(175 days)
Leksell Stereotactic System is intended for localization and diagnosis of intracranial disorders and their surgical treatment including radiosurgery and stereotactic radiation therapy.
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I am sorry, but the provided text does not contain the information requested in your prompt regarding acceptance criteria, study details, sample sizes, ground truth establishment, or any AI-related effectiveness studies. The document is a 510(k) clearance letter from the FDA for a medical device called the "Leksell Stereotactic System," classifying it as substantially equivalent to a predicate device for specific indications for use.
Therefore, I cannot generate a response that includes:
- A table of acceptance criteria and reported device performance.
- Sample sizes or data provenance for a test set.
- Number or qualifications of experts for ground truth.
- Adjudication method for a test set.
- MRMC comparative effectiveness study details or effect size.
- Standalone performance details.
- Type of ground truth used.
- Sample size for the training set.
- How ground truth for the training set was established.
§ 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).