(112 days)
OTC:
PuraDerm is used for the management of minor cuts, minor abrasions, minor wounds and minor burns (1st degree burns).
Rx:
Under the supervision of a health care professional PuraDerm is used for the management of partial and full-thickness wounds, such as pressure ulcers, diabetic ulcers, and surgical wounds.
PuraDerm™ Gel is a sterile gel composed of a synthetic peptide and sterile water for injection. It is provided as a prefilled syringe (2.5% peptide content) ready for use as a wound dressing with or without the optional sterile application nozzle. PuraDerm forms a moist wound environment that is supportive of the healing process and allows non-traumatic removal of the secondary dressing without damaging newly formed tissue.
PuraDerm is completely non-animal and non-plant derived, and contains no preservatives that might present a risk of allergic reaction or skin irritation.
Exposure to physiological fluids such as blood causes the peptide solution to quickly form a transparent gel without expansion in volume. PuraDerm can be easily rinsed away by gently flushing the wound with sterile saline, without causing trauma to the underlying wound.
The provided text describes the 510(k) premarket notification for the PuraDerm Gel, which is a wound dressing. The document focuses on demonstrating substantial equivalence to predicate devices rather than proving the device meets specific performance-based acceptance criteria through an AI study.
Therefore, the information required to answer the prompt regarding acceptance criteria and a study proving a device meets these criteria (especially related to AI performance, human-in-the-loop, MRMC studies, ground truth establishment for AI models, etc.) is not present in the provided document.
The document details:
- Device Description: PuraDerm Gel (a sterile gel of synthetic peptide and sterile water).
- Intended Use: Management of minor cuts, abrasions, minor burns (OTC), and management of partial and full-thickness wounds (Rx).
- Comparison to Predicate Devices: DuoDerm® Hydroactive® Gel and Woun'Dres® Collagen Hydrogel. The comparison focuses on presentation, function, and indication for use, highlighting similar material properties and hydration function.
- Performance Data: This section mentions non-clinical performance testing, specifically in vivo performance testing in an established porcine wound healing model and biocompatibility testing. It states that DuoDerm was used as the control device in the animal study.
- Statement of Substantial Equivalence: Concludes that PuraDerm is as safe, as effective, and performs as well as the proposed predicate(s) based on benchtop and animal testing.
There is no mention of:
- Acceptance criteria in terms of specific performance metrics (like sensitivity, specificity, accuracy) for an AI device.
- An AI component or algorithm within the PuraDerm Gel device.
- Test sets, training sets, or data provenance relevant to AI model development or validation.
- Experts establishing ground truth for AI model testing.
- Adjudication methods for AI model ground truth.
- Multi-Reader Multi-Case (MRMC) studies or human reader improvement with AI assistance.
- Standalone AI performance or human-in-the-loop performance studies.
- Ground truth types (pathology, outcomes data, etc.) in the context of AI.
In summary, the provided text does not contain the information requested in the prompt because it pertains to a traditional medical device (wound dressing) submission focused on substantial equivalence to existing predicate devices, not an AI/ML-enabled device.
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