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The VersaCross Connect Transseptal Dilator is indicated for use in procedures where access to the left atrium via the transseptal technique is desired.

The subject VersaCross Connect™ Transseptal Dilator (VXA-AG) is a single-use device that is supplied sterile to the user.

The subject VersaCross Connect™ Transseptal Dilator (VXA-AG) represents modifications to the legally marketed VersaCross Connect™ Transseptal Dilator (K241720).

The VersaCross Connect™ Transseptal Dilator (VXA-AG) is designed for safe and easy catheterization and angiography of specific heart chambers and locations. The dilator provides torque control and is flexible. The dilator features a tapered tip and a shaft that can be reshaped manually. The echogenic shaft and tip and radiopaque tip maximize visualization of the dilator during manipulation in procedures.

The dilator can be used with separately cleared compatible access sheaths such as Agilis™ NxT Steerable Introducer (K061363 or K081645). The dilator provides support and helps guide separately cleared compatible transseptal wires to the atrial septum for puncture. The dilator subsequently dilates the atrial septal defect to enable larger diameter devices to cross the septum. The subject device can be used by electrophysiologists, interventional cardiologists, and other users trained in catheter techniques for any procedure that requires left atrial access via transseptal puncture. Procedures using the devices are performed in fully equipped catheter labs with imaging equipment, including fluoroscopy and echocardiography under sterile technique.

The provided FDA 510(k) Clearance Letter for the VersaCross Connect™ Transseptal Dilator does not contain information related to an AI/ML-driven medical device. The clearance is for a physical medical device (a vessel dilator) which has undergone design modifications.

Therefore, the requested information regarding acceptance criteria and studies proving the device meets those criteria, specifically concerning AI/ML performance, human reader improvement with AI assistance, standalone algorithm performance, and ground truth establishment for training and test sets, is not applicable to this document.

The document details the following for the physical device:

• Device: VersaCross Connect™ Transseptal Dilator
• Purpose: Used for procedures requiring access to the left atrium via the transseptal technique.
• Modifications: Design changes (hub color, dilator shaft dimensions, snap fit hub geometry, hub length) and non-patient contacting material changes from its predicate device (K241720).
• Verification and Validation Activities: These focused on the physical and material properties of the dilator, ensuring it meets performance, safety, and biocompatibility standards. Examples include:
  • Torque Transmission, Dilator Protrusion Length, Shaft Outer Diameter, Flexural Rigidity, etc.
  • Biocompatibility, Sterilization, Pyrogen testing, Packaging integrity.
  • Benchtop validation to confirm performance during normal intended use.
• Substantial Equivalence: The submission demonstrates that the modified device is substantially equivalent to its predicate, sharing the same intended use, indications for use, fundamental scientific technology, operating principles, and mechanism of action. The changes do not raise new questions of safety or effectiveness.

In summary, there is no AI/ML component described or evaluated in this 510(k) clearance document, and thus, no information is available to address the specific questions about AI/ML acceptance criteria and performance studies.

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The VersaCross Connect™ Transseptal Dilator is indicated for use in procedures where access to the left atrium via the transseptal technique is desired.

The subject VersaCross Connect™ Transseptal Dilator is a single-use device that is supplied sterile to the user. The subject VersaCross Connect™ Transseptal Dilator represents modifications made to the dilator component of the legally marketed VersaCross Connect™ Transseptal Dilator (K220414) (comprising of a dilator and J-tipped guidewire). A guidewire is not supplied with the subject device. However, the end user can use a separately cleared compatible 0.035″ quidewire. The VersaCross Connect™ Transseptal Dilator is designed for safe and easy catheterization and angiography of specific heart chambers and locations. The dilator provides torque control and is flexible. The dilator features a tapered tip and a shaft that can be reshaped manually. The echogenic shaft and tip and radiopaque tip maximize visualization of the dilator during manipulation in procedures. The dilator can be used with separately cleared compatible access sheaths such as CARTO VIZIGO™ Bi-Directional Guiding Sheath (K231412). The dilator provides support and helps guide separately cleared compatible transseptal wires to the atrial septum for puncture. The dilator subsequently dilates the atrial septal defect to enable larger diameter devices to cross the septum.

The provided document is an FDA 510(k) clearance letter for the VersaCross Connect™ Transseptal Dilator. It primarily focuses on demonstrating substantial equivalence to a predicate device through non-clinical performance testing.

Crucially, this document does not describe a study involving "acceptance criteria" for an AI/ML powered device, nor does it detail a study proving such a device meets these criteria.

The device in question, the VersaCross Connect™ Transseptal Dilator, is a mechanical medical device (a vessel dilator), not an AI/ML-powered one. The testing described is typical for a mechanical device and includes:

• Mechanical Testing: Torque Transmission, Torque Withstand, Flexural Rigidity, Shapeability, Curve Retention, Hub-Shaft Tensile, Tip to Tip Cap Cantilever and Tensile, Clamshell Tensile, Clamshell Cantilever.
• General Physical Testing: Luer Tests, Air and Liquid Leakage Tests, Corrosion Test.
• System Verification Testing: Compatibility Test, Snap Force Test.
• Biocompatibility Verification: Evaluated through adopted biological data of the predicate device (K220414).
• Sterilization Verification: Ethylene Oxide sterilization to a SAL of 10-6.
• Pyrogen Testing: Limulus Amoebocyte Lysate (LAL) testing.
• Packaging Verification: Ship testing and sterile barrier integrity.
• Benchtop Validation: To validate performance during normal intended use.

Therefore, I cannot extract the information required to populate the requested table and answer the questions about AI/ML device acceptance criteria and study details from the provided text.

The document states: "The proposed VersaCross Connect™ Transseptal Dilator met all test requirements as specified by applicable standards and test protocols. The verification and validation activities for safety and effectiveness, along with the testing completed for the design changes demonstrated the subject device meets its intended use and is as safe, as effective, and performs in a manner that is substantially equivalent to the predicate device." This is the general statement of compliance, but it does not provide specific acceptance criteria values or performance metrics in a tabulated format that would be relevant for an AI/ML device.

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The sheath is indicated for introducing various cardiovascular catheters to the heart, including the left side of the heart through the interatrial septum.

The sheath curve can be visualized when used with impedance-based electroanatomical mapping systems.

The proposed SureFlex HD Steerable Sheath and VersaCross HD Steerable Sheath subject devices are non-pyrogenic, single use devices that are supplied sterile to the UD Steerable Sheath families are comprised of the following components that are packaged together:

• . One Steerable Sheath
• . One Transseptal Dilator
• . One J-tip Mechanical Guidewire

The SureFlex and VersaCross HD Steerable Sheaths are intended for introducing various cardiovascular catheters to the heart, including the left side of the heart through the interatrial septum. The sheath curve can be visualized when used with separately cleared impedancebased electroanatomical mapping (EAM) systems. The steerable sheath component used in conjunction with a compatible transseptal dilator can facilitate transseptal puncture using separately cleared compatible needle or wire-based puncture devices. The steerable sheath component is connected to the impedance-based EAM system via a compatible legally marketed accessory cable. The subject device is used in a sterile environment where facilities are appropriately equipped and staffed to perform transseptal procedures.

The steerable sheath component is 8.5 Fr with a 63 cm or 73 cm useable length and is available in three curve options (small, medium, large). It is flexible and bi-directionally deflectable at the distal end (180 degrees clockwise and counterclockwise). The radiopaque tip (containing a platinum/iridium marker band) maximizes visualization of the sheath during manipulation. The sheath contains 4 electrodes equi-spaced along the shaft to enable shaft visualization. The sheath has two distal sideports and the proximal end includes a hemostasis valve and a 3-way stopcock to facilitate the injection or fluids. A silicone lubricant is applied to the outer surface of the shaft for smoother device manipulation. The sheath handle allows the user to control the deflection of the sheath tip through rotation of the knob in the direction of desired distal deflection.

The compatible dilator component is 8.5F with a 95cm usable length and is comprised of HDPE material with a tungsten radiopaque marker coil at the tip for visualization. The dilator has a tapered distal tip that provides support for the sheath. The compatible mechanical guidewire (0.032″ or 0.035″) component is J-tipped, 180 cm in length and is comprised of a stainless-steel core mandrel with a PTFE coating.

The provided document is a 510(k) Premarket Notification for medical devices, specifically steerable sheaths (SureFlex HD Steerable Sheath and VersaCross HD Steerable Sheath). It details the substantial equivalence determination made by the FDA.

