(147 days)
The Optical Digitizer Option for ViewPoint does not change the intended use of the ViewPoint system.
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-cranial surgical procedures involving space occupying lesions or malformations (including soft tissue, vascular and osseous).
The Optical Digitizer Option uses infrared emitting diodes to determine the position and orientation of the probe during intra-operative localization. This option has accuracy and resolution similar to that provided with the ultrasonic digitizer currently used with ViewPoint.
Here's an analysis of the provided text regarding the acceptance criteria and study for the ViewPoint - Optical Digitizer Option:
This submission is a 510(k) premarket notification, and as such, the primary goal is to demonstrate substantial equivalence to a predicate device, not necessarily to independently prove the safety and effectiveness from scratch. Therefore, the "acceptance criteria" are interpreted as the performance characteristics that need to be sufficiently similar to the predicate device, and the "study" is the comparison made to the predicate.
Acceptance Criteria and Reported Device Performance
The acceptance criteria are implicitly defined by the parameters of the predicate device (ViewPoint K961168) that the new device (ViewPoint with Optical Digitizer Option) aims to match or be comparable to.
| Parameter | Acceptance Criteria (Predicate Device K961168) | Reported Device Performance (ViewPoint with Optical Digitizer Option) |
|---|---|---|
| Type of Digitizer | Ultrasonic pulses emitted from two locations on a hand-held wand detected by four microphones in a detector array mounted to the OR table. | Infrared signals emitted from diodes on a hand-held wand detected by a Position Sensor Assembly with two optical detectors (mobile pedestal, OR table, or ceiling mounted). |
| Active Digitizer Volume | 0.75 cubic meter (26.5 cu. ft.) | Silo shape, with 1 meter diameter and 1 meter length. |
| Max. Digitizer Rate | 100 pts/sec/emitter | 30 Hz for one or two tools; for three tools, 30 Hz for one, 15 Hz for others. |
| Wand/Localizer Average Accuracy | 2.0 - 5.0 mm | Same (implying 2.0 - 5.0 mm) |
| Registration Technique | Scanned Fiducials | Same (Scanned Fiducials) |
| Type of Sterilization | Wand is ETO Sterilizable. | Same (Wand is ETO Sterilizable) |
| Computer | Superscalar RISC microprocessor, sufficient RAM and image storage, single high-res monitor, DICOM v3.0 networking. | Same |
| Operating Software | Graphical user interface, multiplanar reformatting, surface rendering, shows diagnostic images at probe tip. | Same operating software, selections for optical wands and Position Sensor Assembly added. |
| Intended Use | Assist physician with presurgical planning and provide orientation/reference during intra-cranial surgical procedures involving space-occupying lesions or malformations. | Does not change the intended use of the ViewPoint system. |
Summary of "Study" and How it Meets Criteria:
The "study" presented is a comparison table demonstrating the substantial equivalence of the new device to the predicate device (ViewPoint K961168). For many parameters (Wand/Localizer Average Accuracy, Registration Technique, Type of Sterilization, Computer, Operating Software, Intended Use), the new device is stated to be "Same" as the predicate. For parameters where there are differences (Type of Digitizer, Active Digitizer Volume, Max. Digitizer Rate), the submitter implicitly argues that these differences do not raise new questions of safety or effectiveness. For example, while the digitizer type is different, the crucial accuracy is stated to be the "Same." The digitizer volume is larger for the new device, which is generally not a concern. The digitizer rate is lower in some cases for the new device, but the implication is that it is still adequate for the intended use and does not compromise safety or effectiveness compared to the predicate's higher rate.
Additional Information
Based on the provided text, the following information is either not applicable or not explicitly detailed:
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Sample sizes used for the test set and the data provenance:
- Sample Size: Not applicable. This document does not describe a clinical performance study using a test set of patient data. The comparison is based on technical specifications and functionality.
- Data Provenance: Not applicable.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable, as there is no mention of a test set requiring expert ground truth.
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Adjudication method for the test set: Not applicable.
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If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This device is an image-assisted surgery device option, not an AI-assisted diagnostic tool for "human readers." Its purpose is to guide surgeons, not aid in diagnostic interpretation.
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If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: The device is inherently "human-in-the-loop" as it assists a surgeon during a procedure. No standalone algorithmic performance is described in isolation. However, the accuracy of the wand/localizer itself would be a standalone performance metric for the device's hardware, and this is stated to be 2.0 - 5.0 mm, which is "Same" as the predicate.
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The type of ground truth used: Not applicable in the context of a diagnostic test performance. For the device's functional performance (e.g., accuracy), the "ground truth" would be established through engineering measurements and calibration against known physical standards.
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The sample size for the training set: Not applicable. This is not a machine learning or AI-based submission that would typically involve a training set of data.
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How the ground truth for the training set was established: Not applicable.
§ 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).