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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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