The XiO RTP System is used to create treatment plans for any cancer patient for whom external beam radiation therapy or brachytherapy has been prescribed. The system will calculate and display, both on-screen and in hard-copy, either two- or three-dimensional radiation dose distributions within a patient for a given treatment plan set-up.

Device Description

The XiO Radiation Treatment Planning system accepts a) patient diagnostic imaging data from CT and MR scans, or from films, and b) "source" dosimetry data, typically from a linear accelerator. The system then permits the user to display and define (contour) the target volume, which is the structure to be treated, and critical structures, or organs-atrisk, to which radiation dose must be limited.

Based on the dose prescribed, the user, typically a Dosimetrist or Medical Physicist, can then create multiple treatment scenarios involving the type, number, position(s) and energy of radiation beams and the use of treatment aids between the source of radiation and the patient (wedges, blocks, ports, etc.). The XiO system produces a display of radiation dose distribution within the patient, indicating doses to the target volume and critical structures. Appropriate clinical personnel select the plan that they believe most effectively maximizes dose to the target volume while minimizing dose to critical structures. The parameters of the plan are output in hard-copy format for later reference placed in the patient file.

This Premarket Notification addresses the addition of the Electron Monte Carlo dose calculation algorithm. XiO provides the user with the ability to choose between multiple dose calculation algorithms, selecting the algorithm most appropriate for the given clinical scenario. More accