(26 days)
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
| Acceptance Criteria (N/A for 510(k) Equivalence) | Reported Device Performance (N/A for 510(k) Equivalence) |
|---|---|
| No specific performance-based acceptance criteria detailed in the document. The submission is based on substantial equivalence to predicate devices. | No quantitative performance data reported for this specific device in the document, as it relies on substantial equivalence. |
| The device passed biocompatibility tests: Kligman Maximization, Primary Dermal Irritation, Agarose Diffusion Cytotoxicity, in conformity to EN/ISO 10993 guidelines. | Device demonstrated biocompatibility by passing the specified tests. This is a conformance to safety standards, not a performance metric for scar reduction. |
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.
§ 878.4025 Silicone sheeting.
(a)
Identification. Silicone sheeting is intended for use in the management of closed hyperproliferative (hypertrophic and keloid) scars.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 878.9.