Crucially, this document does NOT describe the acceptance criteria and study proving a device meets acceptance criteria for an AI/Software as a Medical Device (SaMD) product. The medical devices in question are physical catheters/sheaths, and the performance testing summarized refers to mechanical, electrical, biocompatibility, sterilization, pyrogen, and packaging testing, as well as a simulated-use animal study. These are typical validation activities for a physical medical device.

The only mention of "visualization" or "mapping systems" is in the context of the sheath's curve being visualized when used with impedance-based electroanatomical mapping systems, and the predicate device's compatibility with CARTO® 3 EP Navigation Systems. This refers to the ability of the physical sheath to be seen on separate, compatible systems, not an AI or SaMD performing a diagnostic or therapeutic function itself.

Therefore, I cannot provide the requested information regarding acceptance criteria and study proving a device meets acceptance criteria for an AI/Software as a Medical Device (SaMD) product based on the provided text, as this information is not present. The document focuses on the substantial equivalence of a physical medical device.

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The VersaCross Connect™ Transseptal Dilator is indicated for use in procedures where access to the left atrium via the transseptal technique is desired.

The subject VersaCross Connect™ Transseptal Dilator is a single-use device that is supplied sterile to the user. The device is comprised of a single dilator.

The subject VersaCross Connect™ Transseptal Dilator represents modifications made to the dilator component of the legally marketed VersaCross Connect™ Transseptal Dilator (K220414) (comprising of a dilator and J-tipped guidewire). A quidewire is not supplied with the subject device. However, the end user can use a separately cleared compatible 0.035″ quidewire.

The VersaCross Connect™ Transseptal Dilator is designed for safe and easy catheterization and angiography of specific heart chambers and locations. The dilator provides torque control and is flexible. The dilator features a tapered tip and a shaft that can be reshaped manually. The echogenic shaft and tip and radiopaque tip maximize visualization of the dilator during manipulation in procedures.

The dilator can be used with separately cleared compatible access sheaths such as FARADRIVE™ Steerable sheaths. The dilator may also be used as a standalone device to facilitate access to the left atrium following transseptal puncture. The dilator provides support and helps quide separately cleared compatible transseptal wires to the atrial septum for puncture. The dilator subsequently dilates the atrial septal defect to enable larger diameter devices to cross the septum.

This document describes the premarket notification (K233647) for the VersaCross Connect™ Transseptal Dilator. It is an updated version of a previously cleared device (K220414), with modifications primarily in dimensions and design for compatibility and the absence of a supplied guidewire. The FDA's review confirms substantial equivalence to the predicate device due to identical indications for use, fundamental scientific technology, and operating principles, supported by a comprehensive suite of non-clinical performance tests.

Here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance:

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

The document does not specify exact sample sizes for each mechanical, physical, or system verification test conducted. It generally refers to "test requirements" being met. The data provenance is not explicitly stated in terms of country of origin, but the tests were conducted by Baylis Medical Company Inc., which is based in Canada. These tests are non-clinical (benchtop) and are typically performed in a laboratory setting. They would be considered prospective in the sense that they were designed and executed to evaluate the new device.

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 device is a medical dilator, not an AI or diagnostic imaging device that requires expert interpretation for "ground truth" in the traditional sense of clinical data. The "ground truth" for this device's performance is established through adherence to recognized international standards (e.g., ISO, ANSI/AAMI) and the manufacturer's internal engineering requirements. Therefore, the "experts" involved would be a team of engineers, regulatory affairs specialists, quality assurance personnel, and potentially design validation specialists from Baylis Medical Company Inc. with expertise in medical device design, testing, and regulatory compliance. The document does not specify the number or specific qualifications of these individuals, as it's typically understood to be part of standard manufacturing and quality system practices.

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

Not applicable. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies involving human interpretation (e.g., reading medical images) to resolve discrepancies among experts. For a physical medical device undergoing non-clinical benchtop testing, the results are objectively measured against predefined scientific and engineering standards, not subject to subjective adjudication among experts.

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 (dilator), not an AI algorithm for diagnostic interpretation or a device designed to assist human readers. Therefore, an MRMC comparative effectiveness study, which is relevant for AI-powered diagnostic tools, was not performed.

