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The NES Reprocessed Visions PV .018 Digital IVUS Catheter is designed for use in the evaluation of vascular morphology in blood vessels of the coronary and peripheral vasculature by providing a cross-sectional image of such vessels. This device is not currently indicated for use in cerebral vessels.

The NES Reprocessed Visions PV .018 Digital IVUS Catheter is designed for use as an adjunct to conventional angiographic procedures to provide an image of the vessel lumen and wall structures.

The NES Reprocessed Visions PV .018 Digital IVUS Catheter utilizes a cylindrical ultrasound transducer array close to the distal tip to radiate acoustic energy into the surrounding tissue. By using the information gathered from the ultrasonic echoes, the device can generate real-time images of the coronary and peripheral vessels.

The NES Reprocessed Visions PV .018 Digital IVUS Catheter tracks over a 0.018" (0.46mm) guide wire by through an internal lumen. Approximately 31 cm from the catheter tip is a guidewire port for the exiting guidewire. The NES Reprocessed Visions PV .018 Digital IVUS Catheter is introduced into the vascular system percutaneously or via surgical cutdown.

The NES Reprocessed Visions PV .018 Digital IVUS Catheter may only be used with the Volcano s5 Series or CORE Series of Systems Operator's Manual. If connect to another system, the catheter will not operate.

The NES Reprocessed Visions PV .018 Digital IVUS Catheter is intended to be reprocessed one (1x) time.

The provided FDA 510(k) clearance letter and summary for K250592 describes a reprocessed medical device, the NES Reprocessed Visions PV .018 Digital IVUS Catheter. This document does not detail acceptance criteria or the study that proves the device meets AI/Machine Learning performance standards, as it is a traditional medical device (an Intravascular Ultrasound Catheter) and not an AI-enabled device.

Therefore, many of the requested categories regarding AI model performance, ground truth establishment, expert adjudication, MRMC studies, and training/test set sizes are not applicable to this submission.

However, I can extract the relevant information regarding the device's functional and safety testing as described in the 510(k) summary, which serves as the "study" proving the device meets its acceptance criteria for a reprocessed medical device.

Summary of Device Acceptance Criteria and Performance (for a Reprocessed Medical Device, not AI)

The NES Reprocessed Visions PV .018 Digital IVUS Catheter is a reprocessed version of a predicate device. The acceptance criteria and "study" proving the device meets these criteria focus on demonstrating that reprocessing does not compromise the device's safety and effectiveness compared to the original device. The "study" involves various bench and laboratory tests.

1. Table of Acceptance Criteria and Reported Device Performance

The 510(k) summary states that "The test methods, requirements and acceptance criteria used for the .018 IVUS are the same used in cleared K200195 (reprocessed .014 IVUS)." It also indicates that there are "no changes to the claims, clinical applications, patient populations, performance specifications, or method of operation." This implies that the acceptance criteria are met if the reprocessed device performs comparably to a new device (or the predicate reprocessed device K200195) across all specified tests.

Note: The document states that the "NES Reprocessed Visions PV .018 Digital IVUS Catheter is as safe and effective as the predicate devices described herein," which is the overarching conclusion of meeting all acceptance criteria.

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

• Sample Size: Not explicitly stated for each test, but standard for device validations. For a reprocessed device, this would typically involve a statistically significant number of reprocessed units across multiple reprocessing cycles.
• Data Provenance: The tests are described as "Bench and laboratory testing," implying controlled, experimental data generated specifically for this submission. There is no mention of patient data.

3. Number of Experts Used to Establish Ground Truth and Qualifications

• N/A: As this is a traditional medical device (not an AI/ML device), expert establishment of ground truth in the context of image interpretation or diagnostic accuracy is not relevant. The "ground truth" for the device's performance would be established by validated test methods and engineering specifications.

4. Adjudication Method for the Test Set

• N/A: Adjudication is typically relevant for subjective assessments (e.g., in AI or clinical studies). For bench and lab testing of a physical device, performance is measured against objective, predetermined specifications rather than requiring expert consensus or adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

• N/A: An MRMC study is relevant for evaluating the impact of AI on human reader performance. This device is an IVUS catheter and does not involve AI assistance for image interpretation.

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

• N/A: This question pertains to AI algorithm performance. This device is a physical catheter, not an algorithm.

7. The Type of Ground Truth Used

• Engineering Specifications and Performance Standards: The "ground truth" for this device's performance is compliance with established engineering specifications, safety standards (e.g., sterilization, biocompatibility), and functional performance benchmarks (e.g., image acuity, acoustic output) that are deemed equivalent to the original predicate device. This is determined through objective bench and laboratory testing.

