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The Globe Introducer is intended for percutaneous catheter introduction into the vasculature and into the chambers of the heart, including the left side of the heart through the interatrial septum.

The Globe® Introducer is a single use, ethylene oxide sterilized medical device used to facilitate percutaneous access to the vasculature and into the heart chambers. The device consists of a 16 Fr (5.3 mm) inner diameter (ID) steerable sheath with a hydrophilic coating, a dilator compatible with 0.89 mm (0.035 in) guidewires, and a dilator loader.

The proximal end of the sheath includes a handle with an integrated steering knob for bidirectional deflection control of the sheath tip, a steering indicator, and a slider. The slider contains a loader connection port for the dilator loader and a compatible catheter loader. The slider provides a hemostatic seal and a saline flushing line with a standard Luer fitting stopcock, for air removal and management.

The provided FDA 510(k) clearance letter and summary for the Globe® Introducer primarily focus on demonstrating substantial equivalence to a predicate device, the FARADRIVE™ Steerable Sheath. The information details the device's technical specifications and the non-clinical tests performed to support its safety and performance.

However, the document does not contain the specific information requested about acceptance criteria and studies that prove the device meets those criteria, particularly within the context of a clinical performance study with human subjects, AI involvement, or specific ground truth methodologies.

The provided document describes bench testing to demonstrate performance, but not clinical studies involving patients for performance metrics like sensitivity, specificity, accuracy, or human reader improvement with AI assistance. Therefore, many of the requested fields cannot be directly extracted from this document.

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

Information NOT available in the document:

• A table of acceptance criteria and reported device performance from a clinical study. The document only lists bench test types and states they meet performance criteria, but doesn't provide specific criteria or quantifiable results for each.
• Sample size used for the test set (clinical data).
• Data provenance (country of origin, retrospective/prospective).
• Number of experts used to establish ground truth or their qualifications.
• Adjudication method for the test set.
• Whether a multi-reader, multi-case (MRMC) comparative effectiveness study was done, or the effect size of human readers improving with AI assistance.
• Whether a standalone (AI algorithm only) performance study was done.
• Type of ground truth used (expert consensus, pathology, outcomes data) for clinical performance.
• Sample size for the training set (if an AI/ML device).
• How the ground truth for the training set was established (if an AI/ML device).

Information that can be partially inferred or is available from the document (though not clinical performance-related):

1. A table of acceptance criteria and the reported device performance (Non-clinical Bench Testing)

The document mentions various bench tests conducted to demonstrate performance. While it doesn't state specific numerical acceptance criteria or reported values, it does state that the device "meets the performance criteria for its intended use" for each test.

Specific Bench Tests Mentioned:

• Biocompatibility Testing
• Sterilization Validation
• Packaging Validation
• Shelf-Life Testing
• Particulate Test
• Deployment-Retraction Force Test
• Flushing Test
• Pressure Withstand Test
• Corrosion Resistance Test
• ISO 80369 Luer Test
• Introducer Health Check Test
• Dimensional Inspection Test
• Steering Knob Torque Test
• Sheath Tensile Test
• Mechanical Performance Test
• Torque Test
• Lubricity Test
• Radiopacity Test
• Dilator Performance Test
• Air Egress Test

2. Sample sized used for the test set and the data provenance: Not applicable/Provided. This document focuses on a hardware device (catheter introducer) and its substantial equivalence to a predicate device based on non-clinical (bench) testing, not on a clinical test set with patient data for an AI/ML component.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable/Provided. Ground truth establishment with experts is typical for AI/ML diagnostic devices evaluated with clinical images/data. This document does not describe such a study.

4. Adjudication method for the test set: Not applicable/Provided. This document does not describe a test set requiring adjudication by experts.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done: No. The document does not mention any clinical study involving human readers or AI assistance.

6. If a standalone (i.e. algorithm only, without human-in-the loop performance) was done: No. This device is a medical instrument (catheter introducer), not an AI algorithm.

