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This catheter is intended for temporary intracardiac pacing and recording during electrophysiology studies, e.g., evaluation of arrhythmias or cardiac mapping.

Vanguard reprocessed diagnostic electrophysiology catheters are constructed of a hollow polymer shaft 6 French in diameter and 110 cm in length that terminates with a hand piece. Various configurations of distal platinum alloy electrodes are wired to a proximal connector at the end of the hand piece for bi-directional transmission of electrical signals (pacing and recording). The proximal connector is attached to an interconnecting cable that interfaces with various standard types of sensing, recording, stimulation, and pacing equipment. The distal tip segment of the catheter is capable of unidirectional steering through manipulation of the hand piece. This remote manipulation of the distal tip segment facilitates precise positioning of the electrode array. The catheters are available in a variety of electrode configurations that are selected by the clinician based on preference and/or indication. The shaft polymer is manufactured with additives (typically barium sulfate) that enhance the catheter's radiopacity to enable positioning under fluoroscopic guidance. No lumens of the catheters reprocessed by Vanguard are open to the patient bloodstream.

Here's an analysis of the provided text regarding the acceptance criteria and study for the Vanguard Reprocessed Diagnostic Electrophysiology Catheters:

The provided text (510(k) summary) describes a device undergoing FDA clearance, specifically a reprocessed medical device. For such devices, the primary focus of the regulatory submission is to demonstrate that the reprocessed device is substantially equivalent to its original, new counterpart (the predicate device). This often means demonstrating that the reprocessing does not negatively impact the device's original performance, safety, or effectiveness.

It is important to note that this document does not describe a study involving AI or machine learning. Therefore, many of the requested points related to AI-specific evaluation (multi-reader multi-case studies, standalone algorithm performance, AI specific ground truth, training data) are not applicable.

Here's the information extracted and interpreted based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

Explanation of Implied Criteria: For reprocessed devices, the acceptance criteria are generally to demonstrate equivalence to the predicate device in terms of safety, effectiveness, and functional performance after reprocessing. The specific quantitative criteria for each performance aspect (e.g., electrical impedance within a certain range, mechanical durability) are typically detailed in the underlying test reports, but only a summary statement is presented in the 510(k) summary.

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

The 510(k) summary does not specify the sample size for the performance and biocompatibility testing. It only states that "Cleaning, sterilization, and packaging validations, and performance and biocompatibility testing" were conducted.

• Data Provenance: The studies were internal company validations and testing. The document doesn't specify if clinical data (e.g., from human patients) was used, but implies lab-based performance and biocompatibility testing relevant to the device itself. Given it's a reprocessed medical device, the focus is typically on whether the reprocessing impacts the device's physical and functional properties, rather than new clinical trials with human subjects.

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

This concept is not directly applicable in the context of this 510(k) summary. The "ground truth" for demonstrating substantial equivalence of a reprocessed device typically relies on validated laboratory testing methods and engineering analyses compared against the specifications of the original device, rather than expert consensus on diagnostic interpretations. The "experts" involved would be engineers, microbiologists, and other technical professionals specializing in sterilization, material science, and device performance testing. Their qualifications are not listed.

4. Adjudication Method for the Test Set

Not applicable. This is not a study requiring human adjudication of diagnostic findings. Adjudication would not be a relevant concept for the performance testing of a reprocessed medical device's physical and functional characteristics.

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 device is not an AI-powered diagnostic tool, but rather a reprocessed diagnostic electrophysiology catheter. The concept of human readers improving with AI assistance is not relevant here.

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 device is a physical medical instrument, not an algorithm.

7. The Type of Ground Truth Used

The "ground truth" implicitly used is the original design specifications and performance characteristics of the predicate device (EP Technologies EPT-Dx™). The reprocessed device must demonstrate that its performance (e.g., electrical properties, mechanical integrity, biocompatibility, sterility) meets these original specifications after reprocessing. The types of ground truth involved would be:

• Instrumental measurements: For performance characteristics like electrical conductivity, mechanical strength, dimensional accuracy.
• Chemical analysis: For material composition and degradation.
• Microbiological testing: For sterility and endotoxin levels.
• Biocompatibility testing: According to ISO standards.

