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The intended use of the device is the control of accurate patient positioning with assistance of a 3D Tracking System in a radiotherapy environment.

The iGUIDE 2.1 System is a powered radiation therapy support assembly which provides patient positioning control prior to radiotherapy treatment. iGUIDE 2.1 System consists of the iGUIDE workstation with software, a tracking system, reference frame, calibration tool, isolation transformer, KVM Extender and monitors for the workstation and terminal.

The iGUIDE software controls the combined working of the HexaPOD evo RT System components and provides status detection via the software GUI to the user. The HexaPOD evo RT System consists of iGUIDE and the HexaPOD evo RT Couchtop, a robotic patient-positioning platform with six degrees of freedom, which is cleared under K072898.

This document is a 510(k) summary for the iGUIDE 2.1 system, a medical device for patient positioning in radiotherapy. It focuses on demonstrating substantial equivalence to a previously cleared predicate device (iGUIDE System, K072079).

Here's a breakdown of the requested information based on the provided text:

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

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This product is intended to be used by radiologists and surgeons for the following: . Patient positioning and immobilization - Stereotactic diagnostic localization . - Patient positioning and immobilization device for . stereotactic radiotherapy of extracranial targets

The BodyFIX System is a patient positioning and immobilization device for use with radiotherapy, radiosurgery, sonography, surgery/CAS, imaging neurosurgery and brachytherapy treatments of extracranial targets. The principal parts of the system include the vacuum cushion, cover sheet, vacuum supply (vacuum pump), target positioner and localizer, and carbon fiber baseplate. The BodyFIX Vacuum Pump P3 is a high-performance vacuum pump that contains two separate pumps; the BlueBAG pump and the BodyFIX pump. - 1- BlueBAG pump provides the vacuum for inflating, forming and deflating the BlueBAG vacuum cushions.

Acceptance Criteria and Study Details for BodyFIX System

1. Table of Acceptance Criteria and Reported Device Performance

Note: The provided document primarily focuses on establishing substantial equivalence to a predicate device (BodyFIX K013391). The "Acceptance Criteria" column above is derived from the predicate device's characteristics as a benchmark for the new device. Specific quantitative acceptance criteria for the new device's performance are not detailed in the provided text as separate, predefined thresholds for "passing" a study, but rather a comparison to the predicate's reported performance. The study described shows the new device's performance metrics.

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

The provided document does not explicitly state the sample size used for the test set.

The data provenance (country of origin, retrospective/prospective) is not explicitly stated in the provided summary. However, given the device's manufacturer (Medical Intelligence Medizintechnik GmbH in Schwabmuenchen, Germany), it is likely that any testing involved German facilities, but this is not confirmed.

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

The provided document does not specify the number of experts used to establish ground truth for the test set, nor does it detail their qualifications.

4. Adjudication Method

The provided document does not describe any adjudication method (e.g., 2+1, 3+1, none) used for the test set.

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

The provided document does not mention or describe a Multi-Reader Multi-Case (MRMC) comparative effectiveness study. There is no information regarding human readers improving with or without AI assistance, as the device is a physical patient positioning and immobilization system, not an AI software.

6. Standalone (Algorithm Only) Performance Study

The provided document does not describe a standalone (algorithm only) performance study. The BodyFIX System is a physical medical device for patient positioning and immobilization, not an algorithm.

7. Type of Ground Truth Used

The "ground truth" for the performance metrics (localization and set-up errors) appears to be derived from direct measurements of the device's accuracy in a controlled or simulated environment, as indicated by "Transversal plane CT localisation error x,y" and "Longitudinal plane localisation error z" and "Linac set-up error." This suggests a technical or engineering validation rather than expert consensus, pathology, or outcomes data in the traditional sense of diagnostic accuracy.

8. Sample Size for the Training Set

The provided document does not mention or specify a sample size for a training set. This is expected as the BodyFIX System is a physical device, not an AI or machine learning algorithm that requires a training set.

9. How Ground Truth for the Training Set Was Established

As there is no training set mentioned or implied for this physical device, the concept of establishing ground truth for a training set is not applicable here.

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Fraxion™ is intended to be used for immobilisation, positioning and re-positioning during Stereotactic Radiotherapy (SRT) in all parts of the brain and head in a Linear Accelerator environment.

