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The Cross Vascular RF Transseptal Needle and Connection Cable 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 Cross Vascular RF Transseptal Needle is used in transseptal surgical procedures to puncture the fossa ovalis and gain access from the right side of the left atrium. The RF Transseptal Needle within a compatible transseptal introducer set (Table 4) along with radiofrequency (RF) energy from the RF Generator is used to facilitate the septal puncture. The RF Transseptal Needle delivers RF power in a monopolar mode between the device's distal electrode and a commercially available external Patient Return Electrode (PRE) which is in compliance with IEC 60601-2-2. The RF Transseptal Needle is loaded through a compatible transseptal sheath and dilator (Table 4) and is connected at its proximal end to the Cross Vascular RF Generator via the Cross Vascular Connection Cable. The distal end of the needle contains a small through hole to facilitate injection of contrast solution. The active tip is specially shaped to be atraumatic to the cardiac tissue until RF energy is applied.

This document is a 510(k) Premarket Notification from the FDA regarding the "Cross Vascular RF Transseptal Needle" and "Cross Vascular Connection Cable." It primarily focuses on demonstrating substantial equivalence to a predicate device rather than presenting a detailed study proving the device meets specific acceptance criteria with performance metrics.

Therefore, much of the requested information about acceptance criteria, study details, sample sizes for test and training sets, expert involvement, and ground truth establishment, including specific performance metrics for AI algorithms, is not applicable or unavailable in this document. This document describes a medical device, not an AI-powered diagnostic or assistive technology.

However, I can extract the information that is present and indicate where the requested information is not provided.

1. Table of Acceptance Criteria and Reported Device Performance

This document does not present a table with specific acceptance criteria (e.g., sensitivity, specificity, accuracy targets) and corresponding reported device performance in the manner typically seen for diagnostic algorithms. Instead, it describes various non-clinical performance data and compliance with standards.

For medical devices like the Cross Vascular RF Transseptal Needle, "acceptance criteria" are typically met by demonstrating compliance with recognized standards and performing bench, biocompatibility, and electrical safety testing. The "reported device performance" in this context refers to the successful completion of these tests, indicating the device functions as intended and safely.

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

This information is not provided in the document. The document describes bench testing and compliance with standards, which would involve a number of units, but specific sample sizes for these tests are not detailed. The data provenance is internal to Cross Vascular Inc. and its testing partners (e.g., labs for biocompatibility, electrical safety). This is not a study involving patient data, so "country of origin of the data" or "retrospective/prospective" does not apply in the context of clinical data.

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

This information is not applicable/not provided. The "ground truth" concept, in the way it is typically used for AI-powered diagnostic devices requiring expert consensus on images or outcomes, does not apply here. The device is a physical medical instrument. Bench testing and compliance with standards typically involve engineers, quality assurance personnel, and certified laboratories verifying physical and functional properties, rather than medical experts establishing a "ground truth" for a dataset.

4. Adjudication Method for the Test Set

This information is not applicable/not provided. Adjudication methods like "2+1, 3+1" are relevant for expert review of cases in clinical studies or AI algorithm validation, especially when establishing ground truth. This document pertains to the physical and functional performance of a medical device, where 'adjudication' in this sense is not relevant.

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/not provided. An MRMC study is relevant for evaluating the impact of AI in diagnostic or assistive tools on human performance. This device is an RF transseptal needle, a surgical instrument, not an AI software.

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

This information is not applicable/not provided. This device is a physical medical instrument, not an algorithm.

7. The Type of Ground Truth Used

This information is not applicable/not provided in the sense of expert consensus, pathology, or outcomes data for a diagnostic algorithm. For a physical device, the "ground truth" for testing would be defined by the specifications in recognized standards (e.g., ISO, IEC, ASTM) and the device's design specifications. Performance is measured against these established engineering and safety benchmarks. For example, for biocompatibility, the ground truth is "non-toxic" or "non-hemolytic" as defined by the international standards.

8. The Sample Size for the Training Set

This information is not applicable/not provided. This document does not describe the development or validation of an AI algorithm with training data.

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

This information is not applicable/not provided. This document does not describe the development or validation of an AI algorithm with training data.

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The Cross Vascular RF Generator and Footswitch (optional accessory) are to be used with separately cleared RF puncture devices in cardiovascular transseptal access procedures to create an atrial septal defect.

The Cross Vascular RF Generator (Figure 1) is a rechargeable battery-operated device used with compatible, separately cleared RF Transseptal Needles (i.e., Cross Vascular Models RFN-XX-CX) which are connected to the RF Generator through a Cross Vascular Connection Cable. The RF Generator delivers power in a monopolar mode between the distal tip electrode and a commercially available patient return electrode such as the Valleylabs Patient Return Electrode Model #E7507. An optional Cross Vascular Footswitch may be used with the RF Generator.

