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The Fox Plus PTA Catheter is intended for dilatation of lesions in the femoral, renal, iliac, popliteal, peroneal and profunda arteries and native or synthetic arteriovenous dialysis fistulae. This catheter is not intended for the expansion or delivery of stents.

The Fox Plus PTA Catheter is a standard over-the-wire PTA catheter. The double lumen catheter has a balloon located near the distal tip. One lumen is used for inflation of the balloon, while the second lumen allows access to the distal tip of the catheter for guidewire insertion (max 0.035"). The balloon has two radiopaque markers for positioning the balloon relative to the stenosis. The balloon material expands to a known diameter at specific pressures.

This document is a 510(k) summary for the Fox™ Plus PTA Catheter. This type of submission is for medical devices that are substantially equivalent to a predicate device already on the market. It typically does not involve clinical studies designed to prove performance against specific acceptance criteria in the way that novel devices might. Instead, the focus is on demonstrating equivalence to an existing, legally marketed device.

Therefore, many of the requested elements of your query are not applicable to a 510(k) submission for substantial equivalence based on identical technological characteristics and aging tests.

Here's the breakdown based on the provided text:

1. Table of acceptance criteria and the reported device performance

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: Not applicable/not provided. The document primarily relies on demonstrating identical technological characteristics and aging test results, not a clinical test set in the traditional sense.
• Data provenance: Not applicable/not provided.

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. Ground truth for a clinical test set is not established in this type of submission. The "ground truth" here is the predicate device's established safety and effectiveness.

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

• Not applicable. There is no clinical test set requiring 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 a medical catheter, not an AI-powered diagnostic device. No MRMC study was conducted.

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)

• The "ground truth" in this context is the safety and efficacy profile of the previously cleared predicate device, to which the subject device is deemed substantially equivalent. The substantial equivalence is demonstrated through identical technical characteristics and performance in non-clinical tests (like aging tests).

8. The sample size for the training set

• Not applicable. There is no training set as this is not an AI/machine learning device.

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

• Not applicable.

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The Fox Plus PTA Catheter is intended for dilatation of lesions in the femoral, renal, iliac, popliteal, peroneal and profunda arteries and native or synthetic arteriovenous dialysis fistulae.

This catheter is not intended for the expansion or delivery of stents.

The Fox Plus PTA Catheter is a standard over-the-wire PTA catheter. The double lumen catheter has a balloon located near the distal tip. One lumen is used for inflation of the balloon, while the second lumen allows access to the distal tip of the catheter for guidewire insertion (max 0.035"). The balloon has two radiopaque markers for positioning the balloon relative to the stenosis. The balloon material expands to a known diameter at specific pressures.

Here's an analysis of the provided text regarding the Fox™ Plus PTA Catheter (K080264). Unfortunately, the document does not contain the specific information requested about acceptance criteria and a study proving device performance, as it pertains to AI/ML device evaluations. This document is a traditional 510(k) premarket notification for a medical device that relies on substantial equivalence to predicate devices, rather than a performance study against specific acceptance criteria for an AI algorithm.

The request asks for details typically associated with the evaluation of AI/ML-driven medical devices, especially for topics like:

• Acceptance criteria table with reported device performance for an AI
• Sample size for a test set and data provenance for an AI
• Number and qualifications of experts for ground truth establishment for an AI
• Adjudication method for an AI test set
• MRMC comparative effectiveness study for an AI
• Standalone performance for an AI
• Type of ground truth used for an AI
• Sample size for the training set for an AI
• How ground truth for the training set was established for an AI

Since this is a conventional medical device submission (PTA Catheter), these AI/ML- specific details are not applicable and are therefore not present in the provided text.

The document focuses on:

• Device Description: What the catheter is and its components.
• Intended Use: The medical conditions and procedures for which the catheter is designed.
• Predicate Devices: Previously cleared devices to which the current device is compared for substantial equivalence.
• Technological Characteristics Comparison: How the new device is similar to or different from predicate devices (mostly identical, with minor balloon length changes).
• Substantial Equivalence Justification: Stating that in vitro bench tests, analyses, and biocompatibility testing demonstrate the safety and effectiveness, leading to substantial equivalence to predicate devices.

There is no "acceptance criteria and study that proves the device meets the acceptance criteria" in the context of an AI/ML algorithm's performance. The "acceptance" here is the FDA's determination of substantial equivalence based on the provided engineering and biocompatibility data compared to predicate devices, not specific performance metrics for an AI algorithm.

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The Fox SV PTA Catheter is intended for dilatation of lesions in the femoral, renal, iliac, popliteal, peroneal, and profunda arteries and native or synthetic arteriovenous dialysis fistulae. This catheter is not intended for the delivery or expansion of stents.

The Fox SV PTA Catheter is a standard over-the-wire PTA catheter. The double lumen catheter has a balloon located near the distal tip. One lumen is used for inflation of the balloon, while the second lumen allows access to the distal tip of the catheter for guidewire insertion (max 0.018"). The balloon material expands to a known diameter at specific pressure.

The provided document, a 510(k) summary for the Fox SV PTA Catheter, does not contain information on acceptance criteria or a study proving the device meets acceptance criteria in the format requested.

The document states: "The Fox SV PTA Catheter is substantially equivalent to the predicate device. Substantial equivalence was confirmed through non-clinical testing."

This indicates that the primary method for demonstrating safety and effectiveness for this 510(k) submission was a comparison to a legally marketed predicate device (Fox Plus PTA Catheter K040954) through non-clinical testing, rather than a clinical study with defined acceptance criteria and performance metrics.

Therefore, I cannot provide the requested information as it is not present in the given text. The document focuses on demonstrating substantial equivalence, device description, and intended use as per 510(k) requirements, not on detailed performance study results against specific acceptance criteria.

Ask a specific question about this device

The Fox Plus PTA Catheter is intended for dilatation of lesions in the femoral, renal, iliac, popliteal, peroneal, and profunda arteries and native or synthetic arteriovenous dialysis fistulae. This catheter is not intended for the expansion or delivery of stents.

The Fox Plus PTA Catheter is a standard over-the-wire PTA catheter. The double lumen catheter has a balloon located near the distal tip. One lumen is used for inflation of the balloon, while the second lumen allows access to the distal tip of the catheter for guidewire insertion (max 0.035"). The balloon material expands to a known diameter at specific pressure.

This document is a 510(k) summary for a medical device called the Fox Plus PTA Catheter. It describes the device, its intended use, and its substantial equivalence to a predicate device. However, it does not contain information about acceptance criteria, device performance results, sample sizes for testing or training, ground truth establishment, or any comparative effectiveness studies as requested in the prompt.

Therefore, I cannot provide the requested table and information based on the provided text. The submission focuses on demonstrating substantial equivalence through non-clinical testing, but the details of those tests and their outcomes are not included here.

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