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The Cantata™ Microcatheter is designed for use in small vessel or superselective anatomy for diagnostic and interventional procedures including neuro, peripheral, or coronary use.

The Cantata™ Microcatheter is an infusion catheter with a hydrophilic coating, designed for use in small vessel or superselective anatomy for diagnostic and interventional procedures. The device is available in 2.5 and 2.8 French shafts and is available in 100, 110, 135, and 150 cm lengths. The device is supplied sterile and intended for one-time use.

The provided text is a 510(k) Premarket Notification for the Cantata™ Microcatheter. It focuses on demonstrating substantial equivalence to predicate devices and does NOT describe an AI/ML powered medical device. Therefore, it does not contain information about acceptance criteria for an AI model, study design for AI, sample sizes for test and training sets, expert qualifications, or ground truth establishment relevant to AI/ML devices.

The document lists various physical and biological tests performed on the Cantata™ Microcatheter to assure its reliable design and performance, such as:

• Tensile strength
• Static burst pressure
• Kink radius
• Coating durability and lubricity
• Biocompatibility (Cytotoxicity, Sensitization, Intracutaneous, Systemic Toxicity, Hemolysis, Pyrogen, Complement Activation, ASTM Partial Thromboplastin Time)
• Shelf life
• Endotoxin/bioburden
• Particulate Testing

However, it does not provide specific acceptance criteria values for these tests or the reported performance data in a comparative table format. It simply states that "The results of these tests provide reasonable assurance that the device has been designed and tested to assure conformance to the requirements for its intended use."

To directly answer your request based on the provided text:

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

   • The document lists the types of tests performed but does not provide a table with specific acceptance criteria values or the reported device performance for each test.

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

   • This information is not provided as the tests are for a physical medical device, not an AI/ML algorithm.

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 information is not relevant or provided as the tests are for a physical medical device, not an AI/ML algorithm requiring expert-established ground truth.

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

   • This information is not relevant or provided as the tests are for a physical medical device, not an AI/ML algorithm.

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. This is not an AI/ML device, so an MRMC study related to AI assistance was not conducted or mentioned.

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

   • No. This is not an AI/ML device.

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

   • Not applicable in the context of AI/ML ground truth. The "ground truth" for this physical device would be the established engineering and biocompatibility standards and test protocols.

8. The sample size for the training set

   • Not applicable as this is not an AI/ML device.

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

   • Not applicable as this is not an AI/ML device.

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