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

Not applicable. This is a physical medical device, not an algorithm. Benchtop tests are inherently "standalone" in the sense that the device's physical properties and performance are measured objectively without human-in-the-loop clinical scenarios.

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

The "ground truth" for the performance tests conducted on the VersaCross Connect™ Transseptal Dilator is based on:

• International Standards: e.g., ISO 11070:2014/Amd.1:2018 (Vessel Dilators), ISO 80369-7:2021 (Luer connectors), ISO 10993-1:2020 (Biocompatibility), ISO 11135:2014/A1:2019 (Sterilization), ISO 10993-7:2008/A1:2022 (EO residuals), ANSI/AAMI ST72:2019 (Pyrogen testing), ISO 11607-1:2020 (Packaging).
• Manufacturer's Internal Requirements: Baylis Medical Company Inc. requirements, often derived from risk assessments and design specifications.
• Predicate Device Data: For biocompatibility, data from the predicate device (K220414) was adopted, indicating that prior established safety profiles serve as a ground truth baseline.

8. The sample size for the training set

Not applicable. This is a physical medical device undergoing non-clinical testing, not an AI model that requires a training set.

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

Not applicable, as there is no training set for a physical medical device.

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The ProTrack™ Pigtail Wires are intended for use to introduce and position catheters and other interventional devices within the chambers of the heart, including those used within transcatheter aortic valve procedures (TAVR).

The ProTrack™ Pigtail Wire is a single used for the patients requiring diagnostic and interventional procedures like transcatheter aortic valve replacement (TAVR). It is used to facilitate the introduction and placement of devices in catheterization procedures primarily by Electrophysiologists and Interventional Cardiologists. Procedures using the devices are performed in fully equipped catheter labs with imaging equipment, including fluoroscopy and echocardiography under sterile technique.

The device consists of a stainless-steel core wire with a flexible, spiral shaped stainless steel distal coil. A green PTFE coating is present on the entire length of the device and provides a lubricious surface for smooth tracking through accessory devices and vasculature. The Wire has a radiopaque coil (304V Stainless Steel) around the distal curve to allow visualization under appropriate imaging guidance during procedures. The device is offered in multiple models with two different lengths (230 cm and 275 cm), diameters (0.032″ and 0.035″), and distal curve shapes (regular and small). The device is provided sterilized).

The wire is classified as an external communicating device, contacting circulating blood, with limited exposure and contact up to a maximum of 24 hours. The patient contacting materials are PTFE coating, stainless steel and adhesive.

The provided FDA 510(k) summary (K213898) for the ProTrack™ Pigtail Wire does not contain information about the acceptance criteria or results from a study that typically applies to AI/ML software as a medical device (SaMD). This document is for a physical medical device (guidewire), and the performance testing described focuses on mechanical, physical, biocompatibility, sterilization, pyrogen, and packaging verification, as well as bench-top validation for user needs.

Therefore, the requested information about acceptance criteria for AI/ML performance, sample sizes for test sets, data provenance, expert ground truth adjudication, MRMC studies, standalone algorithm performance, ground truth types, and training set details are not applicable to the content of this document.

The document describes the following types of performance testing and their general outcomes:

1. Table of Acceptance Criteria and Reported Device Performance (as interpreted for a physical device):

The following information is not present in the provided document, as it pertains specifically to AI/ML software performance studies and not to a physical medical device like the ProTrack™ Pigtail Wire:

2. Sample size used for the test set and the data provenance.
3. Number of experts used to establish the ground truth for the test set and their qualifications.
4. Adjudication method for the test set.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and the effect size of how much human readers improve with AI vs without AI assistance.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.).
8. The sample size for the training set.
9. How the ground truth for the training set was established.

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The mechanical guidewire is intended for complex diagnostic and interventional procedures where increased body. flexibility, and low surface friction of the wire guide are needed. The guidewire is intended for perpheral vasculature use only, not intended for coronary or neurovascular use.

