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The PolarCath Peripheral Dilatation System's intended use is for the dilatation of stenoses in the peripheral vasculature (iliac, femoral, popliteal, infrapopliteal, renal and subclavian arteries) and for the treatment of obstructive lesions of polytetrafluoroethylene (PTFE) access grafts or native arteriovenous dialysis fistulae. The PolarCath Peripheral Dilatation System is also indicated for post-deployed stent expansion of self-expanding peripheral vascular stents.

The PolarCath™ Peripheral Dilatation System (PolarCath System) consists of a disposable catheter, a reusable Cryoplasty inflation unit, a disposable nitrous oxide cartridge, and a disposable catheter extension.

The PolarCath System is designed for dilatation of stenotic lesions in peripheral arteries. The procedure consists of inserting a catheter over a quidewire to the target lesion, attaching the catheter to the catheter extension, attaching the catheter extension to the Inflation Unit, inserting a nitrous oxide cartridge into the Inflation Unit, and inflating the balloon catheter for a set time at a set pressure, using the controls on the Inflation Unit.

The Cryoplasty inflation unit functions to: a) deliver the inflation media (liquid nitrous oxide) to the balloon; b) control the pressure inside the inner balloon; c) provide a vacuum between the inner and outer balloons; and d) control the length of time for delivery of the inflation media which is manually extracted at the end of the inflation time. The inflation unit monitors the temperature inside the balloon. Excess pressure is prevented by the presence of a relief valve in the inflation unit.

The provided document is a 510(k) premarket notification for a medical device called the PolarCath Peripheral Dilatation System. It focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study proving device performance against specific acceptance criteria in a clinical context.

Therefore, many of the requested sections regarding clinical study design (sample size, data provenance, expert ground truth, adjudication, MRMC studies) cannot be fulfilled from this document. The document describes non-clinical testing.

Here's an analysis of the available information:

1. Table of Acceptance Criteria and Reported Device Performance & The Study that Proves the Device Meets Acceptance Criteria:

The Study that Proves the Device Meets Acceptance Criteria:

The document describes "non-clinical testing" as the study. This involved "Performance Bench Testing," "Software Verification Validation Testing," and "Electromagnetic Compatibility and Electrical Safety" testing. These tests were conducted to demonstrate that the materials chosen, manufacturing processes, and design meet established specifications and do not raise new questions of safety or effectiveness compared to the predicate device. No animal or clinical testing was required or performed for this submission.

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

• Sample Size: Not specified for any of the non-clinical tests. For bench testing, it refers to multiple aspects (Catheter Extension, Inflation Unit, Simulated Use, Transit Testing), implying a series of tests on various components/systems, but specific quantities are not given.
• Data Provenance: Not applicable as these are non-clinical, bench-level tests.

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

• Not applicable as this was non-clinical and did not involve expert-established ground truth in a clinical diagnostic sense. Performance was measured against engineering specifications and industry standards.

4. Adjudication method for the test set:

• Not applicable as this was non-clinical and did not involve expert 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:

• No. This is a medical device for physical intervention (dilatation system), not an AI-powered diagnostic or assistive tool for human readers.

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

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

7. The type of ground truth used:

• For the non-clinical tests, the "ground truth" was established by engineering specifications, product requirements, and recognized industry standards (e.g., IEC 60601-1, IEC 60601-1-2). For the software, it was the Software Requirements Specification (SRS). For performance, it was also equivalent performance to the predicate device.

8. The sample size for the training set:

• Not applicable. This is not a machine learning or AI device that would have a training set.

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

• Not applicable.

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The PolarCath Peripheral Dilatation System's intended use is for the dilatation of stenoses in the peripheral vasculature (iliac, femoral, popliteal, infrapopliteal, renal and subclavian arteries) and for the treatment of obstructive lesions of polytetrafluoroethylene (PTFE) access grafts or native arteriovenous dialysis fistulae. The PolarCath Peripheral Dilatation System is also indicated for post-deployed stent expansion of self-expanding peripheral vascular stents.

The PolarCath Peripheral Dilatation System consists of a Catheter, Inflation Unit, connecting cable and a rechargeable battery pack with recharging unit and battery receptacle. The inflation medium (liquid nitrous oxide) is provided in a disposable 14 gram cartridge.

The provided text describes the PolarCath™ Peripheral Dilatation System, its indications for use, and its substantial equivalence to predicate devices, but does not contain information about acceptance criteria or a study proving the device meets specific performance criteria.

