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System for patient positioning and fixation on the treatment couch, including transportation of the patient from preparation site and/or diagnostic surveys to the treatment unit

The PatLog 2.0 Patient Logistics System is a combination of separate products that together form a complete patient logistics system for a radiation therapy department. The Loading Station facilitates loading and initial setup of the patient Table Plate, the Transport Trolley provides transport from the Loading Station to diagnostic devices like CT or MR, further to the Radiation therapy treatment room and back to the Loading Station for unloading after the treatment. The Patient Table Plate is docked on the patient table bases at each unit, CT, MR or Proton Gantry, and undocked for the transport between stations with the Transport Trolley. The system has the following components: Patient Table Plates, Transport Trolleys, Patient Loading Stations, Docking Units.

This document, a 510(k) summary for the PatLog 2.0 device, focuses on substantial equivalence to predicate devices rather than presenting a detailed study proving the device meets specific acceptance criteria in the manner typically seen for performance or diagnostic accuracy claims.

Therefore, much of the requested information regarding acceptance criteria and performance studies (e.g., sample size, data provenance, expert consensus, MRMC studies, standalone performance, training set details) is not available in the provided text. The document describes a medical device, a patient logistics system for radiotherapy, and its intended use, but it does not include a clinical performance study with specific acceptance criteria related to numerical performance metrics (like sensitivity, specificity, or accuracy) that would usually be associated with AI or diagnostic imaging devices.

The information provided primarily relates to the device's technical characteristics and its substantial equivalence to previous versions and similar devices.

Device Acceptance Criteria and Performance (Based on available information)

Since a traditional performance study comparing numerical metrics is not available, the "acceptance criteria" here refer to the substantial equivalence determination by the FDA based on the device's technological characteristics and intended use being similar to legally marketed predicate devices.

Study Details (Based on available information)

Due to the nature of the 510(k) summary, specific details about a performance study with numerical acceptance criteria are not presented. The "study" here is essentially the 510(k) premarket notification process itself, where the manufacturer demonstrates substantial equivalence.

1. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):

   • Not Applicable/Not Provided. The document does not describe a test set or clinical study with an explicit sample size for performance evaluation. The 510(k) process relies on demonstrating equivalence to predicate devices.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):

   • Not Applicable/Not Provided. Ground truth establishment for a test set is not described as part of this 510(k) submission.

3. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

   • Not Applicable/Not Provided. No test set or expert adjudication process is described.

4. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

   • No. This device is a patient logistics system, not an AI or diagnostic imaging device that would typically involve human readers or MRMC studies for comparative effectiveness with AI.

5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

   • No. This is a physical medical device system, not an algorithm.

6. The type of ground truth used (expert consensus, pathology, outcomes data, etc):

   • Not Applicable/Not Provided. The concept of "ground truth" for performance metrics in a clinical study is not detailed for this device within this document. The ground truth for regulatory clearance is the established performance and safety of the predicate devices.

7. The sample size for the training set:

   • Not Applicable/Not Provided. The device is not an AI/ML algorithm that requires a training set in the conventional sense.

8. How the ground truth for the training set was established:

   • Not Applicable/Not Provided. As above, no training set for an algorithm is discussed.

In summary, the provided text is a regulatory submission (510(k) summary) focused on demonstrating substantial equivalence to predicate devices, rather than a detailed report of a clinical performance study with specific numerical acceptance criteria and associated methodological details.

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