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Telescope™ Guide Extension Catheter is intended to be used in conjunction with guide catheters to access discrete regions of the coronary and/or peripheral vasculature, and to facilitate placement of interventional devices.

The Telescope™ Guide Extension Catheter is a single-lumen rapid exchange catheter designed to act as an extension to a traditional guide catheter. The Telescope™ Guide Extension Catheter is intended to be used with guide catheters to access discrete regions of the coronary and/or peripheral vasculature, and to facilitate placement of interventional devices.

The Telescope™ Guide Extension Catheter device is 150cm in length and consists of a hydrophilic-coated single-lumen distal guide segment connected to a stainless-steel polytetrafluoroethylene (PTFE) coated proximal pushwire.

The device is offered in two sizes 6F and 7F, with a hub at the proximal end of the pushwire that is used for device identification.

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The Delivery Catheter is indicated for the introduction of pacing and defibrillation leads to the right heart, inclusive of the Left Bundle Branch Area.

The subject Delivery Catheter (CPS Locator 3D Delivery Catheter) is a single-use percutaneous catheter intended for venous introduction of pacing or defibrillation leads.

The subject Delivery Catheter is packaged with a dilator for introduction into the vasculature. Proximally, the subject Delivery Catheter is equipped with a hemostatic valve, and the distal soft, rounded, radiopaque tip facilitates imaging under fluoroscopy. The subject Delivery Catheter is designed to be slittable, thereby allowing its removal after device placement. A variety of curves and lengths are available to accommodate various anatomies and different locations.

This FDA 510(k) clearance letter pertains to a medical device, not an AI/ML software. Therefore, the detailed acceptance criteria and study information requested, which are typical for AI/ML device evaluations, are not applicable in this context.

The document discusses the CPS Locator 3D Delivery Catheter, a physical medical device. The 510(k) process for such devices focuses on demonstrating substantial equivalence to a legally marketed predicate device, primarily through performance testing (bench testing, biocompatibility, sterilization, etc.) and, in this case, some real-world usage data. It does not involve AI/ML performance metrics like sensitivity, specificity, or ground truth established by expert consensus for diagnostic accuracy.

Here's a breakdown of why many of your requested points are not applicable, followed by the information that can be extracted:

• Acceptance Criteria Table & Reported Performance: Not available in an AI/ML context. The document focuses on demonstrating the device's functional integrity and equivalence to a predicate.
• Sample Size (Test Set) & Data Provenance: Not applicable for an AI/ML test set. The clinical data mentioned is retrospective/real-world observational data on the previously cleared device.
• Number of Experts & Qualifications (Ground Truth): Not applicable as there's no diagnostic AI/ML algorithm requiring ground truth establishment by experts.
• Adjudication Method: Not applicable.
• MRMC Comparative Effectiveness Study: Not applicable.
• Standalone Performance: Not applicable as it's a physical catheter, not an AI/ML algorithm.
• Type of Ground Truth: Not applicable. The "ground truth" for a physical device is its functional performance and safety during use.
• Sample Size (Training Set): Not applicable as there's no AI/ML model to train.
• How Ground Truth for Training Set was Established: Not applicable.

Information that can be extracted from the provided document regarding the CPS Locator 3D Delivery Catheter:

The document describes the acceptance criteria and study to demonstrate substantial equivalence for a physical medical device, not an AI/ML system. Therefore, many of the requested fields related to AI/ML software evaluation are not directly applicable.

Here's a summary of the relevant information provided:

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

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

• Test Set (Bench/Performance Testing): Not explicitly stated as a separate "test set" for the new submission, but the document mentions "All testing was performed on test units representative of finished devices." The specific number of units for each bench test is not provided in this summary.
• Clinical Data (Real-World Evidence):
  • Post-market study: Data collected from 42 physicians at multiple US centers.
  • Retrospective Observational Study 1: Not explicitly stated sample size, but mentioned "patients."
  • Retrospective Observational Study 2: 66 patients.
  • HeartRhythm Publication: 8 patients.
• Data Provenance: Primarily United States (US) centers. The data is described as post-market, real-world observational, and retrospective from the previously cleared predicate device (K230363).

