(90 days)
The intended use of the ViewPoint is unchanged by the 3.0 software, but the indications for use have been expanded to include spinal surgical procedures. The intended use and indications for use are as follows:
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 new features in the 3.0 Software include a detector positioning feature and support for the following optional hardware accessories: a tracking device, drill guides and a CT spine phantom. The indications for use of the ViewPoint have also been expanded to include use in spinal surgeries.
The provided text describes a 510(k) submission for the ViewPoint - 3.0 Operating Software, focusing on demonstrating substantial equivalence to a predicate device rather than presenting a de novo study with specific acceptance criteria and performance data. Therefore, many of the requested details about acceptance criteria, study design parameters (like sample size, number of experts, adjudication methods), and specific performance metrics for the device itself are not explicitly stated within the provided document.
The document highlights the substantial equivalence of the ViewPoint 3.0 software to its predicate device (ViewPoint & Optical Digitizer Option - K961168, K963221). The "Acceptance Criteria" here are implicitly linked to demonstrating that the new software maintains the safety and effectiveness characteristics of the predicate device, particularly its accuracy and intended use, while expanding its indications to include spinal surgery.
Here's an analysis based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state "acceptance criteria" in a quantitative, measurable form for the ViewPoint 3.0 software as if it were a new device proving its efficacy. Instead, it demonstrates substantial equivalence to a predicate device. The "performance" is primarily described in terms of matching or improving upon the predicate device's specifications.
| Parameter | Predicate Device Performance / Acceptance (Implicit) | ViewPoint with 3.0 Software Performance | Device Meets Acceptance Criteria? |
|---|---|---|---|
| Average Tool Accuracy | 2.0 - 5.0 mm (from K961168) | Same (2.0 - 5.0 mm) | Yes (Matches predicate) |
| Active Digitizer Volume | Silo shape, with 1 meter diameter and 1 meter length (from K963221) | Same (Silo shape, 1m diameter, 1m length) with Detector Positioning Feature added | Yes (Matches predicate, with enhancement) |
| Intended Use | Uses diagnostic images to assist presurgical planning and intra-operative orientation (from K961168) | Same | Yes (Matches predicate) |
| Indications for Use | Intra-cranial surgical procedures (K961168) | Expanded to include Intra-cranial and Spinal Surgical procedures | Yes (Expands on predicate) |
| Tools | A long and short tool with a minimum of four IREDs per tool (K963221) | Same | Yes (Matches predicate) |
| Type of Detector | Infrared signals from diodes detected by a Position Sensor Assembly (K963221) | Same | Yes (Matches predicate) |
| Accessories | MR/CT Head Phantoms (K961168) | Expanded to include MR/CT Head Phantoms, CT Spine Phantom, Tracking device, Drill Guide | Yes (Expands on predicate) |
| Registration Technique | Scanned Fiducials (K961168) | Expanded to include Scanned Fiducials and Anatomical Fiducials | Yes (Expands on predicate) |
| Operating Software Structure | UNIX environment with three processes (Import, Surgery Application, Foot Switch), Graphical User Interface | Same structure. Modified Graphical User Interface with similar functionality | Yes (Matches predicate, with similar functionality) |
| Image Manipulation | MPR and surface rendering | Same | Yes (Matches predicate) |
| Other Features | None (K961168) | Detector Positioning Feature | Yes (New feature, presumably beneficial) |
2. Sample Size for the Test Set and Data Provenance
The document does not describe a specific test set or clinical study for the ViewPoint 3.0 software in this submission. Its approach is to demonstrate substantial equivalence to previously cleared predicate devices. Therefore, details like sample size, country of origin, or retrospective/prospective nature of a test set are not provided for the 3.0 software itself. The basis for "Average Tool Accuracy" (2.0 - 5.0 mm) would have been established in the predicate device’s 510(k) (K961168), but the specifics of that study are not included here.
3. Number of Experts and Qualifications for Ground Truth Establishment (Test Set)
Not applicable, as no new test set study for the 3.0 software is described in this submission. The ground truth for the predicate device's accuracy would have been established during its clearance.
4. Adjudication Method (Test Set)
Not applicable, as no new test set study for the 3.0 software is described.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No MRMC study is mentioned. This submission focuses on hardware and software feature equivalence and expansion of indications rather than comparative effectiveness with or without AI assistance for human readers.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance)
The ViewPoint system is an "Image Assisted Surgery Device," meaning it is inherently designed for "human-in-the-loop" use to assist the physician. Therefore, a standalone (algorithm only) performance assessment would not be applicable or relevant to its intended use. The "Average Tool Accuracy" is a standalone technical specification of the device's measurement capabilities.
7. Type of Ground Truth Used
For the predicate device's accuracy, the ground truth would likely be established by precise physical measurements (e.g., using a coordinate measuring machine or similar high-precision measurement system on phantoms) to verify the tool's reported position against its true physical position. For the 3.0 software, the ground truth for its new features (like Detector Positioning Feature, support for CT Spine Phantom, Anatomical Fiducials) would be centered around functional verification and validation that these features operate as intended and maintain the previously established accuracy.
8. Sample Size for the Training Set
The document does not describe the development or training of an AI algorithm in the contemporary sense. This device (from 1997) is an early image-assisted surgery system, not a machine learning-based AI device that typically relies on "training sets." Its "operating software" refers to conventional programming.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no mention of a training set for a machine learning model.
§ 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).