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The Extended Range Shifter is an accessory to the PROBEAT-V system that is intended to assist the radiation oncologist in the delivery of proton radiation to defined target volumes while sparing surrounding normal tissue and critical organs from excess radiation.

This accessory is added to the nozzle of the cleared PROBEAT-V to suppress the beam spreading further compared to use of the standard range shifter.

The provided text is a 510(k) summary for the "Extended Range Shifter" device. It describes the device, its intended use, and its technological characteristics. However, it does not contain the type of information typically found in a study proving a device meets specific acceptance criteria, especially for AI/ML-based medical devices.

Specifically, the text is about a physical accessory for a proton therapy system, not a software or AI device that would require detailed performance metrics like sensitivity, specificity, or human reader improvement with AI assistance. The "Performance Data" section simply states that "All the tests were successfully conducted and confirmed the performance of the ERS." without providing any quantitative data or details about the sample size, ground truth, or expert evaluation methods.

Therefore, I cannot fulfill your request for:

• A table of acceptance criteria and reported device performance: The document only generically states tests were "successfully conducted" but provides no specific criteria or performance numbers.
• Sample size and data provenance: Not mentioned.
• Number of experts and qualifications: Not relevant for this type of physical device's performance testing described here.
• Adjudication method: Not applicable.
• MRMC comparative effectiveness study: Not applicable.
• Standalone performance: Not applicable.
• Type of ground truth: Not specified beyond physical measurements.
• Training set sample size and ground truth establishment: Not applicable, as this is not an AI/ML device.

In summary, the provided document does not contain the information required to answer your questions about acceptance criteria and study details for an AI/ML device demonstrating performance. It is a premarket notification for a physical medical device accessory.

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