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The Catalyst+ system and accessories are intended for use in radiation therapy clinics with treatment, to provide:

• · Interactive guidance for setup and positioning of patients for radiation therapy
• · Intra-fraction motion detection during radiation therapy
• · Respiratory gating during radiation therapy
  The device is not intended for use in MR-linac systems.
  The system shall only be used by hospital personnel, qualified to work in radiation therapy departments. Training on the use of the system will be given to users at the time of installation.

The Catalyst product consists of projector unit hardware and Windows based software. The product is intended to be used in radiation therapy clinics for patient positioning, patient monitoring and respiratory gating.
A 3D image of the patient surface can be acquired and compared to a reference image that was either imported from e.g. a treatment planning system, or acquired by surface scanning earlier. The Catalyst system computes the optimal couch correction as well as errors in the patient's posture.
Measurements are done continuously using near UV light (405 nm). The detected errors are in parallel projected using visible light (red and green) in real-time e.g. as a distance map directly on the patient's surface to indicate which body parts that need to be adjusted and how. The rigid-body couch correction is projected numerically and can be sent to the couch control system to enable auto-setup of the couch.
Once that patient is in the correct position, the Catalyst system will continue to monitor the patient during treatment delivery to ensure that it doesn't move out of position. If a large movement is detected, a warning can be issued for the personnel to react on, and/or an interlock can be triggered automatically to shut off the beam.
For optimal coverage of the patient and to support couch kicks, two additional units (Catalyst* system without back projection) can be installed in an angle from the main unit. The configuration is called Catalyst+ HD/PT.
The following application modules are provided:

• cPosition - is the application module that provides a reproducible way of accurately positioning patients. It compares the current patient position with a reference setup bv using surface matching software for calculating adjustments in the patient's position.
• cMotion - is the application module for supervising patient motion during treatment. During treatment the system shall record the patient's position continuously and signal or interrupt treatment when the patient is moving outside specified tolerance intervals.
• cRespiration is the application module for respiratory tracking and gating. ● During treatment the module is able to give a warning or to turn the beam on or off depending on the acquired respiratory signal and on the gating parameters established in the treatment plan. The cRespiration in Catalyst* is based on reference data created in the CT room.

The C-Rad Catalyst+ system and its variations (Catalyst+ HD, Catalyst, Catalyst HD, Catalyst Tomo, Catalyst PT) are intended for use in radiation therapy clinics for interactive guidance during patient setup and positioning, intra-fraction motion detection, and respiratory gating.

Acceptance Criteria and Device Performance (Implicit from the document - no explicit table provided)

The document does not provide a table of explicit acceptance criteria and corresponding device performance metrics. Rather, it states that "Performance data has been submitted to show that the Catalyst system achieves its intended use and that the hardware and software updates raise no new issues of safety or efficacy." The device's substantial equivalence to its predicate device (Catalyst K113276) is also a key aspect of its acceptance.

The document implicitly suggests that the device meets the performance of its predicate, which was already cleared by the FDA for similar functions. The "Technological comparison" section highlights that the core technology (optical 3D scanning, structured light) and principle of the scanner remain unchanged despite hardware and software updates.

Study Details:

The provided document is a 510(k) clearance letter from the FDA, along with the 510(k) Summary for the C-Rad Catalyst device. It describes the device and its intended use, and states that performance data was submitted, but it does not include the actual study details, methodology, or results. Therefore, most of the requested information regarding sample size, data provenance, ground truth establishment, expert qualifications, and MRMC studies cannot be extracted directly from this document.

