(255 days)
Local management of skin wounds, including pressure ulcers, venous stasis ulcers, first and second degree burns, and superficial wounds and scrapes.
Regenecare™ Wound Gel is a viscous hydrogel wound dressing containing 2% w/w lidocaine as a topical anesthetic intended for use in the local management of painful skin wounds. The product is supplied sterile in plastic tubes.
Due to the nature of the device (a medicated wound gel), the provided documents (K020540) do not contain information about acceptance criteria and studies in the context of device performance as one would expect for an AI/software device. Instead, the "study" described is related to biocompatibility and a comparison to a predicate device for substantial equivalence.
Therefore, I cannot directly provide the requested table and detailed information as it pertains to AI/software performance criteria. However, I can extract the relevant information regarding the safety and equivalence arguments made for this specific product.
Here's a breakdown of what the document does provide, structured to address your points as much as possible within the context of a physical medical device submission for substantial equivalence:
Device: Regenecare™ Wound Gel (Medicated Hydrogel Wound and Burn Dressing)
1. Table of Acceptance Criteria and Reported Device Performance
For this type of device, the "acceptance criteria" are related to safety and substantial equivalence to a predicate device, rather than quantitative performance metrics like sensitivity/specificity for AI.
| Acceptance Criteria Category | Reported Device "Performance" (Evidence from Study) |
|---|---|
| Biocompatibility | - Demonstrated by Primary Dermal Irritation Test in Rabbits |
- Demonstrated by Sensitization Test in Guinea Pigs
- Demonstrated by In Vitro Cytotoxicity Test |
| Safety (Lidocaine) | - Pre-established through long history of over-the-counter use of topical lidocaine (up to 4%). - Conclusion: Addition of 2% lidocaine to the original formulation does not raise new biocompatibility issues. |
| Substantial Equivalence | - Similar in composition to MPM Regenecare™ Wound Gel (K992074). - Identical in function to MPM Regenecare™ Wound Gel (K992074).
- Identical in intended use to MPM Regenecare™ Wound Gel (K992074) and other legally marketed hydrogel wound dressing products.
- Conclusion: Safe and effective for intended use, performs at least as well as legally marketed predicate devices. |
2. Sample Size Used for the Test Set and Data Provenance
- Biocompatibility Tests: The document mentions "rabbits" and "guinea pigs" for animal testing, and "in vitro" for cytotoxicity. Specific sample sizes (e.g., number of animals, number of replicates) are not provided in this summary.
- Safety of Lidocaine: This relies on the general historical use of lidocaine, not a specific "test set" in this submission.
- Data Provenance: Not applicable in the context of clinical data for AI. These are laboratory/animal study results and a comparison to existing market data.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This concept is not applicable here. The "ground truth" for biocompatibility is whether the biological response meets accepted safety standards, determined by standard laboratory protocols and expert interpretation of those results. The primary "experts" involved would be toxicologists and regulatory reviewers.
4. Adjudication Method for the Test Set
Not applicable. This is not a study involving human reader interpretation or clinical endpoints requiring adjudication in the context of an AI device.
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
Not applicable. This is a physical wound gel, not an AI or software device.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a physical wound gel, not an AI or software device.
7. The Type of Ground Truth Used
- Biocompatibility: Laboratory test results (irritation, sensitization, cytotoxicity) against established physiological endpoints and safety thresholds.
- Safety of Lidocaine: Historical clinical use and accepted pharmacological profiles.
- Substantial Equivalence: Comparison of device characteristics (composition, function, intended use) to an already cleared (predicate) device.
8. The Sample Size for the Training Set
Not applicable as this is not an AI/ML device.
9. How the Ground Truth for the Training Set was Established
Not applicable as this is not an AI/ML device.
Summary of the "Study" (Biocompatibility & Comparison to Predicate):
The "study" or evidence presented for K020540 relates entirely to establishing the safety and substantial equivalence of the Regenecare™ Wound Gel, particularly with the addition of 2% lidocaine, to an already approved predicate device (MPM Regenecare™ Wound Gel; K992074).
- Biocompatibility: The original predicate device's biocompatibility was established through:
- A primary dermal irritation test in rabbits.
- A sensitization test in guinea pigs.
- An in vitro cytotoxicity test.
- Lidocaine Safety: The submission leverages the well-established long history of over-the-counter use for topical lidocaine (up to 4%) to argue that the 2% concentration does not introduce new biocompatibility issues.
- Substantial Equivalence Argument: The new device (Regenecare™ Wound Gel with lidocaine) is stated to be similar in composition and identical in function and intended use to the predicate device. This comparison forms the basis for demonstrating that the new device is "safe and effective for its intended use, and performs at least as well as legally marketed predicate devices."
In essence, for this traditional medical device, the "acceptance criteria" were that the device be biocompatible and substantially equivalent in safety and efficacy to a previously cleared device, a benchmark they met by referring to prior testing and established safety profiles.
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