(107 days)
The ClearPointer is intended to be used in conjunction with the SmartFrame OR System and a compatible stereotactic optical navigation system for patient registration and navigation.
The ClearPointer Optical Navigation Wand is an optical tracker intended to be used with the SmartFrame OR Stereotactic System and ClearPoint Bone Screw Fiducials, both of which are subject of pending 510(k) submission. The ClearPointer is used in conjunction with a Medtronic StealthStation Navigation System to align the SmartFrame OR tower to the desired target. It is composed of 4 optical spheres and utilizes a sphere positional geometry that is recognizable by the Medtronic StealthStation S8 Optical navigation System. It is equipped with a Pointer attachment to allow for image registration and entry point location. The Pointer Attachment can also be removed from the Optical Tracker component, so that the Tracker can be mounted to a SmartFrame OR. The SmartFrame OR Hardware Kit is provided with the following components:
- 1x ClearPointer™ ●
- 1x Pointer Attachment ●
- 1x Reference Array Bracket Arm ●
- 1x Torx Screwdriver ●
- 10x Reflective Spheres
Here's a summary of the acceptance criteria and study information for the ClearPointer Optical Navigation Wand, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Instrument Error | 0.11 – 0.30 mm |
| Registration Error | 0.2 – 0.6 mm |
2. Sample Size Used for the Test Set and Data Provenance:
The document does not specify the exact sample size used for the accuracy testing (benchtop testing). It only states that the testing was performed, but not how many measurements were taken or how many units of the device were tested.
The data provenance is retrospective bench testing, as it describes the testing performed after the device was developed to verify design specifications. The country of origin for the data is not explicitly stated, but given that ClearPoint Neuro, Inc. is based in the US and is filing with the FDA, it can be inferred that the testing aligns with US regulatory standards.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
The document does not provide information on the number of experts used or their qualifications for establishing ground truth in the accuracy testing. The accuracy measurements (instrument and registration error) were likely determined through objective, quantifiable methods using precise measurement tools in a controlled benchtop environment, rather than expert interpretation of medical images or patient outcomes.
4. Adjudication Method (e.g., 2+1, 3+1, none) for the Test Set:
The document does not specify any adjudication method. Given that the listed tests are objective accuracy measurements (instrument error, registration error) conducted during bench testing, adjudication by multiple experts is not typically applicable in this context.
5. 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:
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done or reported in this document. The ClearPointer Optical Navigation Wand is a physical navigation instrument, not an AI-assisted diagnostic or interpretative tool for medical images, so an MRMC study involving human readers with and without AI assistance is not relevant to its stated purpose.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Yes, a standalone performance evaluation was conducted in the form of "benchtop accuracy testing." This testing measured the inherent accuracy of the device (instrument error and registration error) independent of human variability in a clinical setting, simulating a workflow with Stealthstation S8 software.
7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.):
The ground truth used for the benchtop accuracy testing was based on objective, verifiable measurements of instrument and registration error against known or precisely controlled spatial references. It is not an expert consensus, pathology, or outcomes data, as these are typically associated with diagnostic or prognostic medical devices.
8. The Sample Size for the Training Set:
The document does not mention a training set because this device is a physical medical instrument, not a machine learning or AI algorithm that requires a training set.
9. How the Ground Truth for the Training Set Was Established:
This question is not applicable as there is no training set for this device.
§ 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).