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The SNT Linac Accessories are indicated for use with a Linear Accelerator to perform Stereotactic Radiosurgery or Radiotherapy on cranial lesions. The accessories include a secondary collimation system, components to mount a patient in a stereotactic headring to a linear accelerator's treatment couch, and components to position the patient relative to the isocenter of a linear accelerator in conjuction with a laser alignment system.

The SNT Linac Accessories are indicated for use with a Linear Accelerator to perform Stereotactic Radiosurgery or Radiotherapy on cranial lesions. The accessories include a secondary collimation system, components to mount a patient in a stereotactic headring to a linear accelerator's treatment couch, and components to position the patient relative to the isocenter of a linear accelerator in conjuction with a laser alignment system.

This document is a 510(k) submission summary for the SNT Linac Accessories, a device indicated for use with a Linear Accelerator to perform Stereotactic Radiosurgery or Radiotherapy on cranial lesions. The document does not contain a table of acceptance criteria or a study proving the device meets said criteria.

Therefore, most of the requested information cannot be extracted from the provided text.

Here is what can be extracted or inferred regarding the device and its submission:

Acceptance Criteria and Device Performance

The document does not provide any specific acceptance criteria or reported device performance metrics in a table format. The submission focuses on substantial equivalence rather than novel performance claims against pre-defined criteria.

Study Details

The document refers to a "summary of safety and effectiveness" but does not describe a detailed study methodology, clinical trial, or performance testing that would include:

• Sample sizes (training or test sets)
• Data provenance
• Number/qualifications of experts
• Adjudication methods
• MRMC comparative effectiveness study
• Standalone performance analysis
• Type of ground truth used

The statement "The SNT Linac Accessories were shown to be substantially equivalent to other commercially available linear accelerator accessories" implies that the evaluation was a comparison to predicate devices, but the method of this showing is not detailed. It is highly likely that this involved a comparison of design features, materials, and intended use rather than a performance study with quantitative acceptance criteria. This type of submission often relies on engineering analysis and comparison to existing devices rather than a clinical trial with performance endpoints.

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