MUV 4.0 is a quality assurance (QA) tool intended for independent verification of the dose calculations performed during treatment planning for external beam therapy.

Device Description

MUV 4.0 is a quality assurance (QA) tool intended for independent verification of the dose calculations performed during treatment planning for external beam therapy. The intended user is a medical physicist or someone well familiar with the dosimetric concepts that are of importance in external beam therapy.

The software requires beam data for individual treatment plans to be imported through the DICOM RT Plan format. The parameters associated with the treatment delivery on the accelerator can not be edited within the software, although parameters related to the calculation inside the patient/phantom, such as the coordinates and depths of the calculation points, are open for editing.

The software is validated for broad megavoltage photon beams in the range from 4 up to 30 MV and broad electron beams from 4 to 30 MeV, delivered by standard medical linear accelerators (linacs).

The software runs on a Windows XP, windows Vista and windows 7 systems (32 bit)

AI/ML Overview

This document, K103515, describes the 510(k) premarket notification for the EQUAL Dose 4.0, a quality assurance (QA) tool for independent verification of dose calculations in external beam radiation therapy.

Here's an analysis of the provided information regarding acceptance criteria and the study:

1. Table of Acceptance Criteria and Reported Device Performance

The provided text does not explicitly state specific acceptance criteria in terms of numerical thresholds (e.g., accuracy percentages, deviation limits) for the EQUAL Dose 4.0 software.

However, the document describes the software's validation, which implies its performance meets certain expectations:

Acceptance Criteria (Implied)	Reported Device Performance (Validation Context)
Independent verification of dose calculations for external beam therapy.	Validated for broad megavoltage photon beams (4-30 MV) and broad electron beams (4-30 MeV) delivered by standard medical linear accelerators (linacs).
Accuracy of dose calculation for photons using Pencil Beam algorithm.	Implied to be accurate for photon dose calculations, as it uses a Pencil Beam algorithm.
Accuracy of dose calculation for electrons using Gaussian Pencil Beam algorithm.	Implied to be accurate for electron dose calculations, as it uses a Gaussian Pencil Beam algorithm.
Functionality as a QA tool for treatment planning verification.	Described as a QA tool for "independent verification of the dose calculations performed during treatment planning for external beam therapy."

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

The document does not specify the sample size used for the test set or the data provenance (e.g., country of origin, retrospective or prospective). It mentions "beam data for individual treatment plans" can be imported but doesn't detail the origin or quantity of this data for validation.

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

The document does not provide information on the number of experts used to establish ground truth or their qualifications. It states the intended user is a "medical physicist or someone well familiar with the dosimetric concepts that are of importance in external beam therapy," which suggests expert involvement might be assumed in practice, but no formal ground truth establishment process is detailed.

4. Adjudication Method for the Test Set

The document does not specify any adjudication method (e.g., 2+1, 3+1, none) for the test set.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

The document does not mention a Multi-Reader Multi-Case (MRMC) comparative effectiveness study. This is an independent verification tool for dose calculations, not a diagnostic imaging device typically evaluated with MRMC studies for human reader performance improvement.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

The provided information suggests that the validation described is for the standalone (algorithm only) performance of the EQUAL Dose 4.0. It's a "QA tool intended for independent verification of the dose calculations." The "intended user is a medical physicist," implying that the medical physicist uses the tool, but the validation described is of the software's calculation capabilities itself rather than human-AI combined performance. The validation addresses the accuracy of the software's internal calculations and algorithms (Pencil Beam, Gaussian Pencil Beam) against known physical principles and expected outcomes for radiation beams.

7. Type of Ground Truth Used

The document does not explicitly state the type of ground truth used. However, given it's a dose calculation verification tool, the ground truth would typically be established by:

Established physics principles and analytical models: The algorithms (Pencil Beam, Gaussian Pencil Beam) are based on fundamental physics.
Measurements from phantoms: Often, dose calculations are validated against actual dose measurements in phantoms using ionization chambers, films, or other dosimeters.
Comparison to other validated treatment planning systems: Although this device is for verification, sometimes initial validation involves comparing its output to highly accurate reference systems.

The text's statement "The software is validated for broad megavoltage photon beams... and broad electron beams..." implies a comparison against established physical reality for these beam types.

8. Sample Size for the Training Set

The document does not specify a sample size for the training set. For a physics-based dose calculation software, a traditional "training set" as understood in machine learning might not be applicable in the same way. Instead, the "training" phase would involve the development and internal testing of the algorithms to ensure they correctly implement the physical models.

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

Similar to point 8, the concept of a "training set" for ground truth establishment might not directly apply. If any "training" data were used during development (e.g., to fine-tune model parameters), the ground truth for that would likely be based on:

Known physical properties of radiation beams and materials.
Experimental data from linear accelerators and phantoms.

In summary, the provided submission focuses on the technical specifications and intended use of the EQUAL Dose 4.0 as a verification tool based on established physics algorithms, rather than detailing extensive clinical study results for acceptance criteria, sample sizes, or ground truth establishment in the way typically seen for diagnostic AI models. The validation mentioned is more akin to demonstrating the accurate implementation of known physical models within the software.

