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The ViewFlex Xtra ICE Catheter is indicated for use in adult and adolescent pediatric patients to visualize cardiac structures, blood flow and other devices within the heart.

The ViewFlex Xtra ICE Catheter is inserted into the heart via intravascular access. The ViewFlex Xtra is a sterile, single use, temporary, intracardiac ultrasound catheter indicated for use in adult and adolescent pediatric patients. The ViewFlex catheter shaft is a 9 French catheter constructed with radiopaque tubing with a useable length of 90 cm. The shaft is compatible with a 10 French or larger introducer for insertion into the femoral or jugular veins. The catheter tip is a 64-element linear phased array transducer housed in silicone. The distal portion of the shaft is deflectable in four directions allowing for left-to-right and anterior-to-posterior deflection. The handle of the device has two deflection mechanisms that correspond with the movement of the distal shaft in the four planes of movement. The ViewFlex Xtra is compatible with ViewMate II, ViewMate Z and Philips CX50 ultrasound consoles.

The provided document is a 510(k) summary for the ViewFlex Xtra ICE Catheter, seeking to expand its indications for use. It primarily focuses on demonstrating substantial equivalence to predicate devices and does not contain detailed information about acceptance criteria or specific study results with numerical performance metrics for the device itself.

Based on the provided text, a comprehensive answer to your request cannot be fully generated as the document does not include the detailed information you're looking for regarding acceptance criteria, device performance, sample sizes, expert ground truth establishment, adjudication methods, or MRMC studies.

However, I can extract the relevant information and state what is not present:

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

• Acceptance Criteria: Not explicitly stated in the document. The submission is for an expanded indication for use, relying on substantial equivalence to a previously cleared device.
• Reported Device Performance: Not explicitly stated with numerical metrics. The document mentions "image quality testing and data for the cleared ViewFlex Xtra ICE catheter (K121381)" were referenced to demonstrate the ability to image devices, but no performance metrics (e.g., sensitivity, specificity, resolution) are provided.

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 for Test Set: Not mentioned.
• Data Provenance: Not mentioned.

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 mentioned.

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

• Not mentioned.

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

• MRMC Study: Not mentioned. The device is a diagnostic ultrasound catheter, not an AI or image analysis algorithm that assists human readers.
• Effect Size of AI Improvement: Not applicable, as this is not an AI-assisted device.

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

• Standalone Performance: Not applicable, as this is a medical device for direct visualization, not an algorithm.

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

• Not mentioned directly. The document states that "images collected during the use of the predicates for visualizing other devices within the heart" were used, implying the ground truth was visual confirmation by users of the predicate devices.

8. The sample size for the training set

• Not applicable, as this is a medical device for direct visualization, not a machine learning model.

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

• Not applicable.

Overall Summary:

The 510(k) submission for the ViewFlex Xtra ICE Catheter primarily focuses on demonstrating substantial equivalence to predicate devices for an expanded indication of use (visualizing other devices within the heart). It states that the design, technological characteristics, and materials are identical to the previously cleared ViewFlex Xtra ICE Catheter (K121381). To support the expanded indication, it refers to "image quality testing and data for the cleared ViewFlex Xtra ICE catheter (K121381) and images collected during the use of the predicates for visualizing other devices within the heart."

The document explicitly states: "There have been no device changes and no changes to the visualization location. This submission is to expand the current indications for use to include visualizing other devices within the heart." This implies that the previous clearance (K121381) would have contained the detailed performance data, which is not included in this summary. The current submission's "proof" is the established equivalence and the prior clearance, not new, detailed performance studies.

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The Inquiry™ H-Curve TV Steerable Diagnostic Catheter is a steerable electrophysiology catheter used for recording intracardiac signals and cardiac stimulation during diagnostic electrophysiological studies. The H-Curve TV catheters are to be used to map the atrial regions of the heart.

The Inquiry™ H-Curve TV Steerable Diagnostic Catheter is a flexible, radiopaque catheter with a variable number of electrodes with the first electrode located at the distal tip and the other band electrodes following at predetermined distances. A connecting cable is used to connect the catheter to electrogram devices. The catheter has a distal loop which is parallel to catheter body. The loop allows the electrophysiologist to record the potentials of cardiac structures without changing the position of the catheter. The catheter shaft and/or loop is steerable by manipulating the handle. The placement of the electrodes around the entire circumference of the distal loop also assists the electrophysiologist during fluoroscopy with visualization. The distal loop shape is easily straightened with the thumb and forefinger to facilitate insertion into sheaths and introducers. Once the catheter is extended beyond the sheath, the catheter resumes its pre-formed shape. The device is supplied sterile and is intended for single use only.

The provided document K082061 does not describe the acceptance criteria, the study that proves the device meets the acceptance criteria, or any related details such as sample size for test/training sets, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth establishment.

This document is a 510(k) summary for a medical device (Inquiry™ H-Curve TV Steerable Diagnostic Catheter) and primarily focuses on establishing substantial equivalence to a predicate device. It briefly mentions nonclinical tests but does not provide details on their methodology, results, or how they relate to specific acceptance criteria.

Therefore, I cannot provide the requested information based on the input text.

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The Inquiry Optima Catheter is a steerable electrophysiology catheter used for recording intracardiac signals and cardiac stimulation during diagnostic electrophysiology studies. The Optima catheters are to be used to map the atrial regions of the heart.

The Inquiry Optima PLUS Steerable Electrophysiology Catheter is a flexible, radiopaque catheter with a variable number of electrodes with the first electrode located at the distal tip and the other band electrodes following at predetermined distances. A connecting cable is used to connect the catheter to electrogram devices. The catheter has a distal loop in a plane perpendicular to the catheter body. The circumferential shape or loop allows the electrophysiologist to record the potentials of cardiac structures without changing the position of the catheter shaft and/or loop is steerable by manipulating the handle. The placement of the electrodes around the entire circumference of the distal loop and on the shaft of the catheter also assists the electrophysiologist during fluoroscopy with visualization. The distal loop shape is easily straightened with the thumb and forefinger to facilitate insertion into sheaths and introducers. Once the catheter is extended beyond the sheath, the catheter resumes its pre-formed shape. The device is supplied sterile and is intended for single use only.

The provided text is a 510(k) summary for a medical device and does not contain the specific information requested about acceptance criteria, detailed study design, sample sizes, expert qualifications, or ground truth establishment in the context of device performance metrics like sensitivity, specificity, accuracy, etc. It primarily focuses on demonstrating substantial equivalence to a predicate device.

However, I can extract what is stated regarding testing and comparison:

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

The document does not provide a table of acceptance criteria with specific performance metrics (e.g., sensitivity, specificity, accuracy) and corresponding reported device performance values. Instead, it refers to a non-clinical test plan and its outcome.

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

The document does not specify a sample size for a test set, nor does it mention data provenance (country of origin, retrospective/prospective). The study described is "non-clinical tests."

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

This information is not provided. The non-clinical tests likely involved engineering or laboratory assessments rather than human expert evaluation for "ground truth" in the clinical sense.

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

This information is not provided.

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

A multi-reader multi-case (MRMC) comparative effectiveness study was not done. The device is an electrophysiology catheter, and this type of study is typically associated with AI-driven diagnostic imaging devices.

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

This is not applicable as the device is a physical catheter, not an algorithm, and is used with a human in the loop (electrophysiologist).

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

The concept of "ground truth" as typically applied to diagnostic algorithms is not directly relevant to the described non-clinical performance testing of a physical medical device. The "test results" likely refer to engineering specifications and functional performance.

8. The sample size for the training set

No training set is mentioned as this device is not an AI/ML algorithm.

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

No training set is mentioned.

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For recording intracardiac signals and cardiac stimulation during diagnostic electrophysiology studies. The Inquiry AFocus™ catheters are for use in mapping atrial regions of the heart.

The Inquiry AFocusII™ Bi-Directional Steerable Electrophysiology Catheter is a flexible, radiopaque catheter with a variable number of electrodes with the first electrode located at the distal tip and the other band electrodes following at predetermined distances. A connecting cable is used to connect the catheter to electrogram devices. The catheter has a distal loop in a plane perpendicular to the catheter body. The circumferential shape or loop allows the electrophysiologist to record the potentials of cardiac structures without changing the position of the catheter. The catheter shaft and/or loop are steerable by manipulating the handle. The placement of the electrodes around the entire circumference of the distal loop also assists the electrophysiologist during fluoroscopy with visualization. The distal loop shape is easily straightened with the thumb and forefinger to facilitate insertion into sheaths and introducers. Once the catheter is extended beyond the sheath, the catheter resumes its pre-formed shape. The device is supplied sterile and is intended for single use only.

