(30 days)
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:
- 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.
- 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).
- 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).
- Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable.
- 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.
- 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.
- 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).
- The sample size for the training set: Not applicable. This device is not an AI/ML system that undergoes "training."
- 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.
§ 878.4400 Electrosurgical cutting and coagulation device and accessories.
(a)
Identification. An electrosurgical cutting and coagulation device and accessories is a device intended to remove tissue and control bleeding by use of high-frequency electrical current.(b)
Classification. Class II.