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The Medtronic Guide Catheter is designed to provide a pathway through which therapeutic devices are introduced. The Guide Catheter is intended to be used in the coronary or peripheral vascular system.

The Sherpa NX Balanced Guide Catheter design is fundamentally the same for both sizes of the device. The guide catheter is designed to provide a pathway for diagnostic and therapeutic devices in the coronary and peripheral vasculature. The basic design of Sherpa Guide Catheters is a cylindrical tube with a proximal and distal end. A single lumen extends from the proximal to the distal end of the catheter. The distal end of the catheter is towards the tip and the proximal end is towards the hub and strain relief. The catheter shaft has side holes present towards the distal end depending on the model. The Sherpa NX Balanced product line has two French sizes available, 6F and 7F. Sherpa is available in a range of lengths from 47 cm to 110 com.

The provided text describes a 510(k) premarket notification for the Medtronic 6F Sherpa NX Balanced Guide Catheter and 7F Sherpa NX Balanced Guide Catheter. It outlines the regulatory review and the company's summary of performance/non-clinical testing to demonstrate substantial equivalence to predicate devices. However, the document does not contain information about studies involving acceptance criteria related to a device with AI/algorithm performance.

The acceptance criteria mentioned are for the physical and biological properties of a medical catheter, not for an AI model's performance metrics (like accuracy, sensitivity, specificity, etc., with human-in-the-loop or standalone performance, MRMC studies, or ground truth establishment relevant to AI).

Therefore, based only on the provided text, I cannot complete a table or provide details for most of the requested points related to AI/algorithm acceptance criteria and performance studies.

Here's what can be extracted and what is missing:

Acceptance Criteria and Study for an AI-Powered Device (Information MISSING from provided text)

Since the provided document is for a physical medical device (a guide catheter) and not an AI/algorithm, the following sections will indicate "Not Applicable" or "Information Not Found" as the requested information pertains specifically to AI/algorithm performance studies.

1. Table of Acceptance Criteria and Reported Device Performance (for AI/Algorithm)

Note: The provided document details acceptance criteria for the physical properties and biocompatibility of the catheter (e.g., inner/outer diameters, leak resistance, tensile load, cytotoxicity). These are not AI/algorithm performance metrics.

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

• Test Set Sample Size: Information Not Found (Not applicable for a physical catheter).
• Data Provenance: Information Not Found (Not applicable for a physical catheter). The document only states that "no clinical testing data was required for this special 510k submission."

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

• Information Not Found (Not applicable for a physical catheter, as ground truth in the context of AI relates to diagnostic accuracy, not physical device integrity).

4. Adjudication Method for the Test Set

• Information Not Found (Not applicable for a physical catheter).

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

• Was it done?: No, an MRMC study was not done, as this submission is for a physical medical device, not an AI/algorithm. The document states "No clinical testing data was required for this special 510k submission."
• Effect size of human reader improvement with AI vs. without AI assistance: Not Applicable (No AI component).

6. Standalone (Algorithm Only) Performance Study

• Was it done?: No, a standalone algorithm performance study was not done. The submission is for a physical medical device.

7. Type of Ground Truth Used

• Information Not Found (Not applicable for a physical catheter, which doesn't involve "ground truth" in the AI diagnostic sense).

8. Sample Size for the Training Set

• Information Not Found (Not applicable, as this is a physical device, not an AI model requiring a training set).

9. How Ground Truth for the Training Set Was Established

• Information Not Found (Not applicable for a physical device).