The Mechanical Guidewire consists of a stainless-steel core wire with a flexible, J-tip stainless steel distal tip. A green polytetrafluoroethylene (PTFE) coating is present on the entire length of the guidewire and provides a lubricious surface for tracking through compatible ancillary devices. The distal curve allows visualization under appropriate imaging guidance during diagnostic and interventional procedures. The device is offered in a 180 cm length, with two outside diameters (0.032″ and 0.035″), and one distal curve shape (1-tip). The tip curve radius for the Mechanical Guidewire measures 3 mm.

The provided text is a 510(k) Summary for a medical device called the "Mechanical Guidewire." This document focuses on demonstrating substantial equivalence to a predicate device, not on proving that a new AI/Software device meets specific acceptance criteria through a study.

Therefore, the input does not contain the information necessary to answer the questions about acceptance criteria for an AI/Software device, its performance, a test set, ground truth establishment, MRMC studies, or training sets. The document describes standard performance testing for a physical medical device (guidewire), such as mechanical testing, biocompatibility, sterilization, and packaging.

Specifically:

• 1. A table of acceptance criteria and the reported device performance: This document lists various mechanical, physical, biocompatibility, and sterilization tests performed on the guidewire. It states "All test requirements were met as specified by applicable standards and test protocols." However, it does not provide a table of specific acceptance limits and the quantitative results for each test. More importantly, these are physical device tests, not acceptance criteria for an AI/software device.
• 2. Sample sizes used for the test set and the data provenance: Not applicable. This document describes testing of a physical medical device, not an AI/software device with a "test set" of data.
• 3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for an AI/software device is not relevant to the testing described here for a mechanical guidewire.
• 4. Adjudication method for the test set: Not applicable.
• 5. If a multi reader multi case (MRMC) comparative effectiveness study was done: No, an MRMC study is not mentioned as this relates to human reader performance with AI assistance, which is not relevant to a mechanical guidewire.
• 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: Not applicable.
• 8. The sample size for the training set: Not applicable.
• 9. How the ground truth for the training set was established: Not applicable.

In summary, the provided text describes the regulatory clearance process for a physical medical device (a guidewire) by demonstrating substantial equivalence to a predicate device through various physical, mechanical, and biological tests. It does not pertain to the evaluation of an AI or software device, and thus the questions regarding acceptance criteria, test sets, ground truth, and human reader studies for AI/software are not answerable from this document.

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The Epicardial Access System is intended to access the epicardial surface of the heart via a subxiphoid approach.

The subject Epicardial Access System represents device modifications made to the Epicardial Steerable Guiding Sheath and Epicardial Introducer and Stylet components of the legally marketed Epicardial Access System (K191546). The Epicardial Access Needle component remains unchanged. The System is comprised of the following devices, which are single-use and supplied sterile to the user:

• Epicardial Access Needle
• Epicardial Steerable Guiding Sheath containing:
  • Steerable Sheath
  • Dilator
  • J-tip Guidewire
• Epicardial Introducer and Stylet
  The subject device is designed to provide access to the epicardial surface of the heart via a subxiphoid approach. It is used in percutaneous access procedures primarily by Electrophysiologists and Interventional Cardiologists trained in the subxiphoid approach. Procedures using the devices are performed in fully equipped catheter labs with imaging equipment, including fluoroscopy under sterile technique.

The provided document is a 510(k) premarket notification for a medical device (Epicardial Access System), which focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than undergoing a new product validation with acceptance criteria based on clinical outcomes or performance metrics like accuracy, sensitivity, or specificity, as would be typical for AI/ML-based devices.

Therefore, the supplied text does not contain the information requested for acceptance criteria and a study proving a device meets those criteria, specifically concerning data provenance, clinical performance metrics, expert adjudication, or MRMC studies. The document primarily details non-clinical performance testing (mechanical, general physical, biocompatibility, sterilization, pyrogen, and packaging verification) to show the modified device performs similarly to its predicate.

It describes hardware modifications to an existing system, not the development or validation of an AI/ML algorithm.

Here's a breakdown of why each requested point cannot be addressed from the given text:

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

   • Does not exist in the document. The document describes various non-clinical tests performed (mechanical, physical, biocompatibility, etc.) but does not list pre-defined quantitative acceptance criteria (e.g., success rates, tolerance levels, specific metric thresholds) for these tests, nor does it provide the reported performance values from these tests beyond a general statement that "Epicardial Access System met all test requirements."
   • This type of detailed performance data and acceptance criteria would typically be found in internal test reports, not in an FDA 510(k) summary focused on substantial equivalence.

