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510(k) Data Aggregation
(113 days)
DERMADAPT WOUND DRESSING
The Pegasus Biologics DermADAPT™ Wound Dressing is a collagen-based wound dressing for the local management of moderately to heavy exuding wounds, including:
- Partial and full thickness wounds, .
- . Draining wounds,
- Pressure sores/ulcers, ●
- Venous ulcers, .
- Chronic vascular ulcers, .
- Diabetic ulcers, .
- Trauma wounds (e.g., abrasions, lacerations, partial thickness burns, skin tears), .
- Surgical wounds (e.g., donor sites/grafts, post-laser surgery, post-Mohs' surgery, . podiatric wounds, dehisced surgical incisions)
The Pegasus Biologics DermADAPT™ Wound Dressing is a decellularized, equine pericardial implant that has been crosslinked and passed USP Sterility testing. The product is non-pyrogenic and supplied for single use only. The product must be rinsed prior to use following the procedure described in the IFU.
The provided text describes a 510(k) premarket notification for the DermADAPT™ Wound Dressing, a collagen-based wound dressing. However, it does not contain the specific information requested about acceptance criteria, performance data from a study, sample sizes, expert qualifications, or detailed study methodologies that would typically be found in a clinical trial report or a performance validation study for a device of this nature.
The document focuses on demonstrating substantial equivalence to predicate devices rather than proving performance against specific acceptance criteria through a detailed study.
Here's a breakdown of what can be extracted and what is missing:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state quantitative acceptance criteria or report specific performance metrics for the DermADAPT™ Wound Dressing as would be seen in a clinical study comparing its efficacy to a gold standard or a defined benchmark.
Instead, the document highlights:
| Acceptance Criteria Category | Reported Device Performance (Summary from text) |
|---|---|
| Biocompatibility | "Biocompatibility test results indicate that the device satisfies all biocompatibility requirements." |
| Biomechanical Performance | "Biomechanical test results indicate that the dressing satisfies performance requirements for a wound dressing." |
| Sterility | "DermADAPT™ is subjected to 14 day USP sterility testing and USP endotoxin testing prior to release." (Implies meeting USP standards for sterility and endotoxin levels are the acceptance criteria, and these tests are passed.) |
| Substantial Equivalence | "The results of testing demonstrate that DermADAPT™ Wound Dressing is substantially equivalent to the predicate devices in design, function, source of substrate materials and indications for use." This is the overarching "acceptance" for 510(k) clearance, rather than a clinical performance metric. The predicate devices are BIOPAD® (K040283) and Stimulen™ Collagen (K030774). |
| Material Composition | "The components of the DermADAPT™ Wound Dressing are similar in basic materials, design, construction and performance to the predicate devices. The device consists primarily of Type 1 collagen that has been decellularized, crosslinked, and passes USP sterility testing, and is provided in dimensions appropriate for covering and protecting surface wounds." (Implies acceptance criteria related to material composition and manufacturing steps are met.) |
2. Sample size used for the test set and the data provenance
- Sample Size for Test Set: Not specified. The document only mentions "Biocompatibility testing and in vitro bench testing has been conducted," without any details on the number of samples or specimens tested.
- Data Provenance: Not specified. It's implied the testing was conducted by Pegasus Biologics, Inc., but no information on the country of origin of the data or whether it was retrospective or prospective is given. For biocompatibility and bench testing, this level of detail is often not included in a 510(k) summary unless a specific clinical study involving human subjects was performed.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable/Not specified. This information is typically relevant for studies involving subjective interpretation (e.g., image analysis, diagnostic performance). The tests mentioned (biocompatibility, biomechanical, sterility, endotoxin) are objective laboratory tests.
4. Adjudication method for the test set
Not applicable/Not specified. Adjudication methods are relevant for studies where subjective interpretations are made and need to be reconciled.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, and effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This device is a wound dressing, not an AI-assisted diagnostic tool or an imaging device requiring human reader interpretation. No MRMC study was conducted.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is a physical wound dressing, not an algorithm.
7. The type of ground truth used
The "ground truth" for the tests mentioned are:
- Biocompatibility: Likely established through standardized tests (e.g., ISO 10993 series) with pre-defined pass/fail criteria.
- Biomechanical Performance: Established through "in vitro bench testing" likely against specified physical properties (e.g., tensile strength, absorption capacity, degradation rate) with pre-defined performance requirements for a wound dressing.
- Sterility and Endotoxin: Established by meeting USP (United States Pharmacopeia) standards for sterility and endotoxin levels.
8. The sample size for the training set
Not applicable. This device is a physical wound dressing, not a machine learning model. Therefore, there is no "training set" in the context of an algorithm.
9. How the ground truth for the training set was established
Not applicable (as above).
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