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The Advisor HD Grid Mapping Catheter, Sensor Enabled, is indicated for multiple electrode electrophysiological mapping of cardiac structures in the heart, i.e., recording or stimulation only. This catheter is intended to obtain electrograms in the atrial and ventricular regions of the heart.

The Advisor HD Grid Mapping Catheter, Sensor Enabled, is a sterile, singleuse, irrigated, high-density mapping catheter with a 7.5F shaft and an 8F distal shaft deflectable section. It is available in a D-F bi-directional curve model that is deflected using the actuator located on the catheter handle. The catheter working length is 110 cm. The device consists of a paddle-shaped distal tip with 16 electrodes, two distal shaft ring electrodes, two magnetic sensors, polymer braided shaft, handle, fluid lumen extension with a luer, and an electrical connector. The catheter also has an introducer tool intended to compress and guide the distal paddle into, and withdraw from, the hemostasis valve of an introducer sheath. The catheter is compatible with the EnSite Velocity and EnSite Precision Cardiac Mapping Systems and other accessories, including the connecting cable and commercially available irrigation pumps.

The provided text describes the St. Jude Medical Advisor HD Grid Mapping Catheter, Sensor Enabled. It mentions several types of testing conducted to demonstrate substantial equivalence to predicate devices, including bench, in vivo, and biocompatibility testing. However, the document does NOT contain a study that establishes acceptance criteria and provides specific device performance data in the format requested.

The document lists various performance characteristics that were tested (e.g., irrigation pressure, electrical resistance, magnetic resistance, and compliance to various ISO and ANSI/AAMI/IEC standards), as well as a "GLP safety study" and an "Accuracy study" as part of in vivo testing. It states that "The resulting evidence obtained from the design verification and validation testing did not raise new questions of safety and effectiveness, and demonstrates that the subject device is as safe and effective as the predicate devices."

However, it does not provide the acceptance criteria for these tests, nor does it present the reported device performance against those criteria in a quantitative manner. Therefore, I cannot complete the table or answer most of the specific questions about the study design, sample sizes, ground truth establishment, or expert involvement, as this information is not present in the provided text.

Based on the provided text, I can only state that an "Accuracy study" was performed as an in vivo test, but no details about its methodology, results, or how it proved the device met specific acceptance criteria are given.

The information regarding acceptance criteria and a study proving their fulfillment is absent from the provided FDA 510(k) clearance letter and associated indications for use and device description.

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The Confirm Rx™ ICM is indicated for the monitoring and diagnostic evaluation of patients who experience unexplained symptoms such as: dizziness, palpitations, chest pain, syncope, and shortness of breath, as well as patients who are at risk for cardiac arrhythmias. It is also indicated for patients who have been previously diagnosed with atrial fibrillation or who are susceptible to developing atrial fibrillation.

The St. Jude Medical Confirm Rx™ system consists of the following key features and components:

• Confirm RxTM ICM Model DM3500 Implantable Device: The ICM is intended as a minimally invasive, implantable diagnostic monitoring device, with subcutaneous electrodes, looping memory, and automatic as well as patient-activated EGM storage capability, which help physicians monitor, diagnose, and document patients who are susceptible to cardiac arrhythmias. It is predicated on SJM Confirm™ DM2102 with a two-year longevity, MR conditional labeling, and identical sensing and detection algorithms as SJM Confirm™ DM2102, but with downsized hardware and Bluetooth communication.
• Implant Tools: Model DM3520 incision tool and Model DM3510 insertion tool to implant the device subcutaneously.
• Model 3111 Magnet (existing SJM donut magnet) facilitates faster startup of Bluetooth connection and provides user authentication (required for programmer sessions).
• Clinician Programmer (Merlin PCS Programmer Model 3650): The Merlin PCS Programmer 3650 operates using Merlin PCS Model 3330 software and provides the means for the physician to program device parameters and retrieve diagnostic information from the device, including electrograms, heart rate history, episode duration and trend information.
• myMerlin™ Patient App (Model APP1000 Android): The Patient App provides the means for the patient to activate EGM recording in the Confirm Rx™ device, with data pass-through functionality to enable physician follow-up via the Merlin.net Patient Care Network.
• Remote Care/Clinician Portal (Merlin.net MN5000 Report Generator): The Merlin.net MN5000 system allows physicians to remotely monitor and diagnose patients' cardiac events.

