(266 days)
CM005 Standard Topical Skin Adhesive is indicated for topical application only, to hold closed easily approximated skin edges of wounds from surgical incisions, including incisions from minimally invasive surgery, and simple, thoroughly cleansed, trauma-induced lacerations. CM005 STANDARD Topical Skin Adhesive may be used in conjunction with, but not in place of deep dermal stitches. CM005 STANDARD Topical Skin Adhesive should be applied by trained medical or nursing staff.
CM004 Mini Topical Skin Adhesive is indicated for topical application only, to hold closed easily approximated skin edges of wounds from surgical incisions, including incisions from minimally invasive surgery, and simple, thoroughly cleansed, trauma-induced lacerations. CM004 Mini Topical Skin Adhesive may be used in conjunction with, but not in place of deep dermal stitches. CM004 Mini Topical Skin Adhesive should be applied by trained medical or nursing staff.
CM005 Standard Topical Skin Adhesive is a sterile, liquid topical skin adhesive containing a monomeric (2-octyl cyanoacrylate) formulation and the colorant D & C Violet No. 2. It is provided as a single-use applicator in a blister package. The pen style applicator is composed of a crushable glass ampoule contained within a plastic tube and plastic enclosure with silicone brush tip. When applied to the skin, the liquid adhesive polymerizes within minutes.
CM004 Mini Topical Skin Adhesive is a sterile, liquid topical skin adhesive containing a monomeric (2-octyl cyanoacrylate) formulation and the colorant D & C Violet No. 2 It is provided in a singleuse applicator packaged in a blister pack. The applicator is comprised of a crushable glass ampoule contained within a plastic tube and plastic enclosure with silicone brush tip. When applied to the skin, the liquid adhesive polymerizes within minutes.
This document is a 510(k) summary for medical devices (CM005 Standard and CM004 Mini Topical Skin Adhesives) and as such does not contain a study addressing acceptance criteria in the manner requested (i.e., with statistical performance metrics against a defined ground truth, typical for AI-software devices).
The provided text describes performance testing conducted to demonstrate substantial equivalence to predicate devices, rather than a study with acceptance criteria against a clinical outcome or expert ground truth for an AI/software device. The devices are topical skin adhesives, not AI/software devices. Therefore, a table of acceptance criteria vs. device performance, sample sizes for test/training sets, number of experts for ground truth, adjudication methods, MRMC studies, standalone performance, or methods for establishing ground truth for training data are not applicable in the context of this document.
The "acceptance criteria" for these devices are demonstrated through a series of performance tests and biocompatibility assessments, showing that they are substantially equivalent to already cleared predicate devices.
Here's a summary of the type of performance criteria and tests carried out (as described in the document), rather than a direct answer to the prompt's table due to the nature of the device:
1. A table of acceptance criteria and the reported device performance
Since this is not an AI/software device, there aren't explicit numeric "acceptance criteria" in the traditional sense of diagnostic accuracy (e.g., sensitivity, specificity). Instead, substantial equivalence is demonstrated by performing various tests to show that the new devices perform comparably to predicate devices. The document states:
"It was determined through the testing (Bench and Animal) performed in this 510(k) submission, that the subject devices are substantially equivalent to the predicate devices and any minor differences in performance does not affect safety or efficacy."
The specific performance tests conducted were:
| Performance Test | Description / Outcome |
|---|---|
| Lap-shear strength | Tested in accordance with ASTM F2255-05. (Implied: Demonstrated performance comparable to predicate). |
| T-peel adhesion strength | Tested in accordance with ASTM F2256-05. (Implied: Demonstrated performance comparable to predicate). |
| Adhesive strength in tension | Tested in accordance with ASTM F2258-05. (Implied: Demonstrated performance comparable to predicate). |
| Wound closure strength | Tested in accordance with ASTM F2458-05. (Implied: Demonstrated performance comparable to predicate). |
| Adhesive degradation study | Performed. (Implied: Demonstrated degradation properties comparable to predicate or acceptable for safety/efficacy). |
| Heat of polymerization | Measured. (Implied: Demonstrated polymerization characteristics comparable to predicate or acceptable for safety/efficacy). |
| Viscosity | Measured. (Implied: Demonstrated viscosity characteristics comparable to predicate or acceptable for manufacturing/application). |
| Set time | Measured. (Implied: Demonstrated set time comparable to predicate or acceptable for clinical use). |
| Microbial barrier testing | Performed. "In vitro studies have shown that following application and polymerization, CM005 STANDARD Topical Skin Adhesive acts as a physical barrier to prevent microbial penetration as long as the adhesive film remains intact. Clinical studies were not conducted to demonstrate microbial barrier properties and a correlation between microbial barrier properties and a reduction in infection have not been established." |
| Device Yield and Quality of Film | Performed. (Implied: Demonstrated acceptable device yield and film quality). |
| Flow Control | Performed. (Implied: Demonstrated acceptable flow control). |
| Animal wound healing study | Performed. (Implied: Demonstrated wound healing characteristics comparable to predicate or acceptable for safety/efficacy). |
| Biocompatibility | Tests performed per ISO 10993-1: Solvent compatibility, chemical characterization, toxicological risk assessment, cytotoxicity, sensitization, intracutaneous reactivity, material mediated pyrogenicity, acute toxicity, subacute toxicity, implantation. (Implied: All tests passed, demonstrating biological safety). |
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 does not specify sample sizes for each individual test or their provenance. The tests were bench and animal studies (laboratory and pre-clinical, respectively).
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 is not applicable to a non-AI/software device submission. Ground truth for these physical and biochemical tests is established by standardized testing protocols (e.g., ASTM standards) and animal study observations.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable for a non-AI/software device. The tests follow established protocols.
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
Not applicable, as this is not an AI-assisted device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable, as this is not an AI/software device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the performance tests, the "ground truth" is defined by the accepted results or outcomes of standardized physical, chemical, and biological tests (e.g., tensile strength measurements, viscosity values, lack of cytotoxicity as per ISO 10993-1). For the animal wound healing study, the ground truth would be histological assessment and observation of wound closure and healing characteristics.
8. The sample size for the training set
Not applicable, as this is not an AI/software device.
9. How the ground truth for the training set was established
Not applicable, as this is not an AI/software 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.