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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

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.

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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."

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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BioDerm Sciences Wound Solution is intended to cleanse, irrigate and externally manage dermal lesions such as lacerations, post-operative (surgical) wounds, grafts, partial and fullthickness wounds, burns and ulcers (diabetic, venous stasis, pressure). It is meant to be used in conjunction with a sterile dressing that absorbs fluids (i.e. gauze, gel, alginate, foam, hydrocolloid).

BioDerm Wound Solution can also be used as a wound cleanser to remove foreign matter, bacteria and tissue debris.

Bio Derm Wound Solution is an acidic zinc-saline wet dressing for external wound management. It provides an acidic, moist environment that aids the body in the healing process. The non-toxic nature of the solution allow it to be used in the mouth, eyes and on mucous membranes as well as on the skin.

BioDerm Wound Solution is supplied sterile in 50 ml injection bottles with Teflon septums. The solution is applied by withdrawing the contents from the injection bottle with a syringe. The crimp caps have a pull-tab which must be removed to get the syringe through the septum. The pull-tab supplies whether the bottle has been opened or not. The contents must be used within five days after opening.

Here's an analysis of the provided 510(k) summary for the BioDerm Wound Solution, focusing on acceptance criteria and supporting studies:

Acceptance Criteria and Device Performance for BioDerm Wound Solution

Based on the provided K040683 510(k) summary, the device is a wound cleanser and wet dressing. The acceptance criteria are primarily focused on the compositional range compared to legally marketed predicate devices, and its performance as an aid to wound healing.

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size: The document mentions "a porcine model" for performance testing. However, it does not specify the sample size (number of animals or wounds) used in this study.
• Data Provenance: The study was conducted at the "University of Miami (Department of Dermatology & Cutaneous Surgery)." The data provenance is pre-clinical (animal model) rather than human clinical data. It is prospective in nature, as it describes a planned evaluation of various formulations. The country of origin is the USA.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

• The document does not specify the number of experts or their qualifications.
• Given it's a porcine model, the "ground truth" would likely be established by veterinarians, histopathologists, or dermatologists experienced in animal models of wound healing, who would assess wound progression, histological changes, and healing metrics. However, this information is not provided.

4. Adjudication Method for the Test Set

• The document does not describe any adjudication method for the test set. For animal studies, this is less common than for human clinical trials or image-based diagnostic studies. Outcomes would typically be assessed by the research team involved in the study.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, If So, What Was the Effect Size of How Much Human Readers Improve with AI vs Without AI Assistance

• No, an MRMC comparative effectiveness study was not done. This device is a wound cleanser, not an AI-powered diagnostic or assistive tool. Therefore, the concept of human readers improving with AI assistance is not applicable.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

• No, a standalone algorithm performance study was not done. This device is a physical product (liquid solution), not an algorithm.

7. The Type of Ground Truth Used

• The type of ground truth used for the performance study was based on observations and measurements of wound healing in a porcine model. This would likely include:
  • Clinical assessment: Visual inspection of wound size reduction, re-epithelialization, inflammation, etc.
  • Histopathology: Microscopic examination of tissue samples from the wounds to assess new tissue formation, collagen deposition, cellular infiltration, and other healing markers.
  • Potentially other objective measurements: Such as wound tensile strength or biochemical markers, although not explicitly stated.

8. The Sample Size for the Training Set

• Not applicable. This device is a physical product, not a machine learning algorithm. Therefore, there is no "training set" in the context of AI. The "various formulations" evaluated in the study could be considered analogous to different experimental groups, but not a training set for an algorithm.

9. How the Ground Truth for the Training Set Was Established

• Not applicable. As stated above, there is no training set for this type of device.

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