However, based on the information provided, we can deduce the following:

• Sample size used for the test set and data provenance: Not specified in the provided document.
• Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not specified in the provided document.
• Adjudication method for the test set: Not specified in the provided document.
• 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 specified in the provided document. The device primarily functions as a patient positioning and monitoring system, not for diagnostic interpretation that would typically involve human readers in the same way an imaging AI would.
• If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: The device is described as providing "interactive guidance" and signaling for personnel, implying a human-in-the-loop system. Standalone performance for the core functionalities (e.g., accuracy of position detection) would have been assessed as part of the performance data submission, but the details are not included here.
• The type of ground truth used: Not specified in the provided document. For a positioning system, ground truth would likely involve highly accurate physical measurements by independent devices or methods.
• The sample size for the training set: Not specified in the provided document.
• How the ground truth for the training set was established: Not specified in the provided document.

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The system is intended for use in radiation therapy clinics together with diagnostic or treatment equipment and provides: · accurate and reproducible patient positioning. • a respiratory signal to be supplied to diagnostic imaging equipment (primarily CTs) for prospectively (aka 4DCT) gated imaging and reconstruction. The system cannot directly determine the intended treatment target, since only the patient external surface is detected. The actual target position must therefore, whenever deemed necessary by qualified personnel, be verified using other systems such as CBCT or EPID.

The Sentinel hardware consists of a single scanner unit containing the laser and camera, mounted in the ceiling in front of the CT. The scanner is connected to the PC running the c4D software. During patient surface acquisition, a laser line is swept along the patient while the camera records a number of images. From the data acquired, a complete 3D surface of the patient can be reconstructed using laser line triangulation. On this surface the user, a health care professional, virtually marks where on the patient the respiratory motion signal shall be measured and in the next step, when the 4DCT imaging starts, the signal is measured with a frequency of around 16Hz. In general, the system is capable of acquiring more than 50 contours per second. The acquired 3D surface can also be exported and used as a reference image in the treatment room. The Sentinel system for the CT room is used in radiation therapy clinics to perform prospective or retrospective gated imaging (4DCT) prior to treatment. The system provides information about a patient's respiratory motion during the localization of the tumour in CT imaging. The system shall only be used by hospital personnel, qualified to work in radiation therapy or diagnostics departments. The Sentinel platform is based on advanced laser technology with multipurpose software modules covering different tasks in the diagnostic procedure. The software is user friendly and requires a minimum of user interaction in the daily clinical workflow. The software is designed to integrate with existing CT systems at the clinic. The Sentinel system does not require any markers to be placed on the patient or the couch and doesn't subject the patient to any additional radiation. This also means that the personnel can stay in the CT room during the whole set up procedure. Sentinel for the CT room includes the cRespiration module for respiratory gating during diagnostic CT imaging, so called 4D CT studies.

Here's a breakdown of the acceptance criteria and study information, based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The provided document (a 510(k) summary) does not explicitly list quantitative acceptance criteria in a table format with specific performance metrics for the Sentinel system or its cRespiration module. It makes a general statement about safety and effectiveness.

• Acceptance Criteria (Implied): The device Sentinel, in particular its cRespiration module, should:

  • Provide "accurate and reproducible patient positioning."
  • Deliver "a respiratory signal to be supplied to diagnostic imaging equipment (primarily CTs) for prospectively and retrospectively (aka 4DCT) gated imaging and reconstruction."
  • Be substantially equivalent to its predicate device (Sentinel K120668) in terms of technological characteristics, safety, and efficacy.
  • Not introduce new issues of safety or efficacy due to software update (64-bit architecture) and rephrasing of intended use.

• Reported Device Performance:

  • "The system is capable of acquiring more than 50 contours per second."
  • Respiratory signal measured with a frequency of around 16Hz.
  • Allows for two detection points for thoracic and abdominal breathing motions.
  • Functionality of the software with respect to 64-bit support is unchanged.
  • "Performance data has been submitted to show that Sentinel achieves its intended use and that the software update and rephrasing of intended use raise no new issues of safety or efficacy." (This is a general statement, not specific quantitative performance data in the document itself).

2. Sample Size Used for the Test Set and Data Provenance

The provided document does not specify the sample size used for the test set or the data provenance (e.g., country of origin, retrospective/prospective). It only mentions that "re-verification has been performed to verify that the design outputs meets the design inputs after the change from 32-bit to 64-bit support."

