Search Results

For percutaneous transluminal angioplasty of lesions in peripheral arteries including iliac, renal, popliteal, infrapopliteal, femoral and ilio-femoral and are also intended to treat obstructive lesions of native or synthetic arteriovenous dialysis fistulae. The ATB All-Terrain Balloon PTA Dilatation Catheter is also intended for post-dilatation of balloon-expandable peripheral vascular stents.

The ATB All-Terrain™ Balloon Dilatation Catheter is comprised of a nylon balloon and a nylon shaft. It is used percutaneously over a pre-positioned wire guide. The and a nylen bhat. Tela connector which provides access to the end hole proximal ona mer connector which permits access to the balloon inflation lumen.

The catheter component of this device measures a nominal 5.0 French in outside diameter. The overall catheter lengths of 40, 80 and 120 cm are available. The catheter is offered with inflated balloon diameters of 4, 5, 6, 7, 8, 9 and 10 mm and in lengths of 2, 3, 4, 6 and 8 cm. The catheter incorporates radiopaque markers to assist fluoroscopic visualization of the balloon during use.

The provided document describes the "ATB All-Terrain™ Balloon PTA Dilatation Catheter" and its equivalence to predicate devices, but does not contain the detailed information requested regarding specific acceptance criteria, a comprehensive study for performance validation, or specifics on ground truth establishment from expert opinions.

This document is a 510(k) premarket notification summary, which primarily aims to demonstrate substantial equivalence to legally marketed predicate devices, rather than providing a detailed performance study with quantitative acceptance criteria and ground truth analysis as typically found in clinical trials or AI/software validation studies.

However, based on the information provided, here's what can be extracted and what is explicitly missing:

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

Missing Information/Cannot Answer based on provided text:

While the document states that tests were performed to evaluate the ATB All-Terrain™ Balloon PTA Dilatation Catheter and provide "reasonable assurance that the device has been designed and tested to assure conformance to the requirements for its use," it does not provide the specific quantitative acceptance criteria or the actual performance results (e.g., minimum burst pressure values, fatigue cycles passed, tensile strength in Newtons, etc.) for each test mentioned.

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

• The document does not specify sample sizes for any of the tests mentioned.
• Data Provenance: Not applicable in the context of this document, as the "performance data" refers to in-vitro engineering tests (e.g., burst strength, fatigue) rather than clinical data or patient data.

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)

• Not applicable. The "performance data" described are engineering tests. There is no mention of experts establishing a "ground truth" for a test set in the clinical or diagnostic sense within this document.

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

• Not applicable. There is no mention of adjudication methods as this document does not describe a study involving expert review or diagnostic assessment.

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

• No MRMC comparative effectiveness study was done. This document pertains to a medical device (dilatation catheter), not an AI or diagnostic imaging system that would typically involve human readers.

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

• Not applicable. This device is a physical medical instrument, not a standalone algorithm.

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

• Not applicable. The "ground truth" for the engineering tests would be established by physical measurement standards and established engineering principles (e.g., material properties, pressure sensors, force gauges).

8. The sample size for the training set

• Not applicable. This document describes a physical medical device, not a machine learning model that requires a training set.

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

• Not applicable. As above, a training set and its ground truth are not relevant to this device and its documentation.

Ask a specific question about this device

For percutaneous transluminal angioplasty of lesions in peripheral arteries including iliac, renal, popliteal, infrapopliteal, femoral and ilio femoral and are also intended to treat obstructive lesions of native or synthetic arteriovenous dialysis fistulae.

The ATB™ All-Terrain Balloon™ PTA Dilatation Catheter is an over-the wire balloon catheter indicated for percutaneous transluminal angioplasty of lesions in peripheral arteries including iliac, renal, popliteal, infrapopliteal, femoral and ilio femoral and are also intended to treat obstructive lesions of native or synthetic arteriovenous dialysis fistulae. The device will be made with 5.0 French nylon tubing compatible with an 0.035-inch guidewire. It will be supplied sterile, intended for one-time use.

The provided document is a 510(k) Premarket Notification for a medical device, specifically a balloon catheter. However, it does not contain specific acceptance criteria or a detailed study report that would typically describe device performance against such criteria.

Instead, the document primarily focuses on regulatory approval based on demonstrating substantial equivalence to predicate devices, and lists general types of tests performed. It lacks quantitative data, statistical analyses, or detailed methods for establishing ground truth or expert involvement as requested in the prompt.

Therefore, I cannot fulfill most of your request directly from the provided text. I will outline what information is available and explicitly state what is missing.

