The TOPSLANE product ARTP with WIMRT is a Radiation Therapy Treatment Planning System for radiation dose planning of patients undergoing external beam treatment in the oncology clinic. ARTP with WIMRT is used to plan radiation treatments with linear accelerators and other similar teletherapy devices with x-ray energies from 1 to 25MV, as well as Cobalt-60, and electron energies from 1 to 25 MeV.

Device Description

AI/ML Overview

The provided document, K041971, is a 510(k) premarket notification for the WIMRT Radiation Treatment Planning System. It does not contain information about the acceptance criteria or a study proving the device meets acceptance criteria in the manner typically expected for diagnostic AI devices with quantifiable performance metrics (e.g., sensitivity, specificity, AUC).

Instead, this submission focuses on establishing substantial equivalence to predicate devices based on design, construction, intended use, and performance characteristics. The "performance" discussed here refers to functional capabilities and algorithms rather than statistical accuracy against a ground truth.

Therefore, the following information cannot be extracted from the provided text:

A table of acceptance criteria and the reported device performance: No specific performance metrics (like sensitivity, specificity, accuracy) are reported for WIMRT against a defined ground truth, nor are explicit acceptance criteria for such metrics stated. The document compares technical specifications of WIMRT with predicate devices.
Sample size used for the test set and the data provenance: No test set is described.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: No ground truth establishment process for a test set is described.
Adjudication method for the test set: Not applicable as no test set or ground truth adjudication is described.
Multi-reader multi-case (MRMC) comparative effectiveness study: Not conducted or reported in this document.
If a standalone performance (algorithm only without human-in-the-loop performance) was done: Not reported. The device is a treatment planning system, implying human interaction.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.): No ground truth for performance evaluation is mentioned.
The sample size for the training set: No training set is mentioned.
How the ground truth for the training set was established: No training set or ground truth establishment is mentioned.

Summary of Device Features (from the provided table, which serves as a comparison of specifications rather than performance metrics against a ground truth):

Specification	WIMRT Module
Application (Use)	Inverse Planning
Imaging Modalities Supported	CT, MR, PET-Spec
Dose Calculation Algorithm	Super-position Convolution
Optimization Engine	Simulated Annealing and Descending Gradient
IMRT Modalities Supported	Sliding Window and Step and Shoot
Operating System	Windows
Image Registration	Automatic
Automated Planning	Yes
Inhomogeneity Corrections	Yes
Forward IMRT via Field within a Field technique	Yes
Forward IMRT via MLC Based compensators	Yes

Summary

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K041971

MAY 2 0 2005

Summary of Safety and Effectiveness Compliance with 513 (i) of the Federal Food, Drug and Cosmetic Act

October 30, 2003

General Provisions 1.

RADIATION TREATMENT PLANNING SYSTEM Common/Usual Name:

Proprietary Name: WIMRT

Applicant Name and Address:

Prodigm Group, Inc. 19078 Chaparral Drive Penn Valley, CA 95946 Telephone: 530-432-5846 Fax: 530-432-2882

Name of Predicate Devices: 2.

(1)
l

Manufacturer	K Number
NOMOS Corvus Inverse Planning System	K940663
Varian Helios Inverse Planning Module	K984532
ADAC Laboratories P3IMRT Module	K002237

Any statement made in conjunction with this submission regarding substantial equivalence to any other product only relates to whether the product can be lawfully marketed without pre-market approval or reclassification and is not to be interpreted as an admission or used as evidence in patent infringement litigation. As the Commissioner of the FDA has indicated, "... a determination of substantial equivalence under the Federal Food, Drug, and Cosmetic Act relates to the fact that the product can be lawfully marketed without pre-market approval or reclassification. This determination is not intended to have any bearing whatsoever on the resolution of patent infringement suits." 42 Fed. Reg. 42,520 et seg. (1977).

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Classification 3.

This device is classified as a class II device according to 21 CFR 892.5050 .

4. Performance Standards

Performance standards for Brachytherapy applicators have not been established by the FDA under Section 514 of the Food, Drug and Cosmetic Act.

Intended Use and Device Description ડ.

6. Biocompatibility

No new issues of biocompataibility are raised with regard to this device.

Summary of Substantial Equivalence 7.

