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The FoxCross 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 FoxCross 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 guide wire 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.

The provided text is a 510(k) summary for the FoxCross PTA Catheter and describes its substantial equivalence to predicate devices, but it does not contain information about acceptance criteria or a study proving that the device meets specific performance criteria through a clinical trial or algorithm evaluation.

Instead, the document states: "The results of the in vitro bench tests and analyses demonstrate the safety and effectiveness of the FoxCross PTA Catheter Line Extension." This indicates that the device's safety and effectiveness were demonstrated through bench testing and analyses, not through a clinical study with human subjects, an MRMC study, or a standalone algorithm performance study.

Therefore, I cannot provide the requested information in the table format because the details are not present in the provided text.

Here's an explanation of why the requested information cannot be extracted:

• Acceptance Criteria and Reported Device Performance: This information is typically found in a clinical study report or a detailed summary of verification and validation testing, which is not included here. The document only mentions "in vitro bench tests and analyses" in general terms.
• Sample size for test set and data provenance: No test set is described, as the evaluation was based on bench tests.
• Number of experts and qualifications: Not applicable, as there was no study involving human readers or expert ground truth establishment for a test set in the context of an algorithm.
• Adjudication method: Not applicable.
• Multi Reader Multi Case (MRMC) comparative effectiveness study: No such study is mentioned or implied.
• Standalone (algorithm only) performance: This device is a physical medical device (a catheter), not an algorithm or AI. Therefore, standalone algorithm performance is not relevant.
• Type of ground truth used: Not applicable for this type of device and evaluation.
• Sample size for training set: Not applicable for this type of device.
• How ground truth for training set was established: Not applicable.

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The Emboshield® Embolic Protection System is indicated for use as a guidewire and embolic protection system to contain and remove embolic material (thrombus/debris) while performing angioplasty and stenting procedures in carotid arteries. The diameter of the artery at the site of the Filtration Element placement should be between 2.5 and 7.0 mm.

The Emboshield NAV6 Embolic Protection System is a temporary percutaneous transluminal filtration system designed to capture embolic material released during angioplasty and stent procedures within carotid arteries. The system consists of the following components: Bare Wire, RX Delivery Catheter, Filtration Element, and RX Retrieval Catheter.

The provided text describes a 510(k) premarket notification for the Emboshield NAV6 Embolic Protection System. It outlines the device's intended use and design, and summarizes the substantial equivalence to a predicate device. However, it does not explicitly state acceptance criteria or provide a detailed study report proving the device meets specific performance criteria beyond general statements of safety and performance.

Thus, a direct answer to the request to populate the table with "acceptance criteria" and "reported device performance" is not possible from the provided text, as these specific metrics are not present. Similarly, details for most of the other questions are either not provided or only vaguely mentioned.

Here's an analysis of what can be extracted and what is missing:

1. Table of Acceptance Criteria and Reported Device Performance

Information Not Provided in the Text. The document states:

• "Results of testing have demonstrated that all materials are biocompatible, no new adverse effects were introduced and physical properties are appropriate for the intended use."
• "In vitro and in vivo testing was conducted."
• "The PROTECT Study was conducted enrolling a total of two hundred and twenty (220) patients at 34 sites."
• "In summary, the results of the testing and clinical study support the safety and performance of the Emboshield NAV6 device and its components for the intended indication when used in accordance with the Instructions for Use."

These are general conclusions, not specific quantitative acceptance criteria or reported performance metrics.

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

• Sample size for the test set: 220 patients (from the PROTECT Study).
• Data provenance: Not explicitly stated (e.g., country of origin, retrospective/prospective outside of "clinical study"), but given it's a 510(k) submission to the US FDA, it likely includes US data, potentially multi-national given "34 sites". The study was "conducted," implying prospective collection for the clinical study.

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

Information Not Provided in the Text.

4. Adjudication method for the test set

Information Not Provided in the Text.

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

The device is an Embolic Protection System (a physical medical device, not an AI or imaging diagnostic tool). Therefore, an MRMC comparative effectiveness study involving human readers (typically associated with AI/imaging for diagnosis/detection) is not applicable to this type of device. The "PROTECT Study" seems to be a clinical trial for the device's safety and performance in patients, not an AI efficacy study.

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.)

For the PROTECT Study (clinical trial): It can be inferred that outcomes data (related to safety and efficacy in removing embolic material during carotid procedures) would be the primary ground truth. Specific details on how "embolic material" removal or "protection" was quantified and verified are not provided.

8. The sample size for the training set

Not applicable. This is a physical medical device, not a machine learning algorithm that requires a "training set."

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

Not applicable. As above, no training set for a physical device.

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The Absolute® Pro .035 Biliary Self-Expanding Stent System is intended for palliation of malignant strictures in the biliary tree.

The Absolute® Pro .035 Biliary Self-Expanding Stent System includes a selfexpanding nickel titanium stent that is pre-mounted on an over-the-wire Delivery System. A total of 12 (6 at each end) radiopaque markers made of a radiopaque nickel titanium alloy are located at the ends of the stent. The Absolute Pro .035 Biliary Self-Expanding Stent System utilizes a 0.035" (0.89 mm) guide wire. The system includes radiopaque markers that identify the stent location.

