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The RT Elements are applications for radiation treatment planning for use in stereotactic, conformal, computer planned, Linac based radiation treatment of cranial, head and neck, and extracranial lesions.

The "Dose Review" application as one RT Element contains features for review of isodose lines, review of DVHs, dose comparison and dose summation.

The "Multiple Brain Mets SRS" application as one RT Element provides optimized planning and display for cranial multimetastases radiation treatment planning.

The "Adaptive Hybrid Surgery Analysis" application as one RT Element simulates an automated tadiation treatment plan. The simulated plan is intented for treatment evaluation for example in tumor board meetings or operating rooms.

The "Cranial SRS" application as one RT Element provides optimized planning and display for cranial radiation treatment planning.

The "Spine SRS" application as one RT Element provides optimized planning and display for single spine metastases.

"RT QA" is an accessory to the RT Elements and contains features for patient specific quality assurance.

Use "RT QA" to recalculate patient treatment plans on a phantom to verify that the patient treatment plan fulfills the planning requirements.

The Dose Review application as one RT Element contains features for review of isodose lines, review of DVHs, dose comparison and dose summation.

The Multiple Brain Mets SRS application as one RT Element provides optimized planning and display for cranial multi-metastases radiation treatment planning.

The Adaptive Hybrid Surgery Analysis application as one RT Element simulates an automated template-based radiation treatment plan. The simulated plan is intended for treatment evaluation for example in tumor board meetings or operating rooms.

The Cranial SRS application as one RT Element provides optimized planning and display for radiation treatment planning for single lesions in the cranium. Cranial SRS 1.0 provides single lesion planning using a Volumetric Modulated Arc Therapy (VMAT) optimization, thus allowing dose modulation with both the MLC leaf positions and the dose rate or gantry speed. It particularly offers planning for lesions in the brain which benefit from dose modulation like large tumors close to organs at risk with a complex geometry. These indications include, but are not limited to Vestibular Schwannomas, Pituitary Adenomas, Meningiomas and Gliomas. Cranial SRS 1.0 can also be used for treating vascular anomalies like arteriovenous malformations (AVMs).

The Spine SRS application as one RT Element provides optimized planning and display for single spine metastases.

RT QA is an accessory to the RT Elements and contains features for patient specific quality assurance.

Use RT QA to recalculate patient treatment plans on a phantom to verify that the patient treatment plan fulfills the planning requirements.

The provided text is a 510(k) Summary for the Brainlab RT Elements device. It describes the device, its intended use, and argues for its substantial equivalence to predicate devices. However, this document does not contain specific acceptance criteria and the detailed study results that prove the device meets these criteria in the format requested.

The document states:

• "All test reports were rated as successful according to the acceptance criteria."
• "The verification was done according to verification plans to demonstrate that the design specifications are met."
• "The validation was done according to the validation plans containing usability tests which ensure that workflows or user interface are suitable for radiotherapy treatment planning. Furthermore clinical experts evaluated the clinical suitability of radiation therapy planning using the Cranial SRS and Spine SRS workflows. The acceptance and deliverability of VMAT treatment plans was successfully validated."

This indicates that acceptance criteria and study data exist internally at Brainlab and were submitted to the FDA, but they are not detailed in this public summary. The summary focuses on comparing technological characteristics to predicate devices (K170355 Raystation 6, K142108 RT Elements, K103246 iPlan RT) to demonstrate substantial equivalence, rather than providing the performance metrics of a specific clinical study with granular acceptance criteria.

Therefore, I cannot populate the requested table and fully answer the questions as the specific details of the acceptance criteria and the study that proves them are not present in the provided text.

Here's a breakdown of what can be inferred or stated based on the text, and what cannot:

What Can Be Inferred/Stated:

• Study Type: The "Validation" section mentions "usability tests" and clinical experts evaluating "clinical suitability." This suggests a form of human-in-the-loop evaluation and verification that the software functions as intended for its radiotherapy planning purpose. It also mentions "acceptance and deliverability of VMAT treatment plans was successfully validated," implying a technical performance assessment for this specific planning type.
• Ground Truth (for calculation accuracy): For the dose calculation algorithms (Pencil Beam and Monte Carlo), it states: "The accuracy of both algorithms is tested according to IAEA-TECDOC-1540 to be better than 3%." This implies that a ground truth for dose calculation is established by the IAEA-TECDOC-1540 standard, which could involve physical measurements or highly accurate simulations.
• Experts: "Clinical experts evaluated the clinical suitability of radiation therapy planning." No number or specific qualifications are given.
• Data Provenance: Not specified, but generally, medical device validation data for such systems would involve imaging and treatment planning data, likely from various clinical cases.
• Training Set: Not mentioned, as this document describes a 510(k) for a radiation treatment planning system, not an AI/ML device that requires explicit training data. The "acceptance criteria" discussed here are more about the software's functional performance and suitability for its intended use, rather than a diagnostic AI model's precision/recall.

What Cannot Be Provided from the Text:

1. A table of acceptance criteria and the reported device performance: This detailed information is not present.
2. Sample sizes used for the test set: Not specified.
3. Country of origin of data, retrospective/prospective: Not specified.
4. Number of experts used: Not specified.
5. Qualifications of experts: Only "clinical experts" is mentioned, no specific qualifications or years of experience.
6. Adjudication method for the test set: Not specified.
7. If a multi-reader multi-case (MRMC) comparative effectiveness study was done: Not specified, nor is an effect size provided for human readers with/without AI assistance (as this is a planning system, not a diagnostic AI).
8. If a standalone (algorithm only) performance was done: The document mentions "verification" and "validation" against design specifications and usability, but doesn't detail standalone performance for AI-like metrics. The dose calculation accuracy (better than 3% to IAEA-TECDOC-1540) is a standalone algorithm performance metric.
9. The type of ground truth used (expert consensus, pathology, outcomes data, etc.) for the overarching "validation": Beyond the dose calculation accuracy, the "ground truth" for clinical suitability would likely be expert judgment and successful plan generation/deliverability.
10. The sample size for the training set: Not applicable/not provided as this is not an AI/ML training context.
11. How the ground truth for the training set was established: Not applicable.

Conclusion:

The provided 510(k) Summary serves its purpose of establishing substantial equivalence for regulatory approval. It mentions that tests were conducted per acceptance criteria but does not disclose those criteria or the detailed results of those tests. To answer your question thoroughly, one would need access to the full "verification plans," "validation plans," and "test reports" referenced in the document, which are typically proprietary and submitted directly to the FDA.

Summary Table (based on available information):

Additional Information (from text):

• Sample size for test set: Not specified.
• Data provenance: Not specified.
• Number of experts used: Not specified (only "clinical experts").
• Qualifications of experts: Not specified.
• Adjudication method: Not specified.
• MRMC comparative effectiveness study: Not specified (not applicable for this type of device).
• Standalone performance: Dose calculation accuracy is a standalone algorithm performance metric.
• Type of ground truth: IAEA-TECDOC-1540 for dose calculation accuracy. Expert judgment for suitability/usability.
• Training set sample size: Not applicable.
• Training set ground truth: Not applicable.

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