7. The type of ground truth used: Not applicable/Provided in a clinical context. For the bench tests, the "ground truth" would be established by engineering specifications and expected physical performance parameters.

8. The sample size for the training set: Not applicable/Provided. This device does not appear to be an AI/ML device requiring a training set.

9. How the ground truth for the training set was established: Not applicable/Provided. This device does not appear to be an AI/ML device requiring a training set.

Summary based on the provided document:

The FDA 510(k) clearance for the Globe® Introducer is based on demonstrating substantial equivalence through non-clinical bench testing. The document comprehensively lists the types of tests performed (e.g., biocompatibility, sterilization, mechanical performance tests like torque, tensile strength, flushing, etc.) and states that these tests confirm the device meets performance criteria and does not raise new safety or effectiveness concerns compared to its predicate. There is no information in this document regarding clinical studies, AI involvement, specific acceptance criteria beyond a general statement of meeting performance, or details on ground truth establishment, as these are typically associated with clinical performance evaluations or AI/ML devices.

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The FARADRIVE Sheath is intended for percutaneous catheter introduction into the chambers of the heart, including the left side of the heart through the interatrial septum.

The FARADRIVE Steerable Sheath is used to facilitate access to the vasculature and into the chambers of the heart. The handle is furnished with a rotating Actuator Knob that enables a single plane unidirectional deflection and has the ability to actively straighten the distal end of the FARADRIVE Steerable Sheath curve when rotated.

The FARADRIVE Steerable Sheath includes an integral hemostasis valve to minimize blood loss or air ingress during catheter and dilator manipulation and a side flush line with three-way stopcock for blood aspiration, fluid infusion, blood sampling and pressure monitoring. The sheath also includes distal vent holes to facilitate aspiration and minimize cavitation. The supplied dilator is shaped to assist in facilitating vascular or chamber access when fully inserted into the sheath. The proximal end of the dilator includes a feature that will lock to the sheath hub when fully inserted.

The provided text is a 510(k) summary for the FARADRIVE™ Steerable Sheath. This document primarily focuses on demonstrating substantial equivalence to a predicate device through comparison of technological characteristics and non-clinical performance testing. It does not describe a study involving an algorithm or AI, nor does it establish ground truth with experts or involve human readers.

Therefore, I cannot provide the requested information about acceptance criteria and the study proving a device meets acceptance criteria using an AI/algorithm-based evaluation. The available information pertains to the regulatory clearance of a medical device (a steerable sheath), not a diagnostic algorithm.

Specifically, the document details physical and performance characteristics of the FARADRIVE™ Steerable Sheath and compares them to a predicate device (POLARSHEATH™ Steerable Sheath 12F) to establish substantial equivalence for regulatory approval.

Here's a breakdown of why the requested information cannot be extracted from the provided text:

• No AI/Algorithm: The submitted device, FARADRIVE™ Steerable Sheath, is a physical medical device (a catheter sheath), not an AI or algorithm-based diagnostic tool.
• No "Test Set" or "Training Set": These terms are relevant to machine learning studies. The "test set" mentioned in the document refers to performance testing of the physical device per design specifications, not an image or data set used for evaluating an algorithm.
• No "Ground Truth" by Experts: The "ground truth" concept is typically used to establish the correct diagnosis or finding in data used for training/testing AI. This document does not describe such a process.
• No "MRMC Comparative Effectiveness Study": This type of study compares the diagnostic performance of human readers with and without AI assistance. This is not applicable to a physical steerable sheath.
• No "Standalone Performance": "Standalone performance" refers to the algorithm's performance without human intervention. Again, this is not relevant to a physical device.

What the document does provide is a summary of non-clinical performance testing for a physical device:

The "Summary of Non-Clinical Performance Testing" on page 8 confirms that the testing aimed to show the device "conforms to user needs and its intended use and is thus substantially equivalent to the predicate." The listed tests include:

• Sterilization validation
• Biocompatibility assessment
• Design verification testing (at nominal and accelerated aging timepoints)
• Design validation testing summary for the FARAPULSE Pulsed Field Ablation System (presumably to show compatibility or a larger system context, not a performance study of the sheath itself)

These tests are standard for physical medical devices to ensure they meet safety and performance requirements, but they do not involve the concepts of AI, algorithms, ground truth, or expert readers as outlined in your request.

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POLARSHEATH Steerable Sheath 12F: The POLARSHEATH steerable sheath is indicated for percutaneous catheter introduction into the vasculature and into the chambers of the heart.
POLARMAP Circular Mapping Catheter: The POLARMAP Catheter is indicated for electrophysiological mapping (recording or stimulating only) of the cardiac structures of the heart.
POLARMAP EP Electrical Cable: The EP Electrical Cable is designed for use with the POLARMAP Mapping Catheter and the hospital EP recording system. The EP Electrical Cable connects the POLARMAP Mapping Catheter to the hospital EP recording system. Use of the EP Electrical Cable is optional.
SMARTFREEZE ETS Cables: The Esophageal Temperature Sensor (ETS) Cable (model M004CRBS6310 or M004CRBS6320) is designed for use with the SMARTFREEZE Console and a general purpose series 400 temperature sensor. The ETS Cable is used to connect a general purpose series 400 temperature sensor to the ICB. Use of the ETS Cable is optional. The ETS Cable (CIRCA) (model M004CRBS6340) is designed for use with the SMARTFREEZE Console and the CIRCA S-CATH™ Esophageal Temperature Probe. The ETS Cable (CIRCA) is used to connect the CIRCA S-CATH™ Esophageal Temperature Probe to the ICB (Model M004CRBS4130 only). Use of the ETS Cable (CIRCA) is optional. NOTE: The role of esophageal temperature monitoring using this device in reducing the risk of cardiac cryoablation-related esophageal injury has not been established. The performance of the SMARTFREEZE ETS Cables and compatible temperature probe in detecting esophageal temperature changes as a result of energy delivery during cardiac cryoablation procedures has not been evaluated.
SMARTFREEZE Pressure Sensor Cable: The Pressure Sensor Cable is designed for use with the SMARTFREEZE Console and the cryoablation balloon catheter. The Pressure Sensor Cable is used to connect an intravascular pressure transducer to the ICB to measure the ventricular pressure during ablation procedures to aid in determining vein occlusion. Use of the Pressure Sensor Cable is optional.

POLARSHEATH™ Steerable Sheath 12F: Single-use, steerable percutaneous introducer sheath designed for additional maneuverability of diagnostic and therapeutic catheters that are advanced through the POLARSHEATH™ Sheath and into cardiac chambers.
POLARMAP™ Circular Mapping Catheter: Single-use, multi-electrode catheter designed to record intracardiac electrograms and provide pacing stimulation during electrophysiology procedures.
POLARMAP™ EP Electrical Cable: Single-use electrical cable that connects the POLARMAP™ mapping catheter to the hospital EP recording system.
SMARTFREEZE™ Esophageal Temperature Sensor (ETS) Cable: Re-usable cables used to connect a temperature probe to the Inter Connection Box (ICB); used for continuous temperature monitoring during ablation procedures (optional).
SMARTFREEZE™ 16 PIN Esophageal Temperature Sensor (ETS) Cable: Re-usable cables used to connect a temperature probe to the Inter Connection Box (ICB); used for continuous temperature monitoring during ablation procedures (optional).
SMARTFREEZE™ CIRCA Esophageal Temperature Sensor (ETS) Cable: Re-usable cables used to connect a temperature probe to the Inter Connection Box (ICB); used for continuous temperature monitoring during ablation procedures (optional).
SMARTFREEZE™ Pressure Sensor Cable: Re-usable cable that connects an intravascular pressure transducer to the ICB. The pressure sensor is used to measure the ventricular pressure during ablation procedures to aid in determining vein occlusion.

