DCM is a three-dimensional radiotherapy dose engine for radiation dose planning of patients undergoing external beam treatment in the oncology clinic.

Based on quality assured radiation therapy input data Dose Calculation Module is used to plan radiation treatment with:

Linear accelerators with X-ray energies from 4 to 50MV and electron energies from 6 . to 25 MeV
Cobalt-60 units .

DCM will calculate dose for 3D radiotherapy treatment approaches of combined modality plans, asymmetric and non-coplanar fields; total body irradiation; multi-leaf collimators;

motorized and dynamic wedges; customized blocking and bolus.

Device Description

DCM 2.0 is intended for calculations of dose plans, the calculations are based on DICOM objects and other information conveyed by a control communication protocol from the THERAPLAN treatment planning system.

DCM is a three-dimensional radiotherapy dose engine for radiation dose planning of patients undergoing external beam treatment in the oncology clinic.

Based on quality assured radiation therapy input data Dose Calculation Module (DCM) is used to plan radiation treatment with:

Linear accelerators with X-ray energies from 4 to 50MV and electron energies from 6 . to 25 MeV
. Cobalt-60 units

DCM will calculate dose for 3D radiotherapy treatment approaches of combined modality plans, asymmetric and non-coplanar fields; total body irradiation; multi-leaf collimators; motorized and dynamic wedges; customized blocking and bolus.

AI/ML Overview

Here's an analysis of the provided text to extract information about the acceptance criteria and the study conducted for the DCM 2.0 device:

Important Note: The provided text is a 510(k) summary and FDA clearance letter. It describes the device, its intended use, and its substantial equivalence to predicate devices, but does not contain detailed information about specific acceptance criteria or a comprehensive study report as would be found in a clinical trial or validation study. The FDA clearance process for this type of device typically relies on demonstrating substantial equivalence to a legally marketed predicate, often through performance testing that is not fully detailed in this summary. Therefore, many of the requested fields below will indicate "Not explicitly stated in the provided text."

Acceptance Criteria and Device Performance

Acceptance Criteria (Not explicitly stated as such, but inferred from intended use and comparison to predicate)	Reported Device Performance
Accuracy of Dose Calculations for X-ray energies (4-50 MV) (Inferred from intended use and comparison to predicate DCM 1.0 and Helax-TMS v 5.1)	"DCM 2.0 has the same technological characteristics as DCM 1.0." DCM 1.0 was previously cleared. The intended use states it "is used to plan radiation treatment with... Linear accelerators with X-ray energies from 4 to 50 MV." This implies its calculations are considered accurate within this range, as established by the predicate device.
Accuracy of Dose Calculations for Electron energies (6-25 MeV) (New capability introduced by DCM 2.0)	DCM 2.0 "introduces the capability of performing electron calculations using the Voxel Monte Carlo, (VCM++) algorithm, supported by the electron Beam Model, EBM." The FDA's clearance implies that this new capability has been adequately validated for substantial equivalence. No specific performance metrics (e.g., dose difference, gamma analysis pass rate) are provided in this summary.
Ability to plan for 3D radiotherapy treatment approaches (Inferred from intended use)	"DCM will calculate dose for 3D radiotherapy treatment approaches of combined modality plans, asymmetric and non-coplanar fields; total body irradiation; multi-leaf collimators; motorized and dynamic wedges; customized blocking and bolus." The device is cleared for this intended use, implying it meets this functional requirement.

Study Details

Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Sample Size: Not explicitly stated in the provided text. The submission focuses on substantial equivalence based on technological characteristics and intended use.
- Data Provenance: Not explicitly stated.
- Retrospective or Prospective: Not explicitly stated.
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 explicitly stated in the provided text. The ground truth for dose calculation systems is typically against established physics models, experimental measurements, or other gold-standard dose calculation software, rather than expert human interpretation in the same way an image analysis AI would be evaluated.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable/explicitly stated. This type of adjudication is typically for subjective assessments (e.g., image interpretation), not direct dose calculation comparisons.
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 applicable. DCM 2.0 is a dose calculation system, not an AI-assisted diagnostic tool that humans interact with for interpretation.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Yes, implicitly. As a dose calculation engine, DCM 2.0's primary function is to perform calculations independently based on input parameters. The validation for such a device would focus on the accuracy of these calculations compared to established standards (e.g., experimental measurements, other validated physics models). The text states it uses the Voxel Monte Carlo (VCM++) algorithm for electron calculations, indicating an algorithmic, standalone function.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Not explicitly stated, but for a dose calculation engine, the ground truth would typically be established through:
  - Physics-based models: Comparison to highly accurate physics simulations (e.g., full Monte Carlo simulations).
  - Experimental measurements: Physical measurements using phantoms and dosimeters (e.g., ion chamber, film, TLDs) in controlled environments.
  - Comparison to predicate device: Implicit in the 510(k) process, the device's calculations are compared to those of the legally marketed predicate device (DCM 1.0 and Helax-TMS v 5.1).
The sample size for the training set:
- Not applicable/explicitly stated. Dose calculation algorithms like Voxel Monte Carlo are typically based on deterministic physics principles or experimentally derived beam models, rather than machine learning models that require "training sets" in the conventional sense. While beam models might be "tuned" or "configured" using experimental data, this is different from a machine learning training set.
How the ground truth for the training set was established:
- Not applicable, as a training set in the machine learning sense is not described or implied for this type of device. The "ground truth" for developing the underlying Voxel Monte Carlo algorithm and electron beam model would be physical measurements and established physics principles.