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

• Not Applicable. This is a physical medical device clearance, not an AI/ML diagnostic device requiring expert-established ground truth for performance metrics like sensitivity/specificity. The "ground truth" for the clinical data related to lead delivery success was based on actual surgical outcomes reported by physicians.

4. Adjudication method for the test set

• Not Applicable. No expert adjudication for an AI/ML algorithm's output was performed.

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

• Not Applicable. This is a physical medical device, not an AI/ML system.

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

• Not Applicable. This is a physical medical device.

7. The type of ground truth used

• For the clinical data, the "ground truth" was based on observed clinical outcomes (e.g., successful lead delivery, achievement of LBBAP, reported complications/adverse events) as documented and reported by treating physicians and study investigators. This is akin to patient outcomes data in real-world settings.

8. The sample size for the training set

• Not Applicable. There is no AI/ML algorithm with a training set.

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

• Not Applicable. There is no AI/ML algorithm with a training set.

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The Cora Microcatheters are intended to be used in conjunction with steerable guidewires to access discrete regions of the coronary and peripheral vasculature. They may be used to facilitate placement and exchange of guidewires and other interventional devices and provide a conduit for the delivery of saline solutions of diagnostic contrast.

The CoraFlex and CoraForce Microcatheters (Cora Microcatheters) are single lumen catheters designed to access the peripheral and coronary vasculature. Each configuration has a hydrophilic coated coiled catheter with a braided support matrix, radiopaque distal tip, proximal luer, and "spin-friendly" strain relief. The Cora Microcatheters will also allow for the exchange of guidewires and provide a conduit for delivery diagnostic or therapeutic agents.

This document is a 510(k) clearance letter for medical microcatheters, not an AI/ML device. Therefore, the requested information about acceptance criteria, study data, ground truth, and expert involvement for AI device performance is not applicable to this submission.

The FDA clearance is based on non-clinical (bench) testing demonstrating substantial equivalence to a predicate device, as indicated by the following sections:

1. A table of acceptance criteria and the reported device performance:
This information is not provided in a table format. The document states:
"The Cora Microcatheters met all specified criteria and did not raise new questions regarding safety and effectiveness compared to the predicate."
And
"Based on the performance testing, the Cora Microcatheters were found to be substantially equivalent to the predicate."

The specific criteria and direct performance metrics are not detailed in this summary, but the types of tests performed indicate the areas of performance evaluated:

• Simulated Use
• Dimensional Verification
• Radiopacity
• Leak Testing
• Kink Resistance
• Corrosion Resistance
• Component Integrity
• Bond Integrity
• Particulate Testing
• Torque Testing
• Burst Testing
• Lubricity and Coating Integrity Testing
• Design Validation/Usability
• Sterility Testing
• Biocompatibility Assessment

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 explicitly stated in the provided document. The study was non-clinical (bench testing).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
Not applicable, as this is a non-clinical device clearance.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
Not applicable, as this is a non-clinical device clearance.

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, as this is a non-clinical device clearance and does not involve AI or human readers.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
Not applicable, as this is a non-clinical device clearance and does not involve an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
Not applicable. The "ground truth" for this device would be established by engineering specifications and industry standards for medical device performance, as evaluated through bench testing.

8. The sample size for the training set:
Not applicable, as this is a non-clinical device and does not involve a training set as in AI/ML.

9. How the ground truth for the training set was established:
Not applicable, as this is a non-clinical device and does not involve a training set as in AI/ML.

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

The Hydrophilic Guiding Catheter consists of a reinforced body with a hub and strain relief at the proximal end and an intermediate and soft tip at the distal end. The distal part of the catheter features a specific tip shape. A part of the catheter body features a hydrophilic coating. The (distal part of the) catheter body is provided either with or without "in-line" side holes.