The provided text describes the Confirm Rx™ Insertable Cardiac Monitor (ICM) System, Model DM3500.

Here's an analysis of the acceptance criteria and the studies mentioned:

1. Table of Acceptance Criteria and Reported Device Performance:

The document mentions that the Confirm Rx™ ICM leverages the existing market-cleared SJM Confirm™ (DM2102) algorithms and functionality. Therefore, the "acceptance criteria" for the detection algorithms are implicitly inherited from the predicate device. While specific numerical targets for metrics like sensitivity or specificity are not explicitly stated as acceptance criteria for the Confirm Rx™ ICM in this summary, the key performance aspects verified through testing are:

Important Note: The provided document is a 510(k) summary, which focuses on demonstrating substantial equivalence to predicate devices. It typically does not contain the detailed clinical study reports or comprehensive performance metrics that would be found in a full PMA application or a detailed peer-reviewed publication. The "acceptance criteria" here are therefore inferred from the context of substantial equivalence to a previously cleared device.

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

• Test Set Sample Size: The document does not explicitly state a specific sample size for a clinical test set used to evaluate the Confirm Rx™ ICM's diagnostic performance for arrhythmia detection. It states: "R-wave detection and device migration were verified via bench and animal testing for the Confirm Rx™ ICM DM3500." and "The Confirm Rx™ ICM leverages the existing market cleared SJM Confirm™ (DM2102) algorithms and functionality for which the clinical testing, performed on the SJM Confirm™ (DM2102) device per St. Jude Medical IDE G080090, is applicable and was not repeated."
• Data Provenance: The document does not specify the country of origin for the data, but it refers to an IDE (Investigational Device Exemption) study (G080090) conducted for the predicate device, SJM Confirm™ (DM2102). IDE studies are typically prospective clinical trials.

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

• This information is not provided in the 510(k) summary for the Confirm Rx™ ICM. Since the clinical performance data is leveraged from the predicate device, the details about ground truth establishment would reside in the original IDE G080090 submission for the SJM Confirm™ (DM2102).

4. Adjudication Method for the Test Set:

• This information is not provided in the 510(k) summary. Details on adjudication methods would typically be found in the full clinical study report for the predicate device (IDE G080090).

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and the effect size of how much human readers improve with AI vs. without AI assistance:

• No MRMC comparative effectiveness study is mentioned. The Confirm Rx™ ICM is an insertable cardiac monitor that automatically detects and records cardiac events. It is not an AI-assisted diagnostic tool designed to improve human reader performance in interpreting medical images or complex waveforms. Its primary function is automated detection and recording, with physician review of the recorded electrograms (EGMs).

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

• Yes, the document implies standalone performance evaluation of the detection algorithms. It states that the Confirm Rx™ ICM utilizes "identical sensing and detection algorithms as SJM Confirm™ DM2102." These algorithms are designed for automated triggering of EGM storage based on detected events like tachycardia, pauses, and atrial fibrillation. The verification of R-wave detection (a fundamental aspect of these algorithms) was performed via bench and animal testing, suggesting an evaluation of the algorithm's performance independent of a human in the loop for the core detection task. Physicians later review the automatically captured EGMs.

7. The Type of Ground Truth Used:

• For the R-wave detection and device migration verification in the Confirm Rx™ ICM, the ground truth would likely be based on direct physiological measurements from bench testing and animal studies (e.g., direct electrical signals or physical tracking of device position).
• For the leveraged clinical performance of the detection algorithms (from SJM Confirm™ DM2102 IDE G080090), the ground truth for arrhythmia detection would typically involve expert consensus of ECG/EGM interpretation by cardiologists or electrophysiologists, potentially corroborated with other clinical data or findings.

8. The Sample Size for the Training Set:

• The document does not specify a training set sample size. Given that the device leverages "identical sensing and detection algorithms" from a predicate device, the algorithms were likely developed and "trained" (or more accurately, designed and optimized) at an earlier stage with data that is not detailed in this 510(k) summary. This summary focuses on verifying the new device's implementation of those existing algorithms, not on new algorithm development.

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

• This information is not provided in the 510(k) summary. As mentioned, the algorithms are inherited from a predicate. Details on their initial development and the establishment of ground truth for any underlying "training" or optimization data would be found in the documentation for the predicate device (SJM Confirm™ DM2102).

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The PressureWire™ X guidewire is indicated to direct a catheter through a blood vessel and to measure physiological parameters in the heart and in the coronary and peripheral blood vessels. Physiological parameters include blood pressure. The PressureWire™ X Guidewire can also measure blood temperature.