Further Fraxion™ is used to immobilise and position the head during image acquisition to support treatment planning.

Under certain circumstances (e.g. when the patient will not tolerate an invasive frame) Fraxion™ may also be used for Stereotectic Radiosurgery (SRS) in a Linear Accelerator environment.

Fraxion™ is a device for cranial stereotactic radiotherapy and radiosurgery. The major parts of the system include the Fraxion frame, Patient Control Unit, Frontpiece incl. Mouthpiece, vacuum cushion, thermoplastic mask and Stereotactic Frame.

The provided text is a 510(k) summary for the Fraxion™ device. It describes the device, its intended use, and its substantial equivalence to predicate devices. However, the document does not contain information about acceptance criteria, specific study designs, sample sizes for test or training sets, ground truth establishment, or expert qualifications for evaluating device performance. The document refers to a "preparation date" but doesn't mention any specific technical studies or performance data.

Therefore, I cannot fulfill your request for:

1. A table of acceptance criteria and the reported device performance: This information is not present in the provided text. The document is primarily an administrative summary for regulatory clearance, not a performance study report.
2. Sample sized used for the test set and the data provenance: Not available.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not available.
4. Adjudication method for the test set: Not available.
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 available. The device is a physical immobilization and positioning system, not an AI-assisted diagnostic or assistive tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
7. The type of ground truth used: Not available.
8. The sample size for the training set: Not applicable (not an AI device).
9. How the ground truth for the training set was established: Not applicable.

The document discusses the regulatory clearance of a physical medical device (Fraxion™) used for immobilization, positioning, and re-positioning in stereotactic radiotherapy and radiosurgery. It is not an AI/algorithm-based diagnostic or treatment planning system that would typically have the types of performance studies and metrics you are asking about.

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The intended use of the device is to support and aid in positioning a patient during radiation therapy.

The HexaPOD evo consists of two platforms, which are connected by six length adjustable elements which are powered. By appropriate coordinative adjustment of these elements, the system is able to move the upper platform relative to the lower one. The movement can occur in all three dimensions in space. Additionally the upper platform can rotate around these three axes which results in a tilt or a rotation of the upper platform relative to the lower one. Finally an accurate positioning within all six degrees of freedom (6DOF) can be provided. The HexaPOD consists of a controller unit which is directed by a cable connected hand control. Additionally it can be directed via an external graphics user interface (GUI) which is installed on a PC.

The provided text is a 510(k) summary for the HexaPOD™ evo RT Couch Top, which is a powered radiation therapy patient support assembly. It describes the device, its intended use, and its substantial equivalence to a predicate device.

However, the document explicitly states: "No performance data is required for this Class II device nor requested by the Food and Drug Administration (Office of Device Evaluation)."

Therefore, I cannot provide a table of acceptance criteria and reported device performance or information about a study proving the device meets acceptance criteria, as such data was not required or provided in this 510(k) submission.

Here's a breakdown of why the specific questions cannot be answered based on the input:

• 1. A table of acceptance criteria and the reported device performance: Not applicable. The document states no performance data was required or requested.
• 2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): Not applicable. No performance data or testing on a test set was mentioned.
• 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. No performance data or ground truth establishment was mentioned.
• 4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable. No performance data or adjudication was mentioned.
• 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 device is a physical patient support assembly, not an AI or imaging interpretation device. MRMC studies are not relevant.
• 6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. The device is a physical patient support assembly, not an algorithm.
• 7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable. No performance data or ground truth establishment was mentioned.
• 8. The sample size for the training set: Not applicable. As no performance data from a study was required, there's no mention of a training set.
• 9. How the ground truth for the training set was established: Not applicable. No training set or ground truth establishment was mentioned.

In summary, the 510(k) submission for the HexaPOD™ evo RT Couch Top focuses on its substantial equivalence to a predicate device due to minor hardware changes, and explicitly states that no performance data was required or requested.

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The intended use of the device is the control of accurate patient positioning with assistance of a 3D Tracking System in a radiotherapy environment.

