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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 AcQGuide® Catheter Introducer Sets are indicated for introducing various cardiovascular catheters into the heart, including the left side of the heart through the interatrial septum.

The AcQGuide Catheter Introducer Sets contain either a steerable introducer (AcQGuide FLEX) or fixed curve introducer (AcQGuide MINI), an integrated vessel dilator/transseptal needle (AcQCross Qx), guidewire, and electrocardiogram (ECG) and electrosurgical (ES) adapter cables. The sets are designed to facilitate vascular access to the heart and then provide variable catheter positioning within the cardiac anatomy.

The provided text is a 510(k) summary for the AcQGuide® FLEX and AcQGuide® MINI Introducers with AcQCross™ Qx dilator/transseptal needle. It focuses on demonstrating substantial equivalence to predicate devices rather than providing a detailed study of acceptance criteria and device performance in the typical sense of a clinical trial for AI/software-as-a-medical-device.

Based on the document, here's an analysis of the requested information:

1. Table of acceptance criteria and the reported device performance

The document does not explicitly state quantitative acceptance criteria or a performance table for a device's diagnostic accuracy or efficacy in the way one might expect for an AI device. Instead, it describes performance data related to the safety and functionality of the device, particularly focusing on the changes made (ES adapter cable and hemostasis valve). The "performance" demonstrated is primarily about meeting existing standards and showing substantial equivalence to predicate devices.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document describes bench testing for specific components and functionalities rather than a "test set" in the context of diagnostic performance evaluation for a machine learning model.

• Biocompatibility: No new testing was performed; leveraged prior biocompatibility data from predicate devices (K170373, K171081) and a similar device (K192016).
• Sterilization: Process adoption via AAMI TIR28, not new testing on a sample set.
• Electrical Safety & EMC: Testing was conducted on the AcQGuide Introducer Set devices with the new ES adapter cable. No sample size is explicitly given, but this would typically involve a small number of devices to demonstrate compliance with standards.
• Bench Testing (ES Compatibility, Packaging, Hemostasis): Testing was performed for these aspects. No specific sample sizes are mentioned, but for bench testing, these are typically conducted on a representative sample of devices, often in the range of 3-10 units, to demonstrate compliance with engineering specifications and standards.

The data provenance is not specified, but these are typically retrospective in the sense that they are engineering tests performed by the manufacturer, rather than prospective clinical trials. The country of origin for the data (testing lab location) is not provided.

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 question is not applicable. The product described is a medical device (catheter introducer set), not an AI/diagnostic software. Therefore, there is no "ground truth" to be established by medical experts in the context of diagnostic accuracy, nor a "test set" for expert review. The testing described is engineering compliance and performance testing.

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

This question is not applicable for a hardware device undergoing engineering and compliance testing. Adjudication methods are relevant for interpretation of diagnostic images or clinical outcomes, typically in studies involving human readers or AI algorithms.

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 device is a physical medical instrument, not an AI system. Therefore, no MRMC study, human reader improvement, or AI assistance is relevant to the information provided.

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

This question is not applicable as the device is not an algorithm or AI system.

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

This question is not applicable. As explained in point 3, there is no "ground truth" in the context of diagnostic accuracy for this hardware device. The "truth" in these tests is compliance with engineering specifications, safety standards (e.g., biocompatibility limits, electrical safety thresholds), and functional performance parameters (e.g., hemostasis, mechanical integrity).

8. The sample size for the training set

This question is not applicable. There is no training set mentioned or relevant for this type of medical device submission.

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

This question is not applicable for the same reason as point 8.

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