The PressureWire™ X guidewire has an integrated sensor element at the tip to enable measurements of physiological parameters. The wire is introduced into the patient's blood vessel. A torque device is used to steer the wire and sensor into the required position for pressure measurements according to standard clinical practice. PressureWire™ X guidewire is available in two different lengths. The guidewire is uniquely paired with a specific connection cable or with a specific transmitter. Both PressureWire™ X guidewire connection configurations connect to a diagnostic computer or a catheter laboratory hemodynamic recording system.

This document is a 510(k) premarket notification for the PressureWire™ X device, which is a catheter tip pressure transducer and guidewire. The content primarily focuses on demonstrating substantial equivalence to a predicate device and does not contain detailed information about acceptance criteria, device performance metrics, or specific study designs as would be found in a clinical trial report.

Therefore, many of the requested elements for describing "acceptance criteria and the study that proves the device meets the acceptance criteria" cannot be fully provided from this document. The document describes design verification and validation testing rather than acceptance criteria for a diagnostic algorithm studied in a clinical setting.

Here's what can be extracted and what cannot:

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

This document does not provide a table of acceptance criteria for a diagnostic performance study (e.g., sensitivity, specificity, accuracy). Instead, it refers to compliance with various standards and internal design control procedures for physical, mechanical, and coating integrity.

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

This information is not provided in the document. The testing described is primarily bench testing and compliance with standards, not a clinical study on a patient test set.

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)

This information is not provided because the document describes verification and validation against pre-defined engineering and material standards, not the establishment of ground truth for a diagnostic performance test set by clinical experts.

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

This information is not provided. The device (PressureWire™ X) is a physical guidewire with sensing capabilities, not an AI or imaging diagnostic algorithm that assists human readers.

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

A standalone performance evaluation for a diagnostic algorithm is not applicable here as the device is a medical instrument (guidewire) for measuring physiological parameters, not an algorithm. Its performance relates to its ability to accurately measure pressure and temperature, as well as its physical and mechanical properties. The document states a "testing summary" was done, concluding it is "safe and effective."

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

For the physical and mechanical tests, the "ground truth" would be the established engineering specifications and manufacturing standards (e.g., specific friction force values, wire diameter tolerances). For biocompatibility and sterilization, the ground truth is compliance with the cited ISO and USP standards.

8. The sample size for the training set

This information is not provided. This device is not an AI/ML algorithm that requires a training set in the conventional sense.

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

This information is not provided as it's not applicable to this type of device.

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The Nanostim™ Introducer Kit is intended to provide a conduit into the venous system for insertion of diagnostic and other interventional devices.

The St Jude Medical Nanostim Introducer Kit is designed to perform as a guiding sheath for introduction of diagnostic and interventional devices. The Nanostim™M Introducer Kit is comprised of an introducer sheath and a dilator. The Introducer Kit is compatible with 0.035" and 0.038" guidewires and is available in one size (18F) and two lengths (30cm and 50cm).

The introducer is fitted with a hemostasis valve to minimize air introduction during insertion and/or exchange, and a sideport with a three-way stopcock. The introducer features a radiopaque tip marker incorporated within the sheath material to identify the location of the distal tip of the sheath. Design modifications were made to the length and packaging of the current device. The changes made to the Nanostim Introducer Kit do not affect the intended use of the device or alter the fundamental scientific technology of the device.

The provided text describes a 510(k) premarket notification for a medical device called the Nanostim Introducer Kit. This document is a submission to the FDA seeking to demonstrate that the modified device is substantially equivalent to a legally marketed predicate device.

Here's an analysis of the acceptance criteria and study information provided, structured as requested:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not explicitly state the specific sample sizes for each non-clinical test (visual, dimensional, torsional, simulated use/kink). It generally refers to "Design verification testing."

• Test Set Sample Size: Not specified for individual tests.
• Data Provenance: The study is reported as "Design verification testing," which implies it was conducted by the manufacturer (St. Jude Medical, Inc.) to verify their modified product. The origin of the data (e.g., country) is not specified beyond being generated by the applicant. It is a retrospective study in the sense that the testing was performed on the manufactured device, not as part of a prospective clinical trial.

