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The SOFIA 88 Catheter is indicated for general intravascular use, including the neuro and peripheral vasculature. The SOFIA 88 Catheter can be used to facilitate introduction of diagnostic agents or therapeutic devices. The SOFIA 88 Catheter is not intended for use in coronary arteries.

The SOFIA 88 Catheter is a non-tapered, single-lumen, flexible catheter equipped with coil and braid reinforcement. The distal seqment is designed to facilitate vessel selection with 60 cm of distal-shaft hydrophilic coating for navigation through the vasculature. The radiopaque marker is located at the distal end of the catheter for visualization under fluoroscopy.

The provided document is a 510(k) summary for a medical device (SOFIA 88 Catheter), demonstrating its substantial equivalence to a predicate device. This type of regulatory submission primarily relies on performance (benchtop) and pre-clinical (animal) testing rather than clinical studies with human subjects or AI algorithm performance.

Therefore, many of the requested criteria (e.g., acceptance criteria for AI performance, sample size for test sets (human data), number of experts for ground truth, MRMC studies, standalone AI performance, training set details) are not applicable to this specific document as it pertains to a physical medical device (catheter) and not an AI/ML powered device.

However, I can extract the relevant information regarding the performance and equivalency testing conducted for the SOFIA 88 Catheter.

Device: SOFIA 88 Catheter

Type of Device: Percutaneous Catheter (physical medical device)

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

The acceptance criteria are generally implied by the "Pass" result for each test, indicating that the device met the pre-defined standards for each physical and functional characteristic. The document doesn't explicitly state quantitative acceptance limits for each test but rather confirms successful completion.

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

• Benchtop Testing: While specific sample sizes for each benchtop test are not provided in this summary, these tests generally involve a statistically significant number of device units (e.g., n=3, 5, or more depending on the test and standard requirements) to ensure reproducibility and reliability. The provenance is internal laboratory testing by MicroVention, Inc. and its contracted labs.
• Biocompatibility Testing: Sample sizes are mentioned for some tests (e.g., New Zealand White Rabbits for irritation/pyrogenicity, Guinea Pigs for maximization, ND4 mice for systemic toxicity, sheep blood for blood loop assay, three rabbits for hemolysis, human serum/plasma for others). The provenance is laboratory testing conducted according to ISO and USP standards.
• Animal Study: The document refers to "a porcine model" without specifying the exact number of animals. It's an acute animal study. The provenance is internal or contracted laboratory animal testing (conducted in accordance with FDA GLP Regulation 21 CFR Part 58).

All data provenance is internal R&D and pre-clinical testing, not human clinical retrospective or prospective data.

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

This section is not applicable as the ground truth for a physical medical device like a catheter is established through objective physical and chemical measurements (benchtop tests) and observed physiological responses in animal models, not through expert human interpretation of medical images or data requiring "ground truth" establishment in the context of an AI algorithm.

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

This is not applicable as there is no human interpretation or subjective judgment that would require an adjudication method in the context of this device's testing. Measurements are objective and pass/fail criteria are pre-defined.

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. This device is a physical catheter, not an AI application, so no MRMC study or AI assistance evaluation was performed.

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

This is not applicable. This is a physical device, not an AI algorithm.

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

The "ground truth" for this device's performance is established via objective engineering and material science measurements (e.g., dimensions, pressure, force), validated laboratory biological assays (e.g., cytotoxicity, hemolysis), and observed physiological responses and pathological findings in an animal model. It is not derived from expert consensus, pathology, or outcomes data in the sense of clinical diagnostic accuracy.

8. The sample size for the training set

This is not applicable as this is a physical medical device, not an AI/ML powered device that requires a training set.

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

This is not applicable for the reason stated above.

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The TracStar LDP Large Distal Platform is indicated for the introduction of interventional devices into the peripheral, coronary, and neuro vasculature.

The Zoom 88 Large Distal Platform is indicated for the introduction of interventional devices into the peripheral, coronary, and neuro vasculature.

The Imperative Care Large Distal Platform (LDP) Catheters include the TracStar™ LDP Large Distal Platform and Zoom™ 88 Large Distal Platform. The LDP Catheters are 0.038" diameter or smaller guidewire compatible single lumen guide catheters that provide access to peripheral, coronary and neuro vasculature. The catheters are comprised of a hollow cylindrical tube bonded at the proximal end to a standard luer fitting. The wall of the tube is constructed using a combination of metal coils/braids and medical grade polymers. The distal section of each catheter has a hydrophilic coating to enhance tracking through tortuous vasculature. An angled distal soft tip facilitates smooth tracking past vessel branches. A radiopaque marker provides visual confirmation of the distal tip location under fluoroscopy. LDP Catheters have an inner diameter of 0.088" (6F compatible), and a maximum outer diameter of 0.110". The LDP guide catheters are packaged with a rotating hemostasis valve (RHV) that is attached to the proximal luer to help maintain hemostasis.

This document describes the premarket notification for the Imperative Care TracStar LDP Large Distal Platform and Zoom 88 Large Distal Platform, which are guide catheters. The submission is based on substantial equivalence to predicate devices, meaning extensive new studies were not required. The provided text details the acceptance criteria and study findings for this medical device.

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size Used for the Test Set and Data Provenance

The document does not explicitly state the specific sample sizes (number of units tested) for each individual bench and laboratory test. It generally refers to "bench and laboratory (in-vitro) testing." The data provenance is in-vitro, conducted in a laboratory setting. There is no information regarding country of origin of the data or if it was retrospective or prospective, as these terms typically apply to clinical studies with human participants.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This information is not provided. For performance testing of a medical device like a catheter, "ground truth" is typically established by physical measurements, engineering specifications, and adherence to recognized standards (like ISO 10555-1), rather than expert consensus on interpretive data.

4. Adjudication Method for the Test Set

This information is not applicable and not provided. Adjudication methods (e.g., 2+1, 3+1) are typically used in clinical studies involving interpretation of data (e.g., imaging) by multiple readers to resolve discrepancies. The performance tests described here are objective, pass/fail engineering tests.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. The submission is for a medical device (catheter) and relies on bench and laboratory testing for substantial equivalence, not comparative clinical effectiveness with human readers.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

This question is not applicable to the device described. The TracStar LDP Large Distal Platform and Zoom 88 Large Distal Platform are physical guide catheters, not algorithms or AI software. Therefore, there is no "algorithm only" or "human-in-the-loop" performance to report.

7. The Type of Ground Truth Used

For the bench and laboratory tests, the "ground truth" is based on pre-defined engineering specifications and performance standards, particularly ISO 10555-1 for catheters. The results are objective measurements against these established criteria, leading to a "Pass" or "Fail" outcome.

8. The Sample Size for the Training Set

This information is not applicable. The device is a physical catheter, not an AI/ML algorithm that requires a training set. The substantial equivalence pathway relies on demonstrating that the new device performs similarly to a predicate device through bench testing, not on learning from a dataset.

9. How the Ground Truth for the Training Set Was Established

This information is not applicable, as there is no training set for a physical medical device.

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