3. Number of Experts Used to Establish Ground Truth and Qualifications

The document does not provide details on the number of experts, their qualifications, or how they were used to establish ground truth for testing. It states that "the actual target position must therefore, whenever deemed necessary by qualified personnel, be verified using other systems such as CBCT or EPID," implying that qualified personnel are involved in clinical use and verification but not necessarily for structured testing with ground truth establishment.

4. Adjudication Method

The document does not mention any adjudication methods (e.g., 2+1, 3+1) for establishing ground truth in a test set.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

The document does not mention a multi-reader multi-case (MRMC) comparative effectiveness study, nor does it provide any information on the effect size of human readers improving with AI vs. without AI assistance. The device in question is a positioning and respiratory gating system, not an AI-based diagnostic tool for interpretation.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

The document focuses on the system's capabilities (acquiring contours, measuring respiratory signals) and its integration into the clinical workflow, which inherently involves human interaction. It does not present data relevant to a standalone algorithm-only performance study. The system provides signals and positioning information to human professionals and other diagnostic equipment.

7. Type of Ground Truth Used

The document does not explicitly state the type of ground truth used for testing. For its intended use of patient positioning and respiratory signal provision, ground truth would likely involve highly accurate measurements from other, established systems (e.g., precise physical measurements, data from other high-accuracy imaging modalities or motion tracking systems) against which the Sentinel system's output is compared.

8. Sample Size for the Training Set

The document does not provide the sample size for the training set. Given that this is a premarket notification for a predicate device with a software update and rephrased intended use, it's possible that extensive de novo training data for a machine learning model, as would be required for a distinctly AI device, was not the primary focus of this submission. The "re-verification" mentioned suggests testing against design inputs rather than extensive new machine learning model training.

9. How the Ground Truth for the Training Set Was Established

The document does not provide information on how ground truth was established for any training set.

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The system is intended for use in radiation therapy clinics together with diagnostic or treatment equipment and provides:

• accurate and reproducible patient positioning. .
• patient motion supervision with an audible and/or visual alarm whenever . the patient motion during treatment is outside of the specified tolerance values, while still allowing for normal breathing motion without triggering the alarm.
• a respiratory signal to be supplied to diagnostic imaging equipment . (primarily CTs) for prospectively and retrospectively (aka 4DCT) gated imaging and reconstruction.

The system cannot directly determine the location of the intended treatment target, since only the patient external surface is detected. The actual target position must therefore, whenever deemed necessary by qualified personnel, be verified using other systems such as CBCT or EPID.

The Sentinel system is intended for use in radiation therapy clinics to accurately position patients in a reproducible way, prior to treatment and to monitor the patient continuously during treatment. The system provides information about a patient's position and the adjustments required in order to position the patient as close as possible to a reference setup. During monitoring, the system reports deviations in the patient's position during treatment.

The system shall only be used by hospital personnel, qualified to work in radiation therapy or diagnostics departments.

The Sentinel platform is based on advanced laser technology with multipurpose software modules covering different tasks in the treatment procedure. The c4D multi-application software supports all modes of operation in one integrated package. The software is user friendly and requires a minimum of user interaction in the daily clinical workflow, while providing the advanced user with sophisticated data management, analysis and reporting functionalities. The software is designed to integrate with existing systems at the clinic, such as CT, linacs and R&V systems, and with motorized couch tops.

The Sentinel system does not require any markers to be placed on the patient or the couch, and doesn't subject the patient to any additional radiation. This also means that the personnel can stay in the treatment room during the whole set up procedure.

Sentinel includes three application modules, cPosition for fast and accuracy patient positioning, cMotion for motion detection during the treatment delivery procedure and cRespiration for respiratory gating diagnostic CT imaging, so called 4D CT studies. Patient positioning before the actual treatment begins, together with subsequent motion detection, ensures that the patient's position is correct both before and during the whole treatment delivery.