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

This information is not applicable to this submission. The tests conducted are non-clinical, design verification tests, not clinical evaluations relying on expert interpretation of medical data (like imaging or pathology). The "ground truth" for these engineering tests would be established by objective measurements and defined specifications, not expert consensus.

4. Adjudication Method for the Test Set

This information is not applicable. Since the tests are non-clinical, objective measurements against pre-defined specifications determine success or failure. There is no human variability in interpreting results that would require an adjudication method.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. The document explicitly states: "Clinical evaluation is not required for this device." This type of study is typically performed for AI/image analysis devices where human reader performance is a key metric.

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 (an introducer kit), not an AI algorithm or software device.

7. The Type of Ground Truth Used

The ground truth used for the non-clinical tests would be based on engineering specifications and industry standards for medical device performance. For example:

• Visual test: Conformance to manufacturing standards, absence of defects.
• Dimensional measurement test: Conformance to specified dimensions (e.g., diameter, length).
• Torsional Strength: Ability to withstand a specified torsional force without breaking or deforming.
• Simulated use/kink test: Ability to perform as intended under simulated use conditions without kinking or failure.

8. The Sample Size for the Training Set

This information is not applicable. This submission is for a physical medical device. There is no "training set" in the context of machine learning or AI models. The device's design is based on engineering principles and prior iterations, not trained on a dataset.

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

This information is not applicable for the same reason as point 8. There is no training set for this device.

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The Nanostim™ Introducer Kit is intended to provide a conduit into the venous system for insertion of diagnostic and other interventional devices.

The St Jude Medical Nanostim Introducer Kit is designed to perform as a quiding sheath for introduction of diagnostic and interventional devices. The Nanostim™ Introducer Kit is comprised of an introducer sheath and a dilator. The Introducer Kit is compatible with 0.035" and 0.038" guidewires and is available in 18F and one length of 30 cm.

The introducer is fitted with a hemostasis valve to minimize air introduction during insertion and/or exchange, and a sideport with a three-way stopcock. The introducer features a radiopaque tip marker incorporated within the sheath material to identify the location of the distal tip of the sheath. Design modifications were made to the current design to improve the manufacturability and to increase the product shelf life. The changes made to the Nanostim Introducer Kit do not affect the intended use of the device or alter the fundamental scientific technology of the device.

The provided text is a 510(k) summary for the Nanostim Introducer Kit, which is a medical device. This document focuses on demonstrating substantial equivalence to a predicate device, rather than proving a device meets specific clinical performance criteria for accuracy or diagnostic efficacy in the way an AI or diagnostic imaging device would.

Therefore, many of the requested categories for AI/diagnostic studies (e.g., sample size of test set, ground truth experts, MRMC studies, standalone performance) are not applicable here. This document primarily describes engineering verification and biocompatibility testing.

Here's the information extracted from the document that is relevant to acceptance criteria and device performance:

1. Table of Acceptance Criteria and Reported Device Performance

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The Nanostim™ Introducer Kit is intended to provide a conduit into the venous system for insertion of diagnostic and other interventional devices.

The St Jude Medical Nanostim Introducer Kit is designed to perform as a guiding sheath for introduction of diagnostic and interventional devices. The Nanostim™ Introducer Kit is comprised of an Introducer sheath and a dilator. The Introducer Kit is compatible with 0.035" and 0.038" guidewires and is available in 18F and one length of 30 cm. The introducer sheath is fitted with a hemostasis valve to prevent blood loss and minimize air introduction during introducer insertion and/or exchange. A sideport with a three-way stopcock is provided for air or blood aspiration and fluid infusion. The introducer features a radiopaque tip marker incorporated within the sheath material to identify the location of the distal tip of the sheath.

This document is a 510(k) summary for the St. Jude Medical Nanostim Introducer Kit and does not contain information about a study proving the device meets specific acceptance criteria in the context of AI/ML performance, nor does it involve expert reviews or clinical trials in the way typically associated with AI/ML medical devices. The document concerns a physical medical device (catheter introducer) and its substantial equivalence to predicate devices.

Therefore, I cannot fulfill your request to describe acceptance criteria and a study proving the device meets those criteria, as the provided document does not contain this information in the context you've outlined.

The document discusses:

• The device's intended use and technological characteristics.
• Non-clinical testing (e.g., visual, dimensional, tensile, leak tests, biocompatibility).
• A statement that clinical evaluation is not required.
• A comparison to predicate devices to establish substantial equivalence.

