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Oleeva Fabric is indicated for the management of hypertrophic scars and keloids. Consistent use of Oleeva Fabric can reduce hypertrophic scaring and keloid formation resulting from surgical or traumatic injury of the skin.

Oleeva Fabric may be useful as a prophylaxis after surgical or traumatic dermal injury to aid in the prevention of hypertrophic scars and keloids.

Oleeva Fabric is used topically to reduce hypertrophic scars and keloids. Consistent use of Oleeva may minimize scars resulting from traumatic or surgical injuries. Oleeva can reduce existing scars, and may be used after traumatic or surgical injury to aid in the prevention of new scars.

The provided document is a 510(k) summary for the Oleeva® Fabric, a silicone elastomer for scar management. It discusses the device identification, classification, product description, and indications for use. Crucially, it asserts substantial equivalence to existing predicate devices rather than presenting a study demonstrating new acceptance criteria or device performance against specific targets.

Therefore, many of the requested categories in your prompt are not applicable (N/A) based on the content of this document, as a clinical study with detailed performance metrics and ground truth establishment was not part of this 510(k) submission.

Here's a breakdown of the information that can be extracted or determined to be N/A:

1. A table of acceptance criteria and the reported device performance

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Sample Size for Test Set: N/A. No clinical test set data is presented for this 510(k) submission. The submission relies on substantial equivalence.
• Data Provenance: N/A.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

• Number of Experts: N/A. No clinical test set data where ground truth would need to be established is presented.
• Qualifications of Experts: N/A.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

• Adjudication Method: N/A. No clinical test set.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

• MRMC Study: N/A. This is a medical device (silicone fabric), not an AI-powered diagnostic or assistive technology for human readers.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

• Standalone Performance: N/A. This is a medical device, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

• Type of Ground Truth: N/A. No clinical study requiring ground truth generation is described. The basis for approval is substantial equivalence to legally marketed predicate devices, supported by biocompatibility testing.

8. The sample size for the training set

• Sample Size for Training Set: N/A. This is a medical device, not an AI model requiring a training set.

9. How the ground truth for the training set was established

• Ground Truth for Training Set: N/A.

Summary based on the provided text:

This 510(k) submission for Oleeva® Fabric is based on demonstrating substantial equivalence to existing legally marketed predicate devices (Oleeva Fabric K982036, Oleeva Foam K002109, and other silicone sheeting products from Bio Med Sciences, Inc.). The document explicitly states: "The new device is substantially equivalent to the existing Oleeva Fabric product (K982036), Oleeva Foam (K002109), as well as the other silicone sheeting products manufactured by Bio Med Sciences, Inc."

The primary "evidence" in this submission, beyond the claim of equivalence, is a biocompatibility summary, indicating the product's safety for human contact. It passes the following tests in conformity with EN/ISO 10993 guidelines:

• Kligman Maximization
• Primary Dermal Irritation
• Agarose Diffusion Cytotoxicity

The FDA's response letter confirms that the device is deemed "substantially equivalent" to predicate devices for its stated indications for use, thereby permitting its marketing. This regulatory pathway does not typically involve new clinical studies to prove performance against novel acceptance criteria but rather a demonstration that the new device is as safe and effective as a device already on the market.

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For the management of partial and full thickness wounds including the following:

• Second Degree Burns
• Skin Graft Donor Sites
• Autograft Sites
• Abrasions
• Lacerations
• Stage II III Chronic Wounds (Venous Stasis, Decubitus & Diabetic)
• Skin Tears

Silon® Dual-Dress™ is a single dressing with two different sides. One side consists of an open-celled hydrophilic foam. The other side consists of a non-adherent semi-occlusive film. The semi-occlusive film is perforated to allow wound exude to wick away from the wound.

With the foam side of the dressing down against the wound, the product provides an adhesive surface for difficult fixation conditions. With the film side down, the dressing provides a non-adherent covering for fragile and sensitive wounds. One side of the dressing is clearly marked with the product name and the words "Foam on Other Side" printed with a biocompatible ink.

This document does not contain information about the acceptance criteria or a study that proves the device meets acceptance criteria.

The provided text is a 510(k) summary for the Silon® Dual-Dress™ wound dressing. It includes a product description, indications for use, contraindications, and claims of substantial equivalence to predicate devices. The subsequent pages are the FDA's response letter indicating that the device has been found substantially equivalent to predicate devices and can be marketed under certain limitations.

