(273 days)
Ross Ru Wound Dressing Gel is indicated for use in the management of 1st and 2nd degree burns, wounds such as stasis ulcers, pressure ulcers, diabetic ulcers, lacerations, skin tears, surgical incision sites, device insertion site wounds, graft sites and donor sites.
Ross Ru is a wound dressing gel that helps maintain a moist wound environment that is conducive to healing, by either absorbing or donating the moisture and wound exudates. Ross Ru Wound Dressing Gel is supplied in a collapsible low density polyethylene tube sealed at one end and fitted with a dispensing orifice at the other end accessible by the removal of its screw cap.
This document is a 510(k) summary for a medical device (Ross Ru Wound Dressing Gel), which focuses on demonstrating substantial equivalence to a predicate device rather than presenting a performance study with acceptance criteria in the manner typically seen for new AI/ML-based diagnostic devices.
Therefore, many of the requested elements (acceptance criteria table, sample sizes for test/training sets, expert qualifications, HRMC studies, standalone performance, ground truth establishment) are not applicable to this type of regulatory submission because the device is a wound dressing gel, not an AI/ML diagnostic.
The submission focuses on:
- Intended Use Equivalence: Showing the indications for use are the same as the predicate device.
- Technological Characteristics Comparison: Demonstrating similar materials and properties, with minor differences justified.
- Non-Clinical Performance Data: Biocompatibility, irritation, sensitization, and antimicrobial effectiveness tests to show safety.
Here's how to address the prompt based on the provided document:
Acceptance Criteria and Study to Prove Device Meets Criteria
As this is a 510(k) submission for a wound dressing gel, the "acceptance criteria" are not framed as statistical thresholds for diagnostic performance (e.g., sensitivity, specificity, AUC) but rather as successful completion of non-clinical safety tests to demonstrate substantial equivalence to a legally marketed predicate device.
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria Category | Specific Test/Requirement | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|---|
| Biocompatibility | Cytotoxicity Assay (ISO 10993-5:2009) | No cytotoxic potential | "The test product extract showed no cytotoxic potential." |
| Sensitization Test (ISO 10993-1:2009, -10:2010, -12:2012) | Non-sensitizing | "The test substance was non-sensitizing." | |
| Irritation Test (ISO 10993-10:2010) | Non-irritating | "Ross Ru Wound Dressing Gel was determined to be non-irritating." | |
| Product Functionality | Antimicrobial Effectiveness Test | Demonstrate preservative activity and inhibition of specified microorganisms | "Ross Ru Wound Dressing Gel was evaluated for preservative activity... Exposure to Ross Ru Skin Discontinuities caused an inhibition in Pseudomonas aeruginosa, E. coli, Staphylococcus aureus, Candida albicans, and Aspergillus niger." |
| Material Properties | Adherence to ISO 10993-1 standards | Compliance with biocompatibility standards | "Complies with ISO 10993-1: Yes" and "Biocompatibility testing per ISO 10993-1" |
| Sterility | (Implied by comparison to predicate) | Non-sterile | "Non-sterile: Same (as predicate)" |
| Shelf Life | Stability for specified period | 3 years | "A maximum shelf life of 3 years has been assigned..." |
| Packaging Integrity | Storage and Transport Testing | No evidence of damage to packaging after transport | "all packaging layers remained in a satisfactory condition following testing with no evidence of damage being observed." |
| Intended Use | Match predicate device | Indications are equivalent to predicate device | "Ross Ru Wound Dressing Gel is indicated for use in the management of 1st and 2nd degree burns, wounds such as stasis ulcers, pressure ulcers, diabetic ulcers, laceration, abrasions, skin tears, surgical incision sites, device insertion site wounds, graft sites and donor sites." (Matches predicate) |
2. Sample sizes used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
- Sample Sizes: The document does not specify exact sample sizes for each non-clinical test (e.g., how many gel samples were tested for cytotoxicity, how many animals for irritation). These are standard laboratory tests, and specific sample sizes would be detailed in the full test reports, which are not part of this summary document.
- Data Provenance: The tests are standard biological and chemical tests. The provenance is implied to be from certified labs conducting tests for BioTD, S.A. (Manufacturer: Costa Rica) to support the 510(k) submission to the FDA (USA). No country of origin for data (e.g., patient data) is relevant as this is not a clinical study involving patients. The tests are prospective laboratory experiments.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)
- Not Applicable. This is a physical wound dressing product, not a diagnostic device requiring human expert interpretation to establish "ground truth" for a test set. The "ground truth" for the non-clinical tests is established by the accepted scientific methodologies and results of the respective assays (e.g., if cells died or not in a cytotoxicity assay).
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
- Not Applicable. There is no a human-interpreted test set requiring adjudication in this submission.
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 medical device (wound dressing gel), not an AI-assisted diagnostic tool. No human reader studies were conducted or are relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable. This is a physical medical device. There is no algorithm or AI component.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- The "ground truth" is established by the results of standardized laboratory assays and tests according to recognized international and national standards (e.g., ISO 10993 series, USP 51). For example, for cytotoxicity, the ground truth is the biological response of cells; for antimicrobial effectiveness, it's the observed inhibition of microbial growth.
8. The sample size for the training set
- Not Applicable. This device does not involve machine learning or AI that requires a "training set."
9. How the ground truth for the training set was established
- Not Applicable. No training set exists for this type of device.
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