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The CrossWise™ RF Transseptal Cannula and accessories are used to create an atrial septal defect in the heart. Secondary indications include infusing solutions including heparinized saline and mixtures of 50% contrast media and 50% saline.

The CrossWise RF Transseptal Access System is used to puncture the Fossa Ovalis (FO) to establish transcatheter access from the right atrium to the left atrium. Monopolar radiofrequency (RF) energy is delivered between the CrossWise focal force electrode and a patient return electrode. The unique design of the focal force electrode minimizes trauma to cardiac tissue unless RF energy is applied. A colored sleeve is provided on the CrossWise RF Transseptal Cannula handle to indicate to the user when the tip of the catheter is still within the dilator.

The CrossWise RF Transseptal Cannula is supplied with a compatible dilator and a Super Stiff 0.032" PTFE-Coated Fixed Core J-Tip guidewire for vascular introduction using an over-the-wire technique. The RF Transseptal Cannula is connected to a ValleyLabs Force2 Electrosurgical Generator (Medtronic, Inc) via the CrossWise Multi-Use RF Adapter Cable (packaged separately – Model CW-1001) and a commercially available Electrosurgical Pencil.

This 510(k) clearance letter details the substantial equivalence of new models of the CrossWise RF Transseptal Access System to a previously cleared predicate device. It specifically states that the new models have minor modifications and leverage most of the performance data of the predicate device.

Therefore, the acceptance criteria and study details discussed below refer to the bench testing conducted for these minor modifications, as this is the only performance data explicitly mentioned for the subject device. The document does not contain information about clinical studies with human participants, expert ground truth adjudication, or AI performance, as it is related to a medical device's physical and functional equivalence, not an AI or diagnostic tool.

Acceptance Criteria and Study Proving Device Meets Acceptance Criteria

The provided 510(k) clearance letter details the acceptance criteria and the non-clinical performance data for the CrossWise RF Transseptal Access System line extensions (Models CW-1085C, CW-1085V, and CW-1013F). The study conducted to prove the device meets these criteria was a series of bench tests.

1. Table of Acceptance Criteria and Reported Device Performance

The letter explicitly states that the new models leverage most of the performance data of the predicate device. The following table summarizes the specific tests conducted for the minor modifications of the new models and the implied performance criteria based on the conclusion of substantial equivalence.

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

• Sample Size: Not explicitly stated in terms of a number of devices or units. The testing refers to "minor modifications" to the dilator hub and compatibility with new introducer sheaths. For bench tests like these, a statistically representative sample size would have been used for each test (e.g., n=3, 5, or 10 units per test configuration), but the exact numbers are not provided.
• Data Provenance: The data is non-clinical bench testing conducted by the manufacturer, Circa Scientific, Inc. The location of the testing is not specified, but it would have been conducted in a laboratory setting under controlled conditions. This is not retrospective or prospective in the clinical sense, as it does not involve patient data.

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

• Not applicable. This document describes the clearance of a medical device (a transseptal access system), not an AI or diagnostic tool that relies on expert interpretation of data to establish ground truth. The acceptance criteria are based on objective engineering and performance standards demonstrated through bench testing.

4. Adjudication Method for the Test Set

• Not applicable. As this is non-clinical bench testing of a physical medical device against engineering standards, there is no expert adjudication process in the manner of medical image interpretation or clinical outcomes. Test results would have been analyzed and verified by qualified engineering and quality personnel.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

• No. An MRMC study is typically conducted for diagnostic devices or AI systems where human readers interpret patient cases. This clearance is for a physical medical device used in interventional cardiology.

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, so the concept of standalone algorithm performance is not relevant.

7. The Type of Ground Truth Used

• Engineering and Performance Standards: The "ground truth" for the bench tests would have been established by predefined engineering specifications, internationally recognized standards (e.g., ISO 80369-7, ISO 10993-1, ISO 11070-1), and the performance characteristics of the predicate device. For example, the ground truth for "Dilator Leak Test" would be "no leakage observed under specified pressure," and for "ISO 80369-7 Luer Testing" would be "full compliance with all requirements of the standard."

