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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 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 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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