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The Lotus Introducer Set is intended to provide femoral access to the vascular system.

The Lotus™ Introducer Set is a sterile, single-use introducer catheter that provides percutaneous access to the femoral artery for introduction of catheter-based devices into the vascular system. The Lotus Introducer Set will be inserted into the femoral artery using conventional minimally invasive catheterization techniques. The Lotus Introducer Set is composed of a dilator and an introducer sheath with a flush port. The design features a PTFE liner on the ID of the introducer sheath and an external coating on both the introducer sheath and the dilator. When activated, the external hydrophilic coating increases the lubricity of the surface to aid in delivery.

This document is a 510(k) summary for the Creganna-Tactx Lotus Introducer Set. It provides information about the device, its intended use, and substantial equivalence to a predicate device. However, it does not contain specific acceptance criteria or details of a study demonstrating the device meets those criteria, as one would expect for an AI/ML medical device.

The information provided (K140338) describes a mechanical medical device (Introducer Catheter), not an AI/ML-driven device. The "Testing" section details a series of in-vitro physical and biocompatibility tests, which are standard for such medical devices, but these are not related to AI/ML performance.

Therefore, for an AI/ML device, the following information cannot be extracted from the provided text:

1. A table of acceptance criteria and the reported device performance: Not applicable for a mechanical device. The listed tests are not AI performance metrics.
2. Sample size used for the test set and the data provenance: Not applicable.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
4. Adjudication method for the test set: Not applicable.
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. The document explicitly states "Clinical studies were not deemed necessary since in vivo testing and a literature review were sufficient to demonstrate safety and effectiveness by way of comparison to a legally marketed predicate device."
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable.
8. The sample size for the training set: Not applicable.
9. How the ground truth for the training set was established: Not applicable.

In summary, the provided text describes the regulatory clearance for a mechanical medical device and does not contain any information relevant to the acceptance criteria or study details for an AI/ML-driven device.

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The EMPIRA Rx PTCA Catheter and EMPIRA NC Rx PTCA Dilatation Catheter are indicated for balloon dilatation of the stenotic portion of a coronary artery or bypass graft stenosis for the purpose of improving myocardial perfusion.

The EMPIRA NC Rx PTCA Dilatation Catheter is also indicated for post-delivery expansion of balloon expandable stents.

The EMPIRA and EMPIRA NC Rx PTCA Dilatation Catheters, hereafter referred to as the EMPIRA Catheter, are similar in design. The catheters differ in available configurations (diameter versus balloon working length). The EMPIRA Catheter is a sterile, single-use rapid exchange catheter with a nylon-blend balloon near the distal tip. The distal section of the catheter is dual lumen and coaxial. The outer lumen is used for inflation of the balloon and the inner lumen permits the use of a guide wire (≤ 0.014 in. / 0.36 mm) to facilitate advancement of the catheter to and through the stenosis to be dilated. The proximal section of the catheter is a single lumen stainless steel PTFE coated hypotube with a single luer port for the inflation of the balloon. The balloon is designed to provide an inflatable segment of specified diameter and length at recommended pressures. The balloon is folded to achieve a low crossing profile and is connected to a tapered, soft tip. The tapered tip facilitates advancement of the catheter to and through the stenosis. A hydrophilic coating is applied from the distal tip to the guide wire port and over the balloon for increased lubricity. All models have two radiopaque marker bands that aid in the placement of the catheter's balloon segment under fluoroscopy. A balloon protector is placed over the balloon to maintain a low profile and a mandrel is placed in the lumen to maintain patency. The proximal end of the catheter is comprised of a hypotube connected to a plastic hub. The hub can be connected to a standard inflation device and is used to inflate/deflate the balloon. A needle with a luer port is included for flushing the distal lumen prior to the insertion of a guide wire.

The EMPIRA Catheter is compatible with standard 0.014" coronary guide wires and 5F guiding catheters. The catheter length is approximately 139 cm. The EMPIRA and EMPIRA NC Rx PTCA Catheters are offered in diameters of 1.5- 4.0 mm and 2.0-4.0, respectively. The working lengths of the treatment balloon are offered in lengths from 6.0 to 30mm. The EMPIRA and EMPIRA NC Rx PTCA Balloon Dilatation Catheter product family consists of multiple sizes.

The provided text describes non-clinical testing performed on the EMPIRA and EMPIRA NC Rx PTCA Dilatation Catheters to demonstrate their substantial equivalence to predicate devices, rather than a study proving the device meets specific performance acceptance criteria for a diagnostic or AI-driven device.

The document lists various tests conducted, primarily focusing on biocompatibility, physical device characteristics, and packaging/sterilization. For most of these, the "Results" column simply states "PASS," indicating that the device met the criteria for each specific test. However, the specific acceptance criteria themselves are not explicitly detailed in a standalone table within the provided text. Instead, the document notes that testing was performed "in accordance with applicable requirements of FDA Guidance Document - Class II Special Controls Guidance Document for Certain Percutaneous Transluminal Coronary Angioplasty (PTCA) Catheters" and ISO standards.

Therefore, a table of acceptance criteria and reported device performance as typically expected for diagnostic devices is not directly extractable in the requested format. Instead, the document presents a summary of non-clinical tests and their pass/fail outcomes against established standards for PTCA catheters.

Given this context, here's an attempt to address your request based on the available information, noting the limitations:

1. Table of Acceptance Criteria and Reported Device Performance

As specific numerical acceptance criteria for each test are not listed in the document, and only a "PASS" result is provided, a direct fulfillment of this table with detailed criteria is not possible. The table below lists the tests performed and their reported results against the implicit acceptance criteria of the referenced FDA Guidance and ISO standards.

2. Sample Size and Data Provenance

• Test Set Sample Size: The document does not specify the sample sizes used for each non-clinical test (e.g., number of catheters tested for burst pressure, fatigue, etc.).
• Data Provenance: The data provenance is not specified in terms of country of origin or whether it's retrospective or prospective. These are non-clinical (laboratory/animal) studies, not human clinical trials.

3. Number of Experts and Qualifications for Ground Truth

This information is not applicable to the provided document. The studies described are non-clinical, involving laboratory testing and an animal study, not human expert interpretation to establish ground truth for a diagnostic device.

4. Adjudication Method

This information is not applicable. The studies are non-clinical laboratory and animal tests, not studies requiring expert adjudication for a diagnostic output.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No MRMC study was done, as this is a medical device (PTCA catheter), not an AI-driven diagnostic tool involving human readers.

6. Standalone Performance (Algorithm Only without Human-in-the-Loop Performance)

No standalone algorithm performance was done, as this is a medical device (PTCA catheter), not an AI algorithm.

7. Type of Ground Truth Used

For the non-clinical tests, the "ground truth" implicitly refers to the known physical, chemical, and biological properties of the materials and device and their performance under predetermined test conditions as defined by the referenced ISO standards and FDA guidance documents. For the animal study, the ground truth would be the observed physiological responses and device performance in the animal model.

8. Sample Size for the Training Set

This is not applicable. The document describes non-clinical testing for a PTCA catheter, not an AI model that would require a training set.

9. How the Ground Truth for the Training Set was Established

This is not applicable, as no AI model training was involved.

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