8. The Sample Size for the Training Set

• Not applicable. This is a physical medical device, not an AI or machine learning algorithm. Therefore, there is no "training set."

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

• Not applicable. As there is no training set, this question is not relevant.

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The CrossWise™ RF Transseptal Cannula and accessories are used to create an atrial septal defect in the heart. Secondary indications include infusing solutions including heparinized saline and mixtures of 50% contrast media and 50% saline.

The CrossWise RF Transseptal Access System is used to puncture the Fossa Ovalis (FO) to establish transcatheter access from the right atrium to the left atrium. Monopolar radiofrequency (RF) energy is delivered between the CrossWise focal force electrode and a patient return electrode. The unique design of the focal force electrode minimizes trauma to cardiac tissue unless RF energy is applied. A colored sleeve is provided on the CrossWise RF Transseptal Cannula handle to indicate to the user when the tip of the catheter is still within the dilator.

The CrossWise RF Transseptal Cannula is supplied with a compatible dilator and a Super Stiff 0.032" PTFE-Coated Fixed Core J-Tip guidewire for vascular introduction using an over-thewire technique. The RF Transseptal Cannula is connected to a ValleyLabs Force2 Electrosurgical Generator (Medtronic, Inc) via the CrossWise RF Adapter Cable (packaged separately - Model CW-1002) and a commercially available Electrosurgical Pencil.

The CrossWise RF Transseptal Cannula is designed to facilitate injection of heparinized saline and/or contrast solution. The dimensions for the CrossWise RF Transseptal Cannula can be found on the device label. The CrossWise RF Transseptal Access System offers four configurations compatible with various commercially available guide sheaths (Table 5). All four configurations require use of a single model (CW-1002) CrossWise RF Adapter Cable Model which is packaged separately.

This document does not describe a study involving device performance metrics relevant to AI/ML, such as sensitivity, specificity, or F1 score, or any human reader studies using AI assistance. The provided text is a 510(k) summary for a medical device (CrossWise RF Transseptal Access System) to demonstrate substantial equivalence to predicate devices, focusing on non-clinical performance data like biocompatibility, sterilization, electrical safety, and bench testing.

Therefore, many of the requested categories related to acceptance criteria, device performance, ground truth, and human reader studies cannot be populated from the given text.

Here's a breakdown of the information that can be extracted:

1. A table of Acceptance Criteria and the Reported Device Performance:

The document doesn't provide specific numerical acceptance criteria for performance metrics in a table format. Instead, it states that the device was tested to conform with various international standards and that "The nonclinical bench data support the safety of the device and demonstrate that the CrossWise RF Transseptal System performs as intended in the specified use conditions."

The types of tests performed and the general findings are:

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

• Test Set Sample Size: Not specified in terms of number of devices or number of tests for each type, other than "Devices were subjected to 2X sterilization and distribution simulation". The document states "Design verification testing was performed on the CrossWise RF Transseptal Access System with CrossWise RF Adapter Cable at two time points: immediately after manufacturing (T=0) and after six months of accelerated aging (T=6M AA)."
• Data Provenance: Not explicitly stated, however, the testing appears to be internal validation performed by the manufacturer, Circa Scientific, Inc., or a contract lab on their behalf. It is non-clinical (bench).

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 non-AI/ML medical device submission based on physical and electrical performance. Ground truth would be based on instrument readings, standardized methods, and expert evaluation of physical properties, not clinical expert consensus.

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

• Not applicable for this type of device and testing.

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:

• No. This is not an AI/ML device.

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

• No. This is not an AI/ML device.

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

• For the non-clinical performance data, the "ground truth" is based on:
  • Validated test methods outlined in international standards (e.g., ISO 10993 for biocompatibility, IEC 60601 for electrical safety, ISO 11135 for sterilization).
  • Objective measurements from laboratory equipment and physical inspection.
  • Functional verification against design specifications.

8. The sample size for the training set:

• Not applicable. This is not an AI/ML device.

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

• Not applicable. This is not an AI/ML device.

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