(230 days)
Barle Tissue Adhesive 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. Barle Tissue Adhesive topical skin adhesive may be used in conjunction with, but not in place of, deep dermal stitches.
Barle Tissue Adhesive is a sterile, topical tissue adhesive containing 2-octyl cyanoacrylate for wound closure. Barle Tissue Adhesive is supplied in a single patient use configuration. The applicator is composed of a crushable glass ampoule contained within a plastic polypropylene applicator. The ampoule is crushed through force applied by the clinician to the 'wings' of the applicator body. It is applied to easily approximated skin edges and polymerizes within minutes. The device is contained within a PET/tyvek blister.
The provided text describes a 510(k) premarket notification for the Barle Tissue Adhesive, which is a medical device for wound closure. The document focuses on demonstrating substantial equivalence to predicate devices rather than proving a device meets specific, quantitative acceptance criteria through a clinical study. Therefore, some of the requested information, particularly regarding specific numerical performance metrics, sample sizes for test sets in clinical studies, expert involvement in ground truth establishment for a test set, MRMC studies, or standalone algorithm performance, is not available in the provided text.
However, the document does list several nonclinical tests performed to demonstrate substantial equivalence and safety/effectiveness.
Here's the information extracted from the provided text as it relates to your request:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state quantitative "acceptance criteria" for performance metrics in a table format that would typically be seen in a clinical study report for a new AI device. Instead, it refers to a "performance and safety profile" established in accordance with a regulatory guidance document and demonstrates "substantially equivalent performance" through comparative nonclinical testing.
| Performance Metric Demonstrated | Reported Device Performance |
|---|---|
| Tensile strength (adhesion) | Substantially equivalent to predicate devices |
| Degradation by hydrolysis | Substantially equivalent to predicate devices |
| Heat of polymerization | Substantially equivalent to predicate devices |
| Ease of actuation | Substantially equivalent to predicate devices |
| Polymerization setting time | Substantially equivalent to predicate devices |
| Purity analysis | Substantially equivalent to predicate devices |
| Moisture content | Substantially equivalent to predicate devices |
| Porcine wound healing (in vivo performance and safety) | Considered safe, effective, and performs as well or better |
| Biocompatibility testing (cytotoxicity, irritation, sensitization, acute dermal toxicity, intramuscular implantation) | Safe and biocompatible for intended use, substantially equivalent |
2. Sample Size Used for the Test Set and Data Provenance
The document refers to "nonclinical testing" and "comparative testing" without specifying sample sizes for these tests. For the porcine wound healing study, it's an in vivo animal study, not a human clinical test set. The data provenance is from tests conducted by the manufacturer, Advanced Medical Solutions (Plymouth) Ltd., in the UK, as implied by the submission details. These are pre-market, nonclinical studies, not clinical trials with human patient data.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
This information is not provided because the reported studies are nonclinical (e.g., in-vitro, animal) and primarily focus on comparative performance to predicate devices and adherence to biocompatibility standards, rather than expert-adjudicated ground truth on human data.
4. Adjudication Method for the Test Set
Not applicable/not provided, as the studies are nonclinical and don't involve expert adjudication of human clinical cases to establish ground truth.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC comparative effectiveness study was not done. The submission focuses on substantial equivalence based on technological characteristics and nonclinical performance, primarily comparing the new device to existing predicate devices.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Not applicable. This device is a topical tissue adhesive, not an AI algorithm.
7. The Type of Ground Truth Used
For the porcine wound healing study, the "ground truth" would be direct observation of healing outcomes in the animal model, likely assessed by veterinarian scientists or researchers. For other nonclinical tests (tensile strength, degradation, etc.), the "ground truth" is measured physical/chemical properties. For biocompatibility, it's the results of standardized biological tests. This is not "expert consensus," "pathology," or "outcomes data" in the typical clinical AI context, but rather data derived from controlled laboratory and animal studies.
8. The Sample Size for the Training Set
Not applicable. The device is a physical product (tissue adhesive), not an AI model that requires a training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable. The device is a physical product, not an AI model.
§ 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.