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The SJM Confirm " ICM is indicated for the monitoring and diagnostic evaluation of patients who experience unexplained symptoms such as: dizziness, palpitations, chest pain, syncope, and shortness of breath, as well as patients who are at risk for other cardiac arrhythmias.

The SJM Confirm ICM, Model DM2102, is also indicated for patients who have been previously diagnosed with atrial fibrillation or who are susceptible to developing atrial fibrillation.

The SJM Confirm ICM is a cardiovascular monitoring device used to record and play back. physiological signals.

The provided text for SJM Confirm (DM2102) ICM 5 10(k) Premarket Notification (K133481) indicates that clinical performance testing was performed to demonstrate the device meets the required performance criteria. However, the document does not provide specific acceptance criteria or detailed results of this clinical study. It primarily focuses on asserting substantial equivalence to predicate devices based on technological characteristics and general performance.

Therefore, much of the requested information cannot be extracted from the provided text.

Here is what can be inferred and what is missing:

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

• Acceptance Criteria: Not explicitly stated in the provided text. The document broadly states the device "meets the required performance criteria" and "performs as intended."
• Reported Device Performance: Not explicitly stated in terms of quantitative metrics. The document concludes that "the SJM Confirm ICM functions to its specifications, performs as intended, and exhibits the appropriate characteristics of an implantable cardiovascular monitoring device."

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

• Sample Size for Test Set: Not specified. The document mentions "clinical performance testing" but does not provide details about the number of patients or cases.
• Data Provenance (e.g., country of origin of the data, retrospective or prospective): Not specified.

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

• Not specified. There is no mention of expert review or ground truth establishment in the context of the clinical study described.

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

• Not specified.

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 document implies that the SJM Confirm is a standalone cardiac monitoring device rather than an AI-assisted interpretation tool for human readers. Therefore, an MRMC study comparing human readers with and without AI assistance is not relevant to this device's function as described. No such study is mentioned.

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

• The document states "clinical performance testing were performed to demonstrate the SJM Confirm ICM meets the required performance criteria." While it doesn't explicitly use the term "standalone performance," given that it's an "Implantable Cardiac Monitor," its primary function would be continuous, automated monitoring and recording of physiological signals. This suggests the evaluation would focus on the device's ability to accurately detect and record these signals on its own. However, specific metrics are not provided.

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

• Not specified.

8. The sample size for the training set

• Not applicable as this seems to be a hardware device with embedded firmware/software rather than a machine learning algorithm that requires a separate training set. The relevant testing is "Software Verification and System Validation" and "Clinical Study."

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

• Not applicable.

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The EnligHTN™ Renal Guiding Catheter system is indicated for percutaneous use through an introducer sheath to facilitate a pathway to introduce interventional and diagnostic devices into the renal arterial vasculature.

The EnligHTN Renal Guiding Catheter consists of two primary components, the guiding catheter assembly and the dilator. The guide catheter assembly is the renal access device and has a usable length of 55cm. The outside diameter (OD) of the catheter shaft is 8F (2.7mm) with a distal tip inner diameter (ID) of 0.089 inches. The device is single use and packaged sterile via Ethylene oxide (EO) sterilization. The dilator fits inside the guiding catheter providing support during advancement through the vasculature and placement near the renal ostia. At the proximal end of the guiding catheter is a molded hub equipped with a hemostasis valve that is secured by an ultrasonically welded cap. The hub has a side port feature with an extension tubing and stopcock assembly attached. The distal end of the guiding catheter is formed to match the RDC-1 curve common to the industry and incorporates a radiopaque marker band. The dilator lumen is designed to accommodate a guidewire with an outside diameter of 0.035" or less.

The EnligHTN Renal Guiding Catheter system includes the following design aspects:

• 55cm Usable Length
• Renal double curve (RDC-1) at the distal end to assist in engagement of renal ostium
• Radiopaque marker band at the distal tip to aid in visualization under fluoroscopy
• Hub with hemostasis valve
• Extension tube with 3-way stopcock
• Compatible Dilator

Here's an analysis of the provided text regarding the acceptance criteria and study for the EnligHTN Renal Guiding Catheter:

Summary of Acceptance Criteria and Device Performance (Assumed from Testing Summary)

The document describes various performance tests conducted to demonstrate that the EnligHTN Renal Guiding Catheter meets product specifications and intended uses, and is as safe and effective as the predicate device (Cordis Guide Catheter). While explicit "acceptance criteria" are not listed with quantitative thresholds, the successful completion of these tests implies that the device met the required performance standards.

