(30 days)
The ClearPoint System is intended to provide stereotactic quidance for the placement and operation of instruments or devices during planning and operation of neurological procedures within the MRI environment and in conjunction with MR imaging. The ClearPoint System is intended as an integral part of procedures that have traditionally used stereotactic methodology. These procedures include biopsies, catheter and electrode insertion, including deep brain stimulation (DBS) lead placement. The System is intended for use only with 1.5 and 3.0 Tesla MRI scanners.
The ClearPoint System is comprised of a workstation laptop with software, the SMARTGrid™ MRI-Guided Planning Grid, the SMARTFrame™ MRI-Guided Trajectory Frame, the SMARTFrame™ Accessory Kit and the SMARTFrame™ Thumbwheel Extension.
The SMARTGrid and associated Marking Tool are designed to assist the physician to precisely position the entry hole as called out in the trajectory planning software.
The SMARTFrame is an Adjustable Trajectory Frame (ATF) that provides the guidance and fixation for neurosurgical tools. The MRI visible fluids of the Targeting Cannula along with the fiducial markers in the base of the frame allows for trajectory feedback when the physician views the MRI images, makes changes and confirms with subsequent MR images. The ClearPoint System can be used with any MRI-compatible head fixation frame to immobilize the patient's head with respect to the scanner table, as well as with any imaging coil(s) (supplied by scanner manufacturers) that meet the physician's desired imaging quality. MRI Interventions also supplies an optional head fixation frame that can be used with the ClearPoint System.
The ClearPoint Workstation includes the following:
- ClearPoint Workstation Software (for trajectory planning and monitoring)
- Laptop Computer
The hardware components of the current ClearPoint System are the SMARTFrame and Accessories. They are all single use devices that are provided sterile. They include the following:
- SMARTGrid MRI Planning Grid (interacts with the software to determine the desired location of the burr hole)
a. Marking Grid
b. Marking Tool - SMARTFrame Pack (SMARTFrame or SMARTFrame XG)
a. SMARTFrame ("ATF") with Base
b. Centering Device and Wharen Centering Guide
c. Dock
d. Device Lock (2 different diameters)
e. Screwdriver
f. Roll Lock Screw and Washer - Thumbwheel Extension
- Accessory Kit
a. Peel-away Sheath (2)
b. Stylet
c. Lancet
d. Depth Stop (2)
e. Ruler - Scalp Mount Base
- Guide Tubes and Device Guide Packs (Guide Cannulas).
MRI Interventions Devices that can also be used with ClearPoint
- SmartTip Drill Bit Kit
- MRI Hand Drill
- SmartFrame MR Fiducial
- MRI Neuro Procedure Drape
- Camera Fiberscope Accessory Kit
- ClearPoint Pursuit
The provided text describes a 510(k) premarket notification for a medical device called the "ClearPoint System." This submission is a modification to a previously cleared predicate device (K181195). The document does not contain information about an AI/ML-driven device or a Multi-Reader Multi-Case (MRMC) comparative effectiveness study. Instead, it focuses on physical and performance testing of hardware modifications.
Therefore, many of the requested elements for describing "acceptance criteria and the study that proves the device meets the acceptance criteria" related to AI/ML performance, human reader improvement, and ground truth establishment for AI training/test sets are not applicable to this document.
However, I can extract information related to the performance data and the general nature of the testing described.
Here's the information based on the provided document:
Acceptance Criteria and Reported Device Performance
The document states: "Design Verification was performed relative to these specifications [Design inputs provided the requirements for the respective product specifications] with acceptable results. These tests included verification of physical, performance, and safety requirements, as well as benchtop accuracy testing."
While explicit numerical acceptance criteria values are not provided in tabular form, the general acceptance criteria can be inferred as meeting the requirements of the design specifications, ensuring physical, performance, and safety requirements, and demonstrating acceptable benchtop accuracy.
| Acceptance Criteria Category | Reported Device Performance |
|---|---|
| Physical Requirements | Verification performed with acceptable results. |
| Performance Requirements | Verification performed with acceptable results. |
| Safety Requirements | Verification performed with acceptable results. Risk analysis performed with mitigation of all identified risks to acceptable levels. |
| Benchtop Accuracy | Testing performed with acceptable results. |
| Functionality | "demonstrated that the modified ClearPoint system functions as intended" |
| Substantial Equivalence | "established the substantial equivalence of the modified ClearPoint System and accessories to the predicate ClearPoint System and accessories, including design verification testing." |
Study Information (Based on provided text)
- Sample size used for the test set and the data provenance: Not explicitly stated as a "test set" in the context of an AI/ML study. The studies conducted are described as "Design Verification" tests, "physical, performance, and safety requirements" tests, and "benchtop accuracy testing." The "samples" would refer to the modified device components themselves. No information on data provenance (country of origin, retrospective/prospective) is provided, as it's not a clinical data study.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. This is not an AI/ML study requiring expert ground truth for clinical image interpretation. The "ground truth" for the device's performance would be engineering specifications and measurements.
- Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable. This refers to consensus among human readers for AI/ML studies, which is not described.
- 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, an MRMC study was not done or described. This document pertains to hardware modifications, not AI assistance for human readers.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. There is no algorithm-only performance assessment described, as this is a physical device undergoing modifications.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.): The "ground truth" for this engineering verification study would be the established design specifications, physical measurements, and functional requirements. It is not clinical ground truth like pathology or outcomes data.
- The sample size for the training set: Not applicable. This is not an AI/ML device, so there is no training set.
- How the ground truth for the training set was established: Not applicable. As there is no training set for an AI/ML device described.
In summary: The document is a 510(k) summary for hardware modifications to a stereotactic guidance system. The "study" refers to design verification, performance, safety, and benchtop accuracy testing of these hardware components against engineering specifications. It does not involve AI/ML components, clinical data collection for algorithm training/testing, or human reader studies.
§ 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).