(66 days)
Dermaphylyx Hydrophilic Foam Dressing Foam Wound Dressings provide a degree of exudate absorption. They arc intended for use in the management of partial and full-thickness wounds.
The following indications for use are for Prescription Use or under the direction of a health care professional:
Venous stasis ulcers
Diabetic ulcers
Pressure sores
Donor sites
Burns, (superficial)
Abrasions and lacerations
Incisions
Additionally Fenestrated dressings are intended for use in the management of surgically induced drainage sites such as:
G-tubes, J-tubes, Penrose drains, chest tubes, nephrotomy tubes, and sump drains.
The following indications for use are for Over-the-Counter Use:
Minor Burns
Minor cuts
Minor abrasions
Minor lacerations
Dermaphylyx Hydrophilic Foam Wound Dressings are sterile, and absorptive. Dermaphylyx Hydrophilic Foam Wound Dressing is composed of a hydrophilic polyurethane foam, The product provides absorptive qualitics to assist in the management of wound drainage.
This looks like a 510(k) premarket notification for a wound dressing, which typically doesn't involve the kind of performance studies with acceptance criteria, sample sizes, expert ground truth, and statistical analyses that are common for AI/ML-driven diagnostic devices.
The documents provided are for the Dermaphylyx Hydrophilic Foam Wound Dressing. This is a medical device, specifically a wound dressing, not a software or AI-driven diagnostic tool. Therefore, the concepts of acceptance criteria in terms of sensitivity, specificity, AUC, human reader improvement with AI assistance, standalone algorithm performance, or training/test set ground truth as commonly discussed for AI/ML devices do not apply here.
Instead, for a device like a wound dressing, the "acceptance criteria" and "study" would relate to its physical and biological properties, such as:
- Sterility: Demonstrated through microbiological testing.
- Biocompatibility: Demonstrated through ISO 10993 testing (cytotoxicity, irritation, sensitization).
- Absorptive capacity: Measured through specialized laboratory tests.
- Tensile strength/durability: Measured through mechanical testing.
- Adhesion (if applicable): Measured through peel strength tests.
- Shelf-life stability: Demonstrated through accelerated and real-time aging studies.
The provided documents focus on establishing substantial equivalence to predicate devices already on the market (Spyrofoam® Wound Dressings and Hydrasorb® Sterile Dressings). This is the primary regulatory pathway for many Class I and II medical devices that do not raise new questions of safety and effectiveness.
Therefore, I cannot populate the requested table or answer the specific questions related to AI/ML device performance, as they are not applicable to the Dermaphylyx Hydrophilic Foam Wound Dressing.
The "study" here is the substantial equivalence argument, which relies on comparing the device's characteristics and intended use to legally marketed predicate devices, not on clinical performance studies in the way you might expect for an AI diagnostic.
§ 880.5090 Liquid bandage.
(a)
Identification. A liquid bandage is a sterile device that is a liquid, semiliquid, or powder and liquid combination used to cover an opening in the skin or as a dressing for burns. The device is also used as a topical skin protectant.(b)
Classification. Class I (general controls). When used only as a skin protectant, the device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 880.9.