The Sentinel hardware consists of a single scanner unit containing the laser and camera, mounted in the ceiling in front of the gantry. The scanner is connected to the PC running the c4D software.

During patient surface acquisition, a laser line is swept along the patient while the camera records a number of images. From the data acquired, a complete 3D surface of the patient can be reconstructed using laser line triangulation. For patient positioning, the acquired surface is captured in a few seconds and can contain several hundred contours. For motion detection the number of contours are typically lowered so that the desired frame rate is achieved. The system is capable of acquiring more than 50 contours per second.

The provided text does not contain detailed information about the acceptance criteria and a specific study that definitively proves the device meets those criteria in the format requested.

The document is a 510(k) Summary for the Sentinel device, primarily focused on demonstrating substantial equivalence to a predicate device. It briefly mentions "Verification and validation has been carried out according to the C-RAD quality management system" and refers to a "V&V report," but the details of this report, including specific acceptance criteria and study results, are not provided in this summary.

It does state: "For the functionality of sending data to the CT for gated imaging and/or reconstruction, non-clinical (phantom) tests have been performed in collaboration with three hospitals in Europe: Uppsala (Sweden), Malmö (Sweden), and Lisbon (Portugal)." However, the details of these phantom tests (e.g., specific metrics, acceptance thresholds, sample sizes, a table comparing expected vs. observed performance) are not included.

Therefore, I cannot directly extract the full requested information from the provided text.

Here's a breakdown of what can be inferred or what is missing based on the prompt's requirements:

1. A table of acceptance criteria and the reported device performance

• Acceptance Criteria: Not explicitly stated in a quantifiable, tabular format. The general intent is that the device provides "accurate and reproducible patient positioning" and "patient motion supervision with an audible and/or visual alarm whenever the patient motion during treatment is outside of the specified tolerance values, while still allowing for normal breathing motion without triggering the alarm" and provides "a respiratory signal to be supplied to diagnostic imaging equipment (primarily CTs) for prospectively and retrospectively (aka 4DCT) gated imaging and reconstruction." Specific numerical thresholds for accuracy, reproducibility, or alarm triggers are not provided.
• Reported Device Performance: Not presented in a quantifiable, tabular format. The document states that "non-clinical (phantom) tests have been performed" and concludes that "the non clinical tests demonstrates that the device is safe, as effective, and performs as well as the legally marketed device Sentinel (K082582)." No specific performance metrics or results from these tests are given.

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

• Sample Size (Test Set): Not specified. The "non-clinical (phantom) tests" were performed, implying inanimate objects were used, not human patients. The number of phantom tests or data points is not mentioned.
• Data Provenance: "non-clinical (phantom) tests have been performed in collaboration with three hospitals in Europe: Uppsala (Sweden), Malmö (Sweden), and Lisbon (Portugal)." This indicates a prospective testing approach on phantoms.

3. 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 as the tests were "non-clinical (phantom) tests." Ground truth for phantom tests would typically involve precisely known physical properties or measurements rather than expert human interpretation of medical images.

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

• Not applicable/Not mentioned. Given it was non-clinical phantom testing, adjudication methods for human interpretation of medical data are not relevant.

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

• No MRMC comparative effectiveness study was done. This device is a positioning and monitoring system, not an AI-assisted diagnostic tool that requires human reader improvement studies. The document focuses on the device's ability to position and monitor, not interpret.

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

• The non-clinical phantom tests likely represent a standalone performance evaluation of the system's accuracy and functionality in controlling and monitoring without direct human intervention in the positioning process itself (though humans would set up the tests). The document doesn't explicitly describe these tests as "standalone" in the context of an AI-only performance evaluation, but rather as demonstrating the device's technical capabilities.

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

• For the non-clinical phantom tests, the ground truth would inherently be based on the known, precisely engineered properties of the phantoms and/or reference measurements established through highly accurate measurement tools. It's not expert consensus, pathology, or outcomes data.