The provided documentation is a 510(k) summary for a medical device (Inquiry™ AFocusII™ Diagnostic Catheter). It primarily focuses on demonstrating substantial equivalence to a predicate device and does not contain information typically found in a study or report that proves a device meets specific quantitative acceptance criteria.

The summary outlines the device's intended use, comparison to predicate devices, and mentions that nonclinical tests were conducted based on a preliminary guidance document. However, it does not provide any specific acceptance criteria for performance, nor does it detail the results of studies that would demonstrate the device meets such criteria.

Therefore, I cannot fulfill your request for the following information based on the provided text:

• A table of acceptance criteria and the reported device performance: This information is not present. The document states "Test results indicate reliable performance when the device is used in accordance with the Instructions for Use," but it doesn't specify what "reliable performance" entails in terms of quantitative metrics or acceptance criteria.
• Sample size used for the test set and the data provenance: Not provided.
• Number of experts used to establish the ground truth for the test set and their qualifications: Not applicable, as no human expert-based ground truth is reported for performance assessment.
• Adjudication method for the test set: Not applicable.
• If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and its effect size: Not done or reported. This type of study is more common for diagnostic imaging AI systems, not typically for an electrophysiology catheter's performance documentation in this context.
• 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/AI.
• The type of ground truth used: Not explicitly stated for performance testing beyond general "reliable performance."
• The sample size for the training set: Not applicable, as this is not an AI/ML device requiring a training set.
• How the ground truth for the training set was established: Not applicable.

The document's purpose is to establish substantial equivalence with a previously cleared device, not to present a detailed performance study with quantitative acceptance criteria in the way an AI/ML device or a novel diagnostic test might. The "nonclinical tests and results" section simply states that the tests were based on a guidance document and "indicate reliable performance," without further detail.

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The Steerable Electrophysiology Catheter is used for electrogram recording and cardiac stimulation during diagnostic electrophysiologic studies. The catheter is indicated for mapping the atrial regions of the heart.

The Inquiry™ AFocus™, Inquiry™ AFocus IITM, or Inquiry™ Optima™ Steerable Electrophysiology Catheter is a flexible, radiopaque catheter with a variable number of electrodes with the first electrode located at the distal tip and the other band electrodes following at predetermined distances. A connecting cable is used to connect the catheter to electrogram devices. The catheter has a distal loon in a plane perpendicular to the catheter body. The circumferential shape or loop allows the electrophysiologist to record the potentials of cardiac structures without changing the position of the catheter shaft and/or loop is steerable by manipulating the handle. The placement of the electrodes around the entire circumference of the distal loop also assists the electrophysiologist during fluoroscopy with visualization. The distal loop shape is easily straightened with the thumb and forefinger to facilitate insertion into sheaths and introducers. Once the catheter is extended beyond the sheath, the catheter resumes its pre-formed shape. The device is supplied sterile and is intended for single use only.

I am sorry, but the provided text does not contain the detailed information needed to fill out the requested table and answer the specific questions about acceptance criteria and a study proving device performance.

The document is a 510(k) summary for a steerable electrophysiology catheter. It discusses:

• Device identification: Names, classification, and predicate devices.
• Device description and function: How it works and its components.
• Intended use: Electragram recording and cardiac stimulation during diagnostic electrophysiological studies, mapping atrial regions.
• Comparison to predicate devices: States that modifications do not affect intended use or scientific technology.
• Nonclinical tests: Mentions that a test plan was based on a guidance document and that results indicate reliable performance, but no specifics about the tests, acceptance criteria, or performance outcomes are provided.

