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.

Device Description

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.

AI/ML Overview

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.

Acceptance Criteria (e.g., Specific Accuracy, Precision)	Reported Device Performance (e.g., Achieved Accuracy, Precision)
Not specified in the provided text.	Not specified in the provided text.
(General expectation: The device performs equivalently to the predicate CadPlan Version 2.62)	(Implied: The device's dose calculation and planning capabilities are comparable to the predicate.)

Study Details

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.
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.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not specified in the provided text.
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.
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.
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.
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.
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.

Summary

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JUL 2 3 2004

TriMed Systems, Inc.

KOSTOR

SUMMARY OF SAFETY AND EFFECTIVENCESS

1. Submitter's Information:	Dated: March 28, 2003TriMed Systems, Inc.1804 Loehr Estates Ct.Ballwin, MO 63021
	Contact:Sherry ZhangVP of Quality Assurance And Regulatory Affairs
2. Common or Usual Name:Product Name:Classification Name:	Radiation Treatment Planing SystemTriMed TPSSystem, Simulation, Radiation TherapyRA(90)KPQ Class 221 CFR 892.5050
Version Number:	2.2
3. Predicate Device:	CadPlan Version 2.62Radiation Therapy Treatment Planning SystemK962950Varian Cadplan
4. Description:	TriMed Plan is a comprehensive 3D radiation treatmentplanning system for modeling dose distribution of radiationof patient undergoing photon or electron therapy based onmodern personal workstation running Windows NT,Windows 2000 and Windows XP. External beam dosecalculations for both photon and electron machines are allin 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 thesame plan. State-of-the-art 2D/3D graphics user interfacemakes the system very user friendly.
5. Intended Use:	TriMed Plan is used to plan radiation therapy treatmentsemploying linear accelerators and other similar teletherapydevices with X-ray energy from 1 MV to 24 MV, as well asCobalt-60, and electron energy from 4 MeV to 50 MeV.TriMed Plan uses 3D radiotherapy treatment approaches tocombine modality plans, asymmetric and non-coplanarfields, total body irradiation, multi-leaf collimators, handblocking, customized blocking, and wedges.

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6. Technological Considerations:

TriMed Plan has no significant differences in design, materials, energy source or other technological characteristics compared to the predicate device.

7. Software Development and Verification:

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.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. In the center of the circle is an abstract symbol that resembles an eagle or other bird-like figure.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL 2 3 2004

Ms. Sherry Zhang VP of Quality Assurance and Regulatory Affairs TriMed Systems, Inc. 1804 Loehr Estates Ct., BALLWIN MO 63021

Re: K031088

Trade/Device Name: TriMed Plan 2.2 Regulation Number: 21 CFR 892.5050 Regulation Name: Medical charged-particle radiation therapy system Regulatory Class: II Product Code: 90 MUJ Dated: June 24, 2004

Received: June 25, 2004

Dear Ms. Zhang:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave teviewed your becamed the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the enclosers) vo ttgms.
commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to commerce pror to may 20, 2017) in accordance with the provisions of the Federal Food, Drug, devices that have occh roomstred in aquire approval of a premarket approval application (PMA). and Costlictic Act (110) that to not required to the general controls provisions of the Act. The I ou may, therefore, marries include requirements for annual registration, listing of general controls provisions or ractice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it If your device is classinod (500 a0070) cols. Existing major regulations affecting your device can
may be subject to such additional controls. Existing major regulations and may be subject to satin additions, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean i loast be advised that I Dr over device complies with other requirements of the Act that I DX has made a cerefits and regulations administered by other Federal agencies. You must comply or any I cacares and reguirements, including, but not limited to: registration and listing (21 CFR Part with an the Free Prequirement 801); good manufacturing practice requirements as set forth in the our ; idocimig (21 CFR Part 820); and if applicable, the electronic product quality by control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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Page 2

This letter will allow you to begin marketing your device as described in your Section 510(k) I his letter will anow you to organization of substantial equivalence of your device to a legally premarket notication: "The Privation for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please If you desire spoolite at one of the following numbers, based on the regulation number at the top of the letter:

8xx.1xxx	(301) 594-4591
876.2xxx, 3xxx, 4xxx, 5xxx	(301) 594-4616
884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx	(301) 594-4616
892.2xxx, 3xxx, 4xxx, 5xxx	(301) 594-4654
Other	(301) 594-4692

Additionally, for questions on the promotion and advertising of your device, please contact the Additionally, for quebellers of (301) 594-4639. Also, please note the regulation entitled, "Misbranding Other of Othphallos av (21CFR Part 807.97) you may obtain. Other general information on your responsibilities under the Act may be obtained from the Division of Small miormation on Jour responder Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.

Sincerely yours,

Nancy C. Brydon

Nancy C. Brogdon Director, Division of Reproductive, Abdominal and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Statement of Indication for Use

510(k) Number:

Device Name: TriMed Plan - Radiation Treatment Planning System

Indication for User: 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.

Prescription Use

Nancyc bridon

(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number K031088

Regulation Number and Section

§ 892.5050 Medical charged-particle radiation therapy system.

(a)
Identification. A medical charged-particle radiation therapy system is a device that produces by acceleration high energy charged particles (e.g., electrons and protons) intended for use in radiation therapy. This generic type of device may include signal analysis and display equipment, patient and equipment supports, treatment planning computer programs, component parts, and accessories.(b)
Classification. Class II. When intended for use as a quality control system, the film dosimetry system (film scanning system) included as an accessory to the device described in paragraph (a) of this section, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.