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

   • Not applicable/Not present. The performance testing described is primarily non-clinical (benchtop mechanical, physical, etc.). There is no "test set" in the sense of a clinical dataset with patient data.
   • There is no mention of "data provenance" (country of origin, retrospective/prospective) because no clinical data or clinical test sets are used or described for device acceptance.

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

   • Not applicable/Not present. Since there is no clinical test set requiring human expert ground truth establishment, this information is not provided.

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

   • Not applicable/Not present. 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/Not present. This document discusses a physical medical device (catheter introducer system), not an AI/ML device. Therefore, no MRMC study or AI assistance evaluation was performed.

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

   • Not applicable/Not present. Not an AI/ML algorithm.

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

   • Not applicable/Not present. The "ground truth" for the non-clinical tests would be defined by engineering specifications and established test methods, not clinical outcomes or expert consensus.

8. The sample size for the training set:

   • Not applicable/Not present. This is not an AI/ML device; therefore, there is no training set mentioned.

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

   • Not applicable/Not present. No training set.

In summary, the provided FDA document pertains to a hardware medical device (Epicardial Access System) undergoing modifications and seeking 510(k) clearance by demonstrating substantial equivalence through non-clinical performance and engineering tests, not a software/AI device validated with clinical performance metrics against ground truth data.

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The VersaCross Connect™ Transseptal Dilator is indicated for use in procedures where access to the left atrium via the transseptal technique is desired

The subject device is comprised of the following components, which are single-use and supplied sterile to the user:

• One Dilator
• One J-tipped Guidewire

The subject VersaCross Connect™ Transseptal Dilator represents modifications made to the legally marketed ExpanSure™ Large Access Transseptal Dilator (K201288) (comprising a dilator and J-tipped Guidewire).

The VersaCross Connect™ Transseptal Dilator is designed for safe and easy catheterization and angiography of specific heart chambers and locations. The dilator provides torque control and is flexible. The dilator features a tapered tip and a shaft that can be reshaped manually. The echogenic shaft and tip and radiopaque tip maximize visualization of the dilator during manipulation.

The dilator can be used with separately cleared compatible introducer/access sheaths such as WATCHMAN™ Access sheaths. The dilator provides support and helps guide separately cleared compatible transseptal wires to the atrial septum for puncture. The dilator subsequently dilates the atrial septal defect to enable larger diameter devices to cross the septum.

The provided text is a 510(k) summary for a medical device called the VersaCross Connect™ Transseptal Dilator. It describes the device's characteristics, its comparison to a predicate device, and the non-clinical performance testing conducted to demonstrate its safety and effectiveness.

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

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly list quantitative acceptance criteria in a table format alongside specific device performance values. Instead, it states that the device "met all test requirements as specified by applicable standards and test protocols" for various tests. The acceptance criteria are implicitly defined by compliance with specified ISO standards and "Baylis self-enforced requirements."

A summary based on the provided text would look like this:

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

The document does not specify the sample sizes used for any of the non-clinical performance tests (mechanical, physical, system verification, biocompatibility, sterilization, pyrogen, packaging, benchtop).

The data provenance is from non-clinical performance testing conducted by Baylis Medical Company Inc. It is not patient or human data.

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

This question is not applicable to this document. The studies described are non-clinical performance tests on the device itself, not studies involving human interpretation or clinical data where "ground truth" would be established by medical experts for diagnostic or treatment purposes.

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

This question is not applicable. Adjudication methods are typically employed in clinical studies involving human assessments (e.g., radiology reads) to resolve discrepancies among experts. The studies here are objective engineering and laboratory 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 question is not applicable. The document describes the 510(k) submission for a physical medical device (Transseptal Dilator), not an AI/software device that assists human readers with interpretation. No MRMC study was conducted or mentioned.

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

This question is not applicable. The device is a physical dilator, not an algorithm or AI system.

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

This question is not applicable in the sense of clinical "ground truth." For the non-clinical tests, the "ground truth" is established by the specified ISO standards and internal Baylis requirements/protocols, which define the expected performance characteristics of the device.

8. The sample size for the training set

This question is not applicable. There is no "training set" as this is a physical medical device, not an AI or machine learning model.