Therefore, I cannot fulfill the request for a table of acceptance criteria, device performance, sample sizes, expert details, adjudication methods, MRMC studies, standalone performance, ground truth types, or training set information.

The document is a 510(k) clearance letter from the FDA, which focuses on regulatory approval based on demonstrating "substantial equivalence" to existing legally marketed devices. It explicitly states:

"The substantial equivalence of the modified PolarCath Peripheral Dilatation System is demonstrated with design control activities and bench testing on file at Boston Scientific."

This means that while performance data and acceptance criteria presumably exist and were submitted to the FDA as part of their "design control activities and bench testing," they are not detailed or presented in this public document. The FDA's letter (K092455) confirms the device's clearance but does not publish the specific performance study results or acceptance criteria used for that clearance.

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The PolarCath™ Peripheral Dilatation System is indicated to dilate stenoses in the peripheral vasculature (iliac, femoral, popliteal, infrapopliteal, renal and subclavian arteries) and for the treatment of obstructive lesions of polytetrafluoroethylene (PTFE) access grafts or arteriovenous dialysis fistulae. The PolarCath™ Peripheral Dilatation System is also indicated for post-deployed stent expansion of self-expanding peripheral vascular stents.

The PolarCath™ Peripheral Dilatation System consists of a Catheter, Inflation Unit, connecting cable and a rechargeable battery pack with recharging unit and battery receptacle. The inflation medium (liquid nitrous oxide) is provided in a disposable 14 gram cartridge.

The provided text describes a 510(k) premarket notification for a modification to the PolarCath™ Peripheral Dilatation System, specifically focusing on changes to the Inflation Unit's circuit board. This filing is for a device modification and does not involve a study to establish the diagnostic or predictive performance of an AI/ML algorithm. Therefore, many of the requested elements pertaining to such studies are not applicable.

Here's an analysis of the provided information in the context of the requested questions:

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

Since this is a submission for a modification to an existing device, the "acceptance criteria" are related to ensuring the modified device performs equivalently to the predicate device. The performance reported here relates to the safety and functionality of the changed component.

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

The information states "12 sequential runs, or inflations, of the balloon" were performed during verification testing. This implies a sample size of 12 tests on the modified inflation units. There is no information provided about the country of origin or whether the data was retrospective or prospective. This type of testing is typically prospective, performed in a controlled lab setting, rather than on 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)

This is not applicable. The "ground truth" for this type of engineering verification testing would be the pre-defined functional specifications of the device, assessed by engineers or technicians, not clinical experts.

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

This is not applicable as there's no clinical "ground truth" being established by experts through adjudication for this type of engineering verification. The assessment would likely involve comparing device output/functionality against engineering specifications.

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, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This submission is for a physical device modification, not an AI/ML algorithm that assists human readers.

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

No, a standalone algorithm performance study was not done. This submission is for a physical device, not an algorithm.

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

The ground truth for this verification testing would be the functional specifications and performance parameters of the device's inflation unit and circuitry. It would be measured against engineering benchmarks, not clinical outcomes or expert consensus.

8. The sample size for the training set

This is not applicable. There is no "training set" as this is a physical device modification, not a machine learning model.

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

This is not applicable for the same reason as above.

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The PolarCath Peripheral Dilatation System is indicated to dilate stenoses in the peripheral vasculature (iliac, femoral, popliteal, infrapopliteal, renal and subclavian arteries) and for the treatment of obstructive lesions of polytetrafluoroethylene (PTFE) access grafts or native arteriovenous dialysis fistulae. The PolarCath Peripheral Dilatation System is also indicated for post-deployed stent expansion of self-expanding peripheral vascular stents.

The PolarCath Peripheral Dilatation System consists of a Catheter, Inflation Unit, connecting cable and a rechargeable battery pack with recharging unit and battery receptacle. The inflation medium (liquid nitrous oxide) is provided in a disposable 14 gram cartridge.

This request cannot be fulfilled. The provided text is a 510(k) summary for a medical device (PolarCath™ Peripheral Dilatation System) and does not contain information about studies related to AI/algorithm performance, acceptance criteria for such, or details like sample sizes for training/test sets, expert qualifications, or ground truth establishment. The document describes a traditional medical device submission based on substantial equivalence to a predicate device, not an AI-powered device.