8. The Sample Size for the Training Set

Not applicable. There is no AI algorithm being "trained" for this device.

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

Not applicable.

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This catheter is intended for temporary intracardiac pacing and recording during electrophysiology studies, e.g. evaluation of arrhythmias or cardiac mapping.

Vanguard reprocessed diagnostic electrophysiology catheters are constructed of a hollow polymer shaft 6 - 8 French in diameter and 110 cm in length that terminates with a hand piece. Various configurations of distal platinum alloy electrodes are wired to a proximal connector at the end of the hand piece for bi-directional transmission of electrical signals (pacing and recording). The proximal connector is attached to an interconnecting cable that interfaces with various standard types of sensing, recording, stimulation, and pacing equipment. The catheters are available with various steerable distal curves for remote manipulation of the distal tip segment to facilitate precise positioning of the electrode array. The catheters are also available in a variety of electrode configurations that are selected by the clinician based on preference and/or indication. The shaft polymer is manufactured with additives (typically barium sulfate) that enhance the catheter's radiopacity to enable positioning under fluoroscopic guidance. No lumens of the catheters reprocessed by Vanguard are open to the patient bloodstream. In clinical use, diagnostic electrophysiology catheters are placed under fluoroscopy within the heart, near major structures of the conduction system. The effects of pacing on the conduction system and time intervals between waveforms are recorded, measured, and compared to baseline and normal values. The electrocardiogram normally has atrial, His, and ventricular components in order to obtain accurate interval measurements which are used to establish the baseline and current status of the conduction system.

This document is a 510(k) Summary of Safety & Effectiveness for Vanguard Reprocessed Diagnostic Electrophysiology Catheters. It describes the device, its indications for use, and a conclusion of substantial equivalence to predicate devices. However, it does not contain the detailed information requested regarding acceptance criteria and a study proving the device meets those criteria from an AI/ML perspective.

Specifically, the provided text is for a medical device (reprocessed catheters) and not an AI/ML powered device. Therefore, many of the requested categories (like sample sizes for test/training sets, number of experts for ground truth, adjudication methods, MRMC studies, standalone performance, etc.) are not applicable to this document.

The "Test Data" section only generally states: "Cleaning, sterilization, and packaging validations, and performance and biocompatibility testing demonstrate that the reprocessed devices perform as intended and are safe and effective." It does not provide any specific acceptance criteria or study details.

Since the input document is for a non-AI/ML device, I cannot fill out the requested information.

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This catheter is intended for temporary intracardiac pacing and recording during electrophysiology studies, e.g. evaluation of arrhythmias or cardiac mapping. In addition, the preformed shape of the Halo XP catheter's tip section is designed particularly for the tricuspid annulus.

The Cordis Webster deflectable 720 electrode catheter has been designed for electrophysiological mapping of the tricuspid annulus. The catheter has a high-torque shaft with a halo-shaped tip section containing ten pairs of platinum electrodes that can easily be seen under fluoroscopy. The tip section also contains a radiopaque marker in the center of the electrode array. The tip section of the catheter has a halo-shaped preformed loop which can be positioned around the atrial aspect of the tricuspid annulus.

A piston in the handpiece is attached to an internal puller which changes the radius of curvature. When the piston is pushed forward, the radius of curvature of the preformed loop is reduced: when the thumbknob is pulled back, the radius of curvature is increased until the tip section returns to the preformed shape. The high-torque shaft allows the plane of the loop to be maneuvered in order to facilitate accurate positioning.

The Cordis Webster deflectable T20 electrode catheter facilitates simultaneously local electrograms spanning the tricuspid annulus, from midseptal to anterior to lateral to posterolateral. Recordings of the entire annulus can be obtained without repositioning the catheter tip.

The provided 510(k) summary for the T20 Diagnostic Deflectable Tip Catheter does not contain information about specific acceptance criteria or a study designed to prove the device meets those criteria in the way typically expected for an AI/ML or imaging device.

Instead, the submission focuses on demonstrating substantial equivalence to a predicate device through non-clinical performance testing. The "acceptance criteria" here are implicitly linked to showing that the new device performs "as well as" the predicate device and that any differences are not statistically significant in a way that would affect safety and effectiveness.