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

This question is not applicable. As there is no training set for an AI model, the concept of establishing ground truth for it does not apply.

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The ExpanSure™ Large Access Transseptal Dilator is indicated for use in procedures where access to the left atrium via the transseptal technique is desired.

The subject ExpanSure™ Large Access Transseptal Dilator represents a modification to the dilator component of the legally marketed ExpanSure™ Transseptal Dilation System (K182064). The modification was for the addition of a metallic marker coil to the dilator distal tip for increased visibility under imaging during procedures.

The subject device is comprised of a dilator (ExpanSure Dilator) and J-tip guidewire, which are single-use and supplied sterile to the user. The ExpanSure Dilator is designed for safe and easy catheterization and angiography of specific heart chambers and locations. The dilator consists of an inner and outer polyethylene layer containing radio-pacifier for visibility under imaging during procedures. The inner and outer shaft layers are separated by a braid material for torqueability. The dilator distal tip includes a metallic marker coil to facilitate visualization under imaging during procedures. The outer surface of the dilator is coated with a silicone lubricant. The ExpanSure Dilator is compatible with 0.032″ and 0.035″ transseptal devices/quidewires and 12.5 Fr introducer sheaths. The J-tip quidewire is comprised of stainless steel.

This document describes the ExpanSure™ Large Access Transseptal Dilator (K201288), a medical device. However, it does not describe a software-based medical device or AI system. Therefore, the provided text does not contain information about acceptance criteria or a study proving that a device meets acceptance criteria in the context of AI/software performance.

Instead, this document is a 510(k) Premarket Notification summary for a traditional medical device (a vessel dilator). The "acceptance criteria" and "study" described herein refer to non-clinical performance testing (mechanical, physical, pyrogen, biocompatibility, packaging, and sterilization verification) to demonstrate substantial equivalence to a predicate device, not performance against clinical metrics for an AI algorithm.

Therefore, I cannot provide the requested information in the format of AI/software performance as the input document does not pertain to such a device.

Here's why the provided input doesn't fit the request about AI/software performance:

• Device Type: The device is a "vessel dilator for percutaneous catheterization," a physical, sterile, single-use medical instrument, not a software system.
• Performance Testing: The "Performance Testing" section lists mechanical tests, general physical tests, pyrogen testing, benchtop validation (for intended use), biocompatibility, packaging verification, and sterilization verification. These are standard tests for physical medical devices, not for evaluating AI model performance.
• Substantial Equivalence: The entire submission focuses on demonstrating "substantial equivalence" to a predicate physical device (K182064) based on shared intended use, technology, and similar materials, with modifications (a metallic marker coil) validated through the non-clinical tests listed.
• Absence of AI/Software Specifics: There is no mention of algorithms, data sets (training, validation, test), ground truth, expert readers, or performance metrics like sensitivity, specificity, or AUC, which would be expected for an AI/software device.

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The Epicardial Access System is intended to access the epicardial surface of the heart via a subxiphoid approach to facilitate electrophysiology studies.

The Epicardial Access System by Baylis Medical Company Inc. is a single use device that is supplied sterile to the user. The System is comprised of the following devices:

• Epicardial Access Needle
• Epicardial Steerable Guiding Sheath containing:
  • Steerable Sheath,
  • Dilator and
  • J-Tip Guidewire
• Epicardial Introducer and Stylet

The device is designed to provide access to the epicardial surface of the heart via a subxiphoid approach. It is used in percutaneous access procedures primarily by Electrophysiologists and Interventional Cardiologists trained in the subxiphoid approach. Procedures using the devices are performed in fully equipped catheter labs with imaging equipment, including fluoroscopy under sterile technique.

Here's an analysis of the provided text regarding acceptance criteria and the study proving device performance, specifically focusing on the Epicardial Access System.

It's important to note that the provided FDA 510(k) summary primarily focuses on benchtop and mechanical testing for substantial equivalence rather than a clinical study evaluating the device's accuracy or effectiveness in a diagnostic or AI-assisted context. Therefore, many of the requested elements (like MRMC studies, specific performance metrics for an AI algorithm, or detailed ground truth establishment for a diagnostic output) are not applicable or not explicitly stated in this type of submission. This document describes a medical device, a catheter introducer, not an AI/ML-driven diagnostic device.

