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510(k) Data Aggregation
(83 days)
SoloSite® Gel Conformable Dressing is used to create a moist wound environment for the treatment of minor conditions such as:
- Minor burns
- Superficial lacerations, cuts and abrasions (partial thickness wounds) and skin tears
Under the direction of a healthcare professional, SoloSite® Gel Conformable Dressing is used to create a moist wound environment for the management of: - Venous ulcers (leg ulcers)
- Surgical incisions
- Diabetic foot ulcers
- Pressure ulcers (including stage IV).
Additionally, SoloSite® Gel Conformable Dressing, creates a moist wound environment which assists in autolytic debridement of wounds covered with necrotic tissue.
SoloSite® Gel Conformable Dressing is a non woven (70/30 rayon polyester blend) dressing impregnated with SoloSite® wound gel contained in a heat sealable, peal apart metalized/polyethylene pouch.
The product is applied in such a manner to completely cover the wound surface with the dressing and secured in place with an appropriate secondary dressing.
Gel conformable dressings are indicated to provide covering of the wound bed as well as creating a moist wound healing environment.
The provided text is a 510(k) summary for a medical device called SoloSite® Gel Conformable Dressing. It focuses on demonstrating substantial equivalence to previously marketed devices and biocompatibility testing, rather than a clinical study evaluating its performance against specific acceptance criteria. Therefore, much of the requested information regarding acceptance criteria, study design, and performance metrics for a comparative effectiveness study is not present in this document.
However, I can extract the information that is available and clarify what is not.
Acceptance Criteria and Study Information for SoloSite® Gel Conformable Dressing
1. A table of acceptance criteria and the reported device performance
No explicit acceptance criteria with numerical targets for clinical performance are presented in this 510(k) summary. The document primarily focuses on demonstrating the device's biocompatibility and substantial equivalence to predicate devices. The "performance" reported relates to the results of biocompatibility tests, indicating the device meets safety standards.
| Acceptance Criteria (Implied from testing) | Reported Device Performance |
|---|---|
| Biocompatibility: | |
| In vitro cytotoxicity (ISO 10993-5) – No significant cell lysis or toxicity. | "The test article showed no evidence of causing cell lysis or toxicity grater then a USP grade of 2 (mild reactivity). The test article was mildly cytotoxic and passed this ISO study." |
| Primary skin irritation (FHSA Regulations, 16 CFR 1500) – Not a primary irritant (Irritation Index < 5.00). | "Barely perceptible irritation was observed on the skin of the rabbits. The primary irritation index was calculated to be 0.88." "The test article would not be considered a primary irritant to the skin since the empirical score was less than 5.00." |
| Delayed dermal contact sensitization (ISO Part 10) – No evidence of sensitization. | "The test article showed no evidence of causing delayed dermal contact sensitization in the guinea pig." |
| Acute systemic toxicity (ISO Part 11) – No mortality or significant systemic toxicity. | "Under the conditions of this test there was no mortality or evidence of significant systemic toxicity." |
| Genotoxicity (Salmonella typhimurium Reverse Mutation Study) – Not mutagenic. | "SoloSite CWD was not considered to be mutagenic to Salmonella typhimurium tester strains." |
| Hemolysis (In Vitro Procedure - Extract Method) – Non-hemolytic. | "The mean hemolytic index for the test article extract was 0%. The test article extract was nonhemolytic." |
| Functional Equivalence: | |
| Technologically the same as predicate devices (hydrogel impregnated dressing) | "The SoloSite® Gel Conformable Dressing is technologically the same as the substantially equivalent products... in that all products are hydrogel impregnated dressings indicated to provide covering of the wound bed as well as creating a moist wound healing environment." |
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:
- Biocompatibility Tests: The document refers to standard in vitro and in vivo animal tests. Specific sample sizes for each test (e.g., number of cells for cytotoxicity, number of rabbits for irritation, number of guinea pigs for sensitization, number of mice for systemic toxicity) are not explicitly stated within the provided text. These are typically defined by the referenced ISO/FHSA standards.