Therefore, I cannot extract the following information from the provided text:

1. A table of acceptance criteria and the reported device performance: The document only vaguely mentions "test results indicate reliable performance" but provides no specific criteria or performance metrics.
2. Sample size used for the test set and the data provenance: Not mentioned.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not mentioned.
4. Adjudication method for the test set: Not mentioned.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and its effect size: Not mentioned.
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 AI algorithm.
7. The type of ground truth used: Not mentioned, and not directly applicable in the sense of AI ground truth as this isn't an AI/diagnostic imaging device.
8. The sample size for the training set: Not applicable as this is a physical medical device, not an AI model requiring a training set.
9. How the ground truth for the training set was established: Not applicable.

The document is a regulatory submission focused on substantial equivalence to predicate devices, not on a detailed clinical study demonstrating specific performance against quantitatively defined acceptance criteria.

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The IBI Luma-Cath™ Steerable Electrophysiology Catheters are used for electrogram recording and cardiac stimulation during diagnostic electrophysiologic studies. The catheters are commonly placed in the high right atrium, right ventricular apex, and the His bundle.

The Irvine Biomedical, Inc. Luma-Cath™ Steerable Electrophysiology Catheter System is a multiple-electrode electrophysiology recording catheter and its connecting cable. The diameter of the catheter is between 6 and 8 French. The diameter of the electrodes is between 6 and 8 French. There is a lumen with nominal internal diameter of 0.036 inch.

The provided text does not contain information regarding detailed acceptance criteria, a specific study proving device performance against those criteria, or the methodology typically associated with such studies (like sample sizes, expert qualifications, ground truth establishment, or comparative effectiveness studies).

The text is a summary of safety and effectiveness for a 510(k) submission, confirming the device's substantial equivalence to predicate devices and its compliance with general controls. It focuses on biocompatibility, performance tests (without detailing them or their outcomes), manufacturing quality, and regulatory approval.

Therefore, I cannot fulfill your request for the specific points listed (Table of acceptance criteria, sample sizes, expert qualifications, ground truth, MRMC study, standalone performance, training set details) because this information is not present in the provided document.

The document indicates:

• Device: Luma-Cath™ Steerable Electrophysiology Catheter System
• Purpose: Electrophysiology recording and cardiac stimulation during diagnostic electrophysiologic studies.
• Safety and Effectiveness Claim: Based on biocompatibility, passed unnamed performance tests, manufacturing process following GMP, and substantial equivalence to predicate devices.
• Predicate Device: K961924 for accessory cables (though this is for the cables, not the catheter itself, which is stated to have patient contact materials "the same as the predicate devices").
• Regulatory Conclusion: Device is "substantially equivalent" to legally marketed predicate devices.

Without specific performance metrics and a study design, I cannot populate the requested table or answer the detailed questions about the study's execution.

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The Luma-Cath™ Fixed Curve Electrophysiology Catheters are used for measurement of electrical activity in the heart.

The Irvine Biomedical, Inc. Luma-Cath™ Fixed Curve Electriophysiology Catheter System is a multiple-electrode electrophysiology recording catheter and its connecting cable. The diameter of the catheter is between 5 and 8 French. The diameter of the electrodes is between 5 and 8 French. There is a lumen with nominal internal diameter of 0.036 inch for insertion of a guidewire.

The provided text for the Luma-Cath™ Fixed Curve EP Catheters describes its intended use, design, and biocompatibility, but it does not contain information about acceptance criteria or a study proving that the device meets specific performance criteria.

The document is a summary of safety and effectiveness, and a 510(k) clearance letter from the FDA. These documents primarily focus on demonstrating substantial equivalence to a predicate device and confirming adherence to general safety and manufacturing standards, rather than detailing specific performance studies with quantitative acceptance criteria.

Therefore, I cannot provide the requested table of acceptance criteria and device performance, nor can I answer the questions related to sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth details. These types of details are typically found in more extensive preclinical or clinical study reports, which are not included in the provided text.

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The ORTHOGONAL TM Electrophysiology Catheters are used forelectrogram recording and cardiac stimulation during diagnosticelectrophysiologic studies. The electrophysiology catheters arecommonly placed at the high right atrium, right ventricular apex,and His bundle.

The Irvine Biomedical, Inc. ORTHOGONAL™ Steerable Electrophysiology Catheter System is a multiple-electrode electrophysiology recording catheter and its connecting cable. The diameter of the catheter is between 5 and 8 French. The diameter of the tip electrode is between 5 and 8 French.