The provided text is a 510(k) summary for medical devices and does not contain information about acceptance criteria or a study proving that an AI device meets acceptance criteria. The document describes several medical devices:

• POLARSHEATH™ Steerable Sheath 12F
• POLARMAP™ Circular Mapping Catheter
• POLARMAP™ EP Electrical Cable
• SMARTFREEZE™ Esophageal Temperature Sensor (ETS) Cables (various models)
• SMARTFREEZE™ Pressure Sensor Cable

These devices are hardware components used in cardiology procedures. The document establishes substantial equivalence to predicate devices based on technological characteristics and non-clinical performance testing. It does not refer to any AI/ML components or studies related to AI device performance.

Therefore, I cannot extract the requested information regarding acceptance criteria, device performance, sample sizes, expert ground truth, adjudication methods, MRMC studies, standalone performance, or training set details as this information is not present in the provided text.

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The Steerable Guide Catheter is used for introducing various catheters into the left side of the heart through interatrial septum.

The Steerable Guide Catheter (including a dilator) consists of a distal and proximal catheter shaft, a radiopaque tip ring, a handle with a steering knob, a hemostasis valve with a luer lock flush port, an atraumatic distal tip, and a dilator with a single central lumen. The device provides a conduit into the left side of the heart through the interatrial septum. The Steerable Guide Catheter is provided EtO sterile and for single use only.

This document is a 510(k) Premarket Notification from the FDA regarding a MitraClip G4 Steerable Guide Catheter. It focuses on establishing substantial equivalence to a predicate device, rather than proving the performance of a novel AI/ML-driven device against specified acceptance criteria using a study.

Therefore, the requested information regarding acceptance criteria, device performance tables, sample sizes for test and training sets, expert ground truth establishment, adjudication methods, MRMC studies, standalone algorithm performance, and types of ground truth cannot be extracted from this document.

This document primarily discusses:

• Regulatory Classification: Class II device, product code DRA.
• Device Description: A steerable guide catheter, including a dilator, used for introducing other catheters into the left side of the heart through the interatrial septum.
• Predicate Device: K190167 Steerable Guide Catheter.
• Comparison of Technological Characteristics: Stating that the subject device has the "same technological characteristics" as the predicate device in terms of intended use, indications for use, principles of operation, fundamental technology, materials, dimensions, and sterilization. Minor design modifications and shelf-life changes are noted.
• Performance Data: Only states that "Testing was performed to support substantial equivalence, including: Performance Shelf Life." It does not provide details of these tests, specific acceptance criteria, or performance results.
• Conclusion: The device is equivalent to the predicate device, with no differences raising new safety or effectiveness questions.

In summary, this document is a regulatory approval letter based on substantial equivalence, not a study report detailing performance metrics against specific acceptance criteria for an AI/ML-driven medical device.

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The AcQGuide® VUE Steerable Sheath with electrodes is intended for percutaneous catheter introduction into the vasculature and into the chambers of the heart.

The AcQGuide® VUE deflection facilitates catheter positioning.

The electrodes help facilitate visualization of the sheath when used with a compatible localization system, such as the AcQMap System.

The AcQGuide® VUE Steerable Sheath, Model 900201 is a single use, percutaneous catheter introducer designed to provide additional maneuverability to interventional catheters that are advanced through the sheath and into the right or left chambers of the heart. The distal portion of the sheath is comprised of a composite structured single lumen shaft. At the proximal end, an ergonomic handle provides torque and active deflection, a hemostasis valve allows safe introduction of an interventional catheter, and a side port provides access for aspiration, fluid flushes and fluid/medication infusions. There is a cable exiting from the handle of the sheath to provide connection for the distal electrodes. This cable terminates with four standard 2mm pins that are connected to the Auxiliary Interface Box or Auxiliary Catheter Cable of the AcQMap High Resolution Imaging and Mapping System, Model 900100 or 900000. The pin connections are assigned by the user for electrode identification (D1, 2, 3, 4) to the corresponding channel on the AcQMap System 900100. No designated order of pin connection is required. The AcQGuide® VUE Steerable Sheath includes a valve bypass tool as an optional accessory to facilitate the insertion of a loop or circular catheter.