Summary of Available Information (and Missing Information):

This document is a 510(k) Premarket Notification for the ATB™ All-Terrain Balloon™ PTA Dilatation Catheter. It declares substantial equivalence to predicate devices based on intended use, materials, and technological characteristics. The document lists general types of tests performed but does not provide specific acceptance criteria, quantitative results, or detailed study methodologies.

Here's an breakdown based on your request:

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

• Acceptance Criteria: Not explicitly stated. The document mentions "conformance to the requirements for its use as a PTA dilatation balloon catheter" but does not define these requirements quantitatively (e.g., "burst pressure must exceed X psi in Y% of samples").
• Reported Device Performance: No specific quantitative performance data is reported. The document lists types of tests performed (Tensile, Balloon deflation, Balloon burst, Balloon compliance, Balloon fatigue, Balloon profile) and states that "The results of these tests provide reasonable assurance that the device has been designed and tested to assure conformance..." However, no numerical results, ranges, or pass/fail rates are provided.

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

• Sample Size for Test Set: Not specified.
• Data Provenance: Not specified (e.g., country of origin, retrospective/prospective). This type of detail is not typically included in a 510(k) summary focused on substantial equivalence.

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)

• Not applicable / Not specified. This type of information (expert consensus for ground truth) is relevant for studies involving imaging or diagnostics where subjective interpretation is key. For a physical medical device like a balloon catheter, "ground truth" would typically refer to objective physical properties measured against engineering specifications, not expert interpretation of data. The document does not describe any human-read data or ground truth establishment relevant to expert review.

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

• Not applicable / Not specified. Adjudication methods are typically used in clinical trials or studies where human readers or experts are evaluating outcomes, often in cases of disagreement. This is not relevant for the types of physical device tests mentioned (tensile, burst, etc.).

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

• No. This is definitively stated as "No". An MRMC study is relevant for diagnostic or AI-assisted devices that involve human interpretation of cases. This document is for a physical interventional medical device and does not involve AI or diagnostic interpretation in its reported testing.

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

• No. This is definitively stated as "No". Similar to point 5, this is not an AI-driven device, so standalone algorithm performance is irrelevant.

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

• For the physical tests mentioned (burst, tensile, etc.), the "ground truth" would be established by engineering specifications and validated testing methodologies (e.g., measuring pressure at which a balloon bursts, force required for tensile failure). The document does not specify these in detail, but it's implied that standard physical testing methods were used. It is not expert consensus, pathology, or outcomes data.

8. The sample size for the training set

• Not applicable / Not specified. This device does not involve AI/machine learning, so there is no training set in the conventional sense.

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

• Not applicable / Not specified. As there is no training set, this question is not applicable.

Ask a specific question about this device

For percutaneous transluminal angioplasty of lesions in peripheral arteries including iliac, renal, popliteal, infrapopliteal, femoral and ilio femoral and are also intended to treat obstructive lesions of native or synthetic arteriovenous dialysis fistulae.

The ATB™ All-Terrain Balloon™ PTA Dilatation Catheter is an over-the wire balloon catheter indicated for percutaneous transluminal angioplasty of lesions in peripheral arteries including iliac, renal, popliteal, infrapopliteal, femoral and ilio femoral and are also intended to treat obstructive lesions of native or synthetic arteriovenous dialysis fistulae. The device will be made with 5.0 French nylon tubing compatible with an 0.035-inch guidewire. It will be supplied sterile, intended for one-time use.

The provided submission K023504 describes a Special 510(k) Premarket Notification for a PTA Balloon Catheter, the ATB™ All-Terrain Balloon™ PTA Dilatation Catheter. This type of submission focuses on demonstrating substantial equivalence to a predicate device, primarily through performance testing rather than clinical study.

Here's an analysis based on the provided text, addressing the requested information:

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

The submission lists the tests performed but does not explicitly state the acceptance criteria for each test or the detailed numerical results (performance data) in the provided text. It generally states that "The results of these tests provide reasonable assurance that the device has been designed and tested to assure conformance to the requirements for its use as a PTA dilatation balloon catheter."

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

The submission does not specify the sample sizes used for each of the listed tests (Tensile, Balloon deflation, Balloon burst, Balloon compliance, Balloon fatigue, Balloon profile).
The data provenance is not explicitly stated, but it would be from internal laboratory testing conducted by Cook Incorporated, likely in the USA where the company is based. This is prospective testing, as it's performed specifically to demonstrate device performance prior to marketing.

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

This question is not applicable to this type of device submission. The "ground truth" for evaluating a PTA balloon catheter's physical performance is established through established engineering and materials science testing standards, not by expert medical consensus. The tests are objective measurements of the device's physical properties.

