(444 days)
LiquiBand® Plus 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. LiquiBand® Plus may be used in conjunction with, but not in place of, deep dermal stitches.
LiquiBand® Plus topical skin adhesive is a sterile, liquid topical skin adhesive containing a monomeric (2-Octyl-cyanoacrylate) formulation and the colorant D&C Violet #2. It is provided in a single patient use applicator and packaged in a pouch. The LiquiBand® Plus topical skin adhesive product is comprised of a crushable glass ampoule contained within a plastic applicator with attached foam applicator tip. LiquiBand® Plus topical skin adhesive remains liquid until it is applied to the skin. Upon application LiquiBand® Plus topical skin adhesive polymerizes within minutes.
In vitro studies have shown that LiquiBand® Plus topical skin adhesive acts as a barrier to microbial penetration as long as the adhesive film remains intact. Clinical studies were not conducted to demonstrate microbial barrier properties and a correlation between microbial barrier properties and a reduction in infection have not been established.
The provided text describes the 510(k) summary for the medical device LiquiBand Plus, a topical skin adhesive. It outlines its indications for use, technological characteristics, and performance data from various tests. However, the document does not explicitly state acceptance criteria in a quantitative manner or provide specific performance results against those criteria in a table format. It focuses on demonstrating substantial equivalence to a predicate device through various performance and biocompatibility tests.
Therefore, I cannot fulfill the request to provide a table of acceptance criteria and reported device performance with numerical values, nor can I quantify the sample sizes for test sets, the number or qualifications of experts for ground truth, or an adjudication method. The document does not contain information about multi-reader multi-case studies, standalone algorithm performance, or specific ground truth methodologies for any studies, as the device is a physical medical device (skin adhesive), not an AI/software device that would typically involve such studies.
Here's a breakdown of what can be extracted from the provided text, while acknowledging the limitations regarding the core request:
1. Table of Acceptance Criteria and Reported Device Performance:
Not available in the provided text. The document states that "Testing was performed in accordance with the FDA special controls guidance document for 'Tissue Adhesive with Adjunct Wound Closure Device Intended for the Topical Approximation of Skin'". It lists several tests, but does not provide specific numerical acceptance criteria for these tests or the quantitative performance results achieved by LiquiBand Plus against those criteria. It only states that the testing demonstrated substantial equivalence.
2. Sample size used for the test set and the data provenance:
Not available in the provided text. The document lists the types of tests performed (e.g., Lap-shear strength, Animal wound healing study) but does not disclose the sample sizes used for these tests or the data provenance (e.g., country of origin, retrospective/prospective).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
Not applicable/available in the provided text. This device is a topical skin adhesive, not an AI/software for interpretation. "Ground truth" in the context of expert review for image or data interpretation is not relevant here. The evaluation focuses on physical and biological properties.
4. Adjudication method for the test set:
Not applicable/available in the provided text. As above, adjudication methods like 2+1 or 3+1 are typically for resolving discrepancies in expert interpretation, which is not relevant for this device type.
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/available in the provided text. This type of study is for AI-assisted diagnostic or interpretative devices. LiquiBand Plus is a physical medical device.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
Not applicable/available in the provided text. This is relevant for AI/software and not a physical medical device.
7. The type of ground truth used:
Various methods depending on the test, but not explicitly detailed as "ground truth" in the context of expert review. For a physical device like LiquiBand Plus, the "ground truth" would be established through the methodologies of the specific performance tests listed (e.g., standardized testing protocols for strength, degradation, biocompatibility endpoints like cytotoxicity). The document mentions "in vitro studies" and "animal wound healing study," but details on specific ground truth establishment for these are not provided.
8. The sample size for the training set:
Not applicable/available in the provided text. There is no "training set" as this is not an AI/machine learning device.
9. How the ground truth for the training set was established:
Not applicable/available in the provided text. There is no "training set" for this device.
In summary, the provided FDA 510(k) summary for LiquiBand Plus details the regulatory classification, indications for use, and a list of performance and biocompatibility tests conducted to demonstrate substantial equivalence to a predicate device. However, it does not provide the quantitative acceptance criteria, specific performance results against those criteria, sample sizes for the studies, or details related to expert ground truth establishment, as these are typically applicable to AI/software devices for diagnostic or interpretative tasks, not physical medical devices like the one described.
§ 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.