Here's an attempt to structure the information based on the provided text, while noting the absence of details typically found in AI/ML performance studies:

1. Table of Acceptance Criteria and Reported Device Performance

Note: The submission states that tests were performed according to FDA's "Electrode Recording Catheter Preliminary Guidance." This guidance would outline the specific tests and expected results (acceptance criteria) for such devices, but the specific numerical criteria and detailed results are not included in this summary.

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

• Sample Size: Not explicitly stated. The document mentions "nonclinical performance testing" which typically involves a set number of devices tested under laboratory conditions.
• Data Provenance: Non-clinical (bench testing/laboratory testing). No patient data is mentioned as this is a non-clinical submission for substantial equivalence.

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

• Number of Experts: Not applicable. This was non-clinical testing; "ground truth" in the context of clinical endpoints or diagnostic accuracy is not relevant here. The "truth" is based on the physical and electrical measurements of the device compared to the predicate.
• Qualifications of Experts: Not applicable. Testing was likely performed by engineers/technicians in a laboratory setting.

4. Adjudication Method for the Test Set

• Adjudication Method: Not applicable. No human interpretation of results requiring adjudication is described. Measurements would be objective and compared against pre-defined engineering specifications or predicate performance.

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

• MRMC Study Done? No. This type of study is typically for evaluating diagnostic accuracy with human readers, often relevant for AI/ML devices. This submission pertains to an electrophysiological catheter for mapping, not a diagnostic imaging or AI system that interprets data for human readers.

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

• Standalone Study Done? Not applicable in the context of an AI/ML algorithm. The performance testing was on the device's physical and electrical characteristics as manufactured.

7. Type of Ground Truth Used

• Type of Ground Truth: "Ground truth" here refers to established engineering specifications and the measured performance of the predicate device. The performance of the T20 catheter was compared directly to these objective benchmarks and the predicate's performance.

8. Sample Size for the Training Set

• Sample Size: Not applicable. This is not an AI/ML device that requires a training set.

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

• How Ground Truth Established: Not applicable. No training set for an AI/ML model.

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This catheter is intended for temporary intracardiac pacing and recording during electrophysiology studies, e.g. evaluation of arrhythmias or cardiac mapping.

Vanguard reprocessed Livewire diagnostic electrophysiology catheters are constructed of a hollow polymer shaft 5 - 7 French in diameter and 95 to 115 cm in length that terminates with a hand piece. Various configurations of distal platinum alloy electrodes are wired to a proximal connector for bi-directional transmission of electrical signals (pacing and recording). The hand piece is attached to an interconnecting cable that interfaces with various standard types of sensing, recording, stimulation and pacing equipment. The catheters are available with various steerable distal curves for remote manipulation of the distal tip segment that facilitates precise positioning of the electrode array. The catheters are also available in a variety of electrode configurations that are selected by the clinician based on preference and/or indication.

The shaft polymer is manufactured with additives (barium sulfate) that enhance the catheter's radiopacity to enable positioning under fluoroscopic guidance. No lumens of the catheters reprocessed by Vanguard are open to the patient bloodstream.

Vanguard collects previously used diagnostic EP catheters from healthcare facilities, and cleans, inspects, tests, applies a unique serial number, packages, labels, and sterilizes each device for return to a healthcare facility for an additional clinical use.

The provided text describes the 510(k) summary for Vanguard Reprocessed Diagnostic Electrophysiology (EP) Catheters. However, it does not contain details about acceptance criteria, specific device performance metrics (beyond "perform as intended"), or a study design with ground truth, sample sizes, or expert adjudication as typically seen in AI/ML device submissions.

The summary focuses on establishing substantial equivalence to a predicate device through:

• Identical technological characteristics: The reprocessed catheters are stated to be "essentially identical" to the Original Equipment Manufacturer (OEM) devices, with "no changes made to the device materials or specifications."
• Performance and biocompatibility testing: This is a general statement.

Given this, I will describe what is available in the text.

Acceptance Criteria and Device Performance

Study Details (as inferred from the provided text):

The submission does not detail a study in the context of an AI/ML device submission, but rather a validation of a reprocessed medical device.

