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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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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 1 0 Pattent Handling System is a combination of separate components that facılıtates setup of the patient on a Patıent Table Plate, transport to diagnostic devices, and/or to the treatment room and back after the treatment The Pattent Table Plate 1s docked on the patient table bases at each unt and undocked for the transport between stations with the Transport Trolley
The system consists of the following components

• Patient table plate
• Docking unit
• Transport trolley

The provided text describes a 510(k) summary for the "PatLog 1.0 Radiotherapy Patient Handling System." It focuses on demonstrating substantial equivalence to predicate devices rather than providing detailed acceptance criteria or a dedicated study proving performance against such criteria. The document explicitly states: "The technological characteristics and the intended use are substantially the same for Pat-Log Patient Handling system as for Hercules Radiation Therapy Couch and ATLAS Couch Top."

Consequently, most of the requested information regarding acceptance criteria, specific study details, sample sizes, ground truth establishment, expert involvement, and MRMC studies is not available in the provided text. The submission is a regulatory filing for market clearance based on substantial equivalence, not a scientific publication detailing performance studies.

Here's a breakdown of what can be extracted and what cannot:

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not provide a table of acceptance criteria or specific performance metrics (e.g., accuracy, precision, error rates) for the PatLog 1.0 system. The basis for clearance is demonstrating "substantial equivalence" to existing predicate devices, implying that its performance is expected to be comparable to those devices, but no quantitative performance data for PatLog 1.0 is given.

2. Sample size used for the test set and the data provenance:

Not applicable. The filing is a 510(k) submission based on substantial equivalence. It does not describe a clinical performance study with a dedicated test set in the way a diagnostic AI might. The focus is on technological characteristics and intended use being similar to the predicate devices.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not applicable. As no performance study with a test set aiming to establish "ground truth" for the PatLog 1.0 is described, there's no mention of experts or their qualifications for this purpose.

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

Not applicable. No test set requiring expert adjudication is described in the document.

5. 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:

Not applicable. The PatLog 1.0 is a patient handling system, not an AI-powered diagnostic or assistive tool for human readers. Therefore, an MRMC comparative effectiveness study is irrelevant to this device type, and no such study is mentioned.

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

Not applicable. The PatLog 1.0 is a physical patient handling system, not an algorithm.

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

Not applicable. No performance study requiring the establishment of a specific "ground truth" (in the context of diagnostic accuracy, for example) is described. The "ground truth" relevant to this submission is the established safety and effectiveness of the predicate devices.

8. The sample size for the training set:

Not applicable. The PatLog 1.0 is a physical device, not a machine learning algorithm that requires a training set.

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

Not applicable. As there’s no training set for an algorithm, there’s no ground truth establishment for it.

Summary regarding the requested information:

The provided document is a 510(k) summary for a "Radiotherapy Patient Handling System." This type of regulatory submission focuses on demonstrating "substantial equivalence" to legally marketed predicate devices, primarily by comparing technological characteristics and intended use. It does not include detailed performance studies with acceptance criteria, test sets, ground truth establishment, or expert evaluations in the manner that would be expected for a diagnostic or AI-driven medical device. Therefore, most of the questions cannot be answered from the provided text.

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