Summary

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Traditional 510(k) Nucletron EQUAL Dose 40

SEP 15 2011

K103515

-Page 28
March 2007

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NUCLETRON B.V. Waardgelder 1 3905 TH Veenendaal P.O.Box 930 3900 AX Veenendaal The Netherlands Phone +31 318 557133 +31 318 550485 Fax

Department of Health and Human Services Centre of Device and Radiological Health Office of Device Evaluation Traditional 510(k) section

510(K) SUMMARY OF SAFETY AND EFFECTIVENESS INFORMATION as required by section 807.92(c)

Submitter of 510(k):

Company name: Registration number: Address:

Phone:
Fax:
Correspondent:

Nucletron Corporation 1121753 8671 Robert Fulton Drive Columbia, MD 21046 410-312-4100 410-312-4197 Manal Yousof, Quality Assurance & Regulatory Affairs Manager

New Device Name:

Trade/Proprietary Name: Common/Usual Name: Classification Name: Classification:

EQUAL Dose 4.0 Radiation Therapy Verification Tool System, Planning, Radiation Therapy Treatment 21Cfr892.5050 Class II

Legally Marketed Device(s)

Our new device is based on the legally marketed device cited in the table below:

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Description:

The software is validated for broad megavoltage photon beams in the range from 4 up to 30 MV and broad electron beams from 4 to 30 MeV, delivered by standard medical linear accelerators (linacs). ·

The software runs on a Windows XP, windows Vista and windows 7 systems (32 bit)

Intended use:

The legally marked predicate device (K073273) has the same intended use as the new device cited:

Equal Dose 4.0

Equal Dose 4.0 is a quality assurance (QA) tool intended for independent verification of the dose calculations performed during treatment planning for external beam therapy.

The intended user is a medical physicist or someone well familiar with the dosimetric concepts that are of importance in external beam therapy.

. Cleared EQUAL Dose1.0 K073273 > same intended use and intended user

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Summary of technological considerations:

Cleared (TMS v5.1) K010682 ✈ Treatment Planning Method: External Beam
- · Treatment modalities: Photon beams and electron beams
- · Dose Calculation:
  - · Photons: Collapsed Cone or Pencil Beam algorithm
  - Electrons: Gaussian Pencil Beam
- ·Dimension: 3D
. Cleared EQUAL Dose1.0 K073273 ✈ Treatment Planning Method: External Beam • Treatment modalities: Photon beams
- ·Dose Calculation:
  - · Photons: Pencil Beam algorithm

· Dimension: Point Calculation

(EQUAL Dose) 4.0(not applicable)	• Treatment Planning Method: External Beam• Treatment modalities: Photon beams and electron beams• Dose Calculation:•Photons: Pencil Beam algorithmElectrons: Gaussian Pencil Beam•Dimension: Point Calculation
--------------------------------------	-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

The cleared device TMS v5.1(K010682)has a wider Scientific Technology than the new device "EQUAL Dose 4.0". The new device is merely a verification tool while TMS v5.1 is a complete treatment planning system

Sept. 20, 2010
Date

Name: John Lapre Title: Vice President Research & Development Nucletron BX Veenendage, The Netherlands

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Image /page/3/Picture/0 description: The image shows the seal for the Department of Health & Human Services USA. The seal is circular, with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter of the circle. In the center of the circle is an abstract image of an eagle.

Public Health Service

Scree 1 5 2011

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room - WO66-G609 Silver Spring, MD 20993-0002 .

Mr. Manal Yousof Quality Assurance and Regulatory Affairs Manager Nucletron Corporation 7021 Columbia Gateway Drive, Suite 200 COLUMBIA MD 21046

Re: K103515

Trade/Device Name: EQUAL Dose 4.0 Regulation Number: 21 CFR 892.5050 Regulation Name: Medical charged-particle radiation therapy system Regulatory Class: 11 Product Code: MUJ Dated: July 29, 2011 Received: July 29, 2011

Dear Mr. Yousof:

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 class II (Special Controls). it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. 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 Parts 801 and 809): medical device reporting of

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medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). 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 marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

ff you desire specific advice for your device on our labeling regulation (21 CFR Parts 801 and 809), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 796-5450. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the

Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely Yours,

Mary Pastel

Mary S. Pastel, Sc.D. Director Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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Traditional 510(k) Nucletron EQUAL Dose 40

Indications for Use

510(k) Number

Device Name

Indications for Use

K0103515

EQUAL Dose 4.0

MUV 4.0 is a quality assurance (QA) tool intended for independent verification of the dose calculations performed during treatment planning for external beam therapy.

The intended user is a medical physicist or someone well familiar with the dosimetric concepts that are of importance in external beam therapy.

Prescription Use _ X (Part 21 CFR 801 subpart D)

AND/OR

Over-The-Counter Use_ (Part 21 CFR 801 subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Mary S Pastil

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Costic Device Evaluation and Safety Office of In Ville

510K K103515

Page 1 of 1

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.