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The VasoPrep Surgical Marking Pen is intended for use prior to or during the harvesting and preparation of vein grafts used in bypass surgery. The pen is used to demarcate selected sites and orientation of the graft.

The VasoPrep Surgical Marking Pen is a single patient use sterile prescription use only marker intended for use on veins prior to or during Coronary-Assisted Bypass Graft (CABG) surgery. The marker (Figure 1) consists of a pen body, barrel, wick and cap with a wide chisel style applicator tip for delivery of ink to mark internal tissue. The formulation is non-toxic as used and is comprised of an ink material (FD&C Blue Dye #1) compounded into a carrier material (i.e., solvent). The wide chisel tip can deliver either a thin line of ink for precise marks or can be rotated 90° to deliver a wide stripe of ink.

This document describes a De Novo classification request for the VasoPrep Surgical Marking Pen, an internal tissue marker. The studies presented are non-clinical/bench studies, therefore, the concept of AI performance, ground truth establishment by experts, adjudication methods, multi-reader multi-case studies, and a standalone algorithm performance are not applicable.

1. Table of Acceptance Criteria and the Reported Device Performance:

The acceptance criteria and reported device performance are presented across several tables in the provided text. For clarity, they are consolidated and summarized below:

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):

• Human Saphenous Vein (HSV) segments: Used for "Internal Tissue Marking Ability" and "Effect of Dye on Human Vein Tissue" studies. The exact number of segments is not specified, but it refers to "segments" which implies a limited number for individual tests. The origin of the human tissue is not specified (e.g., country of origin). These are ex-vivo experiments (retrospective in the sense that the tissue has been harvested, but prospective for the purpose of the experiment itself).
• Porcine Saphenous Vein: Used for "Effect of Dye on Animal Vein Tissue" and product stability testing. The exact number of veins or samples is not specified. The origin is not specified. These are ex-vivo or animal model experiments.
• Animals for Biocompatibility (Guinea Pig): Used for Sensitization testing. A "guinea pig method" is mentioned, implying a standard number of animals for such a test (typically a small cohort).
• Sterilized and Aged Markers: Four markers were tested for product stability functionality, and two real-time aged markers were used for demarcation effectiveness and fluid volume.
• Toxicological Assessment Literature Studies: Canine, porcine, and murine models were used in literature studies for lifetime toxicity/carcinogenicity of FD&C Blue #1 dye. The number of animals in these literature studies is not specified in this document.

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):

Not applicable. This is a non-clinical/bench study. There is no mention of experts establishing a "ground truth" in the context of human interpretation or diagnostic accuracy. Performance criteria are based on objective physical, chemical, and biological measurements.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

Not applicable. This is a non-clinical/bench study. Adjudication methods are typically used in studies involving subjective human interpretation, which is not the case here.

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. This is a non-clinical/bench study for a physical device (marking pen), not an AI-powered diagnostic tool.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

Not applicable. This is a non-clinical/bench study for a physical device, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

The "ground truth" in these studies is based on objective scientific measurements and established standards for biocompatibility (e.g., non-cytotoxic, non-irritant), sterility (sterility assurance level), packaging integrity (visual, dye leak, peel tests), and performance characteristics (visible mark, no detrimental effect on tissue viability). It's a scientific and technical "ground truth" established through laboratory testing.

8. The sample size for the training set:

Not applicable. There is no AI or machine learning component, therefore no training set.

9. How the ground truth for the training set was established:

Not applicable. There is no AI or machine learning component, therefore no training set or ground truth for it. Any "training" or optimization of the pen's design or ink formulation would have been part of the product development process, not a formal training set as understood in AI/ML contexts.

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The VasoPrep Vein Preparation Kit is a sterilized convenience kit indicated for controlling pressure during the preparation and irrigation of bypass grafts prior to use in bypass surgery.

The VasoPrep Vein Preparation Kit is a convenience kit that consists of a pressure relief valve, bulldog clamp, vessel cannula and introducer, stopcock, syringes, extension tube, vein cup and drapes used in the preparation of bypass grafts prior to use in bypass surgery.

The provided text describes a medical device, the VasoPrep Vein Preparation Kit, and its 510(k) summary for FDA clearance. It details the device's intended use and substantial equivalence to predicate devices, along with mentions of performance and biocompatibility testing. However, the text does not include specific quantitative acceptance criteria or detailed study results that would typically be required to answer the questions about device performance in the requested format.

Therefore, I cannot populate the table or answer most of the specific questions about the study design as the information is not present in the provided document.

Here's a breakdown of what can be extracted and what is missing:

1. A table of acceptance criteria and the reported device performance

Missing Information for Table: The document explicitly states that in-vitro testing was performed for "valve cracking pressure" and "system leakage" to demonstrate safety and effectiveness. However, it does not provide the specific numerical acceptance criteria for these parameters (e.g., "valve cracking pressure must be within X to Y mmHg") nor does it provide the numerical results (e.g., "valve cracking pressure was Z mmHg"). It only states that the device "demonstrates" safety and effectiveness.

2. Sample size used for the test set and the data provenance

• Sample size for test set: Not specified. The document mentions "in-vitro testing" but doesn't provide details on the number of samples or trials performed.
• Data provenance: "in-vitro testing" is stated, meaning it was conducted in a lab environment. No information on country of origin or whether it was retrospective/prospective is provided, as these are typically applicable to human or animal studies, not purely in-vitro device performance tests.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

• This question is not applicable as the "test set" described is for in-vitro device performance (e.g., pressure and leakage), not for diagnostic accuracy or interpretation by experts. Ground truth in this context would likely be defined by engineering specifications and measurements.

4. Adjudication method for the test set

• This question is not applicable for the same reasons as #3. Adjudication methods are relevant for subjective interpretations, whereas these tests are objective measurements.

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

• No, an MRMC comparative effectiveness study was not done. This device is a physical medical kit used in surgery, not a diagnostic imaging or AI-assisted interpretation device, so such a study would not be relevant.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

• Not applicable. This is a physical medical kit, not an algorithm or AI device.

7. The type of ground truth used

• The ground truth for the performance tests (valve cracking pressure, system leakage) would be based on engineering specifications and direct measurements. For biocompatibility, the ground truth is compliance with ISO 10993-1 standards.

8. The sample size for the training set

• Not applicable. This device does not involve a "training set" in the context of machine learning or algorithms. Its performance is evaluated through direct physical and material testing.

9. How the ground truth for the training set was established

• Not applicable for the same reason as #8.

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