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The GENESIS IMRT Linear Accelerator is intended to deliver megavoltage x-ray treatment for therapeutic application in the treatment of cancer. The GENESIS delivers these treatments conformally, shaping the field of radiation to the tumor volume. The depth of penetration emulating from the GENESIS ideally suits itself for treating deep-seated tumors while providing a skin sparing effect.

The GENESISTM Linear Accelerator is a single energy, high dose medical linear accelerator. The GENESISTM includes a Multileaf Collimator (MLC), Dual Asymmetric Capability, Virtual Wedge™, and PRIMEVIEW.

The provided document is a 510(k) premarket notification for the Siemens GENESIS™ IMRT Medical Linear Accelerator. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than detailed performance studies against specific acceptance criteria like those often seen for novel diagnostic AI devices.

Therefore, many of the requested points, such as detailed acceptance criteria, sample sizes for test/training sets, expert qualifications, adjudication methods, or MRMC studies, are not applicable or available in this document. The submission's core is a comparison to a predicate device.

Here's an analysis based on the provided text:

Analysis of Acceptance Criteria and Study for Siemens GENESIS™ IMRT Medical Linear Accelerator (K982502)

This 510(k) submission for the Siemens GENESIS™ IMRT Medical Linear Accelerator primarily focuses on demonstrating substantial equivalence to a predicate device (MEVATRON M Class, K882729), rather than presenting a performance study against specific acceptance criteria for a novel AI device. As such, many of the requested details regarding independent performance testing are not explicitly stated.

1. Table of Acceptance Criteria and Reported Device Performance:

2. Sample size used for the test set and the data provenance:

• Not Applicable. This submission is not a performance study evaluating a new algorithm or diagnostic output against a test set. It's a technical comparison to a predicate device. The "test" is essentially the manufacturer's internal engineering analysis showing the new design meets the same performance characteristics as the predicate.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• Not Applicable. No explicit "ground truth" for a test set is discussed in the context of this 510(k) submission.

4. Adjudication method for the test set:

• Not Applicable. No test set or associated adjudication 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:

• Not Applicable. This device is a linear accelerator for radiation therapy, not an AI-assisted diagnostic tool for human readers.

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

• Not Applicable. This is a hardware device for radiation delivery. There is no "algorithm only" performance reported in this context.

7. The type of ground truth used:

• Not Applicable. The "ground truth" in this context is the established safety and effectiveness of the existing predicate device, to which the new device is compared for substantial equivalence.

8. The sample size for the training set:

• Not Applicable. This is not an AI/machine learning device requiring a training set.

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

• Not Applicable. No training set is described.

Summary Explanation:

The K982502 submission for the GENESIS™ IMRT Linear Accelerator is a Pre-Market Notification (510(k)). The primary purpose of a 510(k) is to demonstrate that the new device is "substantially equivalent" to a legally marketed predicate device. This typically involves showing that the device has the same intended use and similar technological characteristics, or if there are differences, that those differences do not raise new questions of safety or effectiveness.

In this case, Siemens argues that the GENESIS™ is equivalent to the MEVATRON M Class system (K882729). The main difference identified is the "path of the electrons prior to striking the target." However, Siemens asserts that "From this point on, the design and functionality for the GENESIS™ and 6 MV MEVATRON M Class are essentially the same," and that it "does not have significant changes in materials, energy source or performance characteristics."

Therefore, the "study" proving the device meets "acceptance criteria" here is the manufacturer's internal engineering analysis and comparison to the predicate device. The "acceptance criteria" are effectively that the device's technical specifications and performance match or are demonstrably equivalent to those of the predicate device, especially considering its intended use. No separate clinical trials or AI performance evaluations with test sets and expert ground truth are described or required for this type of submission.

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