(596 days)
BondEase® Topical Skin Adhesive is intended for topical use only, to hold together the skin edges of incisions and lacerations that are under minimal tension and easily approximated. Where significant tension exists on incisions or lacerations, BondEase® Topical Skin Adhesive should be used in conjunction with deep dermal stiches.
BondEase® Topical Skin Adhesive is a sterile, liquid topical skin closure device composed of a methylidene malonate monomer formulation and the colorant D&C Green #6. It is provided in a single-use applicator, packaged in a foil pouch. The applicator is comprised of a crushable glass ampoule contained within a plastic vial with attached applicator tip and handle. BondEase® is applied to the skin as a viscous liquid which polymerizes to bond approximated wound edges within minutes. In vitro studies have shown that BondEase® acts as a bacterial barrier as long as the adhesive film remains intact.
This document describes the BondEase® Topical Skin Adhesive and presents data to support its substantial equivalence to predicate devices. Here's a breakdown of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for the primary endpoint were established around demonstrating non-inferiority to conventional wound closure devices (CWCD) with a 10% margin.
| Acceptance Criteria (Non-inferiority margin) | Reported Device Performance (100% wound apposition at 10 days) - BondEase - CWCD (95% CI) |
|---|---|
| Lower bound of 95% CI for difference (BondEase-CWCD) > -0.1 (pre-specified non-inferiority margin) | Per protocol population: -0.13 (-0.13 to 0.11) |
| Intent-to-treat population: -0.04 (-0.13 to 0.10) | |
| Note: The lower bound of the 95% confidence interval for the per-protocol population (-0.13) did not 'reach' but was very close to the pre-specified non-inferiority margin of -0.1. |
Additional secondary endpoints and their performance are summarized below, though specific "acceptance criteria" for these were not explicitly stated as non-inferiority targets:
| Secondary Endpoint | BondEase Performance | CWCD Performance |
|---|---|---|
| > 50% wound apposition at 10 days | 93.3% (98/105) | 96.3% (52/54) |
| Optimal cosmesis at 28 days (score of 6) | 70.5% (74/105) | 64.8% (35/54) |
| Cosmesis at 28 days (all scores), mean / median | 5.7 / 6.0 | 5.6 / 6.0 |
| Device-related adverse reactions (Total AEs) | 14 | 6 |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size (Test Set):
- Randomized (Total): 162
- Randomized and treatment applied (Total): 159
- BondEase: 105 subjects
- CWCD: 54 subjects
- Intent-to-treat population (ITT): 159 subjects (BondEase: 105, CWCD: 54)
- Per protocol population (PP): 153 subjects (BondEase: 100, CWCD: 53)
- Data Provenance: Prospective, randomized, controlled, open-label study. The document does not specify the country of origin of the data, but it is an FDA submission for a US market.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
The ground truth for the clinical study was established by investigators and a blinded clinician.
- Wound Apposition: Determined by the "investigator." The qualifications of these investigators are not explicitly stated, but it's implied they are healthcare professionals treating the wounds.
- Cosmetic Outcome: Determined by a "blinded clinician." The qualifications of this clinician are not explicitly stated.
4. Adjudication Method for the Test Set
The document does not explicitly describe an adjudication method for the test set. Outcomes (wound apposition and cosmetic outcome) were assessed by single parties (investigator for apposition, blinded clinician for cosmesis), rather than multiple experts with a defined adjudication process.
5. Multi Reader Multi Case (MRMC) Comparative Effectiveness Study
No, a Multi Reader Multi Case (MRMC) comparative effectiveness study was not conducted. The study compared the device against conventional wound closure methods (CWCD) with human application, but it did not assess the comparative effectiveness of human readers improving with or without AI assistance. The device itself is a topical adhesive; there is no AI component.
6. Standalone Performance
Yes, a standalone performance was done for various characteristics of the BondEase® Topical Skin Adhesive, independent of human application in a clinical setting. This is detailed under "Nonclinical Performance Data":
- Performance Bench Testing: Included tests of adhesive strength, degradation rate, heat of polymerization, and bacterial barrier performance.
- Biocompatibility Testing: Conducted per ISO 10993 guidelines, showing the device to be non-cytotoxic, non-irritating, non-pyrogenic, with no toxicological effect, non-hemolytic, and non-genotoxic.
- Porcine Study: Demonstrated that BondEase® did not inhibit normal wound closure and healing.
7. Type of Ground Truth Used
- For Nonclinical Tests: Ground truth was based on laboratory measurements, validated standards (e.g., ISO 10993 guidelines for biocompatibility), and observations in animal models (porcine study).
- For Clinical Study:
- Wound apposition: Clinical assessment by the investigator.
- Cosmetic outcome: Clinical assessment by a blinded clinician using a validated scale (Hollander JE, et al, 1995).
- Adverse events: Clinically observed and reported events.
8. Sample Size for the Training Set
No "training set" in the context of an AI/algorithm is mentioned since this is a topical skin adhesive product. The device itself does not employ an AI algorithm. The closest equivalent would be the data used for the development and bench testing of the adhesive formulation, or prior clinical experience informing the study design. However, the document does not provide a specific sample size for such a "training set."
9. How the Ground Truth for the Training Set Was Established
As there is no AI algorithm and thus no explicit "training set" in the computational sense, this question is not applicable. The development and testing of the adhesive material itself relied on chemical and biological principles, and extensive non-clinical testing (bench and animal studies) as described under "Nonclinical Performance Data," where ground truth was established through validated test methods and established standards.
§ 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.