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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

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.

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3M™ Liquid Bandage is intended to cover minor cuts, scrapes, and skin irritations.

3M™ Liquid Bandage is a sterile, clear, n-2-butyl cyanoacrylate liquid used to cover minor cuts, scrapes, and minor skin irritations. The device is packaged in an aluminum tube with a reusable cap.

The provided text describes a 510(k) premarket notification for the 3M™ Liquid Bandage. This is a medical device submission seeking to demonstrate substantial equivalence to a legally marketed predicate device, rather than a study designed to prove the device meets specific acceptance criteria based on performance metrics.

Therefore, many of the requested elements about acceptance criteria, detailed study design, and performance metrics (like sensitivity, specificity, or reader improvement with AI) are not applicable to this type of regulatory submission as they are typically associated with performance studies for devices where such metrics are relevant.

However, I can extract information related to the safety tests conducted and the comparison to the predicate device.

Here's the information that can be extracted from the provided text, structured as requested where applicable, with an explanation of why certain items are not present:

1. Table of Acceptance Criteria and Reported Device Performance

• Acceptance Criteria: Not explicitly stated as quantifiable performance metrics for AI or diagnostic accuracy. Instead, the "acceptance criteria" in the context of this 510(k) are related to safety and substantial equivalence to a predicate device.
• Reported Device Performance: The "performance" in this context refers to safety test results.

2. Sample Size Used for the Test Set and Data Provenance

• Test Set Sample Size:
  • In-Vitro Cytotoxicity Test: Sample size not specified.
  • HRIPT: Not explicitly stated, but implies "subjects" were used. "A small number of subjects" for the irritation observation.
  • HCIPT: Not applicable (not performed).
• Data Provenance: Not specified (e.g., country of origin, retrospective/prospective). Human tests would generally be prospective.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

• Not applicable. This device is a liquid bandage, and the tests involve laboratory cytotoxicity and human skin reactions, not diagnostic imaging or clinical interpretation requiring expert readers for ground truth.

4. Adjudication Method for the Test Set

• Not applicable. The tests conducted (cytotoxicity, patch tests) do not involve adjudication by multiple experts in the way clinical diagnostic studies might.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

• No. This is a medical device for wound covering, not an AI or diagnostic tool that involves human readers interpreting cases. Therefore, an MRMC study and effects of AI assistance are not applicable.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

• No. This is a liquid bandage, entirely a physical product, not an algorithm.

7. Type of Ground Truth Used

• In-Vitro Cytotoxicity Test: Ground truth is the cellular response observed in lab conditions.
• Human Repeat Insult Patch Test (HRIPT): Ground truth is the observed human skin reaction (e.g., presence/absence of sensitization or irritation), typically assessed by trained dermatologists or clinicians.
• Substantial Equivalence: Ground truth for comparison is the documented characteristics and performance of the predicate device (Johnson & Johnson BAND-AID® Liquid Bandage).

8. Sample Size for the Training Set

• Not applicable. This is not a machine learning or AI device that requires a training set.

9. How the Ground Truth for the Training Set Was Established

• Not applicable. This is not a machine learning or AI device that requires a training set or ground truth establishment for training.

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