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CadPlan 6.0 is used to plan radiation therapy treatments employing linear accelerators and other similar teletherapy devices with x-ray energies from 1-50 MV, as well as Cobalt-60, and electron energies from 1 to 50 MeV, and to plan brachytherapy treatments. CadPlan will plan the 3D radiotherapy treatment approaches to combined modality plans, asymmetric and non-coplanar field, total body irradiation, multileaf collimators, motorized and dynamic wedges, customized blocking, compensating filters, and bolus.

CadPlan 6.0 includes export capabilities to verify beam and patient date, dose-planning results, and provide on-line information to block-cutting devices.

CadPlan 6.0 is a comprehensive 3D Treatment Modeling Workstation for external beam and brachytherapy planning.

This 510(k) summary for CadPlan 6.0 primarily focuses on demonstrating substantial equivalence to a predicate device (CadPlan ver. 2.62 Radiation Therapy Treatment Planning) based on technological characteristics and intended use. It does not describe specific acceptance criteria and a study proving the device meets those criteria in the way you've outlined for clinical performance studies.

Here's an analysis based on the provided text, highlighting what's not present:

1. Table of acceptance criteria and reported device performance:

   • Not provided. The document states "See the attached 'Specification Comparison Chart', Tab F" for technological characteristics, but this chart itself is not included in the provided text. Therefore, we cannot extract specific performance metrics or acceptance criteria.

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

   • Not provided. There is no mention of a clinical test set, sample size, or data provenance (e.g., country of origin, retrospective/prospective). This submission focuses on demonstrating equivalence through technical specifications rather than a clinical performance study with a test set.

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

   • Not provided. As there's no described test set, there's no mention of experts or their qualifications for establishing ground truth.

4. Adjudication method:

   • Not provided. No adjudication method is described, as there's no performance study involving independent expert review.

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 provided. This document predates common AI/MRMC studies for medical devices. CadPlan 6.0 is described as a "3D Treatment Modeling Workstation" for planning radiation therapy, not an AI-assisted diagnostic or assistive device that would typically undergo MRMC studies comparing human readers with and without AI.

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

   • Not provided. The device is a "Treatment Modeling Workstation," implying intended use with a human operator. There's no discussion of standalone algorithmic performance.

7. The type of ground truth used:

   • Not provided. If a performance study were conducted, common ground truths for radiation therapy planning software might include dosimetric measurements, comparison to established phantoms, or expert physicist review of plans. However, none of this is described in the provided text.

8. The sample size for the training set:

   • Not applicable/Not provided. This device is a software planning tool, not an AI/ML device that requires a "training set" in the modern sense. Its functionality would be based on underlying physics models and algorithms, not trained on patient data in the same way.

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

   • Not applicable/Not provided. (See point 8).

Summary of what is present:

The document is a Premarket Notification [510(k)] Summary for CadPlan 6.0, indicating its submission date, contact person, device name, classification, and predicate device. It briefly describes the product as a "comprehensive 3D Treatment Modeling Workstation" for external beam and brachytherapy planning and lists its intended uses, including planning various radiotherapy treatment approaches and export capabilities. The FDA's response letter confirms the 510(k) clearance based on substantial equivalence.

Conclusion regarding acceptance criteria and performance study:

The provided text does not contain the information requested regarding specific acceptance criteria, a clinical performance study, sample sizes, expert involvement, adjudication methods, or ground truth establishment. This is typical for 510(k) submissions of this era for a software planning tool where substantial equivalence is demonstrated primarily through comparison of technical specifications and intended use against a legally marketed predicate device, rather than through a de novo clinical performance study with defined acceptance criteria. The requested information would typically be found in detailed verification and validation reports, which are part of the full 510(k) submission but not routinely included in the publicly available summary.

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