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Varian Medical System's Optical Guidance Platform (OGP) is for use with a charged particle accelerator to perform precise positioning of treatment target for stereotactic radiosurgery or radiotherapy treatments on cranial or extracranial lesions.

The Optical Guidance Platform provides a method of positioning the patient for either radiosurgery or radiotherapy by using high precision infrared camera to detect the location of the stereotactic localization device comprised of infrared markers (either LED's or reflective markers) attached to the patient or stereotactic immobilization device. It is designed to provide patient positioning for intracranial and extracranial targets. It also provides an option for ultrasound tracking of soft tissue to more accurately define the target in extracranial radiosurgery and radiotherapy.

The provided text describes a 510(k) premarket notification for the Optical Guidance Platform and does not contain specific details about acceptance criteria, device performance results, or a study design. The document is primarily a formal notification of market clearance from the FDA, confirming substantial equivalence to predicate devices based on the indications for use.

Therefore, I cannot provide the requested information from the given text.

The text focuses on:

• Device Name: Optical Guidance Platform
• Manufacturer: Varian Medical Systems, Inc.
• Classification: Medical charged-particle radiation therapy system, Class II (21 CFR 892.5050)
• Indications for Use: Precise positioning of treatment targets for stereotactic radiosurgery or radiotherapy treatments on cranial or extracranial lesions, used with a charged particle accelerator.
• Predicate Devices: Several SNT and other positioning systems.
• FDA Clearance: A letter from the FDA stating that the device is substantially equivalent to legally marketed predicate devices.

To answer your specific questions, I would need a different type of document, such as a summary of safety and effectiveness data (SSE) or the actual study report submitted to the FDA, which would detail performance testing and acceptance criteria.

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