1. Sample size used for the test set and the data provenance: The document mentions "performance and biocompatibility testing" and "cleaning, sterilization, and packaging validations" but does not specify sample sizes for these tests. The provenance of the data is not mentioned, but it would typically be from laboratory testing and validation rather than clinical or retrospective patient data in this context.
2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: This is not applicable. Ground truth as typically understood for AI/ML models is not directly established in this context. The "truth" would be determined by whether the reprocessed device meets established engineering and clinical performance specifications.
3. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable.
4. 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 reprocessed medical device, not an AI/ML diagnostic or assistive device.
5. If a standalone (i.e., algorithm only without human-in-the loop performance) was done: Not applicable. This is a physical medical device.
6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): The "ground truth" for this medical device's performance would be against engineering specifications, biocompatibility standards, and the performance characteristics of the original predicate device as verified through laboratory testing.
7. The sample size for the training set: Not applicable. This is a reprocessed medical device, not an AI/ML model that requires a training set.
8. How the ground truth for the training set was established: Not applicable.

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This catheter is intended for temporary intracardiac pacing and recording during electrophysiology studies, e.g. evaluation of arrhythmias or cardiac mapping.

Reprocessed diagnostic electrophysiology catheters are constructed of a hollow polymer shaft approximately 65 to 125 cm in length that terminates with a hand piece or connector. A range of diameters is available; the most clinically utilized sizes are 4 – 7 French. Various configurations of distal platinum alloy electrodes are wired to a proximal connector for bi-directional transmission of electrical signals (pacing and recording). The connector is attached to an interconnecting cable that interfaces with various standard types of sensing, recording, stimulation and pacing equipment. The catheters are available with various distal curves, either fixed or steerable for remote manipulation of the distal tip segment that facilitates precise positioning of the electrode array.

The catheters are also available in a variety of electrode configurations, connector compatibility and torque-transmitting properties that are selected by the clinician based on preference and/or indication. The shaft polymer is manufactured with additives (typically barium sulfate) that enhance the catheter's radiopacity to enable positioning under fluoroscopic guidance. No lumens of catheters reprocessed by Vanguard are open to the patient bloodstream.

Vanguard collects previously used diagnostic EP catheters from healthcare facilities; cleans, inspects, tests, applies a unique serial number, packages, labels, and sterilizes each device for return to the healthcare facility for an additional clinical use.

This document describes a 510(k) submission for reprocessed diagnostic electrophysiology (EP) catheters. It concerns the substantial equivalence of reprocessed devices to their original equipment manufacturer (OEM) counterparts. The validation studies focused on demonstrating that the reprocessed devices perform as intended and are safe and effective, upholding the original technological characteristics and intended use.

Here's a breakdown of the requested information based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of quantitative acceptance criteria with corresponding performance metrics in a typical AI/software device context. Instead, it states that the reprocessed devices were validated to perform as intended and are safe and effective. The acceptance criteria are implicitly linked to maintaining the original device's safety, effectiveness, and technological characteristics after reprocessing.

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

The document does not specify a distinct "test set" in the context of an AI/software evaluation. The validation described is for reprocessed physical medical devices (catheters). The "sample size" would refer to the number of reprocessed catheters subjected to cleaning, sterilization, packaging, performance, and biocompatibility testing. This specific number is not provided in the document.

Data provenance (e.g., country of origin, retrospective/prospective) is also not specified for the testing. The catheters are collected from "healthcare facilities" without further geographic detail. The nature of the testing is typically prospective (i.e., newly reprocessed devices are tested under controlled conditions).

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

This information is not applicable to this type of device and submission. "Ground truth" established by experts is typically relevant for interpretative tasks (e.g., image analysis, diagnosis) in AI/software evaluations. For reprocessed physical devices, "ground truth" relates to objective physical, chemical, and biological measurements and material integrity, not expert interpretation of outputs.

4. Adjudication Method for the Test Set

This information is not applicable to this type of device and submission. Adjudication methods (like 2+1, 3+1) are used to resolve discrepancies in expert interpretations, which is not the nature of validation for a physical reprocessed medical device.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study assesses human performance with and without AI assistance and is irrelevant for the validation of a reprocessed physical catheter.

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

No, a standalone (algorithm only) performance study was not done. This concept applies to AI algorithms, not reprocessed physical medical devices.