8. The Sample Size for the Training Set

• N/A: No training set is applicable as this is not an AI/ML device.

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

• N/A: Not applicable.

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The Reprocessed Eagle Eye Platinum RX Digital IVUS Catheters are designed for use in the evaluation of vascular morphology in blood vessels of the coronary and peripheral vasculature by providing a cross-sectional image of such vessels. This device is not currently indicated for use in cerebral vessels. The Reprocessed Eagle Eye Platinum RX Digitial IVUS Catheters are designed for use as an adjunct to conventional angiographic procedures to provide an image of the vessel lumen and wall structures.

The Reprocessed Eagle Eye Platinum RX Digital IVUS Catheter incorporates a cylindrical ultrasound transducer array. The array radiates acoustic energy into the surrounding tissue and detects the subsequent echoes. The information from the echoes is used to generate real-time images of the coronary and peripheral vessels.

The Reprocessed Eagle Eye Platinum RX Digital IVUS Catheter utilizes an internal lumen that allows the catheter to track over the 0.014" (0.36 mm) guide wire. The guide wire exits from the guide wire lumen approximately 24 cm proximal to the catheter tip. The catheter is introduced percutaneously or via surgical cut down into the vascular system.

Three 1 mm-long radiopaque markers are incorporated on the internal lumen positioned 10 mm apart from distal edge to distal edge. starting 10 mm from the proximal edge of the portion of the scanner marker tube normally visible under fluoroscopy.

The Eagle Eye Platinum RX Digital IVUS Catheters are exclusive use with Volcano s5 Series and CORE Series of Systems. This catheter will not operate if connected to any other imaging system.

A hydrophilic coating is applied externally to a distal portion of the catheter.

This is a medical device submission, specifically a 510(k) premarket notification for a reprocessed intravascular ultrasound (IVUS) catheter. The document details the device, its intended use, and substantial equivalence to predicate devices. However, it does not contain detailed information about acceptance criteria for a study or the results of such a study proving the device meets those criteria in a way that allows for the extraction of the requested information regarding AI device performance, sample sizes, expert ground truth, adjudication methods, or MRMC studies.

The document focuses on demonstrating that the reprocessed device is substantially equivalent to legally marketed predicate devices, a requirement for 510(k) clearance. The testing mentioned in this document (biocompatibility, cleaning validation, sterilization validation, functional testing, etc.) are standard tests for reprocessed medical devices to ensure they are safe and effective after reprocessing, not necessarily a clinical study to evaluate diagnostic performance against a specific set of acceptance criteria for an AI algorithm.

Therefore, for most of your specific questions, the information is not available in the provided text.

Here's a breakdown of what can and cannot be answered based on the provided text:

Information Not Available in the Provided Text:

• A table of acceptance criteria and the reported device performance (in the context of an AI device or a diagnostic performance study): The document lists functional and safety testing for a reprocessed physical device, not an AI or diagnostic performance study with specific criteria like sensitivity, specificity, or AUC.
• Sample size used for the test set and the data provenance: Not applicable as no diagnostic performance study of an AI device is described.
• Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
• Adjudication method for the test set: Not applicable.
• 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 not an AI device submission.
• If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
• The type of ground truth used: Not applicable for a diagnostic performance study.
• The sample size for the training set: Not applicable.
• How the ground truth for the training set was established: Not applicable.

Information that can be partially inferred or is directly stated (though not in the context of an AI study):

• Device Name: Reprocessed Eagle Eye Platinum RX Digital IVUS Catheter
• Device Type: Intravascular Ultrasound (IVUS) Catheter (a physical medical device, not an AI algorithm)
• Purpose: Evaluation of vascular morphology in blood vessels of the coronary and peripheral vasculature by providing a cross-sectional image.
• Testing Conducted (Functional and Safety, not diagnostic performance):
  • Biocompatibility
  • Cleaning Validation
  • Sterilization Validation
  • Functional testing (Visual Inspection, Dimensional Verification, Simulated Use, Mechanical Characteristics, Hydrophilic Coating, System Compatibility)
  • Drying Validation
  • Packaging Validation
• Conclusion from the document: Innovative Health concludes that the Reprocessed Eagle Eye Platinum RX Digital IVUS Catheter is as safe and effective as the predicate devices described herein, based on the functional and safety testing for a reprocessed device.

In summary, this document is a 510(k) submission for a reprocessed medical device (an IVUS catheter) and does not describe the evaluation of an AI-powered diagnostic device or a study with "acceptance criteria" in the sense of diagnostic performance metrics for an algorithm.

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