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XKnife RT 4 is a radiosurgery and radiotherapy treatment planning system intended for use in stereotactic and non-stereotactic (frameless), collimated beam, computer planned, LINAC based treatment

The above system is a stereotactic treatment planning software with the ability to be used on a Linux workstation, and the ability to use PET scans as an additional image source.

This submission is a 510(k) premarket notification for the Integra Radionics XKnife RT 4, a stereotactic radiation treatment planning system. The document states that the device is substantially equivalent to a predicate device (Radionics XK.nife RT 3 with Non Stereotactic Module 510(k), K041997) and relies on this substantial equivalence rather than presenting an independent study with acceptance criteria and performance data.

Therefore, the requested information regarding acceptance criteria and a study proving the device meets these criteria cannot be fully provided from the given text.

Here's an explanation of why the specific sections of your request cannot be fulfilled:

1. A table of acceptance criteria and the reported device performance:
   The document does not specify any new acceptance criteria for the Integra Radionics XKnife RT 4. It asserts substantial equivalence to a predicate device, meaning its performance is considered acceptable if it is comparable to the predicate. No specific performance metrics or a table comparing them are provided.

2. Sample size used for the test set and the data provenance:
   No new clinical or performance study data is presented for the Integra Radionics XKnife RT 4. The submission relies on the established performance of its predicate device. Thus, there is no test set, sample size, or data provenance to report.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
   Since no new study data is presented, there is no test set for which ground truth would need to be established by experts.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
   As no new study data is presented, no adjudication method was used.

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 device is a treatment planning system, not an AI-assisted diagnostic tool for human readers. Therefore, an MRMC study comparing human reader performance with and without AI assistance is not applicable to this device type and was not performed.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
   While the device is a software system, the 510(k) submission primarily focuses on its technological characteristics and intended use being similar to its predicate. It does not describe a standalone performance study with specific metrics, but rather relies on the established safety and effectiveness of the essentially equivalent predicate.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
   As no new study data is presented, there is no new ground truth established for the Integra Radionics XKnife RT 4.

8. The sample size for the training set:
   This submission is for a medical device that appears to be rule-based or algorithm-based, rather than a machine learning model that would require a dedicated training set. No information regarding a training set or its size is provided.

9. How the ground truth for the training set was established:
   Given that this does not appear to be an AI/ML device requiring a training set, the concept of establishing ground truth for a training set is not applicable here and no information is provided.

Summary of the K061893 Submission:

The Integra Radionics XKnife RT 4 is a stereotactic radiation treatment planning system. The submission (K061893) aims to demonstrate its substantial equivalence to an already legally marketed device, the Radionics XK.nife RT 3 with Non Stereotactic Module (K041997).

The basis for acceptance is this claim of substantial equivalence. The key arguments presented for substantial equivalence are:

• Intended Use: The device is intended for "stereotactic and non-stereotactic (frameless), collimated beam, computer planned, LINAC based treatment," which is the same as its predicate.
• Technological Characteristics: The technological characteristics are stated to be "the same or similar to those found with the predicate devices." The notable updates for XKnife RT 4 are its ability to be used on a Linux workstation and its capability to use PET scans as an additional image source.

In a 510(k) submission based on substantial equivalence, the "study" is often a comparison of the new device's specifications and performance to the predicate device, demonstrating that any differences do not raise new questions of safety or effectiveness. The provided text, however, does not include the detailed comparison data that would typically be part of such a submission, only the summary statement that such a comparison was made and found favorable.

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