Summary of what was actually performed and reported in the document:

The provided 510(k) summary describes non-clinical performance testing and biocompatibility assessment for the catheter:

• Biocompatibility Assessment:
  • Conducted according to ISO 10993-1.
  • Evaluated: Cytotoxicity, Sensitization, Intracutaneous Reactivity, Material-Mediated Pyrogenicity, Hemocompatibility, Acute Systemic Toxicity.
• Product Performance Evaluation (Dimensional & Performance):
  • Tests included: Inner/Outer Diameters, Total/Effective/Exposed Tip Length, Luer Connector Performance, Leak Resistance, Draw-through stiffness, Shaft/Arch bending stiffness & kink resistance, Crush resistance, Torsional Stiffness, Rotational Kink Angle, Rotations to Separation, Curve retention, Soft tip stiffness, Peak shaft/segment/soft tip/hub-shaft tensile load, Internal lubricity.
  • Specific standards cited for some tests: ISO 594-1, ISO 594-2, EN ISO 80369-7 (for Luer Connector Performance); ISO 10555-1 (for Leak Resistance and Peak Hub/Shaft Tensile Load).
• Conclusion: "The necessary tests performed met the acceptance criteria and demonstrated that there are not safety or effectiveness concerns." and "The performance testing along with biocompatibility testing demonstrated that the subject device Sherpa Guide Catheter is substantially equivalent to the predicate device."
• Clinical Data: "No clinical testing data was required for this special 510k submission."

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The 6F Wallaby Long Sheath is indicated for the introduction of interventional devices into the peripheral and neuro vasculature.

The 6F Wallaby Long Sheath is a single-use, vascular catheter consisting of a single lumen, variable stiffness, composite catheter. The device has an inner diameter (ID) of 0.088 inch and outer diameter (OD) of 0.105 inch designed with three different working lengths (80 cm, 90 cm, and 100 cm) and two different tip configurations (straight and multipurpose curve). The distal tip of the 6F Wallaby Long Sheath is visible under fluoroscopy and the distal shaft of the catheter is designed with an external hydrophilic coating to reduce friction during use. The proximal end of the catheter incorporates a strain relief and a standard Luer adapter to facilitate the attachment of accessories. The 6F Wallaby Long Sheath has a semi-rigid proximal shaft which transitions into a flexible distal shaft to facilitate the advancement of the catheter in tortuous anatomy.

The 6F Wallaby Long Sheath is a non-active, surgically invasive device intended for short term use within the vasculature.

The provided text describes the non-clinical testing performed on the "6F Wallaby Long Sheath" to demonstrate substantial equivalence to a predicate device, the "Neuron MAX System." This document does not describe the evaluation of an AI/ML powered medical device. Therefore, the information requested in the prompt related to AI/ML device evaluations (e.g., sample sizes for test and training sets, expert qualifications, adjudication methods, MRMC studies, standalone performance, type of ground truth) is not applicable or available in this document.

However, I can extract the acceptance criteria and reported device performance from the Design Verification Testing - Bench and Biocompatibility sections as they relate to a medical device in general.

1. Table of Acceptance Criteria and Reported Device Performance

Note: The document often states that the device "met all pre-defined acceptance criteria" or "demonstrated similar results to the predicate," rather than providing specific numerical acceptance thresholds. Where quantitative results are provided, they are included.

For the following points, the information is not applicable to this document as it details the clearance of a non-active, surgically invasive device (a vascular catheter), not an AI/ML powered device.

2. Sample size used for the test set and the data provenance: Not applicable. Data provenance is not relevant for bench and biological testing of this type of device.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. "Physician Validation" involved physicians but their exact number or role in "ground truth" establishment (which is an AI/ML concept) is not detailed.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable. Ground truth as typically defined for AI/ML evaluations is not relevant here. The ground truth for device performance is based on established engineering principles, ISO standards, and comparison to a legally marketed predicate device.
8. The sample size for the training set: Not applicable. There is no AI/ML training set.
9. How the ground truth for the training set was established: Not applicable. There is no AI/ML training set.

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The Medcomp@ 6F Triple Pro-Line® CT Power Injectable CVC is indicated for short or long term access to the central venous system. It is designed for administering I.V. fluids, blood products, drugs, and parenteral nutrition solutions. as well as blood withdrawal, allows for central venous pressure monitoring and power injection of contrast media. The maximum recommended infusion rate is 5cc/sec.