Ask a specific question about this device

The PolarCath Peripheral Dilatation System is indicated to dilate stenoses in the peripheral vasculature (iliac, femoral, popliteal, infrapopliteal, renal and subclavian arteries) and for the treatment of obstructive lesions of polytetrafluoroethylene (PTFE) access grafts or native arteriovenous dialysis fistulae. The PolarCath Peripheral Dilatation System is also indicated for post-deployed stent expansion of self-expanding peripheral vascular stents.

The PolarCath Peripheral Dilatation System consists of a Catheter, Inflation Unit, connecting cable and a rechargeable battery pack with recharging unit and battery receptacle. The inflation medium (liquid nitrous oxide) is provided in a disposable 14 gram cartridge.

This 510(k) submission for the PolarCath™ Peripheral Dilatation System does not include a study describing acceptance criteria and device performance.

Instead, it states: "The safety and effectiveness of the modified PolarCath Peripheral Dilatation System is demonstrated with design control activities and bench testing on file at Boston Scientific." This typically means that the device was tested against engineering specifications and industry standards in a lab setting, rather than through clinical trials or performance studies involving human data.

Therefore, I cannot provide the requested information. The document focuses on demonstrating substantial equivalence to a predicate device (K051916) based on design, materials, manufacturing process, and intended use, rather than presenting novel performance data from an acceptance criteria study.

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The PolarCath™ Peripheral Dilatation System is indicated to dilate stenosis in the peripheral vasculature (iliac, femoral, popliteal, infrapopliteal and renal arteries) and for the treatment of obstructive lesions of PTFE access grafts or arteriovenous dialysis fistulae.

The PolarCath Peripheral Dilatation System consists of a Catheter, Inflation Unit, connecting cable and a rechargeable battery pack with recharging unit and battery receptacle. The inflation medium (liquid nitrous oxide) is provided in a disposable 14 gram cartridge.

The provided text describes a 510(k) premarket notification for the PolarCath™ Peripheral Dilatation System, which is a Percutaneous Transluminal Angioplasty Catheter. The document is a regulatory submission, not a study report, and therefore does not contain the requested information about acceptance criteria, study details, sample sizes, expert qualifications, or ground truth establishment relevant to AI/ML device performance.

The "Performance Data" section explicitly states: "The safety and effectiveness of the modified PolarCath Peripheral Dilatation System is demonstrated with design control activities and bench testing on file at CryoVascular Systems, Inc." This indicates traditional device testing (bench testing, design controls) was performed, not clinical studies involving AI performance metrics.

Therefore, I cannot provide the requested table and study details as they are not present in the provided document.

This document is from 2004, a period before AI/ML-driven medical devices were commonly evaluated in the same manner as described in your request. The evaluation framework for devices like this involved demonstrating substantial equivalence to a predicate device through engineering design, material specifications, manufacturing processes, and bench testing, rather than through extensive clinical performance studies with AI components.

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The PolarCath Peripheral Dilatation System is indicated to dilate stenosis in the peripheral vasculature (iliac, femoral, popliteal, infrapopliteal and renal arteries) and for the treatment of obstructive lesions of PTFE access grafts or artcriovenous dialysis fistulae.

The PolarCath Peripheral Dilatation System consists of a Catheter, Inflation Unit, connecting cable and a rechargeable battery pack with recharging unit and battery receptacle. The inflation medium (liquid nitrous oxide) is provided in a disposable 14 gram cartridge.

The provided text describes the 510(k) summary for the PolarCath™ Peripheral Dilatation System. However, it does not include detailed acceptance criteria or a study proving that the device meets those criteria.

The "Performance Data" section explicitly states: "The safety and effectiveness of the modified PolarCath Peripheral Dilatation System is demonstrated with design control activities and bench testing on file at CryoVascular Systems, Inc." This indicates that the supporting data is held internally by the company and is not detailed in the provided 510(k) summary.

Therefore, I cannot provide a table of acceptance criteria and reported device performance, nor can I answer the specific questions about sample size, data provenance, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth establishment for a study that is not described in this document.

The document focuses on:

• Device Description: What the PolarCath Peripheral Dilatation System is.
• Indications for Use: What the device is intended for.
• Substantial Equivalence: How it is similar to predicate devices.
• Regulatory Information: Sponsor, contact person, product codes, classification, and the FDA's letter of clearance.

In summary, based on the provided text, the specific study details and acceptance criteria you've requested are not available.

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