7. The Type of Ground Truth Used

For this device, the "ground truth" is established through:

• Objective Measurements: Directly measuring physical properties (e.g., dimensions, flexibility, electrical conductivity, torque), chemical integrity, and sterility of the reprocessed devices.
• Biological Testing: Biocompatibility tests to ensure safety when in contact with biological systems.
• Performance Specifications: Comparison against the known specifications and performance of the OEM, predicate device.

It is not based on expert consensus, pathology, or outcomes data in the way these terms are typically used for diagnostic AI systems.

8. The Sample Size for the Training Set

This information is not applicable. This submission concerns a physical medical device, not an AI algorithm utilizing a training set.

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

This information is not applicable. There is no "training set" for this type of device.

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This catheter is intended for temporary intracardiac pacing and recording during electrophysiology studies, e.g. evaluation of arrhythmias or cardiac mapping.

Reprocessed diagnostic electrophysiology catheters are constructed of a hollow polymer shaft approximately 92 to 125 cm in length that terminates with a hand piece or connector. A range of diameters is available; the most clinically utilized sizes are 5 – 7 French. Various configurations of distal platinum alloy electrodes are wired to a proximal connector for bi-directional transmission of electrical signals (pacing and recording). The connector is attached to an interconnecting cable that interfaces with various standard types of sensing, recording, stimulation and pacing equipment. The catheters are available with various distal curves, either fixed or steerable for remote manipulation of the distal tip segment that facilitates precise positioning of the electrode array.

The catheters are also available in a variety of electrode configurations, connector compatibility and torque-transmitting properties that are selected by the clinician based on preference and/or indication. The shaft polymer is manufactured with additives (typically barium sulfate) that enhance the catheter's radiopacity to enable positioning under fluoroscopic guidance. No lumens of catheters reprocessed by Vanguard are open to the patient bloodstream.

Vanguard collects previously used diagnostic EP catheters from healthcare facilities; cleans, inspects, tests, applies a unique serial number, packages, labels and sterilizes each device for return to the healthcare facility for an additional clinical use.

This document is a 510(k) summary for the Vanguard Reprocessed Diagnostic Electrophysiology (EP) Catheters. It describes the device, its intended use, and claims substantial equivalence to predicate devices based on validation testing.

Here's an analysis of the acceptance criteria and study information:

Key Takeaway: This document does NOT describe the acceptance criteria and the study that proves the device meets them in the context of an AI/ML medical device. Instead, it details the regulatory submission for a reprocessed medical device (electrophysiology catheters), focusing on demonstrating that the reprocessed devices maintain the same safety and effectiveness as new devices.

Therefore, I cannot extract the requested information regarding AI/ML device performance, ground truth, expert adjudication, or MRMC studies from this document. The questions are designed for AI/ML device submissions, which this is not.

However, I can extract information relevant to the type of validation performed for this reprocessed device:

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

This document does not specify quantitative acceptance criteria in the format of an AI/ML performance table (e.g., sensitivity, specificity thresholds). Instead, the "acceptance criteria" are implicitly that the reprocessed device performs identically to the original equipment manufacturer (OEM) device and is safe and effective.

The reported "device performance" is:

The following numbered points cannot be answered from the provided text as they pertain to AI/ML device studies, which this document is not about.

2. Sample size used for the test set and the data provenance: Not applicable. This is for a reprocessed physical device, not an AI/ML algorithm.
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 an AI/ML model is not relevant here. Device validation involves physical and biological testing.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable.
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 not an AI/ML device.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an AI/ML device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable in the AI/ML context. For this device, "ground truth" would be established via physical, chemical, and biological tests to confirm the device's functionality, cleanliness, sterility, and material integrity compared to the new device specifications and regulatory standards.
8. The sample size for the training set: Not applicable. This is not an AI/ML device.
9. How the ground truth for the training set was established: Not applicable. This is not an AI/ML device.

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This catheter is intended for temporary intracardiac pacing and recording during electrophysiology studies, e.g. evaluation of arrhythmias or cardiac mapping.

