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510(k) Data Aggregation
(368 days)
Exofin Fusion Skin Closure System
Exofin Fusion Skin Closure System is intended for topical application only to hold closed easily approximated skin edges of wounds from surgical incisions, incisions from minimally invasive surgery, and simple, thoroughly cleansed, trauma-induced lacerations. Exofin Fusion Skin Closure System should be used in conjunction with, but not in place of, deep dermal stitches. Additionally, the adjunct wound closure device component maintains temporary skin edge alignment along the length of the wound during application of the liquid adhesive.
Exofin® Fusion Skin Closure System is a sterile, liquid topical skin adhesive containing a monomeric (2- octyl cyanoacrylate) formulation and the colorant D & C Violet #2. It is provided in a single-use applicator packaged in a rigid blister. As applied to skin, the liquid is slightly more viscous than water and polymerizes within minutes. In vitro studies have shown that Exofin® Fusion Skin Closure System acts as a barrier to 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. Exofin Fusion Skin Closure System also incorporates a self-adhering mesh that is applied to the approximated skin edges to provide temporary skin edge alignment of incisions up to 20 cm each in length until the liquid adhesive is applied to achieve skin closure.
The provided text is a 510(k) Summary for the Exofin® Fusion Skin Closure System. It details the device, its intended use, and comparison to predicate devices, along with non-clinical testing performed to demonstrate substantial equivalence. However, it does not contain the specific information required to address the request regarding acceptance criteria, study details, expert involvement, or AI-related metrics.
Specifically, the document states: "No clinical testing has been submitted, referenced, or relied upon for Clinical Testing: determining substantial equivalence." This means there are no clinical study results to describe in terms of direct clinical performance, acceptance criteria, or human reader improvement with AI.
Therefore, I cannot fulfill the request for information on the study that proves the device meets acceptance criteria, sample sizes for test sets, data provenance, number of experts for ground truth, adjudication methods, MRMC studies, standalone performance, type of ground truth, or details about the training set, as these aspects are not present in the provided 510(k) summary.
The document focuses on non-clinical testing to demonstrate substantial equivalence to a predicate device, as outlined in the "Non-clinical Testing" section:
- Acceptance Criteria and Reported Performance (based on non-clinical testing available):
| Acceptance Criteria (Test Standard) | Reported Device Performance (Implied Acceptance) |
|---|---|
| Wound closure strength (ASTM F2458-05) | The testing was performed in accordance with the FDA Class II Special Controls Guidance Document, demonstrating substantial equivalence to the predicate. (Specific numerical performance not provided, but implies meeting the standard for substantial equivalence). |
| Adhesive strength in tension (ASTM F2258-05) | The testing was performed in accordance with the FDA Class II Special Controls Guidance Document, demonstrating substantial equivalence to the predicate. (Specific numerical performance not provided, but implies meeting the standard for substantial equivalence). |
| T-peel adhesion strength (ASTM F2256-05) | The testing was performed in accordance with the FDA Class II Special Controls Guidance Document, demonstrating substantial equivalence to the predicate. (Specific numerical performance not provided, but implies meeting the standard for substantial equivalence). |
| Lap-shear strength (ASTM F2255-05) | The testing was performed in accordance with the FDA Class II Special Controls Guidance Document, demonstrating substantial equivalence to the predicate. (Specific numerical performance not provided, but implies meeting the standard for substantial equivalence). |
| Heat of polymerization | The testing was performed in accordance with the FDA Class II Special Controls Guidance Document, demonstrating substantial equivalence to the predicate. (Specific numerical performance not provided, but implies meeting the standard for substantial equivalence). |
| Microbial barrier effectiveness | The testing was performed in accordance with the FDA Class II Special Controls Guidance Document, demonstrating substantial equivalence to the predicate. (Specific numerical performance not provided, but implies meeting the standard for substantial equivalence). |
| Extractables and Leachables | The testing was performed in accordance with the FDA Class II Special Controls Guidance Document, demonstrating substantial equivalence to the predicate. (Specific numerical performance not provided, but implies meeting the standard for substantial equivalence). |
| Biocompatibility Testing (ISO 10993-1) | Conducted according to the requirements for a surface device in prolonged contact with a breached or compromised surface, demonstrating substantial equivalence. (Specific numerical performance not provided, but implies meeting the standard for substantial equivalence). |
Remaining requested information, not found in the provided text:
- Sample size used for the test set and the data provenance: Not provided, as clinical testing was not relied upon. The non-clinical tests would have their own sample sizes, but these are not detailed.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable as no clinical ground truth established or relied upon.
- Adjudication method for the test set: Not applicable.
- 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. This device is not an AI-based diagnostic device where human-in-the-loop performance with AI assistance would be relevant.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
- The type of ground truth used: For non-clinical tests, the "ground truth" would be the established testing parameters and results as per ASTM and ISO standards, demonstrating compliance. Clinical or expert consensus ground truth is not reported.
- The sample size for the training set: Not applicable, as there is no mention of an algorithm or AI model requiring a training set.
- How the ground truth for the training set was established: Not applicable.
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(132 days)
Exofin Fusion Skin Closure System
Exofin® Fusion Skin Closure System is intended for topical application 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. Exofin Fusion Skin Closure System should be used in conjunction with, but not in place of, deep dermal stitches. Additionally, the adjunct wound closure device component maintains temporary skin edge alignment along the length of the wound during application of the liquid adhesive.
Exofin® Fusion Skin Closure System is a sterile, liquid topical skin adhesive containing a monomeric (2octyl cyanoacrylate) formulation and the colorant D & C Violet #2. It is provided in a single use aluminum collapsible tube packaged in a RXM 48gaPET-200LDPE Film/1059B uncoated Tyvek pouch containing an applicator. The applicator is comprised of a self-puncturing cap and a soft elastomeric brush, which allows the adhesive to spread uniformly. As applied to skin, the liquid is syrup-like in viscosity and polymerizes within minutes. Exofin® Fusion Skin Closure System has a low viscosity. In vitro studies have shown that Exofin® Fusion Skin Closure System acts as a barrier to 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. Exofin Fusion Skin Closure System also incorporates a self-adhering mesh that is applied to the approximated skin edges to provide temporary skin edge alignment of two incisions up to 20 cm each in length until the liquid adhesive is applied to achieve skin closure.
The provided document describes the Exofin® Fusion Skin Closure System and its substantial equivalence to the predicate device, Dermabond™ Prineo™ Skin Closure System. However, it does not contain information on acceptance criteria or a study proving the device meets an algorithm's acceptance criteria.
The document outlines a 510(k) submission for a medical device (a skin closure system), not an AI/ML powered device. The "Performance Data" section details several physical and biological tests conducted on the device components, such as wound closure strength, adhesive strength, biocompatibility, and a porcine wound healing study, to demonstrate its safety and effectiveness. These tests are relevant for a physical medical device.
Therefore, I cannot fulfill the request as it pertains to AI/ML specific acceptance criteria, test set sample sizes, data provenance, expert ground truth, adjudication methods, MRMC studies, or standalone algorithm performance, as this information is not present in the provided text.
The closest information provided is:
- Type of Ground Truth Used (for the animal study): Histological analysis (for the porcine wound healing study).
- Sample size for the training set: Not applicable/not mentioned, as it's not a machine learning study.
- How the ground truth for the training set was established: Not applicable/not mentioned.
Essentially, the device in question is a physical tissue adhesive system, not an AI software.
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