The dilator is designed to introduce the Steerable Sheath into the vasculature and into chambers of the heart. The dilator has a smooth tapered tip and provides a smooth transition to the round edge of the non-traumatic tip of the sheath. The dilator is able to track over a 0.035″ guidewire. The hub section is attached to the shaft. It is a standard female luer made of high-density polyethylene (HDPE) material.

Some of the key design attributes of the Steerable Sheath include:

• Deflectability
• Hemostasis
• Kink-resistance
• Visibility under fluoroscopy
• Easily flushed during the procedure
• Single-handed operation
• Biocompatible materials
• Sterile, single use
• Combined three-way stopcock

The AcQGuide® VUE Steerable Sheath is intended for percutaneous catheter introduction into the vasculature and into the chambers of the heart. Its deflection facilitates catheter positioning, and its electrodes aid in visualization with a compatible localization system like the AcQMap System.

Here's an analysis of the acceptance criteria and the study that proves the device meets them:

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

Based on the provided information, the acceptance criteria are largely implied by successful completion of various nonclinical tests, demonstrating the device's conformance to specifications and comparable safety and effectiveness to the 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)

The document primarily describes nonclinical (bench) testing. For these tests, specific sample sizes are not explicitly provided in the summary. The studies are prospective in nature, as they involve testing newly manufactured devices to verify their performance against established specifications. The data provenance is Acutus Medical, Inc., Carlsbad, CA, U.S.A., implying the testing was conducted or overseen by the company.

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)

The document does not mention the use of experts to establish a "ground truth" for the nonclinical test sets in the way it would for a clinical study with image interpretation or disease diagnosis. The "truth" for these bench tests is derived from engineering specifications, industry standards (e.g., ISO, IEC), and established medical device testing protocols. The "physician simulated use in an animal model" likely involved qualified medical professionals, but their specific number, qualifications, and their role in establishing a "ground truth" (beyond observing performance) are not detailed.

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

No adjudication method is mentioned. For the nonclinical bench tests described, the outcomes are objective and based on meeting predefined specifications, rather than subjective interpretations requiring adjudication.

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 MRMC study was conducted or mentioned. The device described is a steerable sheath with electrodes for visualization, not an AI-powered diagnostic tool for human readers.

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

This refers to a medical device's performance without direct human intervention, especially applicable to AI algorithms. The AcQGuide® VUE Steerable Sheath is a physical medical device that inherently requires human-in-the-loop operation by a physician. Therefore, a "standalone algorithm only" performance study is not applicable to this device. Its performance is evaluated in relation to its mechanical, electrical, and material properties, and its interaction with a compatible localization system.

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

For the nonclinical testing described, the "ground truth" is defined by:

• Engineering Specifications: For dimensional, mechanical, and functional tests.
• International Standards: Such as ISO 10993-1 for biocompatibility, ISO 11135 and AAMI TIR28 for sterilization, and IEC 60601-1/1-2 for electrical safety and EMC.
• Predefined Performance Metrics: For tests like leak testing, torque, and compatibility.
• Physiological Response: In the animal model for physician simulated use.

8. The sample size for the training set

This question is not applicable. The AcQGuide® VUE Steerable Sheath is a physical medical device, not a software algorithm that requires a training set in the context of machine learning or artificial intelligence.

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

This question is not applicable, as there is no "training set" for this physical device.

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The AcQGuide MAX Steerable Sheath is intended for percutaneous catheter introduction into the vasculature and into the chambers of the heart. The AcQGuide MAX deflection facilitates catheter positioning.