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

(See table above)

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: The document does not explicitly state the numerical sample sizes for each specific test (e.g., how many catheters were used for kink resistance, how many animals for animal testing). It lists the types of tests performed.
• Data Provenance: Not specified. Standard practice for medical device testing implies that these tests are performed in a controlled laboratory environment. The country of origin of the data is not mentioned and is typically not a requirement for this type of 510(k) submission unless specific clinical trial data from diverse populations is being used. This would be considered prospective bench and animal testing.

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):

• This information is not provided in the document. For bench and animal testing of this nature, "experts" in the traditional sense of medical specialists establishing ground truth for diagnostic accuracy are not typically involved. The "ground truth" would be defined by engineering specifications and expected physiological responses, assessed by engineers, technicians, and veterinarians.

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

• This information is not applicable to the non-clinical (bench and animal) testing described. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies, particularly those involving human interpretation of medical images, to resolve discrepancies among expert readers.

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, an MRMC comparative effectiveness study was not done. This device is a physical medical device (catheter), not an AI-powered diagnostic or assistive tool. Therefore, the concept of human readers improving with AI assistance is not relevant.

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 medical catheter and does not involve any algorithms or AI.

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

• For the non-clinical tests (bench, biocompatibility, sterilization, packaging, shelf life): The "ground truth" is based on engineering specifications, recognized industry standards, and regulatory requirements (e.g., ISO standards for biocompatibility, sterility assurance levels).
• For the animal testing: The "ground truth" for performance aspects like fit, visualization, engagement, seal, and withdrawal performance would be based on direct observation and assessment by trained personnel (e.g., veterinarians, researchers) in accordance with study protocols, confirming the device performs as intended within the physiological model.

8. The sample size for the training set:

• Not applicable. This document describes the testing of a physical medical device. There is no "training set" in the context of machine learning or AI algorithm development. The device's design is refined through engineering and iterative testing, not through training on a dataset.

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

• Not applicable. As there is no training set for an AI algorithm, the concept of establishing ground truth for it does not apply here.

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The 6F Proxis System controls the flow of fluids in the coronary and peripheral vasculature. This is achieved by temporary vessel occlusion to hold a column of fluid in the vessel stagnant. The stagnant column can be used to aid in the visualization of the lesion or be used as a means of local and temporary delivery of therapeutic solutions.

The 6F Proxis System is also indicated for use as an aid in the removal of fresh, soft emboli and thrombi in the coronary and peripheral vasculature.

The safety and efficacy of this device as an embolic protection system has not been established. The 6F Proxis System is not indicated for use for embolic protection. The device is not intended to be used as a thrombectomy system.

The 6F Proxis System (Proxis System) is a proximal flow control system used in conjunction with other interventional devices. The Proxis System controls the flow of fluids in the coronary and peripheral vasculature. This is achieved by temporarily occluding the vessel which holds the column of fluid stagnant. The stagnant column can be used to aid in the visualization of the lesion and for the delivery of therapeutic solution(s).

The Proxis System consists of an Evacuation Sheath Catheter (Proxis Catheter), inflation device. aspiration syringe, lip seal, and strainer basket. In addition, an optional accessory called the Proxis Infusion Catheter (packaged separately) may be used with Proxis System.

The Proxis Catheter is loaded onto the guide wire and tracked down to the distal portion of the guide catheter and proximal to the lesion. When the sealing balloon is inflated, antegrade flow of the fluid in the target vessel is prevented.

While the vessel is occluded, therapeutic solutions may be infused through the Proxis Catheter and stagnated in the target vessel/lesion during the delivery of the therapeutic device or after the deployment of the therapeutic device.

The aspiration syringe is provided for the removal of stagnated fluid and/or fresh, soft thrombi and emboli during aspiration. Additionally, if there is insufficient venous or collateral flow, the Proxis Infusion Catheter (optional accessory) may be used to infuse saline to augment the retrograde flow of fluid and removal of stagnated fluid.

The provided text describes a Special 510(k) submission for the 6F Proxis™ System. This type of submission is used when modifications to a legally marketed device do not raise new questions of safety or effectiveness. As such, the study performed is a verification study against established specifications of predicate devices, rather than a clinical trial with acceptance criteria for device performancemetrics.