- Clinical Performance: No clinical test set or human subject study designed to evaluate device performance against specific outcomes is described in this 510(k) summary. The submission relies on substantial equivalence to predicate devices for its intended use claims.
- Data Provenance: The biocompatibility studies appear to be laboratory studies conducted as per international standards (ISO) and U.S. federal regulations (FSHC). The country of origin for the data generation (i.e., where the labs are located) is not specified, but the submission itself is to the U.S. FDA. The biocompatibility tests are prospective in nature, meaning they were conducted specifically for this device submission.
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)
This section is not applicable as the provided document describes biocompatibility testing and a substantial equivalence review, not a study requiring expert-established ground truth for clinical outcomes or diagnostic accuracy. The "ground truth" for the biocompatibility tests comes from the objective, quantifiable results of the laboratory assays and animal responses as interpreted by qualified professionals performing those tests.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This section is not applicable. No adjudication method for a test set is mentioned because there isn't a human-reader-dependent test set for clinical performance being described. The biocompatibility results are typically based on direct measurements and observations, not a consensus or adjudication process among multiple human readers.
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 MRMC comparative effectiveness study was done. This document pertains to a medical dressing, not a diagnostic or AI-assisted device. Therefore, questions regarding human reader improvement with or without AI assistance are not relevant to this submission.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. This device is a physical wound dressing, not an algorithm or AI system.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
For the biocompatibility studies, the "ground truth" is established by:
- For cytotoxicity, genotoxicity, and hemolysis: The results of in vitro laboratory assays with measurable endpoints (e.g., cell viability, mutation rates, hemolytic index).
- For irritation and sensitization: Observable physiological responses in animal models, evaluated against established scoring systems.
- For systemic toxicity: Observation of animal health and mortality.
There is no mention of expert consensus, pathology, or outcomes data in the context of clinical performance evaluation for this 510(k) submission.
8. The sample size for the training set
Not applicable. This document does not describe the development of an algorithm or AI model that would require a training set. The "device" is a physical product.
9. How the ground truth for the training set was established
Not applicable. As there is no training set for an algorithm, there is no corresponding ground truth establishment mentioned.
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(22 days)
Local management of skin wounds, including pressure ulcers, Stage I-IV, stasis ulcers, first and second degree burns.
The MPM Hydrogel Dressing is a clear, viscous, non-sterile, hydrogel intended for use in the local management of skin wounds. The product is supplied in 4 oz. tubes, 8 oz. spray bottles, and 0.5 oz. and 1.02. syringes and meets USP requirements for Antimicrobial Preservative Effectiveness.
This document is a 510(k) summary for a medical device (MPM Hydrogel Dressing) and details the "Substantial Equivalence" to predicate devices. It does not contain information about acceptance criteria or a study proving the device meets those criteria in the way typically expected for an AI/CADe device. The provided text focuses on demonstrating that the new device is as safe and effective as existing, legally marketed devices, primarily through comparison of composition and biocompatibility testing, rather than performance metrics against specific acceptance criteria.
Therefore, many of the requested fields cannot be populated from the provided text.
Here's a breakdown of what can be extracted and what cannot:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Non-cytotoxic | Non-cytotoxic |
Explanation: The primary "acceptance criterion" mentioned is non-cytotoxicity. The study performed confirms this.
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 for test set: Not specified. The "test" here refers to a cytotoxicity test of the device material itself, not a clinical study on patients.
- Data provenance: Not specified, but likely laboratory-based (in vitro) testing.
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 was a laboratory test (cytotoxicity), not an expert-driven ground truth assessment.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. This was a laboratory test.
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 not an AI/CADe device.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. This is not an AI/CADe device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable. The "ground truth" for the cytotoxicity test would be the established scientific method for determining cell toxicity.
8. The sample size for the training set
Not applicable. This device does not use a "training set."
9. How the ground truth for the training set was established
Not applicable. This device does not use a "training set."
In summary: The provided text describes a 510(k) submission for a hydrogel wound dressing, focusing on its substantial equivalence to predicate devices based on composition and a single biocompatibility test (cytotoxicity). It does not involve AI, image analysis, or clinical performance studies with human readers, and therefore, most of your requested information elements are not relevant to this type of device and submission.
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