(194 days)
3M™ Liquid Bandage is indicated for use as an over-the-counter (OTC) device for consumer use to cover minor cuts and scrapes that are clean and dry.
3M™ Liquid Bandage is intended to cover minor cuts, scrapes, and skin irritations that are clean and dry.
3M™ Liguid Bandage is a sterile, clear, liquid that covers minor cuts and scrapes that are clean and dry. The device is packaged in an aluminum tube with a reusable cap, a bottle with spray pump, or an individually wrapped swab.
The provided text describes the regulatory filing for the 3M™ Liquid Bandage. It focuses on the substantial equivalence to a predicate device and safety testing, rather than an advanced AI-driven device with detailed acceptance criteria and study results in the format requested.
Therefore, much of the requested information, such as "reported device performance," "sample size for the test set," "number of experts," "adjudication method," "MRMC comparative effectiveness study," "standalone performance study," "type of ground truth," and "training set details," is not applicable or available in this document because it pertains to a different type of device and evaluation.
However, I can extract the relevant information from the provided text regarding the closest equivalent to acceptance criteria and the studies conducted for this liquid bandage product.
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Safety: | |
| In-Vitro Cytotoxicity Test Reactivity Grade | Reactivity grade of 1 (considered safe for use) |
| Induction of Contact Sensitization (Human Repeat Insult Patch Test) | No evidence of induced delayed contact hypersensitivity observed |
| Induction of Cumulative Irritation (Human Cumulative Irritation Patch Test) | Mild material with essentially no evidence of experimental irritation |
| Substantial Equivalence to Predicate Device: | |
| Same Function | Yes (covers minor cuts and scrapes) |
| Over-the-Counter (OTC) Consumer Use | Yes |
| Similar Claims | Yes |
| Same Indications for Use | Yes |
2. Sample size used for the test set and the data provenance
- In-Vitro Cytotoxicity Test: Sample size is not specified. Data provenance is in-vitro (lab-based test).
- Human Repeat Insult Patch Test (HRIPT): Sample size is not specified. Data provenance is prospective human clinical study (presumably within the US, as the submitter is a US company).
- Human Cumulative Irritation Patch Test (HCIPT): Sample size is not specified. Data provenance is prospective human clinical study (presumably within the US).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. The ground truth for safety tests is based on established scientific protocols and observed biological responses, not expert consensus on diagnostic imaging or similar.
4. Adjudication method for the test set
Not applicable. The studies mentioned are primarily laboratory and human patch tests, which rely on direct observation and measurement of biological responses according to set protocols, rather than expert adjudication of interpretations.
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-driven device, so an MRMC study is irrelevant.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an algorithm-based device.
7. The type of ground truth used
- In-Vitro Cytotoxicity Test: Biological response/reactivity grade.
- Human Repeat Insult Patch Test (HRIPT): Clinical observation of contact sensitization.
- Human Cumulative Irritation Patch Test (HCIPT): Clinical observation of cumulative irritation.
- Substantial Equivalence: Comparison of technological characteristics, function, indications, and claims against a legally marketed predicate device.
8. The sample size for the training set
Not applicable. This device does not involve machine learning or a "training set."
9. How the ground truth for the training set was established
Not applicable.
§ 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.