(316 days)
BioDerm Sciences Wound Spray is intended to cleanse, rinsc and externally manage dermal lesions such as lacerations, post-operative (surgical) wounds, partial and full-thickness wounds, burns and ulcers (diabetic, venous stasis, pressure). It may also be used in conjunction with a dressing that absorbs fluids (i.e. gauze, gel, alginate, foam, hydrocolloid).
BioDerm Sciences Wound Spray is intended to clean, rinse and externally manage skin wounds such as minor lacerations, minor cuts, minor burns and abrasions.
BioDerm Wound Spray is an acidic zinc-saline wet dressing for external wound management. It aids the body in the healing process by providing a moist, acidic wound environment. The non-irritating components of BioDerm Wound Spray allow it to be used in the mouth, eyes and on mucous membrancs as well as on the skin.
BioDerm Wound Spray is similar in chemical composition to the previously cleared BioDerm Scicnces Wound Solution with the spray also containing 0.002% of some trace elements. A difference between these products is that the predicate device BioDerm Scicnccs Wound Solution is supplied sterile in injection bottles, while the current device is supplied non-sterile in pump-spray bottles. The dressing is applied by spraying onto the affected arca.
BioDerm Wound Spray is supplied in 100 ml spray bottles with a plunger activated pump applicator.
Here's an analysis of the provided text regarding the BioDerm Wound Spray, focusing on acceptance criteria and the supporting study:
The provided document, a 510(k) summary, is for a medical device called BioDerm Wound Spray. It primarily focuses on demonstrating substantial equivalence to predicate devices rather than establishing novel acceptance criteria or providing a detailed, statistically robust performance study with specific metrics and thresholds.
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly define numerical acceptance criteria or provide quantifiable device performance metrics in the way one would expect for a study designed to meet specific performance thresholds (e.g., sensitivity, specificity, accuracy for a diagnostic device).
Instead, the implied acceptance criterion is "effectiveness as an aid to the body's healing of burns and partial wounds" and "safe and effective as a wound cleanser or wet dressing." The reported device performance is simply that the study "demonstrated the effectiveness of BioDerm Wound Spray."
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Effective as an aid to the body's healing of burns and partial wounds. | A study "demonstrated the effectiveness of BioDerm Wound Spray as an aid to the body's healing of burns, and partial wounds." |
| Safe and effective as a wound cleanser or wet dressing. | "When used as directed, BioDerm Wound Spray is safe and effective as a wound cleanser or wet dressing." |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not explicitly stated. The study was conducted "using a porcine model." The number of porcine subjects or wounds is not mentioned.
- Data Provenance: The study was "performed at the University of Miami (Department of Dermatology & Cutaneous Surgery)." It was a pre-clinical study using an animal model (porcine), not human patient data. It is inherently prospective within the animal model context.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
The document does not provide information on experts used to establish ground truth. As an animal model study assessing healing, the evaluation criteria would likely be objective measurements (e.g., wound size reduction, epithelialization rates) or histological assessments, potentially by veterinary pathologists or researchers involved in wound healing.
4. Adjudication Method for the Test Set
The document does not specify any adjudication method. Given it's a pre-clinical animal study, adjudication is less common than in human clinical trials, where subjective assessments might require reconciliation. Performance assessment would likely follow standardized experimental protocols.
5. Multi Reader Multi Case (MRMC) Comparative Effectiveness Study
No, an MRMC comparative effectiveness study was not done. The study described is a pre-clinical animal model study, not involving human readers or assessment of AI assistance.
6. Standalone (i.e., algorithm only without human-in-the-loop performance)
Not applicable. BioDerm Wound Spray is a physical product (a wet dressing/wound spray), not an AI algorithm or a diagnostic device that would have "standalone performance" in the typical sense of algorithm-only evaluation.
7. The Type of Ground Truth Used
The ground truth or outcome measure for the animal study would relate to wound healing parameters. While not explicitly detailed, common measures in porcine burn/wound models include:
- Rate of wound closure/epithelialization
- Measurement of wound area
- Histological evaluation of tissue regeneration, collagen deposition, inflammation
- Clinical observation of wound condition
This is closer to objective biological observations/outcomes data rather than expert consensus or pathology reports in a diagnostic sense.
8. The Sample Size for the Training Set
Not applicable. BioDerm Wound Spray is a physical product, not a machine learning model. Therefore, there is no "training set."
9. How the Ground Truth for the Training Set Was Established
Not applicable. As stated above, this is a physical product, not an AI/ML model that requires a training set and associated ground truth.
Summary Takeaway:
The provided document is a 510(k) submission focused on demonstrating substantial equivalence for a wound care product. The "performance study" mentioned is a pre-clinical animal model study designed to show the utility of the product, not to meet specific, quantifiable performance acceptance criteria commonly seen for diagnostic devices or AI solutions. The details about the study are very limited in the summary provided.
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