The guiding catheter is a flexible plastic tube featuring a luer hub, strain relief, a body, an intermediate tip, and a soft tip. The body and the intermediate tip consist of an inner liner (basecoat) and an outer jacket (topcoat) reinforced with a tightly wound stainless steel braid wire in between the layers. The central lumen of the catheter is used for the percutaneous, transluminal passage and placement of guidewires, diagnostic and therapeutic devices within the vascular system. After the catheter is inserted through the skin using a dilator, a sheath (introducer) and guide wire is brought into position. Subsequently, a guidewire is advanced through its lumen and tracked over by a diagnostic device and/or a therapeutic devices to the intended location. The distal section of the catheters has a variety of preformed shapes (e.g. Judkins Left (abbreviated as JL), Judkins Right (JR), Amplatz (AL), Multi-purpose (MP), hockey stick) to facilitate placement of the catheter tip in the desired target vessel. Some catheter models feature two (2) small "in-line" side holes in the intermediate tip section to maintain perfusion of the target vessel. This device is a single-use device (i.e., single patient, single procedure, single purpose use). After finalizing the procedure, the catheter is withdrawn, removed and discarded.

This document is an FDA 510(k) clearance letter for a medical device, specifically a "Primum Hydrophilic Guiding Catheter." It is NOT about a software-based AI/ML device, and therefore does not contain the information requested in your prompt regarding acceptance criteria, study details, human reader studies, or ground truth for AI models.

The device discussed is a physical catheter, and its acceptance criteria and proof of performance are based on bench testing (biocompatibility, physical properties tests) and comparison to a "predicate" device (another catheter already on the market) that is essentially the same product under a different trade name.

Therefore, I cannot provide the information requested in your prompt related to AI/ML device evaluation, as the provided text describes a traditional medical device clearance.

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The Delivery Catheter is indicated for the introduction of various types of catheters and pacing or defibrillator leads.

The modified Delivery Catheter (CPS Locator 3D Delivery Catheter) is a single-use percutaneous catheter indicated for the introduction of various types of catheters and pacing or defibrillation leads.

The modified Delivery Catheter is packaged with a dilator for introduction into the vasculature. Proximally, the modified Delivery Catheter is equipped with a hemostatic valve, and the distal soft, rounded, radiopaque tip facilitates imaging under fluoroscopy. The modified Delivery Catheter is designed to be slittable, thereby allowing its removal after device placement. A variety of curves and lengths are available to accommodate various anatomies and different locations.

This document describes the FDA 510(k) clearance for the CPS Locator 3D Plus Delivery Catheter, a medical device. Based on the provided text, the device is a percutaneous catheter used for introducing various types of catheters and pacing or defibrillator leads. The clearance is based on its substantial equivalence to a predicate device (CPS Locator 3D Delivery Catheter, K230363).

However, the provided text does not contain any information about an AI/ML-based device or any study that would typically be described with the requested criteria (e.g., sample sizes, expert adjudication, MRMC studies, ground truth establishment, training sets). The acceptance criteria mentioned are related to engineering and biological performance of a physical medical device (catheter) rather than the performance of an AI/ML algorithm.

Therefore, I cannot fulfill your request for information related to an AI/ML device's acceptance criteria and study data based on this document. The document describes a traditional medical device clearance, not an AI/ML software clearance.

**If your intention was to ask about the acceptance criteria and supporting studies for a physical medical device as described in the document, here is the information: **

1. Table of Acceptance Criteria and Reported Device Performance:

The document outlines performance tests conducted, implying these tests have acceptance criteria which the device met ("passed the following tests"). Specific quantitative acceptance criteria (e.g., "leak rate must be < X ml/min") and exact reported performance values are not detailed in this summary, but the general categories of testing are listed.

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

The document states, "All testing was performed on test units representative of finished devices." However, it does not specify the sample sizes for any of the performance tests. Given this is a physical medical device, the "data provenance" would refer to the characteristics of the test units themselves (e.g., manufacturing lot, material specifications) rather than typical software data provenance like country of origin or retrospective/prospective data. This information is not provided.

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

This information is not applicable or provided for a physical device clearance where performance is typically measured through engineering tests and adherence to standards, not human expert interpretation for "ground truth."

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

This information is not applicable or provided for the type of testing described (engineering performance tests).

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

This information is not applicable or provided. The device is a physical catheter, not an AI/ML software tool that assists human readers.