The iGUIDE System is a powered radiation therapy support assembly which provides patient positioning control before radiotherapy treatment. The iGUIDE System consists of the following system components: iGUIDE Reference Frame with optical markers, iGUIDE Calibration Phantom (calibration phantom for KV-imaginq). NDI Polaris Tracking System, iGUIDE Workstation with iGUIDE software (control room) and iGUIDE Terminal (treatment room). The iGUIDE System is intended to be used together with the HexaPOD RT CouchTop (K041448), which is intended to be used together with the following radiation therapy systems: Elektra Precise Treatment System with Precise Table (K983678), Varian Trilogy Radiotherapy Delivery System (K033343), Clinac 2300 C/D with Exact Couch (K913119),and Siemens PRIMUS or ONCOR Linear Accelerator with Siemens ZXT Treatment Table (K910971)

The provided text does not contain information about acceptance criteria or a study that proves the device meets specific acceptance criteria.

The 510(k) summary explicitly states:

"No performance data is required for this Class II device nor requested by the Food and Drug Administration (Office of Device Evaluation)."

Therefore, I cannot provide the requested information, including:

1. A table of acceptance criteria and the reported device performance
2. Sample size used for the test set and the data provenance
3. Number of experts used to establish the ground truth for the test set and their qualifications
4. Adjudication method for the test set
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, or the effect size of human readers improving with AI vs without AI assistance
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
7. The type of ground truth used
8. The sample size for the training set
9. How the ground truth for the training set was established

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The intended use of the device is to support and aid in positioning a patient during radiation therapy.

The HexaPOD consists of two platforms, which are connected by six linear, rigid but length adjustable elements which are powered. By appropriate coordinative adjustment of these elements, the system is able to move the upper platform relative to the lower one. The movement can occur in all three dimensions in space. Additionally the upper platform can rotate around these three axes which results in a tilt or a rotation of the upper platform relative to the lower one. Finally an accurate positioning within all six degrees of freedom (6DOF) can be provided. The HexaPOD consists of a controller unit which is directed by a cable connected hand control. Additionally it can be directed via an external graphics user interface (GUI) which is installed on a PC.

Here's a breakdown of the acceptance criteria and study information for the HexaPOD RT Couch Top device, based on the provided document:

Acceptance Criteria and Device Performance

Important Note: The document explicitly states: "No performance data is required for this Class II device nor requested by the Food and Drug Administration (Office of Device Evaluation)." Therefore, detailed quantitative performance metrics or specific studies demonstrating device acceptance criteria are not provided in this document. The acceptance is based on demonstrating substantial equivalence to a predicate device, and the modifications being benign in terms of safety and effectiveness.

Study Information

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. The document states that "No performance data is required..." and therefore no specific test set data is presented. The submission relies on demonstrating substantial equivalence to a predicate device.

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. As no specific performance studies or test sets were mandated or performed for this submission, there's no mention of experts establishing ground truth for a test set.

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

   • Not Applicable. No test set or independent performance study was conducted or presented.

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

   • Not Applicable. This device is a mechanical patient support system, not an AI-assisted diagnostic or therapeutic tool. Therefore, MRMC studies or AI assistance are not relevant.

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

   • Not Applicable. This device is a mechanical patient support system, not an algorithm.

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

   • Not Applicable. Since no performance data or test sets were required or presented, no specific ground truth was established for the device itself in this submission. The "ground truth" for its acceptance is its demonstrated substantial equivalence to the predicate device, which implies the predicate device's performance characteristics are the standard.

7. The sample size for the training set

   • Not Applicable. This device is a mechanical patient support system, not an AI or machine learning model that would require a training set.

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

   • Not Applicable. No training set was used.

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The intended use of the device is to support and aid in positioning a patient during radiation therapy.

The HexaPOD consists of two platforms, which are connected by six linear, rigid but length adjustable elements which are powered. By appropriate coordinative adjustment of these elements, the system is able to move the upper platform relative to the lower one. The movement can occur in all three dimensions in space. Additionally the upper platform can rotate around these three axes which results in a tilt or a rotation of the upper platform relative to the lower one. Finally an accurate positioning within all six degrees of freedom (6DOF) can be provided. The HexaPOD consists of a controller unit which is directed by a cable connected hand control. Additionally it can be directed via an external graphics user interface (GUI) which is installed on a PC.

