(210 days)
The Explorer ™ Liver --- Passive Tracking 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 --- Passive Tracking 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 --- Passive Tracking system consists of eight (8) components which are listed below:
- An image-guided surgery software platform installed on a personal computer (PC) (1)
- (2) An optical position sensor --- the Polaris Spectra or Vicra that can accurately localize the tracked devices listed below in passive tracking mode
- . A passive tracked abdominal reference (used for definition of coordinate and instrument calibration)
- . A passive tracked Localization Pen Probe
- . A passive tracked Laser Range Scanner (LRS)
- Two passive tracked adapters (can be attached onto up to two rigid surgical instruments ● simultaneously and used for their localization in 3-D surgical space)
- (3) An LCD display monitor.
The provided text {0-4} discusses the K101979 submission for the Explorer™ Liver - Passive Tracking device. However, it does not contain specific acceptance criteria, detailed performance metrics, sample sizes for test or training sets, information on ground truth establishment at a granular level, expert qualifications, or adjudication methods relevant to an AI/ML device.
The document indicates that performance data involved "Validation and verification studies through bench tests" to evaluate the device's characteristics and demonstrate its capability to safely and accurately perform its intended use, showing "similar effectiveness to the Explorer™ (active tracking) [K071063 & K093494]". This suggests a comparison against a predicate device's performance, but the specifics of that performance are not detailed here.
Therefore, I cannot populate most of the requested table and information based on the provided text alone. The text focuses on regulatory submission details, device description, and substantial equivalence, rather than a detailed performance study report.
In summary, the provided text does not contain the necessary information to complete the requested table and answer the detailed questions about acceptance criteria, study specifics, sample sizes, ground truth, and expert involvement.
§ 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).