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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.

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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