The AcQGuide® MAX Steerable Sheath, Model 900200 is a single use, percutaneous catheter introducer designed to provide additional maneuverability to interventional catheters that are advanced through the sheath and into the right or left chambers of the heart. The distal portion of the sheath is comprised of a composite structured single lumen shaft. At the proximal end, an ergonomic handle provides torque and active deflection, a hemostasis valve allows safe introduction of an interventional catheter, and a side port provides access for aspiration, fluid flushes and fluid/medication infusions. The dilator is designed to introduce the Steerable Sheath into the vasculature and into chambers of the heart. The dilator has a smooth tapered tip and provides a smooth transition to the round edge of the non-traumatic tip of the sheath. The dilator is able to track over a 0.035″ guidewire. The hub section is attached to the shaft. It is a standard female luer made of high-density polyethylene (HDPE) material.

This submission details the AcQGuide MAX ASteerable Sheath (Model 900200), a device for introducing catheters into the vasculature and heart chambers. The submission seeks to demonstrate substantial equivalence to a previously cleared predicate device (AcQGuide Steerable Sheath, Model 900002).

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

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't explicitly state quantitative acceptance criteria in a formal table format. Instead, it describes general performance goals and confirms that testing was conducted to ensure the device "conformed to the design specifications" and "met its established performance specifications." The key performance attributes evaluated are listed, and the conclusion is that the device "meets the specifications necessary for consistent performance."

Thus, the acceptance criteria are implicitly tied to meeting design specifications and established performance specifications, as demonstrated by passing various nonclinical tests.

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

• Sample Size: The document does not specify exact sample sizes for each nonclinical test (e.g., how many units were tested for dimensional inspection, leak testing, etc.). It generally states that "All necessary testing was conducted" and "The necessary bench testing was performed."
• Data Provenance: The testing was conducted by or for Acutus Medical, Inc. in the U.S. (Carlsbad, CA). The studies are nonclinical bench tests and "Physician simulated use in an animal model." This would be considered prospective data for device verification.

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 "Physician simulated use in an animal model" implies expert involvement, but the number and qualifications of these physicians are not detailed. For bench testing, human experts typically set the specifications, but they don't "establish ground truth" for test outcomes in the same way clinical data is adjudicated.

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

This information is not applicable/not provided. Adjudication methods like 2+1 or 3+1 are typically used for clinical studies involving interpretation of medical images or outcomes where expert consensus is needed to establish ground truth. As this is a nonclinical bench testing and simulated animal model study, such adjudication methods would not be relevant.

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 is not applicable. This submission is for a medical device (steerable sheath), not an AI-powered diagnostic or assistive technology. Therefore, an MRMC comparative effectiveness study involving human readers and AI assistance was not performed.

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

This is not applicable. This device is a physical medical instrument, not an algorithm.

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

For the nonclinical bench tests, the "ground truth" is defined by the design specifications and established performance specifications of the device. These are objectively measurable parameters (e.g., dimensions, force resistance, electrical properties, etc.). For biocompatibility and sterilization, the "ground truth" refers to meeting the requirements of established international standards (ISO 10993-1, ISO 11135:2014+A1:2019) and regulations (21 CFR Part 58), which are objectively tested against. The "Physician simulated use in an animal model" would likely have qualitative or quantitative outcomes based on the successful demonstration of the device's function in a physiological setting, but the specific metrics are not detailed here.

8. The sample size for the training set:

This is not applicable. This is a non-AI medical device; therefore, there is no "training set."

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

This is not applicable. As there is no training set, there is no ground truth for it.

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The FlexCath Advance Steerable Sheath is intended for percutaneous catheter introduction into the vasculature and into the chambers of the heart. The sheath deflection facilitates catheter positioning.

