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The SuperCross microcatheter is intended to be used in conjunction with steerable guidewires to access discrete regions of the coronary and/or peripheral vasculature. It may be used to facilitate placement and exchange of guidewires and other interventional devices and to subselectively infuse/deliver diagnostic and therapeutic agents.

The SuperCross microcatheters are single lumen catheters designed for use in the coronary and/or peripheral vasculature. The SuperCross microcatheters provide guidewire support during interventional procedures and allows for the exchange of one distally located guidewire for another while maintaining access to distal vasculature. The SuperCross microcatheters are available in various tip configurations (straight, flexible, angled) and two working lengths (130cm, 150cm). The distal 40cm of the straight tip catheters and the distal 72 cm of the angled tip catheters has a hydrophilic coating. The proximal end of the catheter incorporates a strain relief and a luer-lock adapter for flushing. The SuperCross microcatheters are compatible with .014" guidewires and 5F guide catheters.

The provided text is a 510(k) summary for a medical device (SuperCross microcatheter, SuperCross FT microcatheter, SuperCross AT microcatheter). It focuses on demonstrating substantial equivalence to a predicate device, rather than proving that the device meets specific performance criteria through a study involving diagnostic performance metrics like sensitivity, specificity, or AUC.

Therefore, the typical elements requested about acceptance criteria, study design for diagnostic performance, sample sizes, expert ground truth adjudication, MRMC studies, and training set details are not applicable to this type of regulatory submission.

The "studies" mentioned in the document are engineering performance tests and biocompatibility tests, not clinical studies assessing diagnostic accuracy or human reader performance.

Here's a breakdown based on the provided document and why most of your questions cannot be answered:

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

The document lists types of tests performed, but it does not provide a table with specific quantitative acceptance criteria or the numerical results from these tests. It simply states that:

• "The device performance was verified through the following tests: Deliverability, Hydrophilic Coating Evaluation, Structural Integrity, ISO 10555-1 Verification, ISO 594 Hub Verification."
• "Device samples passed the following biocompatibility tests performed in accordance with ISO 10993-1: Cytotoxicity, Sensitization, Irritation, Systemic Toxicity, Material Mediated Pyrogenicity, Hemolysis, Complement Activation, Thrombogenicity."
• "The results of the verification tests met the specified acceptance criteria and did not raise new questions of safety or effectiveness; therefore, the SuperCross microcatheters are substantially equivalent to the predicate device."

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

• Sample sizes: Not specified. The tests mentioned are likely bench tests using a certain number of device samples, not patient data.
• Data provenance: Not applicable, as this is related to bench and biocompatibility testing of the device itself, not patient data from a clinical setting.

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. Ground truth, in the context of diagnostic accuracy, is not relevant here. The "ground truth" for these engineering tests is adherence to established engineering standards (e.g., ISO) and predetermined acceptance limits for physical properties.

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

• Not applicable. This concept pertains to adjudicating disagreements among human readers or experts for diagnostic ground truth, which is not part of this 510(k) submission for a microcatheter.

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 not an AI-enabled diagnostic device. It's a medical instrument used for accessing vasculature and delivering agents.

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

• Not applicable. This is not an algorithm.

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

• The "ground truth" equivalent for these tests are the pre-defined engineering specifications and ISO standards that the device must meet to demonstrate safe and effective performance for its intended use. For biocompatibility, the ground truth is the absence of adverse biological reactions as per ISO 10993-1.

8. The sample size for the training set

• Not applicable. There is no "training set" as this is not a machine learning model.

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

• Not applicable.

In summary: The provided document is a 510(k) summary for a Class II medical device (microcatheter) that demonstrates substantial equivalence primarily through bench testing and biocompatibility testing, not clinical performance studies involving diagnostic accuracy or human interpretation. The questions posed are highly relevant to AI/ML diagnostic device submissions but do not apply to this specific regulatory filing.

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