8. The sample size for the training set

• Not applicable/Not mentioned. The document describes the system as "based on advanced laser technology with multipurpose software modules." It does not indicate the use of a machine learning model that would require a "training set" in the conventional sense. The software functions based on "advanced surface registration algorithms" and laser line triangulation.

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

• Not applicable, as no training set for a machine learning model is indicated.

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The Catalyst system is intended for use in radiation therapy clinics to accurately set-up and position patients in a reproducible way prior to treatment, and to monitor the patient continuously during treatment. The system provides, information about a patient's position and the adjustments required in order to position the patient as close as possible to a reference setup. During monitoring, the system reports deviations in the patient's position during treatment and disables the treatment beam in case of large detected movements. The system can also track the patient's respiratory motion for supporting synchronized image acquisition or treatment delivery.

The Catalyst system is a further development of the Sentinel system and is using the same software platform but contains a new hardware device which enables overall higher performance and the possibility to run multiple applications in parallel.

Catalyst is an advanced system based on optical surface tracking for patient monitoring during the radiotherapy treatment process. The Catalyst platform is based on advanced structured light measurements with multipurpose software modules covering different tasks in the treatment procedure. The c4D multi-application software supports all modes of operation in one integrated package. The software is user friendly and requires a minimum of user interaction in the daily clinical workflow, while providing the advanced user with sophisticated data management, analysis and reporting functionalities. The software is designed to integrate with existing systems at the clinic, such as CT, linacs and R&V systems, and with motorized couch tops.

Catalyst includes three application modules, cPosition for fast and accuracy patient positioning, cMotion for motion detection during the treatment delivery procedure, and cRespiration for detecting respiratory motion and generating a gating signal for synchronized imaging or gated treatment delivery.

The Catalyst hardware consists of a single scanner unit containing the projector and camera, mounted in the celling in front of the gantry. The scanner is connected to the PC running the c4D software.

During patient surface acquisition, a sequence of structured light patterns is illuminating the patient while the camera records a number of images. From the data acquired, a complete 3D surface of the patient can be reconstructed using the principles of optical triangulation. Information from the system is shown on a PC monitor in the treatment room as well as the control area. The system can also project a high resolution multi-color light field onto the patient surface, thus avoiding the need for the personnel to look at the PC monitor when setting up the patient. The system optionally records data which can be used for further analysis of actual patient motion during each treatment session.

Here's an analysis of the acceptance criteria and study information for the C-RAD Catalyst device, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size Used for the Test Set and Data Provenance

The document does not explicitly state the numerical sample size used for the test set. It mentions "The validation performed at Varian Medical Systems, UAS and Malmö shows that the Catalyst application for patient positioning, monitoring and respiratory gating is functioning according to its intended use." This suggests prospective in-clinic testing at multiple sites (Varian Medical Systems, UAS, Malmö), implying that the data provenance is from clinical environments in those locations. The document does not specify the country beyond naming these sites.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications

The document does not specify the number of experts used or their qualifications for establishing ground truth for the test set. It states the system "shall only be used by hospital personnel, qualified to work in radiation therapy or diagnostic imaging departments," which implies that the validation would involve such qualified personnel, but doesn't detail their role in ground truth establishment.

4. Adjudication Method for the Test Set

The document does not describe the specific adjudication method used for the test set.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No multi-reader multi-case (MRMC) comparative effectiveness study is mentioned that assesses human readers' improvement with or without AI assistance. The device is a positioning and monitoring system, not and AI-assisted diagnostic tool for human readers.

6. Standalone (Algorithm Only) Performance Study

Yes, a standalone performance study was conducted. The "Performance data" section explicitly states, "The measurement accuracy is better than 1 mm for Catalyst and its predicates. The performance test results are presented in the application." This refers to the algorithm's direct measurement capability independently of human interpretation.