The Pro-Line of Power Injectable CVC triple lumen is an open-ended triple lumen catheter designed for power injection through one designated lumen. The power injectable central venous catheter is comprised of a soft radiopaque polyurethane material. The lumen has a reverse taper design and is connected to the extensions via a soft pliable hub with suture wing for secure placement. Clamps are provided on the extension tubes to prevent air/fluid communication. Female luer connectors provide the connection for intravenous administration. The designated 17ga. power injectable extension line and clamp material are purple in color to differentiate it from the clear 19ga. non-power injectable extensions. The purple lumen identifies it as a power injectable catheter. The center extension is also printed with the words power injectable. The I.D. Ring within the clamp on the power extension contains information regarding checking for blood return and flushing along with rate of infusion for power injection.

The catheter has a usable length of 60 cm with numerical markings every 5 cm and depth markings in 1 cm increments. Stylet and adaptor sideport are provided to assist in catheter insertion.

The catheter is packaged sterile with the necessary accessories to facilitate catheter insertion.

The provided text describes a medical device, the Medcomp® Pro-Line CT Power Injectable CVC, and its submission for 510(k) clearance. It does not describe an AI/ML-driven device or diagnostic software. Therefore, the requested information regarding acceptance criteria for device performance, sample sizes, expert ground truth, adjudication methods, MRMC studies, standalone performance, or training set details is not applicable to the provided document.

The document discusses the substantial equivalence of the Medcomp® Pro-Line CT Power Injectable CVC to predicate devices based on:

• Intended Use: Short or long-term central venous access for IV fluids, blood products, drugs, parenteral nutrition, blood withdrawal, CVP monitoring, and power injection of contrast media (max 5cc/sec).
• Technological Characteristics: Basic design, materials, performance, labeling, manufacturing process, and sterilization.
• Bench/Performance Data: Conducted in accordance with applicable international standards and internal engineering protocols, to demonstrate substantial equivalence.
• Biocompatibility: Materials meet ISO 10993 requirements, with testing previously submitted for other Medcomp devices.

"Clinical studies were not deemed necessary since in-vitro testing was sufficient to demonstrate safety and effectiveness by way of comparison to the legally marketed predicate device." This statement directly indicates that performance criteria based on clinical outcomes, or metrics that would necessitate human expert review or an MRMC study, were not part of the clearance process for this specific medical device.

Therefore, I cannot provide the requested table and study details as they pertain to AI/ML device evaluation within this document.

The document is a 510(k) premarket notification for a traditional medical device (catheter), not an AI/ML diagnostic or treatment planning system.

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The introduction of angiographic catheters, closed end catheters, balloon catheters, and electrodes into The introduction of the catheero, emoral, radial, and brachial access) where minimizing blood loss is essential.

Not Found

I am sorry, but the provided text is a letter from the FDA regarding a 510(k) premarket notification for a medical device (Engage™/Engage™ TR Introducer). It confirms that the device is substantially equivalent to legally marketed predicate devices and outlines regulatory requirements.

This document does not contain information about acceptance criteria, device performance, study designs, sample sizes, expert qualifications, or ground truth establishment for an AI/ML medical device.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them based on the provided text.

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The PowerLine™ catheter is indicated for short or long term access to the central venous system. PowerLine™ catheters are designed for the administration of I.V. fluids, blood products, drugs, parenteral nutrition solutions, as well as blood withdrawal. In addition, PowerLine™ catheters allow for power injection of contrast media and central venous pressure monitoring. The maximum recommended infusion rate is 5ml/sec. For central venous pressure monitoring, it is recommended that a catheter lumen of 20 gauge or larger be used.