The FlexCath Advance Steerable Sheath and Dilator is a sterile, single use percutaneous introducer fitted with a valve to allow for introduction, withdrawal and swapping of catheters and wires while minimizing blood loss. A side-port with stopcock is integrated to allow continuous drip infusion, injection through the center lumen, flushing, aspiration, blood sampling and pressure monitoring. The FlexCath Advance Steerable Sheath and Dilator can be deflected to provide additional maneuverability to catheters that are advanced through the sheath and into the right or left chamber of the heart. The sheath is comprised of two (2) main sections: the shaft and the handle. A dilator is included with each sheath.

This premarket notification presents proposed design and material changes to the hemostasis valve component, located within the handle section. Product performance requirement changes related to the updated hemostasis valve are also being implemented for the subject device. All other aspects of the device (overall design/technology, labeling, etc.) remain unchanged and are identical as compared to the predicate device, the FlexCath Advance Steerable Sheath and Dilator cleared under K183174.

The provided text describes the FlexCath Advance Steerable Sheath and Dilator, which is a medical device for percutaneous catheter introduction. The submission is for design and material changes to the hemostasis valve component of the device.

Here's the information about the acceptance criteria and the study that proves the device meets them:

1. Acceptance Criteria and Reported Device Performance:

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

The document states that "All design verification testing was performed on final finished product incorporating the proposed design and material changes." However, the exact sample sizes for each specific test (e.g., number of devices tested for kink, pull force, etc.) are not provided in the given text.

The data provenance is from Medtronic CryoCath LP, Canada, as indicated by the applicant's address: 9000 Autoroute Transcanadienne, Point-Claire, Quebec H9R 5Z8, Canada. The studies appear to be prospective bench and laboratory testing performed to verify the changes.

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

This information is not applicable as the studies described are for design verification, biocompatibility, and sterilization qualification of a physical medical device, not for an AI/algorithm-based diagnostic or assistive system requiring expert ground truth for interpretation.

4. Adjudication Method for the Test Set:

This information is not applicable for the same reason as point 3. The testing involves objective measurements to meet specified product requirements.

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

An MRMC study was not done. This type of study is relevant for evaluating the impact of an AI system on human reader performance, which doesn't apply to this medical device submission focused on physical changes to a sheath and dilator.

6. Standalone (Algorithm Only) Performance:

Standalone performance was not done. This concept is specific to AI algorithms operating without human interaction. The FlexCath Advance is a physical medical device.

7. Type of Ground Truth Used:

The "ground truth" for this device, in essence, is the pre-defined product requirements and established regulatory standards (e.g., ISO 10993-1:2018 for biocompatibility). The tests confirm that the device performs according to these engineering and safety specifications.

8. Sample Size for the Training Set:

This information is not applicable as the submission is not for an AI/machine learning device that would require a training set.

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

This information is not applicable for the same reason as point 8.

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The Steerable Introducer is intended for percutaneous catheter introduction into the vasculature and into the chambers of the heart. The sheath deflection facilitates catheter positioning.

The Steerable Introducer consists of a single use, bi-directional steerable sheath connected to a handle with steering controls, a hemostasis valve with side port and 3-way stopcock, a tapered dilator and compatible guidewire. The device is provided sterile in a sealed Tyvek pouch and carton with IFU.

The sheath distal tip and dilator shaft are radiopaque for visualization under fluoroscopy. The dilator is designed to accommodate a guidewire and includes a proximal hub with a female luer tapered fitting for flushing.

This document is a 510(k) premarket notification for a medical device (Steerable Introducer 12F), seeking a determination of substantial equivalence to a predicate device. It details the device's technical characteristics, intended use, and performance data from various tests. However, it does not describe an AI/ML-based device or its acceptance criteria and study in the context of AI/ML performance.

The information provided in the document refers to a physical medical device (a steerable catheter introducer) and its non-AI related performance testing (e.g., dimensional, material, mechanical, biocompatibility, sterilization).