Acceptance Criteria and Device Performance (Based on available information)

Since this is a submission for a Catheter Introducer (Epicardial Access System), the acceptance criteria are related to its physical and functional performance, ensuring it can safely and effectively provide access as intended. It is not an AI/ML diagnostic device, so criteria like sensitivity, specificity, or reader improvement with AI assistance are not relevant here.

Table of Acceptance Criteria and Reported Device Performance

Study Details (as per the document):

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

   • For Mechanical and General Physical Testing: The document states "All test requirements were met as specified by applicable standard and the test protocols." It doesn't specify an exact sample size for each individual test (e.g., number of needles tested for leakage). These typically involve a statistically determined sample size per test characteristic as per the relevant ISO standards (e.g., ISO 11070:2014).
   • For Bench-top Validation (Usability): "A minimum of 15 users drawn from populations familiar with catheter-based procedures."
   • Data Provenance: The and testing was conducted by Baylis Medical Company Inc., based in Mississauga, Ontario, Canada. The nature of these tests (mechanical, physical, chemical, and simulated usability) means that "country of origin of the data" in the sense of patient data is not applicable. These are in-vitro/ex-vivo tests. All studies described are prospective tests performed on the device prototypes/production samples.

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

   • This question is not applicable in the context of this device and study. The "ground truth" for mechanical testing is defined by engineering specifications and objective measurements (e.g., a specific force to failure, a specific leakage rate). For biocompatibility, it's defined by the biological response in standardized tests. For usability, it's based on observed user performance against pre-defined success criteria.
   • For the bench-top validation, the "experts" were "users drawn from populations familiar with catheter-based procedures" (e.g., Electrophysiologists and Interventional Cardiologists, as mentioned in the device description). Their "errors made" and "ease of use" observations would contribute to validating the device's usability in a simulated environment, rather than establishing a diagnostic "ground truth."

3. Adjudication Method for the Test Set:

   • None applicable in the sense of physician adjudication of image interpretations. For mechanical and physical tests, results are objectively measured against predefined pass/fail criteria. For the bench-top validation, observations were "recorded and evaluated to conclude if customer requirement were met." This implies internal evaluation against a benchmark rather than multi-expert adjudication for a diagnostic task.

4. 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 done, and it is not applicable for this type of device. The Epicardial Access System is a physical medical device (catheter introducer), not an AI-driven diagnostic tool or an imaging software. Its performance is related to its ability to provide access to the heart, not to improve human reading accuracy of images.

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

   • Not applicable. This device does not involve an algorithm for standalone performance.

6. The Type of Ground Truth Used:

   • For Mechanical and Physical Tests: Engineering specifications, ISO standards, and predefined pass/fail criteria (e.g., "Strength of Union," "Air and Liquid Leakage" within specified limits).
   • For Biocompatibility: Standardized in-vitro and in-vivo biological tests (e.g., hemolysis, cytotoxicity, irritation) with results compared against established safety benchmarks (ISO 10993).
   • For Sterilization: Confirmation of Sterility Assurance Level (SAL 10^-6) through validated methods.
   • For Pyrogenicity: LAL testing against FDA and USP limits.
   • For Packaging: Integrity under simulated shipping conditions per ANSI/AAMI/ISO 11607.
   • For Bench-top Validation: User performance against pre-defined tasks and operational criteria in a simulated environment. The "ground truth" is whether users can successfully perform the intended actions and if critical errors occur.

7. The Sample Size for the Training Set:

   • Not applicable. This is not an AI/ML device that requires a training set. The device design and manufacturing process are based on engineering principles and material science, not machine learning.

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

   • Not applicable, as there is no training set for an AI/ML algorithm.

Summary Conclusion:

The document describes the regulatory submission for a physical medical device, an Epicardial Access System, used for catheter introduction. The acceptance criteria and performance evaluation are primarily focused on the device's mechanical, physical, material, and usability characteristics to demonstrate substantial equivalence to a predicate device. It does not involve AI or diagnostic imaging, and therefore, many of the typical questions for AI medical devices (like MRMC, training sets, or expert ground truth for diagnostic accuracy) are not relevant to this submission. The "study" here is a series of comprehensive engineering and simulated-use verification and validation activities.

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