The provided document is a 510(k) Premarket Notification for a medical device called the HexaPOD™ RT Couch Top. It outlines the device's description, intended use, and its substantial equivalence to a predicate device.

However, the document explicitly states: "No performance data is required for this Class II device nor requested by the Food and Drug Administration (Office of Device Evaluation)."

Therefore, I cannot provide the requested information about acceptance criteria, device performance, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth establishment because no such studies were required or performed for this specific device submission.

The 510(k) submission for the HexaPOD™ RT Couch Top focuses on demonstrating substantial equivalence to a previously legally marketed device (Medical Intelligence's "HexaPOD RT Couch Top") rather than proving novel performance against specific acceptance criteria through new clinical or performance studies. The modifications made were evolutionary hardware changes and implementing additional safety functions, which did not trigger a requirement for new performance data.

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The intended use of the device is the control of accurate patient positioning with assistance of a 3D Tracking System in a radiotherapy environment

The iGUIDE® System controls the movement of the Medical Intelligence HexaPOD™ RT CouchTop (K041448), a radiographic treatment table with 6 DOFs (Degrees of freedom). With the integrated 3D Tracking System the device controls also the accuracy of the patient positioning.

The iGUIDE® System consists of a PC workstation, a graphics user interface to the treatment table (software) and the NDI Polaris 3D Tracking System.

The iGUIDE® System is integrated into radiation therapy systems of Elekta, Varian, and Siemens and is connected to them with an Interlock connection.

The provided document is a 510(k) summary for the Medical Intelligence iGUIDE® System, submitted in 2006. It focuses on establishing substantial equivalence to a predicate device rather than presenting a detailed clinical study with acceptance criteria and performance data for a standalone AI device.

Therefore, much of the requested information regarding acceptance criteria, specific study design, expert involvement, and AI performance metrics is not available in this document. The document explicitly states:

"No performance data is required for this Class II device nor requested by the Food and Drug Administration (Office of Device Evaluation)"

This indicates that the regulatory pathway for this device at the time did not necessitate a clinical study demonstrating performance against specific acceptance criteria in the way a modern AI/ML device submission would. The focus was on establishing substantial equivalence to existing devices through technological characteristics and intended use.

However, I can extract the information that is present:

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

No explicit acceptance criteria or reported device performance metrics are provided in the document. The submission focuses on establishing substantial equivalence to a predicate device (BrainLab "ExacTrac system" K003285) rather than meeting defined performance thresholds in a clinical study.

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

Not applicable, as no performance data from a test set is reported.

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 no ground truth establishment for a test set is reported.

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

Not applicable, as no test set requiring adjudication is reported.

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 iGUIDE® System is described as a device that controls movement and aids in patient positioning during radiation therapy, not an AI system that assists human readers in interpreting medical images or data.

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

The iGUIDE® System is a standalone device in the context of its function (controlling the treatment table and patient positioning). However, it is not an "algorithm only" device meant for diagnosis or interpretation. It is a system that physically aids in positioning, potentially with automated components, but it's not a diagnostic AI. The document does not describe "standalone" performance in the modern sense of an AI algorithm's diagnostic accuracy.

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

Not applicable, as no ground truth for diagnostic or interpretive performance is reported. The "accuracy of patient positioning" is mentioned, which would be the relevant "ground truth" if performance data were collected, but no specific methodology for its establishment is detailed in this document.

8. The sample size for the training set

Not applicable, as this submission pre-dates the common concept of "training sets" for AI/ML models in medical device submissions. The iGUIDE® System is not described as an AI/ML device that requires training data in the modern sense.

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

Not applicable, as this information is not relevant to the type of device and submission described.

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The intended use of the device is to support and aid in positioning a patient during radiation therapy.

The HexaPOD consists of two platforms, which are connected by six linear, rigid but length adjustable elements which are powered. By appropriate coordinative adjustment of these elements, the system is able to move the upper platform relative to the lower one. The movement can occur in all three dimensions in space. Additionally the upper platform can rotate around these three axes which results in a tilt or a rotation of the upper platform relative to the lower one. Finally an accurate positioning within all six degrees of freedom (6DOF) can be provided. The HexaPOD consists of a controller unit which is directed by a cable connected teach pad. Additionally it can be directed via an external graphics user interface (GUI) which is installed on a PC.