Summary

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JUN	6 2002	Section 1
510(k) Summary
1.1	Submitter:	MDS Nordion447 March RoadOttawa, Ontario K2K 1X8CANADA	Tel:	613-592-3400 x2372
			Fax:	613-592-2006
	Contact Person:	E. S. MartellVice PresidentQuality & Regulatory Affairs447 March RoadOttawa, Ontario K2K 1X8CANADA
1.2	Device Manufacturer:	MDS Nordion ABBox 1704SE-75147 UppsalaSWEDEN
1.3	Device Name:	DCM 2.0
1.4	Classification Name:	Medical Charged-Particle Radiation Therapy System(892.5050)
1.5	Common or Usual Name:	Radiation Therapy Treatment Planning System
1.6	Legally Marketed Predicate Device:

Helax-TMS v 5.1 (K010682) and DCM 1.0 (K011246)

1.7 Description of Dose Calculation Module (DCM):

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1.8 Intended use of DCM:

DCM is a three-dimensional radiotherapy dose engine for radiation dose planning of patients undergoing external beam treatment in the oncology clinic.

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Ko 20971 20f2

Based on quality assured radiation therapy input data Dose Calculation Module (DCM) is used to plan radiation treatment with:

Linear accelerators with X-ray energies from 4 to 50MV and electron energies from 6 . to 25 MeV
. Cobalt-60 units

Note: This intended use is a direct subset of the Intended Use of the predicate device, DCM with the addition of electron dose calculations for electron beams from 6 to 25 MeV.

1.9 Technological Characteristics

DCM 2.0 has the same technological characteristics as DCM 1.0 and introduces the capability of performing electron calculations using the Voxel Monte Carlo, (VCM++) algorithm, supported by the electron Beam Model, EBM.

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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 consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle or bird-like figure with three parallel lines forming its body and wings.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

6-2002 JUN

MDS Nordion AB % Mr. E. S. Martell Vice President, Quality & Regulatory Affairs MDS Nordion 447 March Road Kanata, Ontario CANADA K2K1X8

Re: K020971

Trade/Device Name: DCM 2.0 Radiation Therapy Treatment Planning System Regulation Number: 21 CFR 892.5050 Regulation Name: Medical charged-particle radiation therapy system Regulatory Class: II Product Code: 90 MUJ Dated: March 20, 2002

Dear Mr. Martell:

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. Iisting of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

Received: March 26, 2002

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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 (QS) 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 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of this 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" (21 CFR Part 807.97). 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 vours.

Nancy C. Brogdon

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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Section 12

Indications for Use

510 (k) Number: K020971

Device Name: DCM version 2.0

Indications For Use:

DCM is a three-dimensional radiotherapy dose engine for radiation dose plaming of patients undergoing external beam treatment in oncology clinic.

Based on quality assured radiation therapy input data Dose Calculation Module is used to plan radiation treatment with:

Linear accelerators with X-ray energies from 4 to 50MV and electron energies from 6 . to 25 MeV
Cobalt-60 units .

DCM will calculate dose for 3D radiotherapy treatment approaches of combined modality plans, asymmetric and non-coplanar fields; total body irradiation; multi-leaf collimators;

motorized and dynamic wedges; customized blocking and bolus.

David h. hyam
(Division Sign-Off)

Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number K020971

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use
(PER 21 CFR 801.109)

Over-The-Counter Use_

(Optional Format 1-2-96)

ి చేస్తుంది.
మూ

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.