(26 days)
The Elekta Esarte™ Frame System is part of Leksell Stereotactic System®, which is intended for localization and diagnosis of intracranial disorders and their surgical treatment including radiosurgery and stereotactic radiation therapy.
The Elekta Esarte™ Frame System is used in stereotactic radiation therapy (SRT) to provide target localization (spatial reference), and the fixation of the patient's head at prescribed geometric coordinates on the Precise table top of the digital accelerator. The Elekta Esarte™ Frame also attaches to the table of the CT scanner that is used to acquire images for the SRT planning.
The provided document is a 510(k) summary for the "Elekta Esarte™ Frame System," a stereotactic instrument. It is a premarket notification to the FDA to demonstrate substantial equivalence to a legally marketed predicate device, not a study evaluating the performance of an AI-powered device. Therefore, the information requested in the prompt about acceptance criteria, study details, sample sizes, expert qualifications, and ground truth for an AI device is not available in the provided text.
The document focuses on:
- Device Description: The Elekta Esarte™ Frame System is used in stereotactic radiation therapy (SRT) for target localization and patient head fixation.
- Intended Use: Localization and diagnosis of intracranial disorders and their surgical treatment, including radiosurgery and stereotactic radiation therapy, as part of the Leksell Stereotactic System®.
- Substantial Equivalence: The device is claimed to be substantially equivalent in safety and effectiveness to its predicate device, the Leksell® Stereotactic System with disposable biobsy needle kit (K031980), with similar fundamental technical characteristics.
- Regulatory Classification: Class II device, product code HAW (Stereotaxic instrument) and LHN (Medical charged-particle radiation therapy system).
Since this document is a 510(k) summary for a physical medical device and not an AI or software as a medical device, it does not contain the information required to answer the prompt. There are no performance metrics, clinical study details, or AI-specific validation information to report.
§ 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).