(175 days)
LiquiBand Exceed 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. LiquiBand Exceed topical skin adhesive may be used in conjunction with, but not in place of, deep dermal stitches.
LiquiBand Exceed 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 Exceed topical skin adhesive product is comprised of a crushable glass ampoule contained within a plastic applicator with attached foam applicator tip. LiquiBand Exceed topical skin adhesive remains liquid until it is applied to the skin. Upon application LiquiBand Exceed topical skin adhesive polymerizes within minutes.
Here's an analysis of the provided text to extract information about the acceptance criteria and the study performed for the LiquiBand Exceed:
Important Note: The provided document is a 510(k) summary for a medical device (LiquiBand Exceed topical skin adhesive). This type of document focuses on demonstrating substantial equivalence to a predicate device rather than presenting a standalone clinical trial with acceptance criteria for device performance. As such, the information you're requesting, especially detailed acceptance criteria with specific performance thresholds and a multi-reader multi-case study, is typically not found in this type of submission. The performance tests listed are primarily to show that the new device performs comparably to or at least as well as the predicate device for relevant characteristics.
Response Based on Provided Document:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state numerical acceptance criteria or specific reported device performance values in a table format for the LiquiBand Exceed itself. Instead, it states that "Testing was performed in accordance with the FDA special controls guidance document for 'Tissue Adhesive for the Topical Approximation of Skin'" and that the results demonstrated "substantial equivalence to the predicate device."
The tests performed, which would have had associated pass/fail criteria (likely defined by the guidance document or established industry standards), are listed as:
| Acceptance Criteria (Implied by Test Name) | Reported Device Performance (Implied) |
|---|---|
| Wound closure strength (ASTM F2458-05) | Demonstrated to meet standards / substantially equivalent to predicate |
| Lap-shear strength (ASTM F2255-05) | Demonstrated to meet standards / substantially equivalent to predicate |
| Peel adhesion strength (ASTM F2256-05) | Demonstrated to meet standards / substantially equivalent to predicate |
| Adhesive strength in tension (ASTM F2258-05) | Demonstrated to meet standards / substantially equivalent to predicate |
| Force to actuate | Demonstrated to meet standards / substantially equivalent to predicate |
| Polymerization set time | Demonstrated to meet standards / substantially equivalent to predicate |
| Microbial barrier | In vitro studies showed barrier to microbial penetration as long as film remains intact. |
| Intraoperative reuse | Suitable for up to 90 minutes on a single patient. |
| Wound closure length | Single device contains sufficient adhesive for wounds up to 30cm. |
| Sterilization and Shelf Life | Confirmed through real-time and accelerated aging studies. |
| Biocompatibility (Cytotoxicity, Sensitization, Irritation, Acute dermal toxicity, Intramuscular implantation) | Performed in accordance with ISO 10993-1; likely passed all tests for substantial equivalence. |
2. Sample sizes used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
The document does not specify sample sizes for any of the performance tests. It also does not provide details on the data provenance, such as country of origin or whether studies were retrospective or prospective. Given the nature of a 510(k) summary and the listed tests (ASTM standards, in-vitro), most of these would be laboratory-based rather than human clinical 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 information is not applicable and not provided in the document. The tests performed are primarily engineering and material science tests (e.g., adhesion strength, polymerization time, sterilization) or laboratory biological tests (biocompatibility, microbial barrier). These types of tests do not typically involve human experts establishing a "ground truth" in the way a diagnostic AI device would.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
This information is not applicable and not provided. Adjudication methods are relevant for clinical studies where human assessment of outcomes is necessary, particularly with multiple reviewers. The tests described are objective, laboratory-based measurements.
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
A multi-reader multi-case (MRMC) comparative effectiveness study was not done. This type of study is relevant for diagnostic devices, particularly those involving image interpretation or AI assistance, which is not the case for a topical skin adhesive.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
This concept is not applicable to a topical skin adhesive. There is no algorithm or AI component mentioned for the LiquiBand Exceed. The device's performance is standalone in the sense that it's a physical product applied directly.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
For the in-vitro and ex-vivo performance tests, the "ground truth" would be established by the methods and criteria specified in the referenced ASTM standards and other relevant industry standards (e.g., ISO 10993-1 for biocompatibility). For example, the "ground truth" for wound closure strength would be the measured force required to cause failure, compared against a pre-defined threshold or the predicate device's performance. For shelf-life, it would be the sustained quality metrics over time. Clinical outcomes data are not presented in this 510(k) summary for the LiquiBand Exceed as the primary means of demonstrating substantial equivalence.
8. The sample size for the training set
This information is not applicable and not provided. 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
This information is not applicable as there is no training set for this 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.