(140 days)
The Explorer™ Liver device is indicated for open liver surgical procedures where image-guidance may be appropriate and where the patient can tolerate long apneic periods under general anesthesia.
The Explorer™ Liver system is an image-guided surgery medical device specifically designed to aid physicians during open liver procedures. The device is capable of mapping the current surgical position of tracked instruments onto preoperative, patient-specific MRI or CT medical images. These images can then be used as a guide by the physician for more accurate localization of tumors and other surrounding anatomic structures during liver surgery. The Explorer™ Liver system consists of six (6) components which are listed below:
- An image-guided surgery software platform installed on a personal computer (PC) (1)
- A three lens active-based optical position sensor that can accurately localize the tracked devices (2) listed below
- A tracked adapter multi tool (used for localization of rigid surgical instruments and to (a) define 3-D surgical space)
- A tracked laser range scanner (b)
- A tracked Localization Probe (c)
- An LCD display monitor. (3)
The provided text is a 510(k) summary for the Explorer™ Liver system. It describes the device, its indications for use, and states that performance data from validation and verification studies demonstrate the device's safety and accuracy. However, this document does not contain explicit acceptance criteria or the details of a study that proves the device meets those criteria.
The "Performance Data" section (VII) is very brief and only states: "Validation and verification studies were conducted to evaluate the performance characteristics of the Explorer™ Liver system. The results of these studies demonstrate that the device is capable of safely and accurately performing the stated intended use." It does not provide any specific metrics, thresholds, sample sizes, or methodologies for these studies.
Therefore, I cannot fulfill your request for a table of acceptance criteria, device performance, sample sizes, data provenance, expert qualifications, adjudication methods, MRMC study details, standalone study details, types of ground truth, or training set information based solely on the provided text.
The document is a high-level summary for regulatory submission, not a detailed technical report of the studies themselves. To answer your questions, one would need access to the actual validation and verification study reports mentioned.
§ 882.4560 Stereotaxic instrument.
(a)
Identification. A stereotaxic instrument is a device consisting of a rigid frame with a calibrated guide mechanism for precisely positioning probes or other devices within a patient's brain, spinal cord, or other part of the nervous system.(b)
Classification. Class II (performance standards).