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TriMed Plan is a radiation treatment planning software developed by TriMed Systems, Inc, running on IBM compatible personal computers with Microsoft Windows operating systems. TriMed Plan provides radiation treatment planning capability, for both photon and electron external beam sources, to satisfy the prescription of the radiation oncology. Tribed Plan uses 3D conformal therapy treatment approaches to combine modality plans, I rimed I har asso on-coplanar fields, total body irradiation, multi-leaf collimators, hand blocking, customized blocking, and wedges. The resulting treatment plan from this system is to be evaluated, modified as necessary, approved and delivered by qualified medical personnel.

TriMed Plan is a comprehensive 3D radiation treatment planning system for modeling dose distribution of radiation of patient undergoing photon or electron therapy based on modern personal workstation running Windows NT, Windows 2000 and Windows XP. External beam dose calculations for both photon and electron machines are all in 3-dimensional volume that support coplanar and non-coplanar fields. Beam modifiers include hand block, customized block, multi-leaf collimators, and wedge. Different energies and modalities can be combined into the same plan. State-of-the-art 2D/3D graphics user interface makes the system very user friendly.

This document describes the TriMed Plan 2.2, a radiation treatment planning system. However, it does not contain the detailed information required to fulfill all aspects of your request regarding acceptance criteria and a study proving device performance.

Therefore, I cannot populate the entire table or answer all your questions with the provided text.

Here's what I can extract and what is missing:

Acceptance Criteria and Reported Device Performance

Note: The provided document is a 510(k) summary for premarket notification, which largely focuses on demonstrating substantial equivalence to a predicate device rather than presenting detailed performance study results against specific acceptance criteria.

Study Details

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

   • Not specified in the provided text. The document states "Software development, validation and verification of the TriMed Plan has been conducted according to the policies and procedures discussed in the 510(k), which includes engineering diagrams, fault tree analyses, the Verification and Validation documentation, and all pertinent reference articles." However, it does not provide details about the specific test set used for performance evaluation.

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 specified in the provided text.

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

   • Not specified in the provided text.

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:

   • No such study is mentioned or implied. The device is a "Radiation Treatment Planning System," which is typically used by medical physicists and dosimetrists to create treatment plans, not directly by "human readers" in a diagnostic sense that would typically involve an MRMC study comparing AI assistance. The document focuses on the system's software functionality and its equivalence to a predicate device for treatment planning.

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

   • The document implies that the "Software development, validation and verification" included testing of the software's calculations ("External beam dose calculations for both photon and electron machines are all in 3-dimensional volume"). However, specific details of standalone performance metrics or a formal "standalone study" with documented results are not provided. The device is intended to be used by qualified medical personnel, who would always be "in-the-loop" to evaluate, modify, and approve plans generated by the system.

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

   • Not specified in the provided text. For a treatment planning system, ground truth might involve comparisons to established physics models, phantom measurements, or clinical experience, but the document does not elaborate.

7. The sample size for the training set:

   • Not applicable / Not specified. Radiation treatment planning systems typically implement physics algorithms (e.g., dose calculation models) rather than using "training sets" in the machine learning sense. The software's development and validation would involve testing these algorithms against known physical principles and data, not training on a dataset.

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

   • Not applicable. (See point 7).

Summary of What the Document Provides:

The document is a 510(k) summary for the TriMed Plan 2.2, a radiation treatment planning system. It primarily aims to demonstrate substantial equivalence to a predicate device (CadPlan Version 2.62). Key points from the document are:

• Intended Use: Planning radiation therapy treatments using linear accelerators for X-ray (1 MV to 24 MV) and electron (4 MeV to 50 MeV) energies, including advanced techniques like 3D conformal therapy, multi-leaf collimators, etc.
• Technological Considerations: No significant differences in design, materials, energy source, or other technological characteristics compared to the predicate device.
• Software Development and Verification: Conducted according to established policies and procedures, including engineering diagrams, fault tree analyses, and V&V documentation.
• Regulatory Conclusion: The FDA determined that the device is substantially equivalent to legally marketed predicate devices.

Missing Information: Comprehensive details on specific acceptance criteria, test set characteristics (size, provenance), expert qualifications, ground truth establishment methods for studies, and quantitative performance results are not part of this 510(k) summary. These details would typically be found in the full 510(k) submission or associated technical documentation.

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