criteria or performance metrics such as those requested in your prompt (e.g., sensitivity, specificity, effect size of AI assistance).

Instead, the document focuses on:

Substantial Equivalence: The device is deemed substantially equivalent to a previously marketed product (ReJuveness, K974380).
Biocompatibility Studies: Testing was performed to ensure the device material is safe for patient contact.

Therefore, I cannot fulfill your request for:

A table of acceptance criteria and reported device performance.
Sample size used for the test set and data provenance.
Number of experts and their qualifications for ground truth.
Adjudication method for the test set.
MRMC comparative effectiveness study results or effect size.
Standalone performance.
Type of ground truth used.
Sample size for the training set.
How ground truth for the training set was established.

However, I can provide the acceptance criteria and study proving the device meets the acceptance criteria as presented in the document concerning biocompatibility:

Acceptance Criteria and Study for Biocompatibility

The acceptance criteria for the "SKIN 2 forté Silicone Sheeting" device are based on demonstrating biocompatibility of its biomedical silicone elastomer component. The study performed is a series of in vitro and in vivo biocompatibility tests, summarized in the table below. The acceptance criteria essentially translate to "no adverse effects" or "non-toxic/non-irritating" compared to controls.

Acceptance Criteria (Test Outcome)	Reported Device Performance (Outcome)
Cell culture with Neutral Red Uptake: No Cytopathic effects (morphology Change)	No Cytopathic effects (morphology Change)
Cell culture medium extract of elastomer: No Cytopathic effects (morphology Change)	No Cytopathic effects (morphology Change)
Acetone extract of elastomer: No evidence of genetic activity or cytotoxicity	No evidence of genetic activity or cytotoxicity
Ames Bacterial Reverse Mutagenicity (Saline extract): No evidence of genetic activity of cytotoxicity	No evidence of genetic activity or cytotoxicity
Hemolysis (Elastomer): Nonhemolytic	Nonhemolytic
Hemolysis (Saline extract of elastomer): Nonhemolytic	Nonhemolytic
USP Pyrogen (Saline extract of elastomer): Nonpyrogenic	Nonpyrogenic
USP Class VI Extractables System Toxicity (Extracts of elastomer in Saline): Nonirritating and nontoxic relative to controls	Nonirritating and nontoxic relative to controls
USP Class VI Extractables System Toxicity (Extracts of elastomer in 5% ethanol in saline): Nonirritating and nontoxic relative to controls	Nonirritating and nontoxic relative to controls
Intracutaneous Reactivity (Polyethylene 400): Nonirritating and nontoxic relative to controls	Nonirritating and nontoxic relative to controls
Intracutaneous Reactivity (Cottonseed oil): Nonirritating and nontoxic relative to controls	Nonirritating and nontoxic relative to controls
Skin Sensitization (Elastomer): No sensitization	No sensitization
Skin Sensitization (Saline Extract): No Sensitization	No Sensitization
Skin Sensitization (Ethanol or acetone extract): No sensitization	No sensitization
90-day Implant (Elastomer): Reaction equivalent to or lesser than negative control	Reaction equivalent to or lesser than negative control

Additional Information (based on the provided text for biocompatibility):

Sample size used for the test set and the data provenance: The document lists "SAMPLES TESTED" for each biocompatibility test, indicating the material type (e.g., "Elastomer," "Cell culture medium extract of elastomer," "Saline extract of elastomer"). It does not specify the numerical sample size (e.g., number of animals for in vivo tests, number of replicates for in vitro tests) or the provenance (country of origin, retrospective/prospective) of these specific test samples.
Experts and qualifications: Not applicable for standard biocompatibility testing; these tests are typically performed by laboratories specializing in such evaluations, following standardized protocols (ISO 10993-1, Tripartite Biocompatibility Guidance).
Adjudication method for the test set: Not applicable; biocompatibility tests have objective pass/fail criteria based on measured biological responses.
MRMC comparative effectiveness study: Not applicable; this device is not an AI diagnostic and does not involve human-in-the-loop performance evaluation in this context.
Standalone performance: The biocompatibility tests represent the standalone performance of the material. All tests performed yielded acceptable outcomes as described in the table.
Type of ground truth used: For biocompatibility, the ground truth is established by standardized biological assays and observation against well-defined criteria and negative/positive controls as per recognized regulatory requirements (ISO 10993-1 and FDA guidance).
Sample size for the training set: Not applicable; this pertains to AI/machine learning models, which are not described here.
How the ground truth for the training set was established: Not applicable.

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