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Dorado™ PTA Balloon Dilatation Catheter is recommended for Percutaneous Transluminal Angioplasty (PTA) of the renal, iliac, femoral, popliteal, tibial, peroneal, and subclavian arteries and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae. This device is also recommended for post-dilatation of balloon expandable and self expanding stents in the peripheral vasculature. This catheter is not for use in coronary arteries.

The Dorado™ PTA Balloon Dilatation Catheter is a high-performance balloon catheter consisting of an over the wire catheter with a balloon fixed at the distal tip. The proprietary non-compliant, low-profile balloon is designed to provide consistent balloon diameters and lengths even at high pressures. Two radiopaque markers delineate the working length of the balloon and aid in balloon placement. The catheter includes an atraumatic tip to facilitate advancement of the catheter to and through the stenosis. The novel catheter consists of a distal triple lumen and a proximal coaxial lumen and is designed to optimize the balance between pushabilty and trackability. The over the wire catheter is compatible with 0.035" guidewire and is available in 40, 80, 120, and 135 cm working lengths. The proximal portion of the catheter includes a female luer lock hub connected to the inflation lumen, and a female luer-lock hub connected to the guidewire lumen. Packaged with every product is a profile reducing sheath that is positioned over the balloon for protection before use. A re-wrapping tool is also provided on the catheter shaft. A stylet is placed into the tip of the catheter to aid in rewrap/refolding of the balloon. These products are not made with natural rubber latex.

This 510(k) clearance letter is for a medical device (Dorado™ PTA Balloon Dilatation Catheter), not an AI/Software as a Medical Device (SaMD).

Therefore, the information requested in your prompt (e.g., acceptance criteria for AI algorithm performance, sample sizes for test/training sets, expert adjudication, MRMC studies, ground truth establishment) is not applicable to this document.

The document discusses the performance evaluation of a physical medical device, focusing on in vitro pre-clinical testing to demonstrate substantial equivalence to a predicate device. This includes:

• Performance Data: Trackability, Balloon Burst Strength, Balloon Fatigue, Sheath Compatibility, Dimensional Verification, Simulated Use, etc.
• Biocompatibility Testing: Cytotoxicity, Sensitization, Irritation, Systemic Toxicity, Hemocompatibility.

The acceptance criteria for this device would be engineering specifications and safety standards for balloon catheters, not statistical metrics for AI algorithm performance.

In summary, based on the provided document, I cannot answer the questions related to AI/SaMD acceptance criteria and study design. The document describes the clearance of a traditional physical medical device.

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The Amethyst HP PTA OTW 0.035" catheter is indicated for:

• Percutaneous Transluminal Angioplasty (PTA) in the peripheral vasculature including iliac, femoral, popliteal, tibial, peroneal, subclavian, renal arteries and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae.
• Post-dilatation of balloon expandable and self-expanding stents in the peripheral vasculature

The Amethyst HP PTA OTW 0.035 catheter is a balloon catheter consisting of an over the wire catheter with a non-compliant inflatable balloon fixed at the distal end of the tip. The balloons are designed to provide consistent balloon diameters and lengths at high pressures. A radiopaque tapered tip positioned at distal of the balloon facilitates the advancement of the catheter to and through the stenosis. A Luer lock fitting (Y hub) at the proximal end allows connection with an inflation device. The catheter is a co-axial catheter with a balloon at the distal tip. One lumen is used for the inflation of the balloon and is accessed via the lateral port of the Y hub. The second lumen, start at the straight entry port of the Y hub, allows access to the distal tip of the catheter for guide wire insertion. The balloon has two radiopaque markers to aid in positioning the balloon relative to stenosis. The balloon is dilated using the lateral port, at which the balloon opens to a known diameter at a specific pressure. The maximum recommended guide wire diameter is 0.035". The catheter is supplied sterile and is intended for single use.

The provided text describes the Amethyst HP PTA OTW 0.035" Catheter, a medical device for Percutaneous Transluminal Angioplasty (PTA). This document is a 510(k) Summary, which is a premarket notification to the FDA to demonstrate that the device is substantially equivalent to a legally marketed predicate device.

However, the information provided does not contain details about acceptance criteria or a study that proves the device meets the acceptance criteria in the context of an AI/ML model for medical image analysis, which your request implies. The document focuses on the physical and performance characteristics of a catheter, and the "performance data" listed are standard non-clinical tests for such a device.

Here's an analysis based on the information available in the document, with a clear statement that the requested AI/ML specific information is not present:

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

The document lists various performance tests carried out on the catheter, and states that the "subject device... met all the predetermined acceptance criteria of design verification and validation as specified by applicable standards, FDA guidance documents and test protocols." However, it does not provide a table specifying the quantitative acceptance criteria for each test or the reported numerical performance outcomes.

Instead, it lists the types of tests performed. To illustrate the concept of such a table based on the provided test types for a physical device, it would generally look like this (but the actual data is missing from the document):

Please note: The actual numerical acceptance criteria and reported performance values are not detailed in the provided text. The document only states that "all the predetermined acceptance criteria" were met.

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

The document relates to a physical medical device (catheter), not an AI/ML system. Therefore, the concepts of "test set," "data provenance," "country of origin," "retrospective or prospective" for data, and "number of experts" are not applicable in the way they would be for an AI/ML study.

For the non-clinical performance tests described (e.g., Catheter Torque Strength, Balloon Rated Burst Pressure), the sample sizes are not explicitly stated. The testing would typically involve a specific number of devices or components to statistically ensure reliability, but these details are not in the summary.

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)

This question is not applicable to the type of device and study described. The document is about a physical catheter, not an AI/ML system requiring expert-established ground truth from a test set.

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

This question is not applicable to the type of device and study described.

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

This question is not applicable to the type of device and study described. The document does not describe an AI-assisted diagnostic or interpretive system.

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

This question is not applicable to the type of device and study described.

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

This question is not applicable to the type of device described. The "truth" for this device's performance is determined by meeting physical and mechanical specifications through direct measurement and testing against established engineering standards and regulatory guidance, not by medical ground truth as in a diagnostic study.

8. The sample size for the training set

This question is not applicable as this is not an AI/ML device.

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

This question is not applicable as this is not an AI/ML device.

In summary: The provided FDA 510(k) summary pertains to a physical medical device (a catheter) and outlines non-clinical performance testing (e.g., mechanical, material, packaging tests) to demonstrate substantial equivalence. It does not describe an AI/ML-based device or a study involving data sets, ground truth establishment by experts, or metrics like sensitivity/specificity, which are associated with AI/ML performance evaluations. Therefore, most of the questions related to AI/ML study specifics cannot be answered from the provided text.

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