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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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