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

This information is not applicable or provided. The device is a physical catheter, not an algorithm.

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

For the engineering and physical performance tests, the "ground truth" would be established by the defined specifications, engineering tolerances, and regulatory standards (e.g., ISO, ANSI/AAMI standards). For biocompatibility, it's compliance with established biological safety profiles and regulatory guidance. No "expert consensus," "pathology," or "outcomes data" is explicitly mentioned for establishing ground truth for these performance tests.

8. The sample size for the training set:

This information is not applicable or provided. The device is a physical catheter; there is no "training set" in the context of an AI/ML algorithm.

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

This information is not applicable or provided.

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The CenterFlow Molding Balloon Catheter is intended to assist in the dilatation of self-expanding endoprostheses in large diameter vessels.

The CenterFlow Molding Balloon Catheter is intended to assist in the dilatation of self-expanding endoprostheses in large diameter vessels. When used in its indications for use, it is a low-permissive, over-the-wire, single-use device comprised of two elongated non-compliant nylon balloons that are attached to and within a nitinol support frame. The two elongated balloons are constrained in a zigzag arrangement by the nitinol support frame. Upon inflation, this configuration enables expansion of the device head through balloon straightening, to assist the dilatation of self-expanding endoprostheses in large diameter vessels. Expansion of the zig-zag balloon configuration creates a central orifice permitting maintained hemodynamic flow during the molding procedure. The inflation lumen is 9 Fr and is made of PEBAX 72D. A co-axial PEBAX 72D guidewire lumen runs through the inflation lumen and device head and terminates into a distal polycarbonate tip. Two platinum-iridium markers provide angiographic visualization of the distal and proximal balloon edges to facilitate intravascular balloon placement prior to inflation. The catheter has a working length of 110 cm and it connects proximally to a standard Y-connector at the proximal end. The Y-connector allows for separation of two lumens - an angled luer-lock hub to inflate and deflate the balloon and a straight luer-lock hub which accepts a 0.035" guidewire. The device is deflated and inserted over the guidewire through the hemostasis valve of a transfemoral introducer sheath.

The provided text is a 510(k) premarket notification letter and summary for the CenterFlow Molding Balloon Catheter. This document details the device's intended use, design, and comparison to a predicate device. However, it does not contain any information regarding specific acceptance criteria or a study that proves the device meets those criteria in terms of performance metrics like accuracy, sensitivity, or specificity.

The "Non-Clinical Tests Summary & Conclusions" section lists the types of tests performed (Benchtop performance testing, Biological Safety Evaluation, In vivo safety evaluation, Packaging validation, Shelf-life validation, Usability Engineering evaluation), but it does not provide any quantitative results, acceptance criteria, or details of a study with a test set, ground truth, or expert involvement.

Therefore, I cannot provide the requested information for acceptance criteria and the study that proves the device meets them because the provided text does not contain any of that specific data.

Here’s what I can extract based on the information not present in the document:

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

   • Acceptance Criteria: Not available in the provided text.
   • Reported Device Performance: Not available in the provided text (beyond a general statement that "the subject device is substantially equivalent to the predicate device" based on non-clinical testing).

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): Not available for performance testing. (Note: "In vivo safety evaluation" is mentioned, which implies animal or human subjects, but no details on size or provenance are given for performance evaluation.)

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 available.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not available.

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 a physical catheter, not an AI or imaging diagnostic tool that would involve "human readers" or "AI assistance."

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable for this type of medical device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not available.

8. The sample size for the training set: Not applicable (not an AI/ML device with a training set).

9. How the ground truth for the training set was established: Not applicable.

In summary, the provided FDA 510(k) notification focuses on establishing substantial equivalence based on design features and general non-clinical testing (benchtop, biocompatibility, in vivo safety, etc.) for a physical medical device (balloon catheter), rather than providing detailed performance metrics typically associated with diagnostic or AI-powered devices. The document explicitly states the "Non-Clinical Tests Summary & Conclusions" showed substantial equivalence but does not elaborate on the specific quantifiable results or the methodology behind them.

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The Delivery Catheter is intended for the venous introduction of pacing or defibrillation leads.

