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The Mira-Flex™ 18 microcatheter is designed for use in small vessel or superselective anatomy for diagnostic and interventional procedures including neuro, peripheral, or coronary use. Supplied sterile in peel-open packages. Intended for one-time use.

The Mira-Flex™ 18 microcatheter is an infusion catheter with a hydrophilic coating, designed for use in small vessel or superselective anatomy for diagnostic and interventional procedures, including neuro, peripheral, or coronary use. This device will be available with a 2.5 French shaft, and is compatible with 0.018" embolization coils and appropriately-sized embolization particles. The device will be supplied sterile, and is intended for one-time use. The Mira-Flex™ 18 will be available in 100, 110, 135, and 150 cm lengths.

The provided document is a 510(k) Premarket Notification for the Mira-Flex™ 18 microcatheter. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than providing extensive clinical study data with acceptance criteria for a novel AI device.

Therefore, the document does not contain the detailed information requested in points 1-9 regarding acceptance criteria and study particulars for an AI device.

Here's an analysis of what is available and why the requested information is absent:

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

• Information in document: The document lists several tests: Tensile tests, Burst and pressure tests, Biocompatibility tests, Leakage tests, and an Acute animal study. It states, "The results of these tests provide reasonable assurance that the device has been designed and tested to assure conformance to the requirements for its use..."
• Why requested information is missing: Specific acceptance criteria (e.g., "tensile strength must exceed X Newtons") and quantitative performance results are not provided. This is typical for a 510(k) summary, which generally summarizes the types of tests performed rather than presenting raw data or detailed performance metrics against specific criteria. The focus is on demonstrating that standard engineering and biocompatibility tests were conducted and passed.

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

• Information in document: The document mentions "Acute animal study."
• Why requested information is missing: No details on the sample size of the animal study, the type of animal, or specific data provenance are provided. The document focuses on regulatory compliance rather than detailed study methodology.

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)

• Information in document: Not mentioned.
• Why requested information is missing: Such information is irrelevant for a physical medical device like a microcatheter. Ground truth determination by experts is typically a requirement for AI/diagnostic devices where human interpretation is involved.

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

• Information in document: Not mentioned.
• Why requested information is missing: Adjudication methods are specific to studies involving human interpretation, often in clinical trials or for AI performance assessment, not for engineering tests of a physical device.

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

• Information in document: Not mentioned.
• Why requested information is missing: MRMC studies are conducted for diagnostic devices, particularly those involving image interpretation or AI assistance. This device is a physical microcatheter for delivery, not a diagnostic tool where reader performance is relevant.

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

• Information in document: Not mentioned.
• Why requested information is missing: This question pertains to AI algorithms. The Mira-Flex™ 18 microcatheter is a physical instrument, not an algorithm.

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

• Information in document: Not mentioned.
• Why requested information is missing: Ground truth is a concept for evaluating the accuracy of diagnostic or AI systems; it doesn't apply in the same way to the performance of a physical device like a microcatheter, where performance is evaluated through engineering tests (tensile strength, burst pressure) and biocompatibility, not against a "ground truth" diagnosis.

8. The sample size for the training set

• Information in document: Not mentioned.
• Why requested information is missing: Training sets are used for machine learning models. This device is a physical microcatheter and does not involve an AI model or training data.

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

• Information in document: Not mentioned.
• Why requested information is missing: As with point 8, this question is relevant for AI/machine learning development, not for a physical medical device.

In summary: The provided document is a regulatory submission for a physical medical device (microcatheter) under a 510(k) pathway. It focuses on demonstrating substantial equivalence to a predicate device through materials, intended use, and general performance (mechanical, biocompatibility). It does not involve AI or diagnostic interpretation, and therefore, the detailed study information regarding acceptance criteria, ground truth, expert involvement, and AI performance metrics as requested is not present in this type of document.

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