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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 Ebony HP PTA OTW 0.035" Catheter is indicated for;

· Percutaneous Transluminal Angioplasty (PTA) in the peripheral vasculature, including iliac, femoral, popliteal, tibial, peroneal, subclavian, and 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 Ebony HP PTA OTW 0.035" Catheter is a standard Over The Wire (OTW) PTA catheter with a non-compliant inflatable balloon at the distal part with an atraumatic, tapered tip at its distal end to facilitate advancement of the catheter through the stenosis, and a luer lock fitting (Y hub) at the proximal end allowing the connection with an inflation device. The catheter is a two lumen catheter; one lumen is used for inflation of the balloon and accessed via the lateral port of the Y hub. The second lumen, starting at the straight entry port of the Y hub, allows access to the distal tip of the catheter for guide wire insertion. The maximum recommended guide wire diameter is 0.035". The internal tubing of the balloon has two radio opaque markers to provide visual reference points for balloon positioning relative to the stenosis within the vessel. The working pressure range for the balloon is between the nominal pressure (NP) and the rated burst pressure (RBP). A hydrophilic coating solution is applied on the distal section of the shaft and on the balloon to improve the pushability of the catheter by reduction of the friction coefficient of the outer body.

This document describes the premarket notification (510(k)) for the Ebony HP PTA OTW 0.035" Catheter. The information provided outlines the device's characteristics, indications for use, and the performance data that supports its substantial equivalence to predicate devices. However, the document does not contain details regarding a study for an AI/ML powered medical device, particularly with the specific criteria asked for in your prompt (e.g., sample size for test/training sets, data provenance, expert adjudication, MRMC studies, standalone performance, ground truth establishment).

Therefore, I cannot extract the information required to populate the fields related to an AI/ML study from the given text. The document focuses on the non-clinical performance testing of a physical medical device (a catheter) and its biocompatibility, mechanical properties, and compliance with standards.

To directly answer your request based on the provided text, the device in question is a physical medical device, not an AI/ML powered one. Thus, the concepts of acceptance criteria for AI performance, training/test sets, expert ground truth establishment for AI, MRMC studies, or standalone algorithm performance are not applicable to this document.

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The Tamarin Blue PTCA RX Dilatation Catheters 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 Tamarin Blue PTCA RX Dilatation Catheter is a standard Rapid Exchange (RX) PTCA catheter with a single lumen proximally, a dual lumen distally, a semi-compliant inflatable balloon and a soft, tapered distal tip to aid in crossing tight stenoses. One lumen of the catheter's dual lumen is used for inflation and deflation of the balloon, and the other lumen allows guide wire access through the distal part of the catheter. The maximum recommended guide wire diameter is 0.014". A luer lock fitting (hub) allows connection with an inflation device. Two radiopaque markers on the guide wire lumen tubing provide visual reference points for balloon positioning across the stenosis. A hydrophilic coating has been applied on the distal portion of catheter i.e., up to the RX port, to improve catheter pushability. The balloon material expands to a known diameter at a specific pressure as defined in the compliance table supplied with the catheter.

The device is supplied sterile and intended for one-time use.

This document is a 510(k) summary for the Tamarin Blue PTCA RX Dilatation Catheter (K210012). It details the device's comparison to predicate and reference devices and non-clinical testing performed to establish substantial equivalence.

Here's an analysis to extract the requested information, although it's important to note that this document pertains to a medical device (catheter) and not an AI/ML-driven diagnostic or image analysis device, which are typically the subject of the detailed acceptance criteria and study design questions you've posed. Therefore, many of the requested fields related to AI/ML performance, ground truth establishment by experts, MRMC studies, training sets, etc., will not be applicable or present in this type of submission.

The information consistently aligns with a submission for a physical medical device, not a software/AI device.

Here's the closest interpretation of your request based on the provided document:

Device Name: Tamarin Blue PTCA RX Dilatation Catheter

Device Type: Medical Device (PTCA Dilatation Catheter)

Acceptance Criteria and Device Performance:

The primary "acceptance criteria" for this device, as detailed in a 510(k) submission, revolve around demonstrating substantial equivalence to a previously cleared predicate device. This is typically achieved through non-clinical bench testing to ensure the device performs as intended and meets established safety and performance standards for its class. The document explicitly states that the technological characteristics (components, design, sterilization method, shelf life, operating principle) are identical to the predicate device, with the only notable difference being the addition of a hydrophilic coating, which was tested and shown not to raise new questions of safety or effectiveness.

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

Since this is a physical medical device, "acceptance criteria" are not reported as classical sensitivity/specificity/AUC metrics for a diagnostic algorithm. Instead, they are engineering and performance benchmarks validated through bench testing. The document states that the device "met all acceptance criteria."

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

• Sample Size: Not explicitly stated as a "sample size" in the context of clinical studies for diagnostic accuracy. The non-clinical bench testing would involve a certain number of manufactured devices for each test (e.g., a specific batch size for burst pressure testing, a number of devices for fatigue testing). These numbers are not detailed in this summary.
• Data Provenance: The testing is non-clinical bench testing, meaning it's performed in a laboratory, not from patient data. Therefore, "country of origin of the data" and "retrospective or prospective" are not applicable.

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

This concept is not applicable here as the "ground truth" for a physical device is its adherence to engineering specifications and performance standards, validated through objective bench testing. There are no "experts" establishing ground truth in the sense of medical image interpretation for diagnosis.

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

Not applicable. This is for objective bench testing, not subjective human interpretations that require adjudication.

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. This is for an AI/ML-driven diagnostic/image analysis device. This product is a physical medical catheter.

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

Not applicable. This is a physical medical catheter, not an algorithm.

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

The "ground truth" for this device is based on engineering specifications, established performance standards (e.g., burst pressure limits), and material properties. Compliance is demonstrated through objective bench testing.

8. The sample size for the training set:

Not applicable. There is no AI/ML "training set" for this physical device.

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

Not applicable. There is no AI/ML "training set" for this physical device.

Summary of the Study:

The study proving the device meets acceptance criteria is a non-clinical bench testing program. The purpose of this testing was to demonstrate that the Tamarin Blue PTCA RX Dilatation Catheter (K210012), with the addition of a hydrophilic coating, is substantially equivalent to its predicate device (Tamarin Blue PTCA RX Dilatation Catheter, K112735) and equivalent to a reference device (Filao NC RX PTCA Dilatation Catheter, K141933) for the coating aspects.

The testing evaluated various performance characteristics, including:

• Coating Inspection
• Coating Integrity (Performance and Durability)
• Balloon preparation, deployment and retraction
• Balloon Rated Burst
• Balloon Fatigue
• Balloon compliance
• Balloon inflation/deflation
• Particulate

The conclusion from these tests was that the hydrophilic coating performed as intended, did not impact the functionality of the device, and that the subject device "met all acceptance criteria" and is biocompatible. The technological characteristics, intended use, and indications for use were found to be identical or substantially similar, with any differences not raising new questions of safety or effectiveness.

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