Here's an analysis based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not specify a "test set sample size" in the context of a clinical study. Instead, it refers to verification testing against specifications. The sample sizes for these engineering and laboratory tests (e.g., for dimensional, strength, functional properties) are not detailed in this summary, but would typically be part of the underlying design verification documentation. The data provenance is implied to be from the manufacturer's internal testing facilities, used for previous 510(k) clearances (K063638 and K052523), and is retrospective in the sense that the current submission leverages prior clearance data. No specific country of origin for the data is mentioned for these engineering tests.

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

Not applicable. For this type of submission (Special 510(k) based on device modifications), clinical expert consensus for "ground truth" on patient data is not the primary basis for demonstrating safety and efficacy. Instead, the focus is on engineering and laboratory performance meeting established specifications.

4. Adjudication Method for the Test Set

Not applicable. Given that this is a Special 510(k) submission primarily relying on design verification and substantial equivalence to predicate devices, an adjudication method for a clinical test set is not described or required.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No. An MRMC comparative effectiveness study is designed to assess human reader performance, often with and without AI assistance, or comparing different diagnostic methods. This submission for the 6F Proxis™ System is for a physical medical device (catheter system) and its modifications, not a diagnostic imaging AI algorithm. Therefore, such a study was not performed.

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

No. This question typically pertains to AI/CADe (Computer-Aided Detection) or CADx (Computer-Aided Diagnosis) devices. The 6F Proxis™ System is a percutaneous catheter system; therefore, a standalone algorithm performance study is not relevant.

7. The Type of Ground Truth Used

The "ground truth" in this context is defined by engineering specifications and performance parameters established for the device components and system. These specifications are derived from recognized standards, clinical needs for the intended use, and the performance of previously cleared predicate devices. The "truth" is that the device meets these predetermined technical and functional requirements.

8. The Sample Size for the Training Set

Not applicable. The concept of a "training set" applies to machine learning algorithms. The 6F Proxis™ System is a physical medical device, not an AI/ML product.

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

Not applicable, as there is no "training set" for this device.

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The EnSite System is indicated for patients for whom electrophysiology studies are indicated.
When used with the EnSite* Catheter, the EnSite System is intended to be used in . the right atrium of patients with complex arrhythmias that may be difficult to identify using conventional mapping systems alone.
OR
When used with the EnSite NavX™ Surface Electrode Kit, the EnSite System is . intended to display the position of conventional electrophysiology catheters in the heart.

The EnSite System is a computerized storage and display system for use in electrophysiology studies of the human heart. The system consists of a console workstation, patient interface unit, and an electrophysiology mapping catheter or surface electrode kit.

This 510(k) summary does not contain the level of detail necessary to answer all the questions about acceptance criteria and the study proving the device meets them as typically presented for AI/ML-based medical devices. This document predates the widespread use of sophisticated AI/ML in medical devices and therefore focuses on traditional medical device validation.

Based on the provided information, here's what can be extracted and what cannot:

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

The document does not explicitly state quantitative acceptance criteria or detailed performance metrics in the format requested for an AI/ML device. Instead, it relies on a qualitative assessment of "safety and effectiveness" compared to a predicate device.

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

This information is not provided in the document. The abstract mentions "bench and user tests," but details on sample size, data type, or provenance are omitted.

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)

This information is not provided. Given the nature of the device (an electrophysiology cardiac mapping system and its components), ground truth would likely be established through physician observation during electrophysiology studies, but the specifics are absent.

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 as typically understood for AI/ML evaluation was not performed or reported. The document describes a traditional medical device submission based on substantial equivalence to a predicate device, not an AI efficacy study. The concept of "human readers improve with AI vs without AI assistance" is not applicable here as it is not an AI/ML device in the modern sense.

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

This concept is not applicable to this device. The EnSite System is a computerized storage and display system that supports electrophysiology studies, not a standalone AI algorithm producing diagnoses or interpretations without human involvement. Its "performance" is inherently linked to its use by an electrophysiologist in conjunction with catheters or surface electrodes.

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

The document does not specify the type of ground truth. For an electrophysiology mapping system, "ground truth" would likely relate to accurate identification and visualization of cardiac activation patterns and catheter positions, validated through clinical observation and established electrophysiological principles, rather than pathology or outcomes data in the traditional sense of a diagnostic AI device.

8. The sample size for the training set

This information is not provided and is not applicable in the context of this traditional medical device submission. The device is not an AI/ML system that undergoes "training" in the computational sense.

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

This information is not provided and is not applicable.

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