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The PTA Balloon Catheter is indicated for Percutaneous Transluminal Angioplasty (PTA) in the peripheral vasculature, including illac, femoral, ilio-femoral, popliteal, infra-popliteal and renal arteries, and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae.

The PTA Balloon Catheters (PVQ) is a sterile, single use, non-pyrogenic balloon catheter for peripheral indication. The device features an ultra-low profile, semi-compliant balloon combined with a low-profile tip.

The PTA Balloon Catheters (PVQ) has a coaxial shaft design. The outer lumen is used for inflation of the balloon, and the wire lumen permits the use of 0.014 in (0.36 mm), 0.018 in (0.46mm), guidewires to facilitate advancement of the catheter to and through the stenosis to be dilated. The PTA Balloon Catheters (PVQ) features a dual lumen shaft that provides rapid inflation/deflation times for the catheters compatible with 0.035 in (0.89mm) guidewires. The balloon is designed to provide an inflatable segment of known diameter and length at recommended pressures. The catheter includes a tapered tip to facilitate advancement of the catheter. The working lengths of the balloon catheter range between 10 mm and 280 mm. and are selected based on patient requirements for PTA. The radiopaque marker(s) (see RMD in Figure 1) are placed beneath the "usable balloon length" of the balloon and are visible when used in conjunction with fluoroscopy and aid in the placement of the balloon. The effective length could increase by 1 cm in a fully hydrated state.

Each balloon inflates to the stated diameter and length at a specific pressure. The maximum rated burst pressure is different for each size. It is important that the balloon not be inflated beyond the rated burst pressure.

The proximal portion of the catheter includes one female luer-lock port connected to the inflation lumen, and one female luer-lock port for the guidewire lumen. The devices can be supplied with and without hydrophilic coating. The hydrophilic coating when applied is applied proximally to the balloon for a length of 20 mm and 40 mm.

Each PTA Balloon Catheters (PVQ) is packaged as follows:

• . The balloon is protected within a protective tube with an inner lumen protective stainless-steel wire.
• The entire catheter is provided in a Polyethylene or Poly propylene Protectivetubing ● spiral dispenser.
• The protected catheter is placed in a Tyvec pouch, which is sealed to form the sterile ● barrier.
• Then the pouch is placed into an outer box. .

The PTA Balloon Catheters (PVQ) is used with commercially available sheath introducers, guide catheter and guidewires. These are not included with the PTA Balloon Catheter (PVQ).

The provided text is a 510(k) summary for the QualiMed USA PTA Balloon Catheter (PVQ). It describes the device, its intended use, and the testing performed to demonstrate substantial equivalence to predicate devices. However, this document does not describe the acceptance criteria or a study proving the device meets said criteria in the format requested for AI/ML devices.

The document outlines performance testing for a medical device (a balloon catheter), which involves established engineering and biocompatibility tests to ensure the catheter's physical characteristics, safety, and functionality. These tests are not AI/ML-related performance studies.

Therefore, I cannot extract the requested AI/ML specific information from this document. The concepts of "test set," "training set," "ground truth," "experts," "adjudication," and "MRMC studies with AI assistance" are not applicable to the type of device and testing described in this 510(k) summary.

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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 illo 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 text describes a Special 510(k) Premarket Notification for the ATB™ All-Terrain Balloon™ PTA Dilatation Catheter. This document is a regulatory submission to the FDA, not a study report demonstrating the device's performance against specific acceptance criteria in a clinical or analytical setting.

Therefore, many of the requested details about acceptance criteria, study design, and performance metrics are not available in this document. The document focuses on demonstrating substantial equivalence to predicate devices through in-vitro testing and manufacturing controls, rather than a standalone clinical study with detailed performance outcomes.

Here's a breakdown of what can be extracted and what is not available based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

This information is not explicitly provided in a table format with specific quantitative acceptance criteria or reported numerical performance data. The document states that the device was "subjected to the following tests to assure reliable design and performance under the specified testing parameters," but it does not list the specific acceptance thresholds for these tests or the exact results obtained.

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

• Sample Size: Not specified. The document mentions various "tests" (Tensile, Balloon deflation, Balloon burst, Balloon compliance, Balloon fatigue, Balloon profile) but does not provide any details about the number of devices or samples tested for each.
• Data Provenance: The tests are described as being conducted "to assure reliable design and performance." This implies in-vitro (laboratory) testing performed by the manufacturer, Cook Incorporated, likely in the USA, as Cook Incorporated is an American company. The data is retrospective in the sense that these tests were performed prior to the 510(k) submission.

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

Not applicable. This type of information is relevant for studies involving human interpretation (e.g., imaging studies where experts establish a diagnostic ground truth). The tests described are benchtop/in-vitro performance tests, not clinical studies requiring expert consensus for ground truth.

4. Adjudication Method for the Test Set

Not applicable. See point 3. Benchtop tests typically have objective, measurable outcomes, not subjective interpretations requiring adjudication.

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

No. The document does not describe any clinical study, let alone an MRMC comparative effectiveness study. The submission focuses on substantial equivalence based on materials, intended use, and in-vitro performance testing.

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

Not applicable. This device is a physical medical device (a balloon catheter), not a software algorithm or AI component.

7. Type of Ground Truth Used

For the in-vitro tests mentioned (Tensile, Balloon deflation, Balloon burst, etc.), the "ground truth" would be established by objective engineering specifications and measurements. For example, a burst test's ground truth is the pressure at which the balloon ruptures, measured by calibrated equipment, and then compared against a pre-defined performance specification. It's not expert consensus, pathology, or outcomes data.

