Search Results

The Acessa Pro Vu System is indicated for use in percutaneous, laparoscopic coagulation and ablation of soft tissue, including treatment of symptomatic uterine fibroids under laparoscopic ultrasound guidance.

The Acessa ProVu System includes optional electromagnetic guidance for enhancing the ultrasonic image of the Acessa ProVu Handpiece and for predicting its future path on a computer monitor screen which also shows the ultrasound B-scan image.

The Acessa ProVu System provides radiofrequency (RF) ablation, ultrasound visualization and guidance within a single console and includes additional accessories. The Acessa ProVu System consists of a console with push buttons to control menu functionality. The console contains the following hardware and electronic components:

• RF Ablation System
• Ultrasound Visualization System
• Guidance System

The following accessories connect to the console:

• Dual Foot pedal (one for RF ablation and one for coagulation)
• Video Cable
• Power Cord
• Acessa Pads and Acessa Pad Cable
• Acessa ProVu Handpiece and Acessa ProVu Handpiece Cable
• Acessa Transducer, either:
  • Acessa ProVu Transducer used with Acessa ProVu Transducer Sleeve (embedded with sensor), or
  • Acessa ProVu Transducer with (embedded) sensor
• Acessa Table Top Field Generator or Acessa ProVu Planar Field Generator
• Monitor (hospital-owned accessory monitor, not provided by Acessa)

The Acessa ProVu System is designed to deliver up to 200 W of RF power at 460 kHz in three operational modes: Temperature Control, Power Control and Coagulation Mode. The graphical user interface (GUI) is displayed on a hospital-owned monitor. The system enables selection of operational parameters such as the mode of operation, the ablation time, the target temperature, and the power delivery level. With the Acessa ProVu Handpiece placed in the tissue to be ablated and its electrodes deployed, RF power can be turned on. The system parameters are continuously monitored and displayed on the monitor. If the measured parameters are outside the acceptable limits, the RF energy delivery automatically stops and a message appears on the graphical user interface. RF energy during an ablation or coagulation can also be stopped at any time by the user by pressing the foot pedal.

The Acessa ProVu System uses electromagnetic tracking technology to track the positions of the Acessa ProVu Transducer used with Acessa ProVu Transducer Sleeve (or the Acessa ProVu Transducer with embedded sensor) and the Acessa ProVu Handpiece shaft and draws virtual representations of them in their spatial relationship, so that a physician can predict the Acessa ProVu Handpiece shaft's future path in relation to the features in the ultrasound slice. The use of the guidance functionality is considered an optional accessory to procedures where ultrasound is currently used for visualization, such as the Acessa System procedure.

The provided text describes the Acessa ProVu System and its premarket notification to the FDA. However, it does not contain a study to prove the device meets acceptance criteria, nor does it define specific acceptance criteria with quantitative performance metrics for the device. The document primarily focuses on demonstrating substantial equivalence to predicate devices through a comparison of technological characteristics and a summary of non-clinical bench testing.

Therefore, I cannot fulfill the request for a table of acceptance criteria and reported device performance, sample size used for the test set, data provenance, number of experts for ground truth, adjudication methods, MRMC study details, standalone performance, type of ground truth, training set sample size, and how training ground truth was established. This information is not present in the provided text.

The closest relevant information is a general statement that "The performance data demonstrate that the subject device is substantially equivalent to the predicate devices" and a list of non-clinical bench tests performed:

• Biocompatibility Testing
• Use Life Testing of Transducers
• Electrical Safety and Electromagnetic Compatibility testing per various IEC/ANSI standards
• Software Validation and Verification Testing per FDA guidance (software considered "major" level of concern)
• Acessa ProVu Console and Guidance System Level Testing
• Benchtop Ablation Testing to validate substantial equivalence to the predicate
• Acessa ProVu Handpiece Performance Testing
• Acessa Pads Performance Testing
• Acessa ProVu Transducer Performance Testing (Acoustical and Thermal Measurement, in conformance with IEC 60601-2-37)
• Acessa ProVu Transducer Sleeve Testing

The document states that the Acessa ProVu System includes optional electromagnetic guidance with an accuracy of ±10 mm. This is the only quantitative performance metric mentioned in relation to the device's functionality. It does not, however, present this as an "acceptance criterion" that was tested in a "study" with specific results.

Ask a specific question about this device