(38 days)
The 3D1 Micropositioning Headstage is indicated for use by a qualified neurosurgeon when precise movement of a surgical instrument is needed along any of three axes. The 3D1 Micropositioning Headstage is intended to be used with a standard stereotactic headframe system.
The 3D1 Micropositioning Headstage is a device that allows for precise positioning of a neurosurgical instrument along three axes. The device is used in neurosurgical procedures in conjunction with a conventional stereotactic head frame and serves as an accessory to those devices. The 3D1 device comes with a mounting adaptor that is specific for the particular stereotactic head frame being used.
This 510(k) summary for K993501, the "3D1 Micropositioning Headstage," does not contain information about acceptance criteria or a study proving the device meets acceptance criteria.
The document is a submission for substantial equivalence to legally marketed predicate devices, not a performance study. It states that the device has similar technological characteristics and slightly different, but not therapeutically altering, indications for use compared to predicate devices. It focuses on demonstrating substantial equivalence based on device description and intended use rather than specific performance metrics or clinical study results.
Therefore, I cannot provide the requested information from the given text.
§ 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).