(75 days)
Intranasal or sinuses
Acute and chronic sinusitis, endoscopic dacryocystorhinostomy, optic nerve and orbital decompression, the removal of polyps, the biopsy and removal of tumors, and the repair of CSF leaks, pituitary disorder, and encephalocele
The device consists of a wheeled cabinet enclosure with a 20-inch color monitor mounted on the top. Mounted within the cabinet is a computer and a spacial tracking device. The electromagnetic, six-degree-of-freedom tracking device is linked to the computer, which provides the monitor with a display of the patient's CT image data and superimposed crosshairs, indicating the position of the tip of the surgical instrument used with the device. The device is controlled via software.
Here's a breakdown of the acceptance criteria and study information based on the provided text:
Note: The document is a 510(k) summary from 1996, so the depth of information regarding rigorous clinical trial methodology (especially regarding modern AI/machine learning studies) is limited. The device described uses image-guided surgery technology, not an AI algorithm in the contemporary sense.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Stated or Implied) | Reported Device Performance |
|---|---|
| Nonclinical Testing | |
| a. Device Accuracy (Laboratory) | Mean device accuracy of 0.79 mm (compares to 1.74 mm for predicate device). |
| b. Electromagnetic Field Distortion Detection | Device detected field distortion under normal use conditions before induced error became larger than 1.0 mm. |
| c. Reproducibility of Replaceable Headset Location | Headset shown to be replaceable such that the overall average effect upon device accuracy was less than 0.74 mm. |
| d. Reproducibility of Replaceable Pointing Instruments Location | Removal and replacement of a pointing instrument resulted in a change of less than ±0.914 mm (±3 σ). |
| e. Electromagnetic Compatibility (EMC) | Satisfactorily passed: Emissions (EN55011/CISPR 11, RE101 of MIL-STD-461C) and Immunity (IEC 801-2, 801-3, 801-4, 801-5, RS101, CS114 of MIL-STD-461C). |
| f. Battery Backup (implied by 10 msec dropout requirement) | Device has a battery backup (due to satisfying 10 msec dropout). |
| Clinical Testing | |
| a. Device Mean Accuracy (Clinical) and Confidence Interval | Mean accuracy of 2.28 mm with a 95% confidence interval of the mean of 0.78 mm. (Compares to 1.8 mm to 4.8 mm for predicate device with CI of 1.1 mm to 1.6 mm). |
| General Safety | |
| a. Enclosure Risk Current | ** |
§ 892.2050 Medical image management and processing system.
(a)
Identification. A medical image management and processing system is a device that provides one or more capabilities relating to the review and digital processing of medical images for the purposes of interpretation by a trained practitioner of disease detection, diagnosis, or patient management. The software components may provide advanced or complex image processing functions for image manipulation, enhancement, or quantification that are intended for use in the interpretation and analysis of medical images. Advanced image manipulation functions may include image segmentation, multimodality image registration, or 3D visualization. Complex quantitative functions may include semi-automated measurements or time-series measurements.(b)
Classification. Class II (special controls; voluntary standards—Digital Imaging and Communications in Medicine (DICOM) Std., Joint Photographic Experts Group (JPEG) Std., Society of Motion Picture and Television Engineers (SMPTE) Test Pattern).