The provided document is limited to the HexaPOD™ RT CouchTop, a medical device designed to support and position patients during radiation therapy. It is a 510(k) submission to the FDA, which focuses on demonstrating substantial equivalence to existing devices rather than new clinical trials for safety and effectiveness.

As such, the document does not contain the detailed information required to fill out most of the points in your request. Specifically, it states:

• "No performance data is required for this Class II device nor requested by the Food and Drug Administration (Office of Device Evaluation)."

This means there was no specific study conducted to prove the device meets acceptance criteria in the way you've outlined for performance metrics (sensitivity, specificity, accuracy, F1 score). The 510(k) process for this device relies on demonstrating that its technological characteristics are "substantially equivalent" to predicate devices, and therefore it is considered safe and effective for its intended use without new clinical performance studies.

Therefore, I cannot provide a table of acceptance criteria with reported device performance, nor can I provide information on sample sizes, data provenance, expert ground truth establishment, adjudication methods, MRMC studies, standalone performance, training set details, or ground truth for the training set.

Here's what can be extracted from the document based on your request, with the understanding that performance data as typically defined for AI/diagnostic devices is not applicable here:

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

• Acceptance Criteria: For a 510(k) submission, the primary acceptance criterion is substantial equivalence to legally marketed predicate devices. This means the device must have the same intended use and either the same technological characteristics or, if different, those differences must not raise new questions of safety or effectiveness. The document asserts that the HexaPOD does not have technological characteristics that raise additional types of questions related to safety and effectiveness.
• Reported Device Performance: The document explicitly states, "No performance data is required for this Class II device nor requested by the Food and Drug Administration (Office of Device Evaluation)." Therefore, there are no reported performance metrics like sensitivity, specificity, or accuracy in the context of diagnostic or AI-driven decision-making. The "performance" in this context is implicitly deemed acceptable by virtue of its substantial equivalence to predicate devices, which are already on the market.

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

• Not Applicable: The document states that no performance data was required or requested. Therefore, there was no "test set" in the context of evaluating performance metrics.

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: No performance data or test set that would require expert ground truth was mentioned.

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

• Not Applicable: No performance data or test set was mentioned.

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: This device is a patient support assembly, not an AI or diagnostic tool. No MRMC study was conducted or mentioned.

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

• Not Applicable: This device is a mechanical patient support system. It does not have an "algorithm only" performance.

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

• Not Applicable: No ground truth in the context of disease detection, diagnosis, or outcome prediction was established or used, as this is a mechanical patient positioning device.

8. The sample size for the training set

• Not Applicable: There is no mention of a training set as this is not an AI/machine learning device.

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

• Not Applicable: There is no mention of a training set or ground truth for such a set.

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Positioning and repositioning of the patient's head; Stereotactic diagnostic localization; and Stereotactic radiotherapy of cranial targets

The VBH HeadFIX™ is a fixation device for cranial stereotactic radiotherapy and radiosurgery. The major parts of the system include the Vacuum Pump, Vacuum Cushion, Target Positioner Screens and Baseplate, Post Set, and Cranial Localizer.

The provided submission for K030439, concerning the VBH HeadFIX™, explicitly states that no performance data was required or requested by the Food and Drug Administration (Office of Device Evaluation) for this Class II device.

Therefore, the following information, which requires specific performance study data, cannot be extracted from the given text:

1. A table of acceptance criteria and the reported device performance: No acceptance criteria or reported performance data is provided.
2. Sample sized used for the test set and the data provenance: No test set information is available.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: No ground truth establishment for a test set is described.
4. Adjudication method for the test set: No adjudication method is described.
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 study was conducted or reported. The device is a physical fixation device, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: No such study was conducted or reported. The device is a physical fixation device, not an algorithm.
7. The type of ground truth used: No ground truth information is available as no performance testing was required.
8. The sample size for the training set: No training set information is available.
9. How the ground truth for the training set was established: No ground truth establishment for a training set is described.

The submission relies on a database search for adverse effects of similar, currently marketed devices rather than prospective performance testing of the VBH HeadFIX™.

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