The PowerLine™ catheters are open-ended polyurethane catheters with a reverse taper design. Catheters are available in 5 F Dual-Lumen and the 6 F Triple-Lumen configurations. The usable length of the catheter is 50 cm. Catheter shaft tubing is marked with depth indicators, with "0" indicated to serve as a reference for the catheter insertion point. The catheters have a tissue ingrowth cuff bonded to the catheter shaft. Purple colorants added to the catheter extension legs and shaft aid in distinguishing the catheter as power-injectable. The molded hub is labeled to identify the catheter as PowerLine™. The catheter extension leg and clamp are labeled with information to facilitate proper use of the device. The PowerLine™ catheters are provided in sterile tray configurations.

The provided text is a 510(k) Pre-market Notification for the Bard Access Systems PowerLine Central Venous Catheters. It describes the device, its intended use, and substantial equivalence to predicate devices, along with verification and validation activities. However, it does not contain information related to software or AI device performance, ground truth establishment, sample sizes for training/test sets, expert qualifications, or MRMC studies.

Therefore, I cannot fulfill most of your request directly from the provided text.

Based on the information available:

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

The document states: "The subject PowerLine™ catheters met all predetermined acceptance criteria derived from the above mentioned references. Design validation was conducted on the subject PowerLine™ configuration and yielded acceptable results."

The "above mentioned references" refer to:

• Guidance on Premarket Notification [510(k)] Submission for Short-Term and Long-Term Intravascular Catheters, March 16, 1995
• ISO 10555-1:1997, Sterile, single-use intravascular catheters, Part 1. General requirements, Amendment 2
• BS/EN/ISO 10555-3:1997, Sterile, single-use intravascular catheters, Part 3. Central venous catheters
• AAMI/ANSI/ISO 10993-1:2003, Biological Evaluation of Medical Devices Part 1: Evaluation and Testing, and the FDA Modified ISO 10993 Test Profile
• AAMI/ANSI/ISO 10993-7:1995, Biological Evaluation of Medical Devices Part 7: Ethylene Oxide Sterilization Results

Actual specific acceptance criteria and detailed quantitative performance results are not provided in this summary.

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 given text. The document mentions "Tests were performed on sterilized, finished devices," but does not specify the number of devices tested or any data provenance details.

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 applicable as the document describes a physical medical device (catheter) and its performance based on engineering and biocompatibility standards, not an AI or diagnostic device that requires expert ground truth for image interpretation or diagnosis.

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

This information is not applicable for a physical medical device performance study as described here.

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 applicable as the document is about a physical medical device (catheter), not an AI-assisted diagnostic or interpretative system.

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

This information is not applicable as this is not an AI device.

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

The "ground truth" for this physical device's performance would be established by physical measurements, material science testing, biocompatibility assays, and sterilization effectiveness indicators, all against established industry standards (ISO, AAMI/ANSI). It does not involve expert consensus, pathology, or outcomes data in the context of diagnostic accuracy.

8. The sample size for the training set:

This information is not applicable as this is not an AI device.

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

This information is not applicable as this is not an AI device.

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The Medtronic Guiding Catheter is designed to provide a pathway through which therapeutic devices are introduced. The guiding catheter is intended to be used in the coronary or peripheral vascular system.

The 6F Taiga™ Guiding Catheter is a single lumen catheter with an atraumatic tip, which provides a pathway for therapeutic devices to be introduced into the coronary or peripheral vascular system.

The provided text describes the 510(k) summary for the Medtronic 6F Taiga™ Guiding Catheter, which is a medical device, not an AI/ML-enabled diagnostic device. Therefore, the requested information regarding acceptance criteria, study details, and AI-specific metrics (like MRMC studies, standalone performance, training sets) is not applicable to this document.

The document explicitly states: "No clinical investigation has been performed for this device."

Instead, the submission for this device relies on non-clinical data and demonstrating substantial equivalence to a predicate device.