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

Not applicable. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies or image-based diagnostic studies where human interpretation of data is involved and discrepancies need to be resolved. This submission details engineering and performance testing.

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 device is a medical instrument (PTA balloon catheter), not an AI-powered diagnostic tool or system that would involve human readers or AI assistance.

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

Not applicable. This is a physical device, not an algorithm.

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

For the performance testing mentioned, the "ground truth" is defined by established engineering specifications and physical measurement standards. For example, balloon burst pressure would be compared against a pre-defined minimum pressure specification derived from clinical needs and recognized standards for such devices.

8. The sample size for the training set

Not applicable. This is a physical device, not a machine learning model, so there is no "training set."

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

Not applicable, as there is no training set for this device.

Ask a specific question about this device

For percutaneous transluminal angioplasty of lesions in peripheral arteries including iliac, renal, popliteal, infrapopliteal, femoral and ilio femoral and are also intended to treat obstructive lesions of native or synthetic arteriovenous dialysis fistulae.

The ATB™ All-Terrain Balloon™ PTA Dilatation Catheter is an over-the wire balloon catheter indicated for percutaneous transluminal angioplasty of lesions in peripheral arteries including iliac, renal, popliteal, infrapopliteal, femoral and ilio femoral and are also intended to treat obstructive lesions of native or synthetic arteriovenous dialysis fistulae. The device will be made with 5.0 French nylon tubing compatible with an 0.035-inch quidewire. It will be supplied sterile. intended for one-time use.

The provided text describes a 510(k) premarket notification for the ATB™ All-Terrain Balloon™ PTA Dilatation Catheter. It outlines the device's intended use, its similarity to predicate devices, and the tests performed to ensure its safety and performance. However, it does not contain a specific table of acceptance criteria with corresponding performance statistics. The document confirms that the device was deemed substantially equivalent to predicate devices based on these tests.

Given the information provided, here's a breakdown of the requested points, focusing on what can be extracted and noting what cannot:

1. Table of Acceptance Criteria and Reported Device Performance

Explanation: The document lists several types of tests performed. For each, it states that "The results of these tests provide reasonable assurance that the device has been designed and tested to assure conformance to the requirements for its use as a PTA dilatation balloon catheter." However, specific numerical acceptance criteria (e.g., minimum tensile strength in Newtons, maximum burst pressure variation) and the exact quantitative results achieved by the device are not detailed in this summary.

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size for Test Set: Not specified. The document lists the types of tests performed but does not state the number of units or samples tested for each.
• Data Provenance: The tests were conducted by Cook Incorporated (the manufacturer). The country of origin and whether the data was retrospective or prospective are not explicitly stated, but it can be inferred that these were controlled, prospective engineering and laboratory tests conducted to support regulatory submission.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

• Not applicable. The tests described (tensile, burst, fatigue, etc.) are engineering and material science tests for device performance, not clinical studies requiring expert ground truth establishment in the traditional sense (e.g., diagnosis of medical conditions). The "ground truth" here would be established by the performance metrics defined by engineering standards and internal specifications. The document does not mention any medical experts involved in validating the results of these specific performance tests.

4. Adjudication Method for the Test Set

• Not applicable. This concept typically applies to clinical studies where multiple reviewers assess a medical outcome or image. For in-vitro device performance tests like those listed, an adjudication method for establishing ground truth is not relevant. The results are typically objectively measured against predefined specifications.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

• No. The document describes laboratory and engineering tests for device performance and safety (e.g., tensile strength, balloon burst). It does not mention any clinical studies, MRMC studies, or human reader performance evaluations, with or without AI assistance. The device in question is a medical catheter, not an AI diagnostic tool.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

• Not applicable. This device is a physical medical instrument (a balloon catheter), not an algorithm or AI system. Therefore, the concept of "standalone algorithm performance" does not apply.

7. The Type of Ground Truth Used

• Engineering Specifications and Industry Standards: For the device performance tests (tensile, burst, fatigue, etc.), the "ground truth" would be the predefined engineering specifications and relevant industry standards that the device must meet to be considered safe and effective for its intended use. This is implicitly what "conformance to the requirements for its use" refers to.

8. The Sample Size for the Training Set

• Not applicable. The document describes a physical medical device submitted for 510(k) clearance based on substantial equivalence to predicate devices and performance testing. There is no mention of an algorithm or AI system requiring a "training set" in this context.

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

• Not applicable. As there is no "training set" for an algorithm, there is no ground truth to be established for it.

Ask a specific question about this device