The modified Delivery Catheter (FlexiGo 3D Delivery Catheter) is a single-use percutaneous catheter intended for venous introduction of pacing or defibrillation leads.

The modified Delivery Catheter is packaged with a dilator and two (2) trans vavular introducers for introduction into the vasculature. Proximally, the modified Delivery Catheter is equipped with a hemostatic valve, and the distal soft, rounded, radiopaque tip facilitates imaging under fluoroscopy. The modified Delivery Catheter is designed to be slittable, thereby allowing its removal after device placement. A variety of curves and lengths are available to accommodate various anatomies and different locations.

This document describes the FDA 510(k) Clearance Letter for the "FlexiGo 3D Delivery Catheter." This is a medical device, and the information provided details its intended use, comparison to a predicate device, and the performance data submitted for its clearance. However, the provided document does not contain any information related to an AI/ML (Artificial Intelligence/Machine Learning) device or study.

Therefore, I cannot provide a response that describes "Acceptance Criteria and the Study that Proves the Device Meets the Acceptance Criteria" in the context of an AI/ML device, nor can I fill in a table of acceptance criteria for an AI/ML device or discuss MRMC studies, training/test sets, or ground truth establishment relevant to AI/ML.

The provided text pertains to a traditional medical device (a catheter) and discusses its physical and functional characteristics, material compatibility, and standard medical device performance testing (biocompatibility, sterilization, dimensional verification, etc.).

To address your request, I would need a document describing an AI/ML medical device and its associated clinical study, statistical methodology, and performance metrics relevant to AI/ML algorithm evaluation.

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Dorado™ PTA Balloon Dilatation Catheter is recommended for Percutaneous Transluminal Angioplasty (PTA) of the renal, iliac, femoral, popliteal, tibial, peroneal, and subclavian arteries and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae. This device is also recommended for post-dilatation of balloon expandable and self expanding stents in the peripheral vasculature. This catheter is not for use in coronary arteries.

The Dorado™ PTA Balloon Dilatation Catheter is a high-performance balloon catheter consisting of an over the wire catheter with a balloon fixed at the distal tip. The proprietary non-compliant, low-profile balloon is designed to provide consistent balloon diameters and lengths even at high pressures. Two radiopaque markers delineate the working length of the balloon and aid in balloon placement. The catheter includes an atraumatic tip to facilitate advancement of the catheter to and through the stenosis. The novel catheter consists of a distal triple lumen and a proximal coaxial lumen and is designed to optimize the balance between pushabilty and trackability. The over the wire catheter is compatible with 0.035" guidewire and is available in 40, 80, 120, and 135 cm working lengths. The proximal portion of the catheter includes a female luer lock hub connected to the inflation lumen, and a female luer-lock hub connected to the guidewire lumen. Packaged with every product is a profile reducing sheath that is positioned over the balloon for protection before use. A re-wrapping tool is also provided on the catheter shaft. A stylet is placed into the tip of the catheter to aid in rewrap/refolding of the balloon. These products are not made with natural rubber latex.

This 510(k) clearance letter is for a medical device (Dorado™ PTA Balloon Dilatation Catheter), not an AI/Software as a Medical Device (SaMD).

Therefore, the information requested in your prompt (e.g., acceptance criteria for AI algorithm performance, sample sizes for test/training sets, expert adjudication, MRMC studies, ground truth establishment) is not applicable to this document.

The document discusses the performance evaluation of a physical medical device, focusing on in vitro pre-clinical testing to demonstrate substantial equivalence to a predicate device. This includes:

• Performance Data: Trackability, Balloon Burst Strength, Balloon Fatigue, Sheath Compatibility, Dimensional Verification, Simulated Use, etc.
• Biocompatibility Testing: Cytotoxicity, Sensitization, Irritation, Systemic Toxicity, Hemocompatibility.

The acceptance criteria for this device would be engineering specifications and safety standards for balloon catheters, not statistical metrics for AI algorithm performance.

In summary, based on the provided document, I cannot answer the questions related to AI/SaMD acceptance criteria and study design. The document describes the clearance of a traditional physical medical device.

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