(76 days)
LiquiBand® Topical Skin Adhesive is indicated for the closure of topical skin incisions including laparoscopic incisions, and trauma-induced lacerations in areas of low skin tension that are simple, thoroughly cleansed, and have easily approximated edges. LiquiBand Topical Skin Adhesive may be used in conjunction with, but not in place of, deep dermal stitches.
LiquiBand Topical Skin Adhesive is a sterile, topical tissue adhesive containing n-butyl-2-cyanoacrylate. LiquiBand Topical Skin Adhesive is supplied in a single patient use 0.5g High Density Polyethylene ampoule with polypropylene applicator tip.
The provided text describes a 510(k) premarket notification for the LiquiBand Topical Skin Adhesive and focuses on demonstrating its substantial equivalence to a predicate device, Indermil® Tissue Adhesive. However, it does not contain information about acceptance criteria, device performance metrics, or a study design in the way one would typically describe for an AI/software as a medical device (SaMD).
The submission categorizes the testing as "Substantial Equivalence Testing Summary," indicating that the purpose was to show that LiquiBand performs similarly to the predicate device, not necessarily to meet specific, pre-defined quantitative acceptance criteria or to conduct a clinical trial demonstrating improvement in human readers or standalone performance.
Therefore, many of the requested sections cannot be filled from the provided text.
Here's a breakdown of what can and cannot be answered:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state quantitative acceptance criteria or specific performance values for a device being measured against an established standard. Instead, it lists types of comparative tests performed to demonstrate substantial equivalence to a predicate device. The performance is implied to be "substantially equivalent" to the predicate.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Demonstrated substantial equivalence in Tensile strength | Met (Implied by FDA clearance) |
| Demonstrated substantial equivalence in Set (polymerization) time | Met (Implied by FDA clearance) |
| Demonstrated substantial equivalence in Heat of polymerization | Met (Implied by FDA clearance) |
| Demonstrated substantial equivalence in Viscosity | Met (Implied by FDA clearance) |
| Demonstrated substantial equivalence in Hydrolytic degradation | Met (Implied by FDA clearance) |
| Demonstrated substantial equivalence in Applicator expression force | Met (Implied by FDA clearance) |
| Demonstrated substantial equivalence in Water vapor transmission rate | Met (Implied by FDA clearance) |
| Demonstrated substantial equivalence in GC Chemical Analysis | Met (Implied by FDA clearance) |
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
- Sample Size for Test Set: Not specified in the provided text. The document refers to "comparative testing," but details about the number of samples or subjects used in these tests are not included.
- Data Provenance: Not specified.
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 provided. The testing described is physical and chemical performance testing of the adhesive and applicator, not a clinical study requiring expert ground truth for interpretation.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
This information is not provided. As the testing is primarily physical and chemical, an adjudication method for ground truth establishment by experts is not relevant in this context.
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
There is no MRMC study mentioned, as this is a topical skin adhesive, not an AI/SaMD.
6. If a standalone (i.e., algorithm only without human-in-the loop performance) was done
This is not applicable as the device is a physical medical device (topical skin adhesive), not an algorithm or AI.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The concept of "ground truth" as typically applied to AI/SaMD is not directly applicable here. The "truth" for the performance tests would be the measurement against a standard or the performance of the predicate device, not an expert-derived clinical ground truth. For example:
- Tensile Strength: Measured directly according to ASTM standards.
- Set Time: Measured directly.
- Chemical Analysis: Measured using GC (Gas Chromatography).
8. The sample size for the training set
This is not applicable as there is no AI/ML model for training.
9. How the ground truth for the training set was established
This is not applicable as there is no AI/ML model for training.
Summary of what the document does provide regarding the study:
The study described is a series of comparative physical and chemical tests conducted to demonstrate that the LiquiBand Topical Skin Adhesive is "substantially equivalent" to an existing predicate device, Indermil® Tissue Adhesive. The tests performed include:
- Tensile strength (according to ASTM F2255-05, F2258-05, F2458-05)
- Set (polymerization) time
- Heat of polymerization
- Viscosity
- Hydrolytic degradation
- Applicator expression force
- Water vapor transmission rate
- GC Chemical Analysis
The FDA's clearance (K083531) indicates that these tests were sufficient to establish substantial equivalence for the stated Indications for Use.
§ 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.