STANDARD IMAGING E.IMRT CALCULATOR by STANDARD IMAGING, INC.

The e.IMRT Calculator is a simple, stand-alone software program provided on a CD-rom for use on an appropriately configured personal computer. It is intended to assist the oncologist or medical physicist in creating an optimum electron treatment plan based on the treatment objective for the patient.

Using previously established mathematical equations, the e.IMRT Calculator suggests several potential electron beam treatment energy solutions, within user selected parameters, by combining several discrete energies typically available on the linear accelerator(s). It uses previously user gathered or generated depth dose data sets for each electron energy available (4, 6, 9, 12, 15, 16, 18, 20 or 22 MeV) on the user's specific liner accelerator(s) as its primary input. Other inputs involve the identification of the facility, specific linear accelerator(s) and bolus used.

The output of the e.IMRT calculator is a hardcopy printout of the suggested electron beam treatment energies, in both numeric and graphical formats. The site, linear accelerator and bolus information are also provided on this printout are the site. The e.IMRT Calculator does not, however, electronically store any patient identification data or information. Inputs involving patient information are only used for hardcopy printouts.

Specific electron beam parameters are selected from the solution options provided by the e.IMRT Calculator for non-direct (manual) input into the user's radiation treatment planning system. The treatment planning system then creates a treatment plan based on the treatment objective for the patient, which is reviewed by the attending oncologist for acceptability prior to implementation with a linear accelerator.

Device Description

The e IMRT Calculator is a simple, stand-alone software program provided on a CD-rom for use on an appropriately configured personal computer. It is intended to assist the oncologist or medical physicist in creating an optimum electron treatment plan based on the treatment objective for the patient.

Using previously established mathematical equations, the e.IMRT Calculator suggests several potential electron beam treatment energy solutions, within user selected parameters, by combining several discrete energies typically available on the linear accelerator(s). It uses previously user gathered or generated depth dose data sets for each electron energy available (4. 6, 9, 12, 15, 16, 18, 20 or 22 MeV) on the user's specific liner accelerator(s) as its primary input. Other inputs involve the identification of the facility, specific linear accelerator(s) and bolus used.

The output of the e.IMRT calculator is a hardcopy printout of the suggested electron beam The butput of the c.HAN's numeric and graphical formats. The site, linear accelerator and bolus information are also provided on this printout are the site. The e.IMRT Calculator does not, however, electronically store any patient identification data or information. Inputs involving patient information are only used for hardcopy printouts.

Specific electron beam parameters are selected from the solution options provided by the e. IMRT Calculator for non-direct (manual) input into the user's radiation treatment planning system. The treatment planning system then creates a treatment plan based on the treatment objective for the patient, which is reviewed by the attending oncologist for acceptability prior to implementation with a linear accelerator.

AI/ML Overview

The Standard Imaging e.IMRT Calculator is a software program designed to assist oncologists or medical physicists in creating optimal electron beam treatment plans. The device suggests potential electron beam treatment energy solutions by combining discrete energies available on linear accelerators, using previously established mathematical equations and user-provided depth dose data.

Here's an analysis of the acceptance criteria and the study proving the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance

The provided document describes a validation process rather than specific quantitative acceptance criteria with numerical targets. The acceptance criteria seem to be qualitative and related to the proper functioning and comparison against existing systems.

Acceptance Criteria	Reported Device Performance
Algorithm transfer	Validated
Results presentation and graphing	Validated
Absolute dose depth measurements	Validated
Interface, compatibility, use and misuse	Validated
Treatment planning system comparison analysis	Validated
Compliance with IEC 60601-1-4 (Edition 1 2000-04)	Designed to comply
Meets predetermined design specifications, risk analysis, and validation objectives	Met

2. Sample Size Used for the Test Set and Data Provenance

The document does not explicitly state a specific "test set" with a defined sample size in terms of patient cases or data points. The validation involved various aspects listed above. The provenance of the data used for depth dose measurements (input to the calculator) is stated as "previously user gathered or generated depth dose data sets for each electron energy available... on the user's specific linear accelerator(s)." This indicates the data provenance is user-generated/user-specific, likely retrospective in the sense that this data would have been collected prior to using the e.IMRT Calculator. The document does not specify countries of origin.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

The document does not specify a number of experts used to establish ground truth for a test set. The validation process appears to be more focused on the computational aspects of the calculator and its comparison to existing systems and measured physical properties. While the e.IMRT Calculator is intended to assist oncologists or medical physicists, the document does not detail expert involvement in generating a ground truth for a validation study.

4. Adjudication Method for the Test Set

No adjudication method is described, as a formal test set requiring adjudication by multiple experts is not detailed for the validation process.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance

No MRMC comparative effectiveness study is mentioned. The device is a "calculator" to assist in treatment planning, not an AI for image interpretation that would typically require MRMC studies.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Yes, the validation implicitly includes standalone performance. The "Algorithm transfer," "Results presentation and graphing," and "Absolute dose depth measurements" evaluations focused on the calculator's inherent performance and accuracy of its outputs based on its algorithms and inputs. The "Treatment planning system comparison analysis" also speaks to its standalone calculation capabilities being compared.