This type of submission (510(k)) focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than conducting new clinical trials to prove device performance against specific acceptance criteria.

Therefore, I cannot provide the requested table or answer the specific questions about sample sizes, ground truth, expert qualifications, adjudication methods, or MRMC studies, as this information is not present in the provided document.

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Silon Scar Strips are indicated for the management of hypertrophic scars and keloids. Consistent use of Silon Scar Strips can reduce hypertrophic scaring and keloid formation resulting from surgical or traumatic injury of the skin.

Silon Scar Strips may be useful as a prophylaxis after surgical or traumatic dermal injury to aid in the prevention of hypertrophic scars and keloids.

The Applicant presently markets Silon-SES® Silicone Elastomer Sheeting for the management of hypertrophic scars and keloids. The new product does not introduce any new concepts in silicone scar management products. Silon-SES is presently labeled for sale by or on the order of a physician. The Applicant hereby intends to remove this restriction and offer the product directly to consumers "over-the-counter."

This 510(k) summary (K982036) describes the Silon Scar Strips, which are intended for the management of hypertrophic scars and keloids. The key aspect of this submission is the intention to remove the "by or on the order of a physician" restriction, allowing the product to be sold directly to consumers "over-the-counter."

The document focuses on demonstrating substantial equivalence to existing, legally marketed predicate devices, rather than presenting a novel clinical study with explicit acceptance criteria and corresponding device performance data for a new efficacy claim. Therefore, many of the requested categories for a new device's performance study will not be applicable or will have limited information.

Here's an analysis based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Since this is a submission for substantial equivalence based on a change in market availability (OTC vs. prescription) for an already marketed material, there are no specific performance acceptance criteria for clinical efficacy studies provided in the document for the new "Silon Scar Strips" product. The acceptance criteria are related to the material's biocompatibility, and the device's substantial equivalence to predicate devices.

2. Sample Size Used for the Test Set and the Data Provenance

• Biocompatibility Tests: The document does not specify the sample size for the in vitro or in vivo biocompatibility tests described. It only states that "All tests were performed by an FDA registered independent testing company." The data provenance is implied to be from a certified testing laboratory, but no country of origin is specified. These tests are usually conducted on material samples, not human subjects, and are retrospective in the sense that the material for testing is prepared and then analyzed.
• Substantial Equivalence: For substantial equivalence, the "test set" is essentially the comparison of the new device's characteristics and indications against the predicate devices. There isn't a "sample size" in the traditional sense for a clinical trial here. The data provenance for this comparison comes from the characteristics of the new Silon Scar Strips and the known characteristics of the predicate devices.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts

Not applicable. This submission relies on biocompatibility testing results and a comparison to predicate devices, not expert review of a test set for clinical performance.

4. Adjudication Method for the Test Set

Not applicable. As noted above, this is not a study requiring adjudication of clinical observations. The "adjudication" for substantial equivalence is carried out by the FDA during its review process.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, an MRMC comparative effectiveness study was not done. The submission is not for a diagnostic device or an AI-assisted device, and it doesn't involve human readers interpreting cases.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Not applicable. "Silon Scar Strips" is a medical device (silicone sheeting), not an algorithm or software. Therefore, no standalone algorithm performance study was conducted.

7. The Type of Ground Truth Used

• Biocompatibility: The "ground truth" for the biocompatibility tests is established by standardized laboratory testing protocols (e.g., Kligman Maximization, Primary Dermal Irritation, etc.) as outlined in the Tripartite Biocompatibility Guidance for Medical Devices. The results (e.g., "non-sensitizing," "non-irritant," "no cytopathic effects") serve as the ground truth for compliance with these standards.
• Substantial Equivalence: For substantial equivalence, the "ground truth" is primarily based on the established safety and effectiveness profiles, and indicated uses of the predicate devices (Silon-SES and Rejuveness). The new device is considered substantially equivalent if it shares the same technological characteristics or has different characteristics that do not raise new questions of safety and effectiveness, and is as safe and effective as a legally marketed device.

8. The Sample Size for the Training Set

Not applicable. There is no training set mentioned or implied, as this is not a machine learning or AI-based device.

9. How the Ground Truth for the Training Set Was Established

Not applicable. There is no training set for this device.

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