This document is a 510(k) summary for the Cross Vascular RF Generator and Footswitch, detailing its substantial equivalence to a predicate device. It primarily focuses on the device's technical specifications, non-clinical performance data, and regulatory compliance.

However, the provided text does not contain information about a study that proves the device meets specific acceptance criteria related to a clinical performance study with a test set, expert involvement, or comparative effectiveness with AI. The document explicitly states "Nonclinical Performance Data" and details software validation, bench testing, electrical safety, and electromagnetic compatibility. It concludes that the device performs as intended and presents no unacceptable risks based on these non-clinical tests.

Therefore, it is not possible to fill in the requested table and answer the study-specific questions based on the provided document. The device in question is a radiofrequency generator, which, in this context, is likely evaluated based on its power output, safety features, and mechanical/electrical performance, rather than on diagnostic accuracy or clinical outcomes that would typically involve a multi-reader multi-case (MRMC) study or ground truth established by experts.

Summary of what can be extracted from the document regarding acceptance criteria and performance (non-clinical):

The document details performance information in the "Nonclinical Performance Data" section (Section 5.5). The acceptance criteria are implicit in the conformance to standards and the successful completion of various bench tests.

Acceptance Criteria (Implicit from testing conducted):

• Software Validation: The custom software for controlling the user interface and device settings/outputs must be validated, and risks appropriately assessed and mitigated. (Major Level of Concer SW, no cybersecurity concerns as it's not Wi-Fi enabled).
• Transit Testing: The device and accessories must withstand simulated transit conditions.
• Labeling Verification: Labels must be accurate and compliant.
• Visual Inspection: Device passes visual inspection.
• Unit Verification:
  • Weight: Meets specified weight.
  • Operational States: All 5 defined operational states (Standby, Ready, RF On, Alert, Error) function correctly.
  • Battery Discharge: Battery discharges as expected.
  • Display: Display functions correctly.
• Cleaning Verification: Device can be effectively cleaned.
• Functionality:
  • Electrical: Electrical functions perform as intended.
  • Footswitch: Footswitch functions correctly.
  • Battery: Battery functions correctly.
  • Alerts: Alerts function correctly.
• Compatibility:
  • Footswitch: Compatible with the RF Generator.
  • Battery: Compatible with the RF Generator.
  • Charger: Compatible with the RF Generator.
• Durability: Device demonstrates durability.
• Electrical Safety & EMC: Compliance with IEC 60601-1, IEC 60601-1-2, and IEC 60601-2-2.
• Power Output: The device successfully delivers RF power, with a maximum output of 25 Watts. (Implicit acceptance that this power is sufficient for the intended use of TSP procedures, highlighted in the comparison table).
• Impedance Range: Operates effectively over a specified impedance range (200-800 ohm: ±10%; 800-3500 ohm: ±20%).

Reported Device Performance (Implicit success in meeting the above criteria):

The document states, "The Cross Vascular RF Generator performs as intended and presents no unacceptable risks to the intended patient population or end user. The software validation, electrical compatibility and safety testing, and non-clinical bench data support the safety of the device and demonstrate that the Cross Vascular RF Generator performs as intended in the specified use conditions." This implies that all the above-mentioned tests were passed successfully, meeting their implicit performance criteria.

Unable to Answer/Not Applicable based on the provided document:

1. A table of acceptance criteria and the reported device performance (for clinical or AI studies): As explained, the document focuses on non-clinical engineering and safety performance. A specific table with quantitative clinical performance metrics (e.g., sensitivity, specificity, AUC) and their acceptance thresholds is not present because this is not a diagnostic AI device requiring such evaluation.
2. Sample sized used for the test set and the data provenance: Not applicable, as no clinical test set data is described. The "test set" discussed is for engineering bench testing (e.g., a sample of devices tested for durability).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable, as there's no clinical "ground truth" or expert review process described for this type of device (RF Generator).
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable.
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 an RF energy delivery device, not a diagnostic imaging AI system.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. While software validation was done, it's for controlling the device, not for a standalone diagnostic algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable. "Ground truth" in this context would relate to the physical and electrical phenomena being measured (e.g., power output accuracy, impedance).
8. The sample size for the training set: Not applicable. This device is not an AI/ML system that undergoes "training."
9. How the ground truth for the training set was established: Not applicable.

In conclusion, the provided document focuses on the engineering, electrical, and safety performance of an RF generator, demonstrating its substantial equivalence through non-clinical testing. It does not contain information related to the clinical performance studies, AI integration, or expert ground truth establishment typically associated with diagnostic AI devices.

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