(207 days)
LiquiBand Dual topical skin adhesive is intended for topical applications only, to hold closed easily approximated skin edges of wounds from surgical incisions, including punctures from minimally invasive surgery and simple, thoroughly cleansed, trauma induced lacerations. LiguiBand Dual topical skin adhesive may be used in conjunction with, but not in place of, deep dermal stitches.
LiquiBand® Dual is a sterile, topical tissue adhesive containing n-butyl-2-cyanoacrylate for initial wound closure and a blend of 30% n-butyl-cyanoacrylate and 70% 2-octyl cyanoacrylate for subsequent over layers . LiquiBand® Dual is supplied in a single patient use dual applicator configuration.
The provided text describes a 510(k) submission for a medical device named LiquiBand® Dual, a topical skin adhesive. The submission aims to demonstrate substantial equivalence to a predicate device, LiquiBand® Ultima (K100284).
However, the document does not provide specific acceptance criteria in terms of performance metrics (e.g., accuracy, precision, sensitivity, specificity) for the device's efficacy. Instead, it outlines comparative testing summary that was performed to demonstrate substantial equivalence to the predicate device.
Given the information, I can construct a table for the "Acceptance Criteria and Reported Device Performance" as it relates to the types of tests performed and the comparative nature of the results, rather than quantitative performance thresholds. The study mentioned is a "Clinical Study" as part of the substantial equivalence testing.
Here's the breakdown of the requested information based on the provided text:
Acceptance Criteria and Study Details for LiquiBand® Dual (K102076)
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implied by Comparative Testing) | Reported Device Performance (Comparative to Predicate) |
|---|---|
| • Tensile strength (ASTM F2255-05, F2258-05, F2458-05) | Substantially equivalent to LiquiBand® Ultima |
| • Set (polymerization) time | Substantially equivalent to LiquiBand® Ultima |
| • Heat of polymerization | Substantially equivalent to LiquiBand® Ultima |
| • Viscosity | Substantially equivalent to LiquiBand® Ultima |
| • GC Chemical Analysis | Substantially equivalent to LiquiBand® Ultima |
| • Clinical Performance (related to Indication For Use, formulation, technology, target population, intended application, mechanism of action, and achieving intended use) | Substantially equivalent to LiquiBand® Ultima |
Explanation: The acceptance criteria are implicitly met by demonstrating "substantially equivalent performance" to the predicate device, LiquiBand® Ultima, across the listed parameters. The document states that the "following comparative testing demonstrated substantially equivalent performance between LiquiBand Dual and LiquiBand Ultima". This means the acceptance criteria were that LiquiBand Dual performed as well as or acceptably close to LiquiBand Ultima in these areas.
2. Sample size used for the test set and the data provenance
- Sample Size for Test Set: The document explicitly mentions a "Clinical Study" but does not provide details on the sample size used within this study or for any other comparative tests.
- Data Provenance: The document does not specify the country of origin of the data or whether it was retrospective or prospective.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- This information is not provided in the document. The type of device (topical skin adhesive) and the nature of the “substantially equivalent” claim suggest that ground truth would likely be established through objective physical/chemical testing and clinical outcomes, rather than expert interpretation of complex data (like imaging). If a clinical study involved expert assessment, the details are not included.
4. Adjudication method for the test set
- This information is not provided in the document.
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, an MRMC comparative effectiveness study was not done. This type of study is relevant for AI-powered diagnostic or interpretive devices and is not applicable to a topical skin adhesive. The LiquiBand® Dual is a physical device, not an AI system.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
- No, a standalone (algorithm only) performance study was not done. This is not an AI/algorithm-based device.
7. The type of ground truth used
- The ground truth for the comparative tests would have been established by:
- Objective physical and chemical measurements: For tensile strength, set time, heat of polymerization, viscosity, and GC chemical analysis, the ground truth is derived from standardized laboratory measurements according to ASTM or other accepted methodologies.
- Clinical Outcomes: For the "Clinical Study," the ground truth would typically involve observed clinical outcomes such as wound dehiscence, infection rates, cosmetic results, or other relevant endpoints related to wound closure efficacy and safety. The document does not detail the specific clinical endpoints used.
8. The sample size for the training set
- This concept is not applicable as the LiquiBand® Dual is not an AI/machine learning device that requires a training set.
9. How the ground truth for the training set was established
- This question is not applicable as the device is not an AI/machine learning device.
§ 878.4010 Tissue adhesive.
(a)
Tissue adhesive for the topical approximation of skin —(1)Identification. A tissue adhesive for the topical approximation of skin is a device intended for topical closure of surgical incisions, including laparoscopic incisions, and simple traumatic lacerations that have easily approximated skin edges. Tissue adhesives for the topical approximation of skin may be used in conjunction with, but not in place of, deep dermal stitches.(2)
Classification. Class II (special controls). The special control for this device is FDA's “Class II Special Controls Guidance Document: “Tissue Adhesive for the Topical Approximation of Skin.” See § 878.1(e) of this chapter for the availability of this guidance document.(b)
Tissue adhesive for non-topical use —(1)Identification. A tissue adhesive for non-topical use, including adhesives intended for use in the embolization of brain arteriovenous malformation or for use in ophthalmic surgery, is a device used for adhesion of internal tissues and vessels.(2)
Classification. Class III (premarket approval). As of May 28, 1976, an approval under section 515 of the act is required before this device may be commercially distributed. See § 878.3 of this chapter.