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The BASHIR™ .035 Endovascular Catheter and BASHIR™ S-B .035 Endovascular Catheter are mechanical thrombolysis catheters indicated for the:

• · Controlled and selective infusion of physician-specified fluids, including thrombolytics, into the pulmonary arteries for treatment of pulmonary embolism.
• · Infusion of physician-specified fluids, including thrombolytics, into the peripheral vasculature, enabling the restoration of blood flow in patients with venous thrombus.

The BASHIRTM .035 Endovascular Catheter is a device intended for mechanical thrombolysis via expanding the distal infusion basket, allowing localized infusion of physician-specified fluids, including thrombolytics, into the peripheral or pulmonary vasculature. The distal infusion segment of the device is 12.50 cm (4.94 in.) long and consists of an expandable basket with a nitinol core surrounded by mini-infusion catheters, each with multiple infusion holes (hereafter referred to as the "infusion basket"). The infusion basket is expanded and closed using the red actuator located on the handle at the proximal end of the device. The BASHIR™ S-B .035 Endovascular Catheter is a second model intended for smaller anatomies, with an infusion basket that is 10.0 cm (3.94 in.). The devices are otherwise the same. The physician-specified fluid is then delivered via the basket infusion line located on the handle. Pulse sprays are followed by infusion through laser-drilled holes in the infusion limbs of the basket after placement in the peripheral vasculature or in the pulmonary artery. After the completion of fluid delivery, the infusion limbs are collapsed to a straight position and then the catheter is retracted into the sheath and removed from the patient. The BASHIR™ .035 Endovascular Catheter and BASHIR™ S-B .035 Endovascular catheters are composed of common biocompatible materials used in vascular catheters are mechanical and contain no electrical components and require no capital equipment.

The provided text is a 510(k) summary for a medical device (BASHIR™ .035 Endovascular Catheter and BASHIR™ S-B .035 Endovascular Catheter) seeking clearance for market, based on substantial equivalence to a predicate device (BASHIR™ Endovascular Catheter and BASHIR™ S-B Endovascular Catheter, K222095).

The document details performance testing for biocompatibility, sterility, bench performance, animal studies, and clinical studies. However, it does not explicitly present acceptance criteria for each of these tests in a quantifiable manner, nor does it provide a direct comparison of specific numerical performance metrics against predefined acceptance thresholds in a table format.

Instead, the document states that "All tests passed" for biocompatibility and sterility, and for bench performance, it indicates that the subject devices "meet product requirements and design specifications" and that simulated use studies "confirmed functionality." For animal studies, it notes "no adverse effects systemically, on gross or histopathology evaluation, and resulted in no animal mortality." For clinical studies, it mentions leveraging data from a "First in Human (FIH)" study with 9 patients and a "pivotal study with 109 patients."

Therefore, I cannot create the requested table of acceptance criteria and reported device performance with specific numerical values from the given text, as these are not explicitly provided in a comparative, quantitative format. The document focuses on demonstrating substantial equivalence by stating that various tests were performed and their outcomes were satisfactory or met requirements, rather than listing specific numerical criteria and results.

However, I can extract the information requested for other sections of your prompt based on the general descriptions of the studies.

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

As explained above, the document does not explicitly list quantitative acceptance criteria and corresponding reported device performance values in a table. It generally states that tests "passed" or "met requirements."

2. Sample size used for the test set and the data provenance

The document mentions several types of studies, some of which are leveraged from the predicate device.

• Biocompatibility: Studies leveraged from the predicate device. Sample size not specified, but likely involved multiple samples for each test type (cytotoxicity, sensitization, etc.).
• Sterility: Studies leveraged from the predicate device. Sample size not specified, but involved testing to achieve a Sterilization Assurance Level (SAL) of 10^-6 CFU.
• Bench Performance Tests (Subject Devices): "Design verification bench performance testing conducted with the subject devices." Sample size not specified, but covered various mechanical and functional aspects such as kink radius, trackability, advancement force, etc.
• Simulated Use Studies (Predicate Devices): Performed with predicate devices. Confirmed functionality over 20 hours. Sample size not specified.
• In-Use Study (Predicate Devices): Performed with predicate devices to evaluate cumulative impact on a representative drug. Sample size not specified.
• Animal Study (Predicate Device): A GLP animal study performed with the predicate device in a swine model. Sample size not specified, but implied to be sufficient for a GLP study.
• Clinical Performance (Predicate Device):
  • First in Human (FIH): 9 patients.
  • Pivotal study: 109 patients.
• Data Provenance: Not explicitly stated (e.g., country of origin, retrospective/prospective for all studies). The clinical studies are implied to be prospective.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This information is not provided in the document. The studies described are primarily technical performance, animal, and clinical outcome studies, not diagnostic interpretative studies requiring expert consensus on ground truth.

4. Adjudication method for the test set

This information is not provided in the document, as the studies described do not involve interpretative ground truth establishment that would require an adjudication method like 2+1 or 3+1.

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

There is no mention of an MRMC study or AI assistance in the provided text. The device is a mechanical thrombolysis catheter, not an AI-powered diagnostic tool.

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

This is not applicable as the device is a mechanical catheter and not an algorithm.

7. The type of ground truth used

For the clinical performance data leveraged from the predicate device:

• The ground truth would likely be clinical outcomes related to the treatment of pulmonary embolism and venous thrombus, such as thrombus reduction, restoration of blood flow, adverse events, etc., as assessed by clinical investigators and objective measurements (e.g., imaging studies, physiological parameters). The document does not specify the exact ground truth endpoints or how they were established, but medical device trials typically use objective clinical and imaging assessments.

For the bench, animal, biocompatibility, and sterility studies, the "ground truth" is established by adherence to predefined standards, specifications, and observed physical, chemical, and biological responses.

8. The sample size for the training set

This is not applicable. The device is a mechanical catheter, not an AI/ML algorithm that requires a training set.

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

This is not applicable as the device is a mechanical catheter and not an AI/ML algorithm.

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