Here's a breakdown of what is relevant from the provided text:

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

Since this is not an AI/ML diagnostic device, there are no "acceptance criteria" in the sense of performance metrics like sensitivity, specificity, or AUC. The acceptance criteria for this device would have been related to engineering and non-clinical performance (e.g., integrity, deliverability, lubricity), which are summarized as:

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

Not applicable. No clinical investigation or test set for performance evaluation was conducted. The evaluation was based on non-clinical (engineering) tests.

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 applicable. There was no clinical test set requiring expert ground truth.

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

Not applicable. No clinical test set.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

Not applicable. This is not an AI/ML-enabled device.

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

Not applicable. This is not an AI/ML-enabled device.

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

Not applicable for clinical performance. The "ground truth" for this device's evaluation would be defined by engineering standards and specifications, confirmed through non-clinical testing.

8. The sample size for the training set:

Not applicable. This is not an AI/ML-enabled device.

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

Not applicable. This is not an AI/ML-enabled device.

Study that proves the device meets the acceptance criteria:

The study proving the device meets the acceptance criteria is summarized as "Non-clinical Data: passed all design verification and validation testing." This indicates a series of engineering tests (e.g., mechanical tests, material compatibility, dimensional verification, flow rate, torque response, etc.) were conducted to ensure the device performs as intended and meets its specifications. The specific reports for these tests are not detailed in this summary but would be part of the full 510(k) submission.

Conclusion from Data:

Medtronic Vascular concluded that the 6F Taiga™ Guiding Catheter is substantially equivalent to the predicate devices based on its indications for use and fundamental scientific technology, supported by the successful completion of non-clinical design verification and validation testing.

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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 Medtronic 6F Sherpa NX Guide Catheter is designed to provide a pathway through which therapeutic devices are introduced. The Sherpa NX guiding catheter is intended for used in the coronary or peripheral vascular system.

The 6F Z4 Guide Catheter consists of a luer hub, a strain relief, inner liner, a braided wire, an outer jacket, a sleeve, a tungsten/nylon band, and a soft tip.

The 6F Z4 Guide Catheter design is based on an inner lumen liner of polyethylene material. The new shaft will be comprised of an inner liner of polyethylene, an intermediate layer of Pebax, stainless steel braid wire and a Vestamid outer jacket. The braided wire, intermediate layer and outer jacket materials have been previously used in others Medtronic Guide Catheters.

This document describes a 510(k) submission for the Medtronic 6F Z4 Guiding Catheter, comparing it to a predicate device, the 6F Launcher Guide Catheter (K021256).

1. Table of Acceptance Criteria and Reported Device Performance:

The provided document does not list specific numerical acceptance criteria or detailed performance metrics. It states that the device has been "subjected to performance testing and it has been determined that the 6F Z4 Guiding Catheter is suitable for its intended use."

The comparison is primarily qualitative, focusing on technological equivalence and manufacturing processes.

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

The document does not specify a "test set" in the context of a clinical study or a dataset for evaluating an AI device. The submission focuses on device design, materials, and manufacturing process equivalency to a predicate device, along with performance testing (without specifying the nature or scale of this testing). Therefore, information regarding sample size, country of origin, or retrospective/prospective nature of data is not provided for a "test set."

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

This information is not applicable. The device is a physical medical device (guiding catheter), not an AI algorithm requiring expert-established ground truth from a dataset. The evaluation is based on engineering principles and comparison to a predicate device.

4. Adjudication Method for the Test Set:

This information is not applicable as there is no "test set" or associated "ground truth" to adjudicate in the context of an AI device evaluation.

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 applicable. The document describes a physical medical device (a guiding catheter), not an AI-powered diagnostic or assistive tool. Therefore, an MRMC study related to AI assistance for human readers is irrelevant.

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

This information is not applicable. The device is a physical guiding catheter, not a standalone algorithm.

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

This information is not applicable. For this type of device submission, "ground truth" would be established through engineering specifications, material testing standards, and predicate device equivalence.