The catheter comprises a retractable sheath that covers the stent during delivery. a radiopaque tip, an I-Beam to support the stent during deployment with an internal guide wire lumen, a detachable outer jacket, and a handle assembly with a safety lock and retraction features. With the handle in the unlocked position, rolling back the thumbwheel deploys the stent.

Here's an analysis of the provided text regarding the acceptance criteria and supporting study for the Absolute® Pro .035 Biliary Self-Expanding Stent System:

Summary of Acceptance Criteria and Device Performance for Absolute® Pro .035 Biliary Self-Expanding Stent System

This 510(k) submission (K072708) relies on demonstrating substantial equivalence to predicate devices rather than meeting specific quantifiable performance acceptance criteria for a novel AI device. The "device performance" reported is that the new device is equivalent to its predicates based on various tests.

Study Information (Based on the provided text):

The provided text describes a 510(k) submission for a medical device (a biliary stent system), not an AI/ML diagnostic or prognostic device. Therefore, many of the typical AI study parameters (sample sizes for test/training sets, experts for ground truth, MRMC studies, standalone performance) are not applicable to this type of submission.

Here's an attempt to address the points based on what's available and an understanding of traditional medical device submissions:

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

   • See the table above. The "acceptance criteria" are effectively the demonstration of substantial equivalence to the predicate devices based on intended use, technological characteristics, and performance data (primarily in vitro).

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

   • Not applicable in the AI sense. This submission is for a physical medical device. The "test set" would be the units of the device subjected to in vitro bench testing. The text does not specify the number of samples used for these bench tests.
   • Data Provenance: The data would be derived from internal laboratory testing conducted by Abbott Vascular. The country of origin for the data is implicitly the USA (Abbott Vascular, Santa Clara, CA). This is generally prospective testing of the manufactured device.

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 in the AI sense. For a physical device like a stent, "ground truth" is established through engineering specifications, material science standards, and established medical device testing methodologies. The "experts" would be the R&D engineers, metallurgists, and quality control professionals who design and test the device against these standards. Their qualifications are not specified but are presumed to be appropriate for medical device engineering and testing.

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

   • Not applicable in the AI sense. The "adjudication method" for traditional device testing involves adherence to predefined test protocols, acceptance limits, and quality control procedures. It's not a consensus-based review by experts of clinical cases.

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 physical device, not an AI diagnostic tool. MRMC studies are not relevant here.

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

   • Not applicable. This is a physical device.

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

   • For the in vitro performance data, the "ground truth" would be the engineering specifications and performance characteristics of the predicate devices, as well as relevant industry standards and design requirements for biliary stents (e.g., radial force, fatigue resistance, deployment accuracy, material biocompatibility, etc., though not detailed in this summary). The goal is to demonstrate that the new device meets or exceeds these established performance benchmarks found in the predicates.

8. The sample size for the training set:

   • Not applicable in the AI sense. There is no "training set" for a physical device in this context. The design and manufacturing process would involve extensive engineering studies and prototypes, but not a "training set" like that used for machine learning.

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

   • Not applicable in the AI sense. See point 8.

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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 Viatrac® 14 PLUS Peripheral Dilatation Catheter is indicated to dilate stenosis in the peripheral vasculature (iliac, femoral, ilio-femoral, popliteal, infra-popliteal, renal arteries, and carotid arties) and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae. This device is also indicated for post-dilatation of balloon-expandable and self-expanding stents in the peripheral vasculature.

The Viatrac 14 PLUS Pcripheral Dilatation Catheter has an integrated shaft system and a balloon near the distal tip. The shaft has a combination of single lumen and dual lumen tubing. One lumen is used for inflation of the balloon with contrast medium. The second lumen in the distal shaft permits the use of a guide wire to facilitate the advancement of the catheter to and through the stenosis to be dilated.

The balloon has radiopaque marker(s) to aid in positioning the balloon in the stenosis, and is designed to provide an expandable segment of known diameter and length at a specific pressure.

On the 135 cm catheter length, there are two proximal shaft markers (95 cm and 105 cm from the distal tip). On the 80 cm catheter length, there is a single proximal marker (55 cm from the distal tip). Both indicate the relative position of the catheter to the end of a brachial, femoral or renal guiding catheter. An additional marker is located at the guide wire exit notch and aids in locating the guide wire exit notch.

The design of this catheter does not incorporate a lumen for distal dye injections and distal pressure measurements.

This is a 510(k) premarket notification for a medical device (Viatrac® 14 PLUS Peripheral Dilatation Catheter), not an AI/ML powered device, therefore the request portions are not applicable.

The document describes a catheter used for dilatation in peripheral vasculature and for post-dilatation of stents. The substantial equivalence was demonstrated through in vitro bench tests and retrospective analyses of clinical studies comparing it to previously cleared predicate devices. The submission indicates no changes to technological characteristics, materials, biocompatibility, performance, sterilization, or packaging. The core of the submission is to align the device's indications for use more closely with clinical use.

Therefore, the information for acceptance criteria, study details, expert involvement, and ground truth establishment, which are common for AI/ML device evaluations, are not found in this document.

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