(413 days)
BioDerm Sciences Wound Cream is intended to externally manage dermal lessions such as lacerations, post-operative (surgical) wounds, partial and full-thickness wounds, 15 and 200 as racerations, post operative (cargenous 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 cream is an aqueous-based, acidic zinc/iron-saline cream for external wound management. It aids the body in the healing process by providing a moist, low pH wound environment and providing essential minerals. BioDerm Sciences Wound Cream is supplied in 100 g aluminum tubes. A metal seal at the tip of the tube must be broken in order to use the contents, thus rendering the packaging tamper-resistant. The dressing is applied by squeezing the cream from the tube onto the affected skin.
Here's an analysis of the provided text regarding the acceptance criteria and supporting study for the BioDerm Sciences Wound Cream:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Safety: | No sensitization demonstrated in tests with guinea pigs. |
| * Non-toxic | No toxicity observed in mice receiving intraperitoneal injections. |
| * No adverse side effects | The identical product has been marketed in Europe for fourteen years under the name "NAWA, Medical Elektrolyt-Salbe S" with satisfactory performance and no reports of adverse side effects. |
| Effectiveness: | A study using a porcine model demonstrated the effectiveness of the solutions contained in the BioDerm Wound Cream as an aid to the body's healing of burns and partial thickness wounds. |
| * Aids in healing (burns, partial thickness wounds) | The porcine model study showed effectiveness in aiding the healing of burns and partial thickness wounds. The device aids the body in the healing process by providing a moist, low pH wound environment and providing essential minerals. |
| * Provides moist, low pH wound environment | BioDerm Sciences Wound cream is an aqueous-based, acidic zinc/iron-saline cream for external wound management. It aids the body in the healing process by providing a moist, low pH wound environment and providing essential minerals. The pH value is 3.0-3.4. (This is a characteristic, and the effectiveness study implies this characteristic contributes to the stated healing aid). |
| * Provides essential minerals | BioDerm Sciences Wound cream is an aqueous-based, acidic zinc/iron-saline cream for external wound management. It aids the body in the healing process by providing a moist, low pH wound environment and providing essential minerals. BioDerm Sciences Wound Cream contains zinc chloride and iron chloride, and other trace elements. (Similar to pH, this is a characteristic that the effectiveness study implies contributes to efficacy). |
| Substantial Equivalence to Predicate Devices (Chemical Composition): | BioDerm Sciences Wound Cream is similar in chemical composition to the previously approved BioDerm Sciences Wound Solution. Although the zinc chloride and iron chloride contents are similar, the pH value is somewhat higher (ph 3.0-3.4 vs. 2.8); and other trace elements have been added, making it somewhat more comparable in content to BioDerm Sciences Wound Spray. Its chemical composition is within the range of chemical compositions of these predicate devices and is substantially equivalent. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Effectiveness Study: Not explicitly stated. The document mentions "a study of various formulations of with varying strength levels of the metallic salts... using a porcine model." It does not provide the number of pigs or wounds studied.
- Sample Size for Sensitization Study: Not explicitly stated. The document mentions "tests with guinea pigs."
- Sample Size for Toxicity Study: Not explicitly stated. The document mentions "mice receiving intraperitoneal injections."
- Data Provenance:
- Effectiveness Study: Prospective, conducted at the University of Miami (Department of Dermatology & Cutaneous Surgery).
- Sensitization Study: Not explicitly stated if prospective or retrospective, but implied prospective ("tests with guinea pigs").
- Toxicity Study: Not explicitly stated if prospective or retrospective, but implied prospective ("mice receiving intraperitoneal injections").
- Adverse Event Data: Retrospective (from 14 years of marketing in Europe as "NAWA, Medical Elektrolyt-Salbe S").
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable for this type of device. The studies described are animal studies (porcine, guinea pig, mouse) and a review of post-market surveillance data. There is no mention of expert human readers/reviewers establishing ground truth for the device's performance in these studies.
4. Adjudication Method for the Test Set
Not applicable. The studies are based on animal models for physiological outcomes (healing, sensitization, toxicity) and a review of past clinical performance, not on interpretation by multiple human experts.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC comparative effectiveness study was not done. The studies mentioned are animal model studies and a summary of post-market data.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Yes, the studies described can be considered standalone performance evaluations of the device itself (the wound cream) without human intervention in its direct 'reading' or 'interpretation'. The device is a therapeutic product, not an diagnostic imaging or AI algorithm.
7. The Type of Ground Truth Used
- Effectiveness Study: Physiological outcomes in a porcine model (healing of burns and partial thickness wounds). The "ground truth" would be the observed healing parameters in the animals.
- Sensitization Study: Observed physiological reactions in guinea pigs (absence of sensitization).
- Toxicity Study: Observed physiological reactions in mice (absence of toxicity).
- Adverse Events: Clinical outcomes and adverse event reports from 14 years of market experience in Europe. The "ground truth" here is the real-world safety profile based on reported incidents.
8. The Sample Size for the Training Set
Not applicable. The device is a wound cream, not an AI or machine learning algorithm that requires a training set. The "training" here would be the development and formulation process, informed by scientific principles and prior knowledge.
9. How the Ground Truth for the Training Set Was Established
Not applicable. As noted above, this is not an AI/ML device.
N/A