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The OuickCat™ Extraction Catheter is indicated for the removal of fresh, soft emboli and thrombi from vessels in the arterial system.

The QuickCat™ Extraction Catheter is a single use, disposable, dual lumen catheter with associated accessories consisting of a 30 ml. vacuum syringe, extension tubing with stopcock, and an independent 40-micron filter basket. The 145 cm working length and is compatible with 6F guiding catheters with an inner diameter (I.D.) > 0.068" (1.73 mm) and 0.014" (0.36 mm) diameter guidewires. The extraction lumen of the catheter facilitates removal of emboli and thrombi via the attached tubing assembly, stopcock and vacuum syringe. The atraumatic distal tip, which incorporates a radiopaque marker for visibility under fluoroscopy, provides for smooth passage in the arterial system. The catheter consists of three segments. The stiffer proximal segment and more flexible distal segments provide the required structural integrity and flexibility to navigate tortuous vasculature. The distal segment consists of a dual lumen to allow for "rapid exchange" attachment to the guidewire. The catheter's distal portion has a hydrophilic coating to enhance deliverability. A 40-micron pore filter basket is supplied to assist in filtering of blood and thrombotic material for visual or laboratory analysis.

I am sorry, but based on the provided document, there is no acceptance criteria or a study described that proves the device meets specific performance criteria in the way you've outlined.

This document is a 510(k) premarket notification approval letter for the QuickCat Extraction Catheter. This type of FDA submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving performance against specific acceptance criteria through detailed clinical or statistical studies as would be required for a novel device or a PMA submission.

Here's a breakdown of why the requested information cannot be extracted from this document:

1. Table of acceptance criteria and reported device performance: This document does not contain any specific performance metrics (e.g., sensitivity, specificity, accuracy, success rates) or acceptance criteria for those metrics. The "Non-Clinical Summary" merely states that "Results of this testing indicate that the QuickCat design meets all specifications and intended use," which is a general statement and not a table of specific criteria and results.

2. Sample size used for the test set and data provenance: No information is provided about a "test set" in the context of performance evaluation. The document mentions "in-vitro bench testing and biocompatibility testing" but does not give details about the sample sizes or the origin of any data used in these tests.

3. Number of experts and qualifications for ground truth: Since there are no specific performance claims or clinical study results beyond the general statement of meeting specifications, there's no mention of experts establishing ground truth for a test set.

4. Adjudication method for the test set: Not applicable, as no information on a test set or expert evaluation is provided.

5. Multi-reader multi-case (MRMC) comparative effectiveness study: This document does not describe any MRMC study, nor does it refer to AI assistance. The device is a physical catheter, not an AI-powered diagnostic tool.

6. Standalone performance (algorithm only): Not applicable. The device is a physical medical device, not an algorithm.

7. Type of ground truth used: Not applicable, as detailed performance studies generating ground truth are not described. The basis for substantial equivalence is primarily the comparison of technological characteristics and intended use to a predicate device, along with verification through bench and biocompatibility testing.

8. Sample size for the training set: Not applicable. The device is not an AI algorithm that requires a training set.

9. How the ground truth for the training set was established: Not applicable for the same reason as above.

In summary, the provided FDA 510(k) approval letter (K073519) for the QuickCat Extraction Catheter focuses on demonstrating "substantial equivalence" to a predicate device rather than presenting detailed performance acceptance criteria and study results in the manner requested for AI/software-as-a-medical-device (SaMD) products.

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