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This submission describes a floorstand based coordinate and fixation system that is intended to be used to place patients at the isocenter of a linear accelerator for stereotactic radiosurgery or radiotherapy procedures. The Linac Scalpel™ Floorstand is designed to provide secondary collimation and a fixed isocenter for Radiosurgery or Radiotherapy when used in conjunction with a commercially available Linear Accelerator.

The Linac Scalpel™ Floorstand consists of a mechanical structure which is located on the floor at predetermined points and attaches via a gimbal bearing to the head of a linear accelerator. The floorstand is designed to precisely control the accuracy of the collimation during the arcing of the radiation beam from the linear accelerator and the accuracy of the patient position during couch repositioning between arcs.

The provided text describes a medical device, the Linac Scalpel™ Floorstand System, and states its intended use and substantial equivalence to other systems. However, it does not contain the detailed study information required to answer your questions about acceptance criteria, device performance, sample sizes, expert involvement, ground truth, or MRMC studies.

Here's why and what information is missing:

• Absence of Performance Data: The document is a "Summary of Safety and Effectiveness" for a 510(k) submission. These summaries typically focus on intended use, substantial equivalence claims, and a brief description of the device. They do not usually include detailed statistical performance metrics (like sensitivity, specificity, accuracy, etc.) or exhaustive study designs.
• No Mention of AI/Algorithm: The device described is a mechanical floorstand system for patient positioning during stereotactic radiosurgery/radiotherapy. It is not an AI-powered diagnostic or predictive algorithm. Therefore, questions regarding "AI assistance," "standalone algorithm performance," "training sets," or "ground truth for training" are not applicable to this device.
• Lack of Study Design Details: While it states the system "was shown to be substantially equivalent," it doesn't describe how this was shown in terms of specific study designs, sample sizes, expert review, or data sources.

Therefore, I cannot populate the table or answer the specific questions based on the provided text. The information simply isn't present.

To answer your questions, one would need access to the full 510(k) submission, bench testing reports, or clinical study reports that would have been submitted to the FDA to support the "substantial equivalence" claim. These documents would detail:

• The specific performance metrics (e.g., precision of positioning, alignment accuracy) that were measured.
• The acceptance criteria for those metrics (e.g., "positioning error must be less than X mm").
• The results of the tests against those criteria.
• The methods used for testing (bench testing, phantom studies, potential limited clinical observation although often not required for 510(k)).

In summary, the provided document is a high-level summary and does not contain the granular detail about device performance studies that your questions inquire about.

Ask a specific question about this device