(14 days)
The ViewPoint is intended for use as a device which uses diagnostic images of the patient acquired specifically to assist the physician with presurgical planning and to provide orientation and reference information during intra-operative procedures.
The ViewPoint is indicated for use in:
- Intra-cranial surgical procedures involving space occupying lesions or malformations (including soft tissue, vascular and osseous)
- Spinal surgical procedures involving spinal stabilization, neural decompression, or resection of spinal neoplasms.
The Microscope Option for the ViewPoint system allows for optical tracking of a surgical microscope. The tip of the tool in this case is the focal point of the Microscope instead of the physical end of the instrument. This option gives the user the ability to see crosssectional images that correspond with the anatomy viewed through the microscope.
Here's a breakdown of the acceptance criteria and the study information for the ViewPoint Microscope Option, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Parameter | Acceptance Criteria (Predicate Device) | Reported Device Performance (ViewPoint Microscope Option) |
|---|---|---|
| Average Tool Accuracy | 2.0 - 5.0 mm | Same (implies 2.0 - 5.0 mm) |
Note: The provided document is a 510(k) submission summary focusing on demonstrating substantial equivalence to a predicate device (ViewPoint 3.0 Software K970604). Therefore, the "acceptance criteria" for the ViewPoint Microscope Option is simply that its performance parameters are "Same" as the predicate device. It doesn't explicitly state new, distinct acceptance criteria for the Microscope Option itself, but rather indicates it maintains the performance of the established system.
2. Sample Size Used for the Test Set and Data Provenance
The provided document does not specify a test set sample size or data provenance (e.g., country of origin, retrospective/prospective) for the ViewPoint Microscope Option.
This submission relies on demonstrating substantial equivalence to a previously cleared device. It effectively states that the Microscope Option does not change the core functionality or performance characteristics (like tool accuracy) of the existing ViewPoint system.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts
The provided document does not mention a specific test set requiring ground truth established by experts for this 510(k) submission. The submission is a comparison to a predicate device, not a de novo study with novel performance claims requiring expert-labeled ground truth for an independent test set.
4. Adjudication Method for the Test Set
The provided document does not mention any adjudication method for a test set, as no specific test set requiring expert adjudication is described.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
The provided document does not mention a multi-reader, multi-case (MRMC) comparative effectiveness study. The submission centers on technological equivalence rather than human reader performance with or without AI assistance.
6. Standalone (i.e., algorithm only without human-in-the-loop performance) Study
The ViewPoint Microscope Option is an "Image Assisted Surgery Device" that provides "orientation and reference information during intra-operative procedures." It is inherently a device that assists a human (the surgeon). Therefore, a purely standalone algorithm only performance as might be seen in diagnostic AI would not be directly applicable or tested in this context. The document does not describe such a study.
7. Type of Ground Truth Used
The concept of "ground truth" as typically defined in diagnostic AI studies (e.g., pathology, outcomes data) is not directly applicable or explicitly mentioned in this 510(k) submission. This device aids surgery, and its metrics (like tool accuracy) would typically be validated against physical measurements and engineering specifications, often using phantoms or established calibration methods, rather than clinical ground truth diagnoses. The core ground truth for equivalence is the proven performance specifications of the predicate device.
8. Sample Size for the Training Set
The provided document does not mention a training set sample size. This device is not an AI/ML algorithm in the modern sense that undergoes supervised training on a dataset. It's a system (software and hardware) designed to perform specific tracking and display functions for surgical navigation.
9. How the Ground Truth for the Training Set Was Established
Given that this is not an AI/ML device that requires a "training set" in the conventional sense, the establishment of "ground truth for the training set" is not applicable and therefore not described in the document.
§ 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).