7. Type of Ground Truth Used

The type of ground truth used is implied to be a combination of:

• Physical measurement/reference: For "measurement accuracy better than 1 mm," the ground truth would likely be established through highly accurate physical measurement systems or phantoms.
• Clinical observation/intended function: For "functioning according to its intended use" for patient positioning, monitoring, and respiratory gating, the ground truth would be based on the established clinical procedures and expected behavior in a real-world scenario.

8. Sample Size for the Training Set

The document does not provide information about a specific "training set" or its size. As a surface tracking and positioning system, it might rely on pre-programmed algorithms and physical principles rather than a large, labeled training dataset in the way a modern AI image classification model would. If machine learning was used, the training data details are not disclosed.

9. How the Ground Truth for the Training Set Was Established

Since no specific training set is mentioned (see point 8), the method for establishing its ground truth is not described.

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The Sentinel system is intended for use in radiation therapy clinics to accurately position patients in a reproducible way, prior to treatment and to monitor the patient continuously during treatment. The system provides information about a patient's position and the adjustments required in order to position the patient as close as possible to a reference setup. During monitoring, the system reports deviations in the patient's position during treatment.

The Sentinel system is a new version of the Positioner system (previously registered with 510(k) Number K063839), updated with an application module for patient monitoring, cMotion (the design control documents are included in Appendices A and B).

Sentinel is an advanced system for surface contour localization and patient monitoring during the radiotherapy treatment process. The Sentinel platform is based on advanced laser technology with multipurpose software modules covering different tasks in the treatment procedure. The c4D multi-application software supports all modes of operation in one integrated package. The software is user friendly and requires a minimum of user interaction in the daily clinical workflow, while providing the advanced user with sophisticated data management, analysis and reporting functionalities. The software is designed to integrate with existing systems at the clinic, such as CT, linacs and R&V systems, and with motorized couch tops.

Sentinel includes two application modules, cPosition for fast and accuracy patient positioning and cMotion for motion detection during the treatment delivery procedure.

The Sentinel hardware consists of a single scanner unit containing the laser and camera, mounted in the ceiling in front of the gantry. The scanner is connected to the PC running the c4D software.

During patient surface acquisition, a laser line is swept along the patient while the camera records a number of images. From the data acquired, a complete 3D surface of the patient can be reconstructed using laser line triangulation. For patient positioning, the acquired surface is captured in a few seconds and can contain several hundred contours. For motion detection the number of contours is typically lowered so that the desired frame rate is achieved.

cPosition

Once the treatment planning has been performed, the resulting plan can be transferred to the Sentinel system through import from the industry-standard DICOM format, creating the reference data necessary for patient positioning. Reference data can also be by created using the Sentinel laser scanner. In the treatment room, synchronization with the LINAC or R & V (Record and Verify) system ensures that the correct reference data is called up automatically when the patient is selected for treatment, and also eliminates the need for any manual selection of the patient in the Sentinel system.

By advanced surface registration algorithms the actual patient position is compared to the predefined reference, suggesting within seconds a correction in six degrees of freedom of the patient's position. With interface to major accelerator vendors the suggested patient position is transferred to the respective couch control system and fast and accurate alignment is achieved.

cMotion

cMotion monitors the movement of the patient during treatment delivery and automatically warns if the patient moves outside the allowed tolerances.

The provided text describes the C-RAD Sentinel system, a radiotherapy positioning system. However, it does not contain the detailed information necessary to fully answer all aspects of your request regarding acceptance criteria and the study that proves the device meets them. This document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device rather than providing a comprehensive study report with specific performance metrics and methodologies.

Here's a breakdown of what can be extracted and what is missing:

1. A table of acceptance criteria and the reported device performance:

The document broadly states the intended use, which implies certain performance goals, but it does not specify quantitative acceptance criteria or detailed reported performance figures in a table format.

What's missing for point 1: Specific numerical values for accuracy (e.g., within X mm or degrees), reproducibility (e.g., standard deviation of Y mm), latency of motion detection, or specific thresholds for "allowed tolerances."

