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The Coregistration function is intended for use as part of an RT planning system (such as CORVUS) in procedures which could benefit from the ability to correlate between multiple image sets regardless of the modality used for scanning. In addition this function may be used to coregister earlier patient scans without a localization system. The Coregistration function enables the use of complementary image data while maintaining the geometric accuracy and tissue density information from the CT.

The Coregistration function is intended for use as part of an RT planning system (such as CORVUS) in procedures which could benefit from the ability to correlate between multiple image sets regardless of the modality used for scanning. In addition this function may be used to coregister earlier patient scans without a localization system. The Coregistration function enables the use of complementary image data while maintaining the geometric accuracy and tissue density information from the CT.

The provided text is a 510(k) summary for a medical device, specifically a "Coregistration function" for an RT planning system. This document aims to demonstrate that the new device is "substantially equivalent" to a legally marketed predicate device.

Crucially, this document does not contain detailed information about acceptance criteria or specific study results showing the device meets those criteria in the way a clinical trial report or a performance validation study would.

It is a regulatory submission for pre-market notification, which focuses on demonstrating substantial equivalence, not on providing granular performance metrics against pre-defined acceptance criteria with statistical power.

Therefore, I cannot fill out the table and answer all the questions as requested, because the information is simply not present in the provided text.

However, I can extract what is available:

Here's what can be inferred or directly stated from the provided text, along with explanations for what cannot be found:

Acceptance Criteria and Device Performance (Limited Information)

Detailed Study Information (Based on Available Text)

1. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

   • Not provided. The document states "Testing shows..." but does not detail the methodology, sample sizes, or data provenance of any specific test set.

2. 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)

   • Not provided. As no specific "test set" study methodology is detailed, there's no mention of how ground truth was established, or by whom.

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

   • Not provided.

4. 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 provided. The device is a "coregistration function," which automates image alignment. It is not described as a diagnostic AI that would assist human readers in interpretation. There is no mention of an MRMC study or assistance to human readers.

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

   • The coregistration function itself is an algorithm. The phrase "Testing shows that the device meets similar performance specifications as those for the predicate devices" implies some form of standalone evaluation of the algorithm's performance against historical data or benchmarks, but no details about such a study are provided.

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

   • Not provided.

7. The sample size for the training set

   • Not provided. This type of document (510k summary for substantial equivalence) typically focuses on the final product's performance and equivalence, not on the developmental training data or methodologies.

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

   • Not provided.

Summary of Limitations:

This 510(k) submission is a regulatory document focused on demonstrating "substantial equivalence" to a predicate device (ImageFusion - Radionics Software Applications (RSA), Inc. (K960071)). It is not a detailed scientific publication of a performance study. Therefore, the granular details about specific acceptance criteria, study methodologies, sample sizes, ground truth establishment, or expert involvement are not included in this type of document. The statement "Testing shows that the device meets similar performance specifications as those for the predicate devices" is the primary evidence provided for performance, without elaboration on the specifics of that testing.

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