Explorer 360™ diagnostic electrophysiology catheters are constructed of a 6 French hollow polymer shaft 100 cm in length. The quadripolar catheters are available with various fixed distal curves and electrode spacing configurations. The polymer shaft is manufactured with additives (typically barium sulfate) that enhance its radiopacity during fluoroscopic positioning of the catheter. The platinum alloy electrodes are sealed to the distal catheter and internally wired to a proximal shielded Nexus connector for bi-directional transmission of electrical signals (pacing and recording). The connector is designed to be attached to a compatible instrument cable that interfaces with various standard types of sensing, recording, stimulation, and pacing equipment.

Vanguard receives previously used diagnostic EP catheters from healthcare facilities; cleans, inspects, tests, refurbishes, applies a unique serial number, repackages, and sterilizes the devices; and returns them to the healthcare facility.

This document is a 510(k) summary for the Vanguard Reprocessed Diagnostic Electrophysiology Catheters. It details the reprocessing of single-use devices, specifically EP Technologies™ Explorer 360™ Diagnostic Electrophysiology Catheters. The core of the submission is to demonstrate that the reprocessed devices are substantially equivalent to the original, legally marketed predicate devices.

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

The document broadly discusses "functional/performance and biocompatibility testing" demonstrating that the reprocessed devices "perform as intended and are safe and effective." However, specific numerical acceptance criteria (e.g., minimum tensile strength, maximum electrical resistance, etc.) and their corresponding reported device performance values are not provided in this 510(k) summary. It states that "No changes are made to the currently marketed device's specifications and they possess the same technological characteristics." This implies that the acceptance criteria are essentially those of the original device.

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

The document mentions "cleaning, sterilization, and packaging validations; and functional/performance and biocompatibility testing." However, it does not specify the sample sizes used for these tests. The data provenance (e.g., country of origin, retrospective or prospective) is also not mentioned.

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

This document is for a medical device (catheter) and focuses on its functional and safety aspects after reprocessing, not on diagnostic accuracy based on expert interpretation like an AI imaging device. Therefore, the concept of "experts used to establish ground truth for the test set" is not applicable in the same way. The evaluation would have been performed by engineers and scientists with expertise in medical device testing, manufacturing, microbiology, and biocompatibility.

4. Adjudication method for the test set:

Not applicable, as this is not a study involving human reader interpretation or diagnostic consensus.

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 submission, not an AI or imaging diagnostic study.

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

Not applicable. This is a medical device submission, not an AI or algorithm-only study. The "standalone" performance here refers to the device itself performing its intended function.

7. The type of ground truth used:

For medical device performance testing, the "ground truth" is typically established through:

• Engineering specifications and standards: The original device's established performance parameters serve as the benchmark.
• Bench testing: Direct measurements of physical, mechanical, and electrical properties.
• Biocompatibility testing: Standardized assays (e.g., cytotoxicity, sensitization, irritation) to ensure no adverse biological reactions.
• Sterilization validation: Ensuring the device meets sterility assurance levels.
• Cleaning validation: Ensuring all biological and chemical contaminants are removed to acceptable levels.

8. The sample size for the training set:

Not applicable. This is a medical device (catheter) submission. There is no AI model being trained, so no "training set" in the context of machine learning.

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

Not applicable, as there is no training set for an AI model.

Ask a specific question about this device

This catheter is intended for temporary intracardiac pacing and recording during electrophysiology studies, e.g. evaluation of arrhythmias or cardiac mapping.

Diagnostic electrophysiology catheters are constructed of a hollow polymer shaft approximately 92 to 125 cm in length that terminates with a hand piece or connector. A range of diameters is available; the most clinically utilized sizes are the 5 – 7 French. Various configurations of distal platinum alloy electrodes are wired to a proximal connector for bi-directional transmission of electrical signals (pacing and recording). The connector is attached to an interconnecting cable that interfaces with various standard types of sensing, recording, stimulation and pacing equipment. The catheters are available with various distal curves, either fixed or deflectable. This allows for remote manipulation of the distal tip segment that facilitates precise positioning of the electrode array.

In addition to a range of diameters, the catheters are also available in a variety of electrode configurations, connector compatibility and torque-transmitting properties that are selected by the clinician based on preference and/or indication. The shaft polymer is manufactured with additives (typically barium sulfate) that enhance the catheter's radiopacity to enable positioning under fluoroscopic guidance. No lumens of the catheters reprocessed by Vanguard are open to the patient bloodstream.

