(90 days)
AtlasPlan is intended to be used for pre- and intra-operative planning of stereotactic procedures. This software module correlates a patient's anatomy (obtained from CT or MRI scans) with an anatomical atlas of the brain. AtlasPlan may be used alone or in conjunction with neurosurgery, radiotherapy, and radiosurgery planning systems.
AtlasPlan is a stereotactic planning tool which gives the clinician access to a digitized atlas of the brain. The AtlasPlan system, addressed in this premarket notification, has the same intended use and technological characteristics as the commercially available MIDCO cass System. Like the cass System, AtlasPlan utilizes a workstation to compare patient scans (CT or MRI) with a digitized stereotactic atlas. In addition, both systems allow the user to view entry and target points and labels for anatomical structures. Both systems output BRW coordinates for use in further procedure planning.
The provided text does not contain detailed acceptance criteria and the results of a specific study to prove the device meets those criteria. Instead, it offers a general summary of safety and effectiveness, stating that "The RSA AtlasPlan system/unit testing rigorously tests the features of the software. The results of the testing indicate that AtlasPlan is safe and reliable for its intended use."
Therefore, I cannot populate the table or provide specific details for points 1-9 as the necessary information is not present in the given document.
Missing Information:
- Specific Acceptance Criteria: The document does not list any quantitative or qualitative metrics that AtlasPlan was required to meet for acceptance.
- Specific Study Details: There is no description of a particular study (e.g., a clinical trial, a performance validation study) that was conducted to demonstrate safety and effectiveness.
- Device Performance Metrics: No reported performance metrics (e.g., accuracy, precision, sensitivity, specificity) for the device are provided.
- Sample Size, Ground Truth Details, Expert Qualifications, Adjudication, MRMC studies, Standalone performance, Training set details: All these critical elements for evaluating a device's performance study are absent.
The 510(k) summary focuses on the substantial equivalence to a predicate device (MIDCO cass System) and general statements about testing, user manuals, and training to ensure safe and effective use. It does not include the detailed performance study information requested.
§ 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).