8. The Sample Size for the Training Set:

This information is not applicable. The device is a physical medical device, not an AI algorithm that requires a training set.

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

This information is not applicable as there is no training set for a physical medical device.

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Mach1 Guide Catheters are intended for use in general intravascular and coronary applications. They provide a pathway through which medical instruments, such as balloon dilatation catheters, guide wires or other therapeutic devices may be introduced. These devices are not intended for use in the cerebral vasculature.

The Boston Scientific 5F, 7F, and 8F Mach1 catheters are similar to the currently marketed 6F Mach1 Guide Catheter, with the addition of three French sizes to the catheter line.

The Boston Scientific Mach1 catheters are designed to provide a pathway through which medical instruments, such as balloon dilatation catheters, guide wires or other diagnostic or therapeutic devices, may be introduced. These devices are not intended for use in the cerebral vasculature. The Mach1 catheters will be offered in 5F, 6F, 7F, and 8F sizes and are available in lengths ranging from 40-125 cm, with optional side holes. The devices are provided sterile and intended for one procedure use only.

The Mach1 catheters are manufactured using similar construction techniques as other currently marketed Boston Scientific guide catheters. The catheter shaft consists of three layers: the inner, middle and outer layers. The outer layer is composed of four segments,(5F has three segments) inclusive of the proximal shaft segment, but not including the distal tip. The outer layer segments are composed of the same material, (Arnitel) but use varying durometers of the Arnitel (polyether-ester) shaft materials providing specific flexibility zones over the length of the catheter. The tip consists of a reinforced tip portion and a non-reinforced tip portion. The 6F, 7F and 8F tip is made of Hytrel, while the 5F has an Arnitel tip.

The provided text describes a 510(k) premarket notification for Boston Scientific's 5F, 7F, and 8F Mach1 Guide Catheters. This document focuses on demonstrating substantial equivalence to a legally marketed predicate device (the 6F Mach1 Guide Catheter), rather than establishing performance against specific acceptance criteria for a novel device through clinical trials involving AI or diagnostic performance.

Therefore, many of the requested categories are not applicable or not present in the provided text, as this type of submission relies on non-clinical (in-vitro) testing and comparison to an existing device rather than a comprehensive clinical study with human readers, AI assistance, or complex ground truth establishment for diagnostic accuracy.

Here's a breakdown based on the information available:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are not explicitly quantifiable metrics like sensitivity or specificity. Instead, they are related to the functional performance and physical characteristics of the guide catheters, ensuring they are safe and perform as intended and are similar to the predicate device. The performance is reported as meeting these criteria.

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

• Sample Size for Test Set: Not explicitly stated as "sample size" in the context of diagnostic or AI performance evaluation. The "test set" consisted of the manufactured 5F, 7F, and 8F Mach1 catheters on which the functional, biocompatibility, packaging, and shelf-life tests were performed. The exact number of units tested for each specific test is not detailed, but it would have been a representative sample from production batches.
• Data Provenance: The tests were non-clinical (in-vitro) conducted by Boston Scientific Scimed, Inc. within their facilities. This is not human-patient data from a specific country, but rather laboratory and engineering test data.

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

• Number of Experts: Not applicable. For this type of submission, "ground truth" refers to established engineering standards, material specifications, and functional requirements for medical devices, not diagnostic interpretations by human experts. The assessment of whether the functional tests met the requirements would be done by product engineers and quality assurance personnel.
• Qualifications of Experts: Not applicable in the context of diagnostic interpretation. The experts involved would be engineers, material scientists, and quality control professionals.

4. Adjudication Method for the Test Set

• Adjudication Method: Not applicable. There was no "adjudication" in the sense of reconciling differing expert opinions on diagnostic findings, as this was a non-clinical evaluation. Test results would be compared against predefined internal specifications and industry standards.