This device is similar in design and construction, and has the same intended use and performance characteristics to the predicate device. It utilizes materials that are already in use in other medical devices. No new issues of safety or effectiveness are introduced by using this device.

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Specification	WIMRT Module	ADAC P3IMRT Module	Varian Helios InversePlanning Module	NOMOS Corvus InversePlanning System
K Number	This filing	K002237	K984532	K940663
Application(Use)	Inverse Planning	Inverse Planning	Inverse Plannning	Inverse Planning
ImagingModalitiesSupported	CT, MR, PET-Spec	CT, MR, PET-Spec	CT, MR. PET-Spec	CT, MR, PET-Spec
DoseCalculationAlgorithm	Super-positionConvolution	Super-positionConvolution	Pencil Beam Convolution	Finite Sum Pencil Beam
OptimizationEngine	SimulatedAnnealing andDescendingGradient	CollapsingGradient	Cone Descending Gradient	Simulated Annealing andDescending Gradient
IMRTModalitiesSupported	Sliding Windowand Step andShoot	Sliding Windowand Step andShoot	Sliding Window and Stepand Shoot	Step and Shoot
OperatingSystem	Windows	UNIX	Windows 2000/WindowsNT	NeXT Step and UNIX
ImageRegistration	Automatic	Manual and Automatic	Manual and Automatic	Manual and Automatic
AutomatedPlanning	Yes	Yes via Scripts	Yes via Templates	No
InhomogeneityCorrections	Yes	Yes	Yes	Yes
Forward IMRTvia Fieldwithin a Fieldtechnique	Yes	Yes	Yes	No
Forward IMRTvia MLC Basedcompensators	Yes	No	Yes	No

Prodigm Group, Inc: WIMRT - 510(K)

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Image /page/3/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features a stylized caduceus, a symbol often associated with medicine and healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus. The seal is black and white.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY 2 0 2005

Lee Potts President Prodigm Group, Inc. 19078 Chaparral Drive PENN VALLEY CA 95946

Re: K041971 Trade/Device Name: WIMRT Regulation Number: 21 CFR §892.5050 Regulation Name: Medical charged-particle radiation therapy system Regulatory Class: II Product Code: MUJ Dated: April 25 2005 Received: May 2, 2005

Dear Mr. Potts:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced w chave and have determined the device is substantially equivalent (for the indications for use stated in above and nave determinerarketed predicate devices marketed in interstate commerce prior to the chorolore) to regarly man date of the Medical Device Amendments, or to devices that have been May 20, 1770, the charantinent 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 do not require upproval or a provisions of the Act. The general controls provisions of the Act device, suojoer to the general 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 (Premarket n your do roo is classion (t to such additional controls. Existing major regulations affecting your Apploval), it they of sabject to actively 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 I DA has made a deceminations administered by other Federal agencies. You must comply with all the I oderal building, 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) (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) I his letter will anow you to begin maneting of substantial equivalence of your device to a legally premarket nothleation: "The PDA midning of backanding or 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 specific advice for your derice of the following numbers, based on the regulation number at the top of this letter:

21 CFR 876.xxxx	(Gastroenterology/Renal/Urology)	240-276-0115
21 CFR 884.xxxx	(Obstetrics/Gynecology)	240-276-0115
21 CFR 892.xxxx	(Radiology)	240-276-0120
Other		240-276-0100

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Also, please note the regulation charact, cornation on your responsibilities under the Act from the 807.97). You may obtain other general missance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

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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Indications for Use

510(k) Number: To be assigned Ko41971

Device Name: WIMRT

Indications for Use:

The TOPSLANE product ARTP with WIMRT is a Radiation Therapy Treatment in the The TOF SEANL produce Artifing of patients undergoing external beam treatment in the oncology clinic. ARTP with WIMRT is used to plan radiation treatments with linear accelerators oncology cinne. Arth mail relies with x-ray energies from 1 to 25MV, as well as Cobalt-60, and electron energies from 1 to 25 MeV.

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use:

ﻢ

ﺎ ﺗﻌ

Over-The Counter Use: ____ (Per 21 CFR 801.109)

David A. Johnson

(Division Sign-Off) Division of Reproductive, Abdomina and Radiological Devices 510(k) Number _

Prodigm Group, Inc: WIMRT - 510(K)

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.