8. Sample Size for the Training Set

Not applicable. There is no mention of a "training set" as this is a physical device, not an AI/ML model being developed. The document refers to manufacturing processes and quality assurance, which fall under good manufacturing practices rather than machine learning training.

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

Not applicable. See point 8.

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

The PTA Balloon Catheter is a double lumen catheter with a balloon near the distal tip. The catheter features a minimally compliant balloon constructed from high density polyethylene material. The balloon is designed to expand to a specified diameter and length at a specific pressure as labeled. The balloon catheter is provided in an overall length of 135cm. The catheter will be made in four balloon diameters of 2.5mm, 3.0mm, 3.5mm and 4.0mm. Balloon lengths will be 1.5cm, 2.0cm, 3.0cm and 4.5cm. The catheter is compatible with 0.014-inch standard PTA wire guides. Two radiopaque marker bands located at the proximal and distal ends of the balloon segment facilitate fluoroscopic visualization of the balloon during use.

The provided text describes a 510(k) Premarket Notification for a PTA Balloon Catheter. This document is a regulatory submission for a medical device and, as such, focuses on demonstrating substantial equivalence to predicate devices rather than proving performance against specific acceptance criteria through clinical studies in the way a novel AI or diagnostic device would.

Therefore, many of the requested categories in your prompt are not applicable to this type of regulatory submission. Specifically, this document does not contain:

• A table of acceptance criteria and reported device performance in a clinical context for AI/diagnostic devices.
• Information on sample sizes for test sets, data provenance, number of experts for ground truth, adjudication methods, or AI-related comparative effectiveness studies (MRMC or standalone performance).
• Details about training sets or how ground truth for training sets was established.

Here's a breakdown of what can be extracted and what is not applicable, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document describes engineering and material performance tests rather than clinical performance or diagnostic accuracy. The "acceptance criteria" for these tests are not explicitly quantified in this document beyond the statement "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 vascular PTA balloon."

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

• Test Set Sample Size: Not specified. The document mentions "the balloon catheter was subjected to the following tests," implying laboratory testing on device prototypes/samples, not a clinical test set with patient data.
• Data Provenance: Not applicable. These are laboratory engineering tests, not clinical data from patients.

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

• Not applicable. Ground truth for clinical data is not relevant to these engineering performance tests.

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

• Not applicable. This concept is for clinical data review, not engineering tests.

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 a medical device for angioplasty, not an AI or diagnostic imaging device that involves human readers.

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

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

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

• Type of Ground Truth: For the engineering tests, the "ground truth" would be the established engineering specifications, standards, and performance limits for each parameter (e.g., minimum burst pressure, maximum distensibility, cycle endurance). The device's performance is compared against these predetermined specifications.

8. The sample size for the training set

• Not applicable. This is a physical medical device, not an AI model that requires a training set.

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

• Not applicable. No training set is involved.

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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 COOK PTA balloon 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 vinyl tubing compatible with an 0.035-inch guidewire. It will be supplied sterile, intended for one-time use.

Here's an analysis of the provided text regarding the COOK PTA balloon catheter, focusing on the requested acceptance criteria and study information:

Acceptance Criteria and Device Performance Study for COOK PTA Balloon Catheter (K972800)

1. Table of Acceptance Criteria and Reported Device Performance

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

The provided document does not specify the sample sizes used for any of the tests (tensile, flow rate, inflation, burst, biocompatibility, or animal tests).

The data provenance is not explicitly stated beyond being part of a 510(k) submission from COOK INCORPORATED, a US-based company. It can be inferred that the testing was conducted by or for COOK INCORPORATED for regulatory submission. Whether the data is retrospective or prospective is not indicated.

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

This information is not provided in the document. The tests described are largely objective engineering and biological assessments, not typically requiring human expert-established ground truth in the way a diagnostic imaging device would.

4. Adjudication Method for the Test Set

This information is not applicable/provided. The described tests are objective measurements, not subjective assessments requiring adjudication among experts.

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

A Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not conducted for this device submission. This type of study is typically relevant for diagnostic devices where human interpretation plays a significant role, not for a PTA balloon catheter which is a therapeutic device with objective performance metrics.

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

This concept is not applicable to a physical medical device like a PTA balloon catheter. There is no "algorithm" in the sense of AI or software that would have a standalone performance. The device's performance is inherently its standalone performance when used as intended.

7. Type of Ground Truth Used

The ground truth for the performance tests would be established by:

• Engineering specifications/standards: For tensile strength, burst pressure, flow rates, etc. (e.g., minimum burst pressure, maximum elongation).
• Biocompatibility standards: For biocompatibility tests (e.g., ISO 10993).
• Physiological/anatomical criteria: For animal tests (e.g., successful dilatation, absence of adverse events like vessel dissection or thrombosis).

The document states that the tests provide "reasonable assurance that the device has been designed and tested to assure conformance to the requirements for its use," implying that predefined acceptance criteria (ground truth) were met.

8. Sample Size for the Training Set

This information is not applicable/provided. This device is a physical medical device, not an AI/ML algorithm that requires a "training set" of data. The "training" for such devices typically involves materials science, engineering design, and manufacturing process optimization.

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

This information is not applicable/provided for the reasons stated in point 8.

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