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iPlan RT is a radiation treatment planning system that is intended for use in stereotactic, conformal, computer planned, Linac based radiation treatment of cranial, head and neck, and extracranial lesions.

iPlan RT is a software program to generate treatment plans and to simulate the dose delivery for external beam radiotherapy. The system is the evolutionary successor of the predicate devices iPlan RT Image (K080886) and iPlan RT Dose (K080888). It is specialized for stereotactic procedures for cranial as well as extracranial lesions. It includes functions for all relevant steps from outer contour detection to quality assurance. It combines most of its predecessor's functionality iPlan RT Image and iPlan RT Dose together with additional improvements. Therefore, the new version shall be called "iPlan RT".

The device incorporates conformal beams, conformal IMRT beams, circular arcs, and both static and dynamic arc treatments. Moreover, a combination of optimized dynamic arc treatments together with IMRT beams was added to the treatment modalities.

The system calculates dose using a convolution algorithm as the previous version. Alternatively, a Monte Carlo method based calculation algorithm can be used as in iPlan RT Dose (K080888). The documentation & export function facilitates printouts of all parameters and results for the creation of DICOM RT (RT Plan and RT Image) files.

Adapting existing treatment plans during fractionated radiotherapy treatments is facilitated using an elastic deformation algorithm. Existing structures are morphed from an existing treatment plan onto a new follow-up scan. If necessary, these structures can be adapted by the physician and can be used to update the current treatment plan accordingly.

The provided document, a 510(k) summary for Brainlab AG's iPlan RT, does not contain a study that proves the device meets specific acceptance criteria in the manner typically seen for novel medical device algorithms or AI. Instead, it demonstrates substantial equivalence to predicate devices (iPlan RT Image K080886 and iPlan RT Dose K080888) through non-clinical testing.

Here's an analysis based on the provided text, addressing the requested points:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of acceptance criteria with corresponding performance metrics. The summary of non-clinical testing only states that the device "has met its specifications" and is "substantially equivalent to the predicate devices" and "safe and effective for its intended use." These are general conclusions rather than detailed performance metrics.

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

The document does not mention the use of a "test set" in the context of clinical data for performance evaluation. The evaluation was based on non-clinical testing and comparison to predicate devices. Therefore, there is no information on sample size or data provenance.

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

Since no clinical test set was used to establish performance against a ground truth, this information is not applicable and not provided in the document.

4. Adjudication Method for the Test Set

As no clinical test set requiring ground truth establishment was used, there is no mention of an adjudication method.

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

The document explicitly states: "Clinical testing is not required to demonstrate substantial equivalence or safety and effectiveness." Therefore, an MRMC comparative effectiveness study was not performed.

6. Standalone (Algorithm Only) Performance Study

The document describes non-clinical "Verification and Validation tests" which confirmed the device "met its specifications." This implicitly refers to the algorithm's performance in generating treatment plans. However, no specific metrics like sensitivity, specificity, accuracy, or a detailed study design for standalone performance are provided beyond the general statement of meeting specifications. The focus is on functionality and equivalence to predicate devices.

7. Type of Ground Truth Used

For the non-clinical testing, the "ground truth" would likely have been the expected computational output based on known physics and engineering principles for radiation dose calculation and planning. This is inferred from the statement that the device "has met its specifications." There is no mention of external clinical ground truth (e.g., pathology, outcomes data, or expert consensus on clinical cases) for this 510(k) submission.

8. Sample Size for the Training Set

The document does not mention a "training set" in the context of machine learning or AI models with data-driven training. The iPlan RT is described as an "evolutionary successor" of previous devices, suggesting a development and refinement process rather than a machine learning training paradigm. The core dose calculation uses a convolution algorithm or Monte Carlo method, which are physics-based models rather than models trained on large datasets.

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

As no explicit training set for a machine learning model is mentioned, this question is not applicable based on the provided text.

In summary, the 510(k) for iPlan RT focuses on demonstrating substantial equivalence to existing predicate devices through non-clinical verification and validation, rather than extensive clinical studies with specific acceptance criteria tables and ground truth evaluations typically associated with novel AI/ML devices.

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iPlan RT Image's indications for use are to prepare and present patient and image data based on CT, MR, angiographic and other imaging sources including

• image preparation -
• image localization
• n image fusion
• image segmentation "
• isocenter handling -
• plan review and approval -
  where the result is used for stereotactic radiation treatment planning that is intended for use in stereotactic, conformal, computer planned, LINAC based radiation treatment of cranial, head and neck and extracranial lesions.

Not Found

The provided text is a 510(k) summary for the iPlan RT Image device from BrainLAB AG. This document focuses on establishing substantial equivalence to predicate devices and detailing the intended use. It does not contain information about acceptance criteria, device performance studies, sample sizes, expert ground truth establishment, or any comparative effectiveness studies.

Therefore, I cannot provide the requested information from this document. The sections you asked for, such as "A table of acceptance criteria and the reported device performance," "Sample sized used for the test set," "Number of experts used," "Adjudication method," "MRMC comparative effectiveness study," "standalone performance," "type of ground truth," "training set sample size," and "how ground truth for training set was established," are not present in the provided text.

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iPlan RT Dose is a stereotactic radiation treatment planning system that is intended for use in stereotactic, conformal, computer planned, Linac based radiation treatment of cranial, head and neck, and extracranial lesions.

Not Found

The provided text is a 510(k) summary for the iPlan RT Dose system. It describes the device, its intended use, and its predicate devices, but does not contain information about acceptance criteria or a study proving the device meets acceptance criteria.