The provided text is a Food and Drug Administration (FDA) 510(k) clearance letter for the ORTHOGONAL™ Steerable Electrophysiology Catheter System. This document primarily focuses on demonstrating substantial equivalence to a predicate device, rather than presenting a performance study with acceptance criteria in the way a medical device typically would for a de novo or PMA submission.

Therefore, the information requested in the prompt, such as specific acceptance criteria, a detailed study proving device performance against those criteria, sample sizes, ground truth establishment, expert qualifications, and MRMC studies, is not present in the provided text.

The document states: "The components of the ORTHOGONAL™ Steerable Electrophysiology Catheter System are all biocompatible and have all been tested for use in the body. Specifically, the patient contact materials are the same as the predicate devices and have been approved by the FDA. The sterilized, finished ORTHOGONAL™ Steerable Electrophysiology Catheter has passed the performance tests."

This indicates that various performance tests were conducted, but the specific details, acceptance criteria, and results are not included in this summary. The FDA's 510(k) process relies heavily on demonstrating substantial equivalence to a legally marketed predicate device, meaning that the new device is as safe and effective as the predicate. The "performance tests" mentioned are likely related to demonstrating this equivalence through bench testing (e.g., biocompatibility, sterilization validation, electrical performance, physical integrity) rather than a clinical study with statistical acceptance criteria for diagnostic accuracy as might be found in AI/imaging devices.

Based on the provided text, I cannot complete the table or answer the specific questions about the study design, sample sizes, or ground truth establishment. The document does not contain the level of detail required for these points.

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Electrogram recording and cardiac stimulation during diagnostic electrophysiologic studies. The catheters are commonly placed in the high right atrium, right ventricular apex, and the HIS bundle.

The Irvine Biomedical, Inc. 181-1100" Bi-directional Steerable Electrophysiology Catheter System is a multiple electrophysiology recording catheter and its connecting cable. The diameter of the catheter is between 5 and 8 French. The diameter of the tip electrode is between 5 and 8 French.

The provided text is a 510(k) Pre-Market Notification for the IBI-1100™ Bi-directional Steerable Electrophysiology Catheter System. This type of submission is for medical devices and focuses on demonstrating substantial equivalence to a predicate device already on the market, rather than a clinical study proving device performance against specific acceptance criteria.

Therefore, the document does not contain details about acceptance criteria, a study proving the device meets those criteria, or information related to AI/algorithm performance. The submission relies on the device being "substantially equivalent" to predicate devices, meaning it has the same intended use, technological characteristics, and safety/effectiveness profile.

Here's why the requested information cannot be extracted from this document:

• Acceptance Criteria & Reported Device Performance: Not mentioned. The focus is on substantial equivalence, not a direct performance comparison against predefined metrics in a clinical study.
• Sample size for test set & data provenance: Not applicable. This isn't a clinical trial with a test set of patient data.
• Number of experts for ground truth & qualifications: Not applicable for a 510(k) that isn't a clinical study.
• Adjudication method: Not applicable.
• MRMC comparative effectiveness study: Not applicable. This device is not an AI-assisted diagnostic tool.
• Standalone algorithm performance: Not applicable. This is a physical medical device, not an algorithm.
• Type of ground truth: Not applicable.
• Sample size for training set & how ground truth was established for training set: Not applicable, as this is not an AI/ML device.

Instead, the document states:

• "The components of the IBI-1100™ Bi-directional Steerable Electrophysiology Catheter System are all biocompatible and have all been tested for use in the body. Specifically, the patient contact materials are the same as the predicate devices and have been a Electrophysiology Catheter has passed the biocompatibility and performance test."
• "Its manufacturing process will follow the Good Manufacturing Practice with quality assurance and validated sterilization process."
• "We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices..."

This indicates that the "proof" for this submission is biocompatibility testing, performance testing (likely bench testing or non-clinical trials demonstrating functionality), adherence to manufacturing standards, and comparison to existing, legally marketed predicate devices. It is not a clinical study with detailed acceptance criteria as one would expect for a novel diagnostic algorithm.

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