(65 days)
The ClearPoint System is intended to provide stereotactic guidance 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. The System is intended for use only with 1.5 and 3.0 Tesla MRI scanners.
The hardware and software components of the SurgiVision ClearPoint System. The hardware and software components of the SurgiVision ClearPoint System 37 are identical to the predicate device. The sole purpose of this 510(k) application is to expand the indications for the ClearPoint System to 3.0 Tesla MRI scanners. The ClearPoint System 3T is intended to provide trajectory planning, guidance and fixation of neurosurgical tools during minimally invasive stereotactic surgical procedures in the brain conducted in the MR suite. The System itself provides no therapeutic or diagnostic functionality. The ClearPoint Stereotactic System is comprised of two separate device groups, a hardware and a software group. The software group is known as the ClearPoint Workstation. It includes the following: ClearPoint Workstation Software (for trajectory planning and . monitoring) Laptop Computer . The hardware device group under the ClearPoint Stereotactic System umbrella is known as the SmartFrame and Accessories.
Here's an analysis of the provided text regarding the SurgiVision ClearPoint System 3T, focusing on the acceptance criteria and the study proving it meets those criteria:
The K111073 submission for the ClearPoint System 3T is a 510(k) to expand the indications for use of the previously cleared ClearPoint System (K100836) to include 3.0 Tesla MRI scanners. Therefore, the primary "acceptance criterion" being evaluated is the device's performance and safety within the 3T MRI environment, specifically demonstrating it is substantially equivalent to the predicate device operating in a 1.5T environment.
Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Compatibility with 3.0T MRI environment | Device functions as intended and is substantially equivalent to the predicate device in the 3T environment. |
| System Accuracy (in 3.0T environment) | Equivalent to ClearPoint System (predicate device, specified as ± 1.5mm). |
| Force Test Outcomes (in 3.0T environment) | Acceptable outcomes. |
| Torque Test Outcomes (in 3.0T environment) | Acceptable outcomes. |
| Heating Test Outcomes (in 3.0T environment) | Acceptable outcomes. |
| Image Artifacts (in 3.0T environment) | Acceptable outcomes. |
| B0 Field Test Outcomes (in 3.0T environment) | Acceptable outcomes. |
| MRI Conditional | ClearPoint SmartFrame and Accessories are MRI Conditional. |
Details of the Study
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Sample Size used for the test set and the data provenance:
- The document does not specify a "sample size" in terms of number of patients or cases. The testing described is bench testing only.
- Data Provenance: Not applicable in the context of patient data, as the tests were bench tests.
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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. The ground truth for bench testing is typically based on engineering specifications and metrology, not expert clinical consensus from patient data.
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Adjudication method for the test set:
- Not applicable, as this was bench testing against engineering standards, not a clinical study requiring adjudication of expert interpretations.
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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:
- No MRMC or comparative effectiveness study was performed. The device, a neurological stereotaxic instrument, is a guidance system, not an AI-driven diagnostic or interpretative tool that would typically involve human readers or AI assistance in the way described.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- The "testing" described is inherently standalone in nature, as it's bench testing of the system alone for its physical and functional characteristics (force, torque, heating, accuracy, etc.) within the 3T MRI environment. While the system is used with a human in the loop during surgery, the specific tests mentioned here evaluate the device's technical performance.
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The type of ground truth used:
- Bench Test Ground Truth: Engineering specifications, physical measurements, and established safety standards for medical devices in an MRI environment (e.g., limits for heating, artifact generation, and system accuracy specifications from the predicate device).
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The sample size for the training set:
- Not applicable. This device is a sterotactic guidance system; there is no mention of a machine learning component requiring a "training set" of data.
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How the ground truth for the training set was established:
- Not applicable, as there is no training set mentioned or implied 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).