Therefore, I cannot fulfill your request to describe acceptance criteria and a study that proves the device meets them based only on the provided input. The document is an FDA approval letter and summary, not a study report.

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iPlan RT Dose is a stereotactic radiation treatment planning system that is intended for use in stereotactic, conformal, computer planned, Linac based radiation treatment of cranial, head and neck, and extracranial lesions.

iPlan RT Dose is a software program to generate treatment plans and to simulate the dose delivery for external beam radiotherapy. The system is the evolutionary successor of the predicate device BrainSCAN (K994413). It is specialized for stereotactic procedures for cranial as well as extracranial lesions. It includes functions for all relevant steps from outer contract detection to quality assurance.

iPlan RT Dose incorporates most capabilities of the predicate device BrainSCAN. The device incorporates conformal beams, conformal IMRT beams, both static and dynamic arc treatments. The system calculates dose using a convolution algorithm similar to the predicate device BrainSCAN. The documentation & export allows producing printouts of all parameters and results for the creation of DICOM RT (RT Plan and RT Image) files.

This document is a 510(k) summary for the iPlan RT Dose system, a radiation treatment planning system. It establishes substantial equivalence to a predicate device (BrainSCAN, K994413). It does not contain information regarding acceptance criteria, device performance metrics, or details of specific studies conducted to establish performance characteristics in the way you've outlined.

The document states: "iPlan RT Dose has been verified and validated according to BrainLAB's procedures for product design and development. The validation proves the safety and effectiveness of the system." However, it does not provide the specifics of these verification and validation studies, including acceptance criteria or performance results.

Therefore, I cannot provide a table of acceptance criteria and reported device performance from this document. The other requested information (sample sizes, ground truth establishment, expert qualifications, adjudication methods, MRMC studies, standalone performance, training set details) is also not present in this 510(k) summary.

In summary, the provided text does not contain the information needed to fill out your request.

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iPlan RT FiberTracking's indications for use is to prepare and present patient and image data based on CT, MR, Angiographic and other imaging sources including

• image preparation -
• image localization -
• image fusion -
• image segmentation -
• isocenter handling -
• plan review and approval
• fiber tracking -
  where the result is used for stereotactic radiation treatment planning that is intended for use in stereotactic, conformal, computer planned, LINAC based radiation treatment of cranial, head and neck and extracranial lesions.

Fiber Tracking:
iPlan RT FiberTracking's indication for use is to prepare and present patient and image data based on MRI scanned with diffusion-weighted sequences. These diffusion images are used for the calculation and display of fiber bundles in a selected region of interest. The created treatment plans of iPlan TT FiberTracking can be used million in a scienced region of interest. The StainLAB medical devices such as BrainSCAN, iPlan RT Image, and iPlan RT Dose where this medical device is used for radiotherapy treatment planning.

iPlan RT FiberTracking is developed to enhance the functionality of Intuition Image software with the import and il lan in 11 Tiber Husking to do volupes (DTI). Additional to the basic functions of Intuition Image (viewing, drawing, planning of annuolen concernment of this application provides functions for the import and inflage fusion and attrootable racessing of the DTI data and the display of calculated fiber tracks.

This document provides a summary of the iPlan RT FiberTracking device and its substantial equivalence to a predicate device, rather than a detailed study proving its acceptance criteria. Therefore, I cannot fully complete all sections of your request based solely on the provided text.

However, I can extract the information that is present and highlight what is missing.

Here's a breakdown of the available and missing information regarding acceptance criteria and a study proving device performance:

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

The provided text does not contain a table of acceptance criteria or reported device performance metrics for the iPlan RT FiberTracking. It states that the device "has been verified and validated according to BrainLAB's procedures for product design and development," and "The trailer was found to be substantially equivalent with the predicate device iPlan! FiberTracking (K041703) and Intuition Image (K032511)." This indicates that the device met internal validation criteria and regulatory substantial equivalence, but specific performance metrics or their comparison against acceptance criteria are not detailed.

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 provided in the text.

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 provided in the text.

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

This information is not provided in the text.

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 information is not provided in the text. The document describes a "planning system" and "medical charged-particle radiation therapy system" that includes "fiber tracking." While fiber tracking involves advanced image processing, the text does not characterize it as an "AI" system in the modern sense or discuss human-in-the-loop performance studies with AI assistance. The focus is on the device's functionality and substantial equivalence.

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

The text describes the iPlan RT FiberTracking as a system that "prepares and presents patient and image data" and is used for "calculation and display of fiber bundles." This suggests it's an algorithm-driven component. However, the document does not explicitly state that a standalone performance study was conducted or provide its results. The substantial equivalence claim implies that its performance is comparable to predicate devices, which would have undergone their own validation.

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

This information is not provided in the text.

8. The sample size for the training set

This information is not provided in the text. The device's description does not explicitly mention "training set" in the context of machine learning, as this document predates the widespread use of deep learning in medical devices. The development process emphasizes "verification and validation," which implies testing against established data, but not necessarily a distinct "training set" as understood today.

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

This information is not provided in the text.

In summary:

The provided document is a 510(k) premarket notification summary focused on establishing substantial equivalence to existing predicate devices. It states that the device was "verified and validated according to BrainLAB's procedures for product design and development" to ensure its safety and effectiveness. However, it does not include the detailed study methodology, acceptance criteria, specific performance metrics, or patient data acquisition details that would typically be found in a clinical study report. The substantial equivalence argument itself serves as the regulatory "proof" that the device meets acceptance criteria by being similar to already-accepted devices.

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