Vanguard receives previously used diagnostic EP catheters from healthcare facilities; cleans, inspects, tests, refurbishes, repackages and sterilizes the devices; and returns them to the healthcare facility.

This document is a 510(k) summary for Vanguard Reprocessed Diagnostic Electrophysiology (EP) Catheters. The company, Vanguard Medical Concepts, Inc., is seeking to market reprocessed versions of these catheters. The summary states that they are substantially equivalent to currently marketed OEM devices.

Here's an analysis of the provided information regarding acceptance criteria and the supporting study:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of acceptance criteria with specific numerical targets. Instead, it broadly states that the reprocessed devices are substantially equivalent to the original equipment manufacturer (OEM) devices and perform as intended. The acceptance criteria are implicitly tied to the performance specifications of new, legally marketed diagnostic EP catheters.

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

The document does not specify the exact sample size used for the test set in terms of the number of reprocessed catheters or tests performed. It states "functional/performance and biocompatibility testing," but no numbers are provided.

Regarding data provenance:

• The devices are "previously used diagnostic EP catheters from healthcare facilities," so the source of the reprocessed devices is retrospective in terms of their initial use.
• The testing itself is presumably prospective in nature, conducted by Vanguard Medical Concepts after reprocessing.
• The country of origin for the data is not explicitly stated, but given the submission to the U.S. FDA, it is highly likely to be U.S.-based or at least conducted to U.S. standards.

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

This type of information (experts establishing ground truth) is typically relevant for studies involving subjective assessments or interpretation (e.g., image analysis, clinical diagnosis). For device performance testing of a physical medical device like an EP catheter, "ground truth" is typically established by objective measurement against engineering specifications or established standards.

The document does not mention the use of experts to establish a "ground truth" in the way one might for a diagnostic AI algorithm. Device performance is evaluated against predefined functional and safety parameters, which are usually determined by engineering standards and regulatory requirements for predicate devices.

4. Adjudication Method for the Test Set

Not applicable in the context of this device's performance testing as described. Adjudication methods (like 2+1, 3+1) are used for resolving disagreements among multiple human readers/experts in subjective assessment tasks. Performance testing of a physical device against objective criteria usually involves direct measurement and comparison, not expert adjudication in this sense.

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 submission for a reprocessed medical device, not an AI-powered diagnostic tool. Therefore, no MRMC study or AI assistance evaluation was performed or is relevant to this document.

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

Not applicable. This is not an algorithm or AI device.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

The "ground truth" for the reprocessed diagnostic EP catheters is implicitly the original design specifications and performance characteristics of the new, legally marketed OEM predicate devices. The testing aims to demonstrate that the reprocessed devices meet these same established performance and safety benchmarks.

• For functional/performance testing: The ground truth would be the expected electrical, mechanical, and physical parameters of a new catheter.
• For biocompatibility testing: The ground truth would be the established biocompatibility profiles for the materials used in such catheters, ensuring no new risks are introduced by reprocessing.
• For cleaning/sterilization: The ground truth would be established microbiological efficacy standards to ensure complete removal of contaminants and pathogens.

8. The Sample Size for the Training Set

Not applicable. This is not an AI/machine learning device, so there is no concept of a "training set."

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

Not applicable. As there is no training set, there is no ground truth established for it.

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This catheter is intended for temporary intracardiac pacing and recording during electrophysiology studies, e.g. evaluation of arrhythmias or cardiac mapping.

Diagnostic electrophysiology catheters are constructed of a hollow polymer shaft approximately 92 to 125 cm in length that terminates with a hand piece or connector. A range of diameters is available; the most clinically utilized sizes are the 5 - 7 French. Various configurations of distal platinum alloy electrodes are wired to a proximal connector for bi-directional transmission of electrical signals (pacing and recording). The connector is attached to an interconnecting cable that interfaces with various standard types of sensing, recording, stimulation and pacing equipment. The catheters are available with various distal curves, either fixed or deflectable. This allows for remote manipulation of the distal tip segment that facilitates precise positioning of the electrode array.

