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The Plato MICROCATH® 27 Microcatheters are intended to assist in the delivery of diagnostic and/or therapeutic agents to the peripheral and neurovascular systems.

The Plato MICROCATH® 27 Microcatheters are single lumen catheters designed to be used with a guiding catheter and a steerable guidewire for accessing the vasculature. The microcatheter contains a metal hypotube reinforced shaft with a maximum diameter of 3.7F, tapering to a distal end of 3.3F, which can be inserted into a 6F guide catheter. The inner diameter is constant throughout the shaft length and accommodates up to a 0.025" guidewire. The catheter is 150 cm in length with two tip configurations; straight and 45°. All have steam shapeable tips, hydrophilic coating and a radiopaque marker at the distal tip. The devices are marketed with an accessory mandrel which allows the catheter tips to be steam-shaped to the doctor's preferred shape when desired.

The provided text describes the "SCIENTIA VASCULAR LLC PLATO MICROCATH® 27 MICROCATHETER". It does not describe a study involving acceptance criteria related to an AI/ML device, but rather the non-clinical performance data for a microcatheter device. Therefore, I will extract information relevant to the device's performance against non-clinical acceptance criteria.

Here's the breakdown of the information as per the request, adapted for a non-AI/ML medical device:

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

The document lists "Non-Clinical Performance Data" which served as the basis for demonstrating substantial equivalence. These can be considered the acceptance criteria for functional and safety aspects of the device.

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

• Sample Size:
  • For the non-clinical bench testing, specific sample sizes are not provided in the document. The tests likely involved multiple units of the Plato MICROCATH 27 Microcatheter.
  • For the simulated use testing, an "anatomical model" was used. The number of models or tests conducted is not specified.
  • For the human cadaver model, the term "a human cadaver model" is used, implying at least one but the exact number of cadavers or trials is not specified.
• Data Provenance: The tests are explicitly described as "Non-Clinical Performance Data" and include "bench testing," "simulated-use testing," and testing in a "human cadaver model." This indicates the data is from controlled laboratory and simulated environments. The country of origin of the testing is not specified, but the submission is to the FDA (United States). This testing would be considered prospective, as it was conducted specifically to evaluate the device.

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 section is not applicable as the document describes non-clinical and simulated-use testing of a physical medical device, not an AI/ML system requiring expert ground truth for interpretation. The evaluation was based on engineering specifications, standardized test methods (ISO 10993, ISO 10555-1), and performance in physical models.

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

This is not applicable. The device's performance was evaluated against physical and functional criteria, not expert interpretations requiring adjudication.

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 document describes a physical medical device (microcatheter), not an AI-assisted diagnostic or therapeutic system that would involve human readers.

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

This is not applicable. This document is about a physical medical device, not an algorithm.

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

The "ground truth" for the device's performance was established through:

• Compliance with international standards (ISO 10993, ISO 10555-1).
• Demonstration of expected functional performance in various bench tests (e.g., kink resistance, tensile strength, burst pressure, coating lubricity).
• Comparative performance to a predicate device in simulated anatomical and human cadaver models for key operational aspects like maneuverability and advancement.

8. The sample size for the training set

This is not applicable. This document describes a physical medical device, not an AI/ML system that requires a training set.

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

This is not applicable. This document describes a physical medical device, not an AI/ML system.

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