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

This information is not available in the provided 510(k) summary. The document mentions "performance data has been submitted," but does not detail the nature of this data, its sample size, or its provenance.

3. 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):

This information is not available in the provided 510(k) summary. Given the device's function (positioning and motion detection), the "ground truth" would likely involve physical measurements or phantoms, rather than expert interpretation of images.

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

This information is not available in the provided 510(k) summary.

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:

This is not applicable to the Sentinel device as described. The Sentinel system is a radiotherapy positioning system that uses laser technology for surface contour localization and patient monitoring. It is not an AI-assisted diagnostic imaging device that human "readers" would interpret or benefit from in the way an MRMC study evaluates. The system provides objective positional data and alerts, rather than complex interpretations requiring human "reading."

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

The device inherently operates with "human-in-the-loop" for the positioning and treatment process, but its core function of detecting patient position and movement is an algorithm-only task. The system "suggests within seconds a correction" and "automatically warns if the patient moves outside the allowed tolerances." This implies a standalone capability for sensing and alerting based on its algorithms. However, the study specific to this standalone performance is not described with details of methodology or metrics.

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

The document does not explicitly state the type of ground truth used for performance testing. Given the nature of the device (positioning and motion detection), the ground truth would likely be established through:

• Physical measurements: Using calibrated phantom devices, external measurement systems (e.g., optical tracking systems, micrometers, or other highly accurate instruments) to verify the accuracy of the Sentinel's reported positions and movements.
• Known displacements: Inducing precise, known movements in phantoms or test setups and verifying if the Sentinel system accurately detects and quantifies these movements.

8. The sample size for the training set:

This information is not available in the provided 510(k) summary. The Sentinel system uses "advanced surface registration algorithms." While such algorithms often involve training data (e.g., to learn surface features or model variations), the document does not specify any training set size. It's possible that the algorithms are based on fundamental physics and geometry rather than large-scale machine learning, in which case a "training set" might not be applicable in the same way as for AI image analysis.

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

This information is not available in the provided 510(k) summary for the reasons mentioned in point 8.

In summary: The provided 510(k) document serves its purpose of demonstrating substantial equivalence by outlining the device's function, intended use, and stating that performance data was submitted. However, it specifically lacks the detailed study methodology, quantitative acceptance criteria, specific performance metrics, sample sizes, and ground truth establishment methods that would be present in a comprehensive study report or a more detailed technical file.

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The Positioner system is intended for use in radiation therapy clinics to accurately position patients for radiation therapy in a teproducible way. The system provides information about a patient's position and the adjustments required in order to position the patient as a close as possible to a reference setup. The system shall only be used by hospital personnel, qualified to work in radiation therapy or diagnostics departments.

The system consists of a laser-camera unit (LS-100) mounted in the ceiling, and a Windows based application (cPosition) running on a standard PC. The system is non-invasive and uses visible laser light (635nm) to project lines on the patient. The laser-camera scans a 3D surface by projecting a series of laser lines which are recorded by the camera. From each camera recording a 3D contour of the measured object is calculated using triangulation technique and by adding the contours a full 3D surface image is achieved. The PC software compares the scanned image with a reference image and calculates the adjustments required in order to match the two images.

I am sorry, but the provided text does not contain the acceptance criteria or a study that proves the device meets the acceptance criteria. The document is a 510(k) summary for a medical device called "Positioner", which describes its intended use, technological comparison to predicate devices, and the FDA's substantial equivalence determination.

The document states: "However, performance data has been submitted to show that Positioner achieves its intended use and that these technological differences raise no new efficacy or safety concerns." This indicates that a performance study was conducted and submitted to the FDA, but the details of the acceptance criteria and the study results are not present in this summary.

Therefore, I cannot extract the information required in your request, such as a table of acceptance criteria, sample sizes, expert qualifications, or details about standalone or MRMC studies.

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