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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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The Athletis™ PTA Balloon Dilatation Catheter is indicated for Percutaneous Transluminal Angioplasty in the peripheral vasculature including upper extremity, renal, iliac, and infrainguinal vessels and the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae.

The Athletis™ PTA Balloon Dilatation Catheter is also indicated for post-dilatation of stents and stent grafts in the peripheral vasculature.

The Athletis™ Percutaneous Transluminal Angioplasty (PTA) Balloon Dilatation Catheter is an over-the-wire (OTW), non-compliant, high performance balloon catheter for peripheral indications. The catheter is compatible with 0.035 in (0.89 mm) guidewires.

The Athletis™ PTA Balloon Dilatation Catheter features a dual lumen shaft ending in a Y-connector manifold with luer lock fittings. The manifold port marked "WIRE" is used to deliver the catheter over a 0.035 in (0.89 mm) guidewire. The manifold port marked "BALLOON" is used to inflate and deflate the balloon during the procedure. Two radiopaque marker bands, in conjunction with fluoroscopy, aid in the visualization of the balloon. A lubricious hydrophobic coating is applied from the distal tip to just proximal of the balloon to assist with delivery of the device. The catheter includes a tapered tip to facilitate advancement of the catheter to and through the treatment site. The working lengths of the balloon catheter are 50 cm, 75 cm and 135 cm to allow device selection for various anatomies.

The provided text describes a 510(k) premarket notification for a medical device, the Athletis™ PTA Balloon Dilatation Catheter. The document focuses on demonstrating substantial equivalence to a predicate device (Mustang Balloon Dilatation Catheter) through comparisons of technological characteristics and performance data (bench testing, biocompatibility, and animal study).

However, the provided text does not contain the kind of information requested in the prompt regarding acceptance criteria and study details for an AI/algorithm-based device. The prompt asks about elements typical for AI/ML medical devices, such as:

• Acceptance criteria table with reported device performance (e.g., accuracy, sensitivity, specificity, AUC).
• Sample sizes for test sets, data provenance (country, retrospective/prospective).
• Number and qualifications of experts for ground truth.
• Adjudication methods.
• Multi-reader multi-case (MRMC) comparative effectiveness studies.
• Standalone algorithm performance.
• Type of ground truth (expert consensus, pathology, outcomes).
• Training set sample size and ground truth establishment for training.

Since the document is for a physical medical catheter (Percutaneous Transluminal Angioplasty Balloon Dilatation Catheter) and not an AI/ML diagnostic or assistive device, the requested information about AI model performance, human reader improvement with AI assistance, and specific AI training/testing methodologies is not applicable and not found within the provided text.

The performance data mentioned in the document are related to the physical and biological characteristics of the catheter itself, such as:

• Bench testing: Working Length, Shaft Outer Diameter, Balloon Crossing Profile, Preparation/Deployment/Retraction, Balloon Rated Burst Pressure and Burst in Stent, Balloon Fatigue/Fatigue in Stent, Balloon Compliance and OD at nominal, Balloon Inflation/Deflation Time, Particulate Evaluation, Device Tensile, Balloon Protector Removal Force, Shaft Kink Resistance, Torque Strength, Radiopacity, Guidewire Compatibility, Sheath Insertion and Withdrawal Force, Coating Integrity, Particulate in Stent.
• Biocompatibility testing: Cytotoxicity, Sensitization, Intracutaneous Reactivity, Acute Systemic Toxicity, Materials Mediated Pyrogenicity, USP Physicochemical, Direct Contact Hemolysis, Complement Activation, In Vitro Hemocompatibility, Ames Mutagenicity, Mouse lymphoma Assays.
• GLP Animal Study (porcine): Evaluation of in vivo thrombogenicity and acute performance and safety.

The summary states that "The results of these tests provide reasonable assurance that the proposed device has been designed and tested to assure conformance to the requirements for its intended use. No new safety or performance issues were raised during the testing." This implicitly serves as the "acceptance criteria" for this type of device – demonstrating that it performs as intended and is safe, comparable to the predicate, through these physical and biological tests.

In conclusion, I cannot provide the requested information because the input text describes the clearance of a physical medical device (a balloon catheter), not an AI/ML-based device, and therefore does not contain data related to AI model performance or associated study methodologies.

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