7. The Type of Ground Truth Used

The ground truth used for validation appears to be a combination of:

Established mathematical equations: The device uses "previously established mathematical equations."
User-generated/measured depth dose data: This data serves as the primary input and a basis for the calculations, presumably validated against physical measurements.
Comparison to existing commercial systems: The device is "substantially equivalent to the electron portion of the ADAC Laboratories (Philips) Pinnacle 3 Radiation Therapy Planning Software," suggesting that Pinnacle 3's output might have served as a comparative ground truth or benchmark for the "treatment planning system comparison analysis."
Empirical absolute dose depth measurements: These measurements would serve as a physical ground truth for calibrating and validating the dose calculation.

8. The Sample Size for the Training Set

The document does not describe a "training set" in the context of machine learning. The e.IMRT Calculator uses "previously established mathematical equations" and "user gathered or generated depth dose data sets." These depth dose data sets could be considered analogous to input data for its operations, but not a "training set" in a machine learning sense where the algorithm learns from the data.

9. How the Ground Truth for the Training Set Was Established

As no "training set" (in the machine learning sense) is explicitly mentioned, the establishment of ground truth for such a set is not applicable. The underlying principles are based on conventional physics-based calculations using established equations and physical measurements for depth dose data.

Summary

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Image /page/0/Picture/0 description: The image shows the logo for "Standard Imaging". The logo is in black and white and features the company name in a bold, sans-serif font. Below the name is a stylized graphic that resembles a burst or star, with lines radiating outward from a central point. The overall design is simple and modern.

MAY 11 2004

KD40668

March 11, 2004

Subject:	510(k) Summary of Safety and Effectiveness Information for theStandard Imaging e.IMRT Calculator
Proprietary Name:	Standard Imaging e.IMRT Calculator
Common Name:	Electron Beam Planning Calculator
Classification Name:	Medical Charged-Particle Radiation Therapy System, Treatment PlanningComputer Program
Classification:	Class II -- 21CFR892.5050, 90MUJ
Panel:	Radiology
Contact Person:	Raymond Riddle, Vice President, Regulatory Affairs

The 510(k) summary of safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 1992.

The Standard Imaging e.IMRT Calculator is substantially equivalent to the electron portion of the ADAC Laboratories (Philips) Pinnacle 3 Radiation Therapy Planning Software covered by 510(k) Numbers K951581, K993923, K032724.

Using previously established mathematical equations, the e.IMRT Calculator suggests several potential electron beam treatment energy solutions, within user selected parameters, by combining several discrete energies typically available on the linear accelerator(s). It uses previously user gathered or generated depth dose data sets for each electron energy available (4. 6, 9, 12, 15, 16, 18, 20 or 22 MeV) on the user's specific liner accelerator(s) as its primary input. Other inputs involve the identification of the facility, specific linear accelerator(s) and bolus used.

Image /page/0/Picture/9 description: The image shows the text "Radiation Calibration and QA Instruments". The text is white and is on a black background. The text is centered in the image.

COMPUTILL SOLUTIONS PROVIDENCE
for the best care

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Image /page/1/Picture/0 description: The image shows a logo for "Standard Imaging". The logo is in black and white and features the words "Standard Imaging" in a stylized font. The word "Standard" is above the word "Imaging", and there is a registered trademark symbol next to the word "Imaging". Below the words is a design that looks like rays emanating from a central point.

Specific electron beam parameters are selected from the solution options provided by the e. IMRT Calculator for non-direct (manual) input into the user's radiation treatment planning system. The treatment planning system then creates a treatment plan based on the treatment objective for the patient, which is reviewed by the attending oncologist for acceptability prior to implementation with a linear accelerator.

The Standard Imaging e.IMRT Calculator was designed to comply with the applicable portions of the following voluntary standard:

IEC 60601-1-4 (Edition 1 1 2000-04) -- Collateral standard for programmable medical 1. systems
The Standard Imaging e.IMRT Calculator has been validated at Standard Imaging and at the University of Wisconsin - Madison. This validation included the following:
Algorithm transfer l .
Results presentation and graphing 2.
Absolute dose depth measurements 3.
Interface, compatibility, use and misuse 4.
Treatment planning system comparison analysis 5.

The Standard Imaging e.IMRT Calculator has met its predetermined design specifications, risk analysis and validation objectives.

Radiation Calibration and OA Instrum

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY 11 2004

Mr. Raymond T. Riddle, PE, RAC Vice President, Regulatory Affairs Standard Imaging, Inc. 7601 Murphy Drive MIDDLETON WI 53562-2532

Re: K040688 Trade/Device Name: Standard Imaging e.IMRT Calculator Regulation Number: 21 CFR 892.5050 Regulation Name: Medical charged-particle Radiation therapy system Regulatory Class: II Product Code: 90 MUJ Dated: March 11, 2004 Received: March 16, 2004

Dear Mr. Riddle:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, 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 may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, 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 that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act), 21 CFR 1000-1050

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This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally promated predicate device results in a classification 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 conact the Office of Compliance 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 Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97) you may obtain. Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer 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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K040688

Indications for Use

510(k) Number (if known): に040688

Device Name:

Standard Imaging e.IMRT Calculator

Indications For Use:

Prescription Use v (Part 21 CFR 801 Subpart D)

and/or

Over-the-Counter-Use (Part 21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Daniel A. Lynn

Division Sir 510(k) Number

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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.