(42 days)
Dermallex Foam Wound Dressings provide a degree of absorption and breathability. They are intended for use in the management of a variety of partial and full-thickness wounds.
The following indications are for Prescription Use or under the direction of a health care professional: Burns, (electrical and chemical) Venous stasis ulcers Abrasions and lacerations Diabetic ulcers Pressure sores Incisions Burns and abrasions associated with resurfacing procedures Donor sites such as dermabrasion, chemical, and laser resurfacing Skin Tears
The following indications are for Over-the-Counter Use: Abrasions Poison Ivy Sunburn Minor burns Minor cuts Minor lacerations Blisters
Dormaflex™ Foam Wound Dressings are sterile, self-adhesive, and absorptive. Dennaflex provides moist wound environment characteristics and absorptive qualities of traditional therapies in a structure, which is both adhesive and conformable. The wound contact surface of Dermallex is composed of a porous adhesive. A second layer consists of a microporous polyurethane foam. The product provides a barrier and dirt while maintaining breathability
The provided document is a 510(k) premarket notification for the Dermaflex™ Foam Wound Dressing. It describes the device, its intended use, and states its substantial equivalence to predicate devices. However, it does not contain information about acceptance criteria, a study proving the device meets acceptance criteria, or any of the detailed study parameters you've requested (sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, training set details).
The document is a regulatory approval letter from the FDA, confirming the device is substantially equivalent to legally marketed predicate devices, subject to certain labeling limitations. This type of regulatory submission primarily relies on demonstrating equivalence to existing devices rather than presenting novel clinical study data against specific performance acceptance criteria.
Therefore, I cannot populate the table or answer most of your detailed questions based solely on the provided input.
Here's a breakdown of what can be extracted and what cannot:
1. A table of acceptance criteria and the reported device performance
- Cannot be provided. The document does not describe specific numerical acceptance criteria or performance metrics derived from a study. The FDA's 510(k) clearance process for this type of device typically relies on demonstrating substantial equivalence to a predicate device, often through bench testing (e.g., absorbency, breathability), biocompatibility, and sometimes limited clinical testing to support specific claims if different from the predicate, but not usually against pre-defined numerical performance acceptance criteria in the way a diagnostic AI device would.
2. Sample sized used for the test set and the data provenance
- Cannot be provided. The document does not mention any test set, sample sizes, or data provenance from a study for the Dermaflex™ device.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Cannot be provided. No such information is present.
4. Adjudication method for the test set
- Cannot be provided. No such information is present.
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
- Cannot be provided. This is not relevant to a wound dressing device and no such study is mentioned.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Cannot be provided. This is not relevant to a wound dressing device.
7. The type of ground truth used
- Cannot be provided. This concept (ground truth) is not applicable to the information provided about a wound dressing.
8. The sample size for the training set
- Cannot be provided. No training set is mentioned.
9. How the ground truth for the training set was established
- Cannot be provided. No training set or ground truth in that context is mentioned.
Information that is available (or can be inferred from the context of a 510(k) for such a device):
The device is a Dermaflex™ Foam Wound Dressing.
It is intended for use in the management of partial and full-thickness wounds.
Its mechanism of action involves providing a moist wound environment, absorption, and breathability, while also being adhesive and conformable, and providing a barrier against dirt.
Predicated Devices:
The Dermaflex™ Foam Wound Dressing is substantially equivalent to:
- Spyroflex® Wound Dressings (Innovative Technologies US. Inc.)
- Flexzan Topical Wound Dressings (Dow Hickarn Pharmaceuticals. Inc.)
These predicate devices are described as self-adhesive wound dressings which provide a degree of absorption and breathability, intended for managing a wide variety of wounds. The "acceptance criteria" here is effectively demonstrating substantial equivalence to these legally marketed devices. This would typically involve showing similar performance in terms of:
- Biocompatibility: Non-toxic, non-irritating (standard ISO 10993 tests).
- Physical Properties: Adhesion strength, absorption capacity, breathability (Moisture Vapor Transmission Rate - MVTR), conformability.
- Sterility: Demonstrated sterile until opened/damaged.
- Shelf Life: Stability over time.
The document does not provide specific test results or numerical thresholds for these properties, but regulatory clearance hinges on them being comparable to the predicate devices.
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