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The QuickPlan Treatment Planning System is indicated for use in planning radiotherapy treatments for patients with malignant or benign diseases. After image acquisition, QuickPlan supports the treatment planning process for external beam irradiation with photon, electron, and proton beams by predicting a plan.

The QuickPlan software does not provide full plan generation; it does not include final dose calculation, final beam geometry, nor does it enable plan approval. QuickPlan is not connected to any radiation emitting equipment. The QuickPlan software is intended for use by trained medical professionals to use in clinical settings. The QuickPlan software is compatible with Treatment Planning Systems that use the DICOM-RT format.

The new QUICKPLAN Software manufactured by Siris Medical is an independent software solution to plan radiotherapy treatments for patients with malignant or benign diseases. It is used to plan external beam irradiation with photon, electron, and proton beams. The new QUICKPLAN Software is intended for trained medical professionals to use in clinical settings. The new QUICKPLAN software application includes three modules:

• QuickMatch Matches a critical structure-set to the closest match within a database. It is a rapid file locator.
• QuickPredict Predicts the dose to critical structures based upon models extracted from historical data looking through previous patient data.
• QuickCompare - Provides dose estimates to critical structures with one or more alternative energy modalities, i.e. Photon vs. Proton.
  The new QuickPlan software does not provide full plan generation; it does not include final dose calculation, final beam geometry, nor does it enable plan approval.

The provided text does not contain the acceptance criteria or the details of a study demonstrating the device meets such criteria.

The document is a 510(k) premarket notification summary for the QuickPlan device, focusing on demonstrating substantial equivalence to a predicate device. It highlights the device's indications for use, technological features, and compliance with software standards, but does not present acceptance criteria or a study with performance metrics against those criteria.

Here's an breakdown of what information is missing based on your request:

1. A table of acceptance criteria and the reported device performance: This is entirely absent. The document mentions "performance bench testing" but does not provide any specific criteria or quantitative results.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): No test set details are provided.
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): No ground truth establishment details are provided.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: No adjudication method is 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: No MRMC study or human reader improvement data is presented.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: The document states "No clinical testing has been performed in support of this QUICKPLAN software 510(k) submission," implying no standalone clinical performance evaluation was done. The bench testing performed would likely be considered standalone in a technical sense, but no performance metrics are given.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not specified.
8. The sample size for the training set: Not specified. The document mentions "models extracted from historical data looking through previous patient data" but does not provide the size of this historical dataset.
9. How the ground truth for the training set was established: Not specified.

In summary: The provided document is a regulatory submission focused on substantial equivalence based on design, intended use, technology, and compliance with general software and medical device standards, rather than a detailed performance study with quantifiable acceptance criteria. It explicitly states, "No clinical testing has been performed in support of this QUICKPLAN software 510(k) submission." Therefore, it does not contain the information required to answer your specific questions about acceptance criteria and a study proving those criteria are met.

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