(371 days)
GluStitch® Twist Tissue Adhesive is intended for the topical skin incisions and trauma-induced lacerations in areas of low skin tension that are simple, thoroughly-cleansed, and have easily approximated skin edges. GluStitch® Twist may be used in conjunction with, but not in place of, deep dermal stitches.
GluStitch Twist Tissue Adhesive is a sterile, topical tissue adhesive containing n-butyl-2-cyanoacrylate. GluStitch Twist Tissue Adhesive is supplied in a single patient use, twist-and-use ampoule that contains at least 0.5g of liquid tissue adhesive.
This document describes the GluStitch® Twist Tissue Adhesive and its performance testing. Below is an analysis of the provided text to extract the requested information regarding acceptance criteria and the study proving the device meets them.
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state acceptance criteria in a quantitative format for most of the performance tests. Instead, it focuses on demonstrating substantial equivalence to the predicate device, Indermil® Tissue Adhesive. The reported performance is primarily in terms of "substantially equivalent" for various characteristics.
| Acceptance Criteria (Implied by Substantial Equivalence) | Reported Device Performance (GluStitch® Twist Tissue Adhesive) |
|---|---|
| Biocompatibility: | All tests performed using Good Laboratory Practices (GLP). |
| - In vitro cytotoxicity (ISO 10993-5) | Met (implied by "All of the testing was performed using Good Laboratory Practices") |
| - Local effects after implantation (ISO 10993-6) | Met (implied by "All of the testing was performed using Good Laboratory Practices") |
| - Irritation and skin sensitization (ISO 10993-10) | Met (implied by "All of the testing was performed using Good Laboratory Practices") |
| Sterilization and Shelf Life: | |
| - Sterility Assurance Level (SAL) | 10⁻⁶ obtained when subjected to 17.5 kGy of radiation |
| - Shelf life | 24 months (supported by real time and accelerated aging) |
| Comparative Testing (Substantial Equivalence to Indermil® Tissue Adhesive): | |
| - Tensile strength (ASTM F2255-05, F2258-05, F2458-05) | Substantially equivalent performance |
| - Set (polymerization) time | Substantially equivalent performance |
| - Heat of polymerization | Substantially equivalent performance |
| - Viscosity | Substantially equivalent performance |
| - Hydrolytic degradation | Substantially equivalent performance |
| - Applicator expression force | Substantially equivalent performance |
| - Chemical analysis | Substantially equivalent performance |
| In vivo assessment of incision closure (Safety and Efficacy): | |
| - Incidence of chemical burn | Substantially equivalent to Indermil® Tissue Adhesive |
| - Incidence of infection | Substantially equivalent to Indermil® Tissue Adhesive |
| - Histopathologic evidence of adverse effects on incision healing | Substantially equivalent to Indermil® Tissue Adhesive |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document mentions an "in vivo assessment of incision closure was conducted in swine," but it does not specify the sample size (number of swine or number of incisions) used for this study.
The provenance of this data is a GLP (Good Laboratory Practices) study, indicating a prospective study design conducted under controlled conditions. The country of origin for the study is not explicitly stated.
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 in the document. The in vivo study evaluated "histopathologic evidence," implying pathological assessment, but details about the number and qualifications of the experts (e.g., pathologists) who interpreted these findings are absent.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not provided in the document.
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
This is not applicable. The device is a tissue adhesive, not an AI-assisted diagnostic tool for human readers. Therefore, an MRMC study comparing human reader performance with and without AI assistance was not performed.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
This is not applicable. The device is a physical tissue adhesive, not a software algorithm. Its performance is evaluated through direct physical and biological testing, not through algorithmic performance.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the in vivo assessment, the ground truth was established through histopathologic evidence in swine, which is a form of pathology. The study also evaluated the incidence of chemical burn and infection as safety outcomes.
8. The sample size for the training set
This is not applicable. The device is a physical product, not a machine learning model that requires a training set.
9. How the ground truth for the training set was established
This is not applicable for the same reason as point 8.
§ 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.