In addition to a range of diameters, the catheters are also available in a variety of electrode configurations, connector compatibility and torque-transmitting properties that are selected by the clinician based on preference and/or indication. The shaft polymer is manufactured with additives (typically barium sulfate) that enhance the catheter's radiopacity to enable positioning under fluoroscopic guidance. No lumens of the catheters reprocessed by Vanguard are open to the patient bloodstream.

Vanguard receives previously used diagnostic EP catheters from healthcare facilities; cleans, inspects, tests, refurbishes, repackages and sterilizes the devices; and returns them to the healthcare facility.

The provided document is a 510(k) summary for Vanguard Reprocessed Diagnostic Electrophysiology Catheters. It outlines the safety and effectiveness of reprocessed medical devices compared to their original equipment manufacturer (OEM) counterparts. However, it does not describe acceptance criteria or a study that proves a device meets those criteria in the context of AI/ML performance metrics (e.g., sensitivity, specificity, AUC).

Instead, this document focuses on demonstrating substantial equivalence for reprocessed medical devices, which follows a different set of validation requirements. The "acceptance criteria" and "study" described in the document relate to the validation of the reprocessing procedure itself, ensuring the reprocessed devices perform as intended and are safe for use, similar to new devices.

Therefore, many of the requested items (e.g., sample size for test/training set, number of experts, adjudication method for ground truth, MRMC study, standalone performance) are not applicable or cannot be extracted from this type of regulatory submission.

Here's an analysis of the information that can be extracted or inferred from the provided text, framed within the context of reprocessed medical device validation:

Acceptance Criteria and Study for Vanguard Reprocessed Diagnostic Electrophysiology Catheters

The document describes the validation of reprocessed single-use diagnostic electrophysiology catheters. The core "acceptance criterion" is demonstrations of substantial equivalence to legally marketed predicate devices, meaning the reprocessed devices are safe and effective for their intended use. The "study" involves various tests to confirm that the reprocessed devices maintain the performance and safety characteristics of the original devices.

1. Table of Acceptance Criteria and Reported Device Performance:

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

• Sample Size: Not explicitly stated for each specific test (e.g., how many catheters were tested for biocompatibility, or functional performance). The document refers to "various models" (21 models listed on Page 3) of catheters being reprocessed and validated.
• Data Provenance: The devices are "previously used diagnostic EP catheters from healthcare facilities" (Page 5). This would imply retrospective data (i.e., used devices collected after patient use). The country of origin of the hospitals/facilities is not specified, but the submission is to the U.S. FDA.

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

• This concept of "experts establishing ground truth" is not directly applicable in the AI/ML sense to this document. The "ground truth" for reprocessed devices is, by definition, the performance and safety of the original new device. The validation tests (functional, biocompatibility, sterility) are designed to confirm that the reprocessed device meets these established standards, which are based on engineering specifications and regulatory requirements, rather than expert consensus on a diagnostic outcome.

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

• Not applicable. This is typically used in reader studies for AI/ML validation. Validation of reprocessed medical devices relies on objective, measurable physical and chemical 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 document is not evaluating AI. It is assessing the substantial equivalence of reprocessed physical medical devices.

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

• Not applicable. This document is not about an algorithm.

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

• The inherent "ground truth" or benchmark for these reprocessed devices is the performance and safety specifications of the original, new OEM devices. Validation tests (functional, mechanical, material, chemical, biological) are conducted to demonstrate that the reprocessed devices conform to these established benchmarks.

8. The sample size for the training set:

• Not applicable in the AI/ML sense. There is no training set for an algorithm here.

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

• Not applicable.

Summary of what the document does provide:

The document describes a regulatory submission (510(k)) to the FDA for reprocessed electrophysiology catheters. The validation provided ("supplemental validation data") aims to demonstrate that these reprocessed devices are substantially equivalent to legally marketed predicate (new) devices. This is achieved through various tests for:

• Cleaning effectiveness
• Sterilization effectiveness
• Packaging integrity
• Biocompatibility
• Functional and performance characteristics (ensuring they operate like the original devices and meet specifications).

The core finding is that the "Vanguard Reprocessed Diagnostic EP Catheters... are substantially equivalent to the predicate devices under the Federal Food, Drug and Cosmetic Act" (Page 6), based on the validation data.

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