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

• MRMC Study: No, an MRMC comparative effectiveness study was not done. This submission does not involve human readers or AI assistance.
• Effect Size of AI Improvement: Not applicable.

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

• Standalone Study: No, a standalone algorithm performance study was not done. This device is a physical medical instrument, not an AI algorithm.

7. Type of Ground Truth Used

• Type of Ground Truth: The ground truth for this submission consists of:
  • Engineering Specifications: Predefined performance metrics, material properties, and design tolerances.
  • Industry Standards: Relevant ISO or ASTM standards for catheter performance and safety.
  • Predicate Device Performance: The established, safe, and effective performance of the 6F Mach1 Guide Catheter (K010874) against which the new sizes were compared for substantial equivalence.

8. Sample Size for the Training Set

• Sample Size for Training Set: Not applicable. There is no "training set" in the context of AI or machine learning for this device submission. The design and manufacturing processes are based on established engineering principles and prior experience with similar devices.

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

• How Ground Truth for Training Set Was Established: Not applicable, as there is no training set mentioned for this type of device submission.

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The St. Jude Medical electrophysiology catheters can be used in the evaluation of a variety of cardiac arrhythmias.

The Evaluator™ Electrophysiology Catheter is a fixed-curve, electrode recording catheter with ring electrodes that are electrically coupled to conductor wires to pace the heart and sense and record bipolar intracardiac electrograms.

The provided text is a 510(k) Pre-Market Notification for the Evaluator™ Electrophysiology Catheter. This type of submission is for demonstrating "substantial equivalence" to a predicate device, rather than proving performance against specific acceptance criteria in the way a de novo or PMA submission might.

Therefore, the document does not contain information about specific acceptance criteria, a study proving the device meets those criteria, or details regarding test sets, expert involvement, or training data typically associated with performance studies.

Instead, the core of this submission is the comparison of technological characteristics to a legally marketed predicate device.

Here's an analysis based on the information provided:

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

• No explicit acceptance criteria or reported device performance are provided in the document. The submission relies on demonstrating substantial equivalence to a predicate device.
• The document states: "All technological characteristics of the Evaluator™ Electrophysiology Catheters are substantially equivalent to the predicate device including product design, sterilization, and labeling." This is the primary claim, but no quantitative or qualitative performance metrics are given.

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

• Not applicable. This submission does not describe a performance study with a test set.

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

• Not applicable. No ground truth establishment for a test set is described.

4. Adjudication method for the test set:

• Not applicable. No test set or adjudication method is described.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

• Not applicable. This device is an electrophysiology catheter, not an AI-assisted diagnostic tool.

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

• Not applicable. This device is an electrophysiology catheter, not an algorithm.

7. The type of ground truth used:

• Not applicable. No ground truth from a performance study is mentioned. The "ground truth" in a 510(k) for substantial equivalence is the predicate device's established safety and effectiveness.

8. The sample size for the training set:

• Not applicable. This submission does not describe a training set for a performance algorithm.

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

• Not applicable. No training set or ground truth establishment is described.

Summary of the 510(k) Submission Approach:

The St. Jude Medical, Daig Division's submission for the Evaluator™ Electrophysiology Catheter (K011766) is based on demonstrating substantial equivalence to their own predicate device, the Response™ Electrophysiology Catheter. This means they are asserting that the new device has the same intended use and similar technological characteristics to a legally marketed device, and therefore does not raise new questions of safety or effectiveness.

The document explicitly states:

• Predicate Device: Response™ Electrophysiology Catheter (St. Jude Medical, Daig Division)
• Basis for Equivalence: "All technological characteristics of the Evaluator™ Electrophysiology Catheters are substantially equivalent to the predicate device including product design, sterilization, and labeling."

The FDA's response confirms that they have "determined the device is substantially equivalent... to legally marketed predicate devices." This substantial equivalence determination is the "proof" in this context, rather than a detailed performance study with specific acceptance criteria.

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