(277 days)
Elastic Skin Liquid Bandage provides a covering over minor cuts and scrapes that are dry and clean.
Elastic Skin Liquid Bandage is indicated for providing a covering over minor wounds and scrapes that are clean and dry.
Elastic Skin is a liquid solution film-forming product. The product solution is packaged in a container with a brush applicator. A thin coating of solution is applied on the wound with the applicator forming a protective clear film in less than one minute. Additional coats may be applied if needed. The film may be removed by peeling away from the skin with the use of mild soap and water.
Elastic Skin Liquid Bandage composition is as follows:
The main component of Elastic Skin is an organic polymer dissolved in an organic solvent.
Here's an analysis of the provided text, focusing on acceptance criteria and study details for the Elastic Skin Liquid Bandage:
1. A table of acceptance criteria and the reported device performance
The provided 510(k) summary does not explicitly state numerical acceptance criteria with pass/fail thresholds for the performance tests. Instead, it states that "All tests gave satisfactory results," implying that the device met the internal criteria used for each study.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Satisfactory Self Preservation (USP Microorganisms) | Satisfactory results |
| Sterility (Mold and Fungus by Agar Plate Count and Identification) | Satisfactory results |
| Non-irritating (PRJ Primary Skin Irritation - Rabbits) | Satisfactory results |
| Non-mutagenic (Bacterial Mutagenicity Test - Ames Assay) | Satisfactory results |
| Non-sensitizing (Repeated Patch Dermal Sensitization - Buehler Method, Guinea Pigs) | Satisfactory results |
| Non-cytotoxic (1$0 Agarose Overlay Using L-929 Mouse Fibroblast Cells) | Satisfactory results |
| Effective microbial film barrier (Psuedomonas Aeruginosa ATCC 9027) | Satisfactory results |
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: The document lists the types of animals used for some tests (Rabbits for skin irritation, Guinea Pigs for sensitization) and specific microorganisms/cell lines, but does not provide the numerical sample size for any of these tests.
- Data Provenance: The studies were conducted as "laboratory tests." There is no information regarding the country of origin of the data or whether the studies were retrospective or prospective. Given the nature of these tests, they would inherently be prospective laboratory studies.
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 to the provided information. The studies performed are laboratory-based safety and performance tests (e.g., microbiology, toxicology, biocompatibility), not studies requiring expert interpretation of medical images or clinical outcomes data to establish ground truth.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
This is not applicable as the studies are laboratory tests, not clinical studies requiring adjudication of outcomes by human experts. The assessment of "satisfactory results" would typically be based on established laboratory protocols and controls, rather than expert adjudication in the context of clinical agreement.
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
This is not applicable. The device is a liquid bandage, not a diagnostic imaging device utilizing AI. Therefore, an MRMC study with human readers and AI assistance is entirely outside the scope of this medical device.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
This is not applicable. The device is a physical medical product (liquid bandage), not an algorithm or AI system.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The concept of "ground truth" as typically discussed in diagnostic AI or clinical studies is not directly applicable here. For these laboratory tests, the "ground truth" is established by:
- Validated laboratory methods and controls: For self-preservation, sterility, mutagenicity, cytotoxicity, and microbial barrier tests, the "ground truth" is determined by whether the test results fall within predefined acceptable ranges or exhibit expected biological responses according to established laboratory standards (e.g., USP for microorganisms).
- Observed biological reactions: For primary skin irritation and dermal sensitization tests, the "ground truth" relates to the absence or presence of specific adverse reactions (e.g., erythema, edema) in the animal models, as assessed by trained laboratory personnel against control groups.
8. The sample size for the training set
This is not applicable. The device is a physical product, not a machine learning algorithm that requires a training set. The "training set" concept is irrelevant in this context.
9. How the ground truth for the training set was established
This is not applicable for the same reason as point 8.
§ 880.5090 Liquid bandage.
(a)
Identification. A liquid bandage is a sterile device that is a liquid, semiliquid, or powder and liquid combination used to cover an opening in the skin or as a dressing for burns. The device is also used as a topical skin protectant.(b)
Classification. Class I (general controls). When used only as a skin protectant, the device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 880.9.