Therefore, I cannot extract the information required by your prompt, as it specifically asks for details related to an AI/ML device's acceptance criteria and the study proving it meets those criteria.

The provided text does not contain any information about:

1. AI/ML Acceptance Criteria or Device Performance: There is no mention of metrics like sensitivity, specificity, AUC, or any other performance indicators typically used for AI/ML models.
2. Test Set Sample Size or Data Provenance: This document is about a physical medical device, not a software algorithm tested on data.
3. Experts for Ground Truth/Adjudication: This concept is not applicable here.
4. MRMC Comparative Effectiveness Study: Not relevant for a physical device.
5. Standalone AI Algorithm Performance: There is no AI algorithm.
6. Type of Ground Truth: Not applicable.
7. Training Set Sample Size or Ground Truth Establishment: Not applicable.

The document focuses on:

• Device Description: Physical attributes and components.
• Intended Use & Indications for Use: What the device is meant to do (introduce catheters into the heart).
• Technological Characteristics: How it operates (bi-directional steering, radiopacity).
• Performance Data: Bench testing (e.g., deflection, kink resistance, hemostasis), biocompatibility testing (ISO 10993-1), and sterilization methods, all aimed at demonstrating the device's safety and effectiveness as a physical product.
• Substantial Equivalence Claim: Comparing the new device's features and performance to a legally marketed predicate device (FlexCath Advance K123591) to show it's "as safe and effective."

In conclusion, based on the provided text, I cannot answer your request as it pertains to AI/ML device performance and testing. The document describes a traditional physical medical device.

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The Steerable Guide Catheter is used for introducing various catheters into the left side of the heart through the interatrial septum.

The Steerable Guide Catheter consists of a Guide and a Dilator provided EtO sterile and for single use only. The Steerable Guide Catheter consists of a distal and proximal catheter shaft, a radiopaque tip ring, a handle with a steering knob, a hemostasis valve with a luer lock flush port, an atraumatic distal tip, and a Dilator with a single central lumen. The central lumen of the Guide allows for aspiration of air and infusion of fluids such as saline, and serves as a conduit during introduction and or exchange of the Dilator and ancillary devices (e.g. catheters) that have a maximum diameter of 0.204". The atraumatic distal tip of the Steerable Guide Catheter is radiopaque to allow visualization under fluoroscopy. The Dilator consists of a radiopaque shaft, an echogenic feature at the distal tip, a hemostasis valve with a flush port and an internal lumen designed to accept ancillary devices that have a maximum diameter of 0.035" (e.g. needles or guidewires). The Steerable Guide Catheter, Dilator and accessories are packaged in a tray that is individually pouched in a Tyvek/Nylon corner peel pouch, heat-sealed one time, and the single sealed pouch is placed into a cardboard nest and top-loading box.

The provided document is a 510(k) premarket notification letter and summary for a medical device called a "Steerable Guide Catheter." It is used for introducing various catheters into the left side of the heart through the interatrial septum.

This document describes a physical medical device, not an AI/ML powered device or a software as a medical device (SaMD). Therefore, the requested information regarding acceptance criteria and a study proving an AI device meets those criteria is not present.

The document states that the device is substantially equivalent to a legally marketed predicate device (K172394 Steerable Guide Catheter). This equivalence is based on:

• Intended use
• Indications for use
• Principles of operation
• Fundamental technology
• Similar or identical materials of composition, dimensions, and sterilization

The "Performance Data" section (number 15) lists general categories of testing performed to support substantial equivalence:

• Biocompatibility
• Sterilization
• Packaging
• Performance (general term, specific details for the physical device would be in the full submission)
• Shelf Life

Without specific details on the "Performance" testing, it's impossible to define "acceptance criteria" and "reported device performance" in the context you've requested (which implies numerical metrics for an algorithm).

Therefore, I cannot provide the requested table or answer the specific questions related to AI/ML device performance and studies, as this document pertains to a physical medical device with no mention of AI or software components.

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