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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

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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Prescription Use: As a prescription topical skin care emulsion to manage and relieve the burning and itching experienced with various types of dermatoses, including atopic and allerge contact dermatitis. SPB helps maintain a moist wound & skin environment, which is be healing process.

Over-The-Counter Use: An OTC topical skin care emulsion to relieve the burning associated with many common types of skin irritation. SP helps maintain a moist wound & skin environment, which is beneficial to the healing process.

SPB Skin Emulsion is a topical skin care emulsion that is indicated to manage and relieve the burning and itching experienced with various types of dermatoses, including atopic and allergic contact dermatitis. SPB Skin Emulsion contains natural extracts to moisturize the skin.

The provided text describes the regulatory clearance for "SPB Skin Emulsion" and outlines the studies conducted to demonstrate its substantial equivalence to a predicate device, MimyX™ Cream. However, it does not contain acceptance criteria for specific performance metrics (like sensitivity, specificity, accuracy, etc.) nor does it report detailed performance values in a table. It also does not involve an AI device.

Therefore, many of the requested fields cannot be extracted or are not applicable.

Here's a breakdown of what can be inferred or explicitly stated based on the provided document:

1. A table of acceptance criteria and the reported device performance

The document does not provide a table with quantitative acceptance criteria (e.g., specific thresholds for reduction in redness or itching) or numerical performance metrics for the device. The "performance" assessment is qualitative, stating that the device "performed similarly to the predicate with no observable events of either redness or itching."

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)

• Sample Size (Test Set): "a limited number of volunteers"
• Data Provenance: Not explicitly stated, but likely prospective as it involved a "double-blind study" with "daily observations." Country of origin is not specified.

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)

The document mentions "daily observations of redness and itching were recorded by trained personnel." It does not specify the number of personnel or their qualifications (e.g., doctors, dermatologists, nurses).

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set

Not explicitly stated. It's likely that the "trained personnel" made direct observations, but no formal adjudication process is described.

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

• MRMC study: Not applicable. This is not an AI device or a diagnostic device involving human readers interpreting results. The study was a "double-blind study" comparing a topical emulsion to a predicate.
• Effect size of human readers with/without AI: Not applicable, as no AI is involved.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

Not applicable, as this is a topical emulsion, not an algorithm or AI device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

The "ground truth" was based on clinical observation of "redness and itching" by "trained personnel" after exposure to a known allergen. This falls under outcomes data or clinical endpoints based on expert observation.

8. The sample size for the training set

Not applicable. This is a medical device (topical emulsion) and the studies described are clinical performance and biocompatibility studies, not machine learning model training.

9. How the ground truth for the training set was established

Not applicable, as there is no training set for a machine learning model.

Summary of what is available:

• Device Name: SPB Skin Emulsion
• Predicate Device: MimyX™ Cream (K041342)
• Type of Study: Double-blind study with a limited number of volunteers with acute contact dermatitis.
• Performance Claim: "SPB Skin Emulsion performed similarly to the predicate with no observable events of either redness or itching, and the placebo showing no positive effects."
• Ground Truth: Daily observations of redness and itching recorded by trained personnel.
• Non-Clinical Testing:
  • Cytotoxicity Assay (ISO 10993-5:2010): "no cytotoxic potential."
  • Sensitization Test (ISO 10993-10:2012): "non-sensitizing."
  • Irritation Test (ISO 10993-10:2012): "non-irritating."

The document focuses on demonstrating that the device is "substantially equivalent" to an existing predicate device based on intended use, technological characteristics, and safety/effectiveness data primarily derived from non-clinical biocompatibility testing and a small clinical comparison study. It does not provide the kind of detailed quantitative performance metrics typically associated with AI/diagnostic device approvals.

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An over-the-counter (OTC) product for topical management of minor cuts, lacerations, abrasions, 1st and 2nd degree burns, and skin irritations.

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 and may inhibit the growth of microorganisms within the dressing. Ross Ru Skin Discontinuities 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.

The provided 510(k) summary for "Ross Ru Skin Discontinuities" does not include information about acceptance criteria or a study proving the device meets said criteria, as it is for a wound gel and not an AI/ML powered device. The document focuses on demonstrating substantial equivalence to a predicate device through non-clinical performance data and a comparison of characteristics.

Therefore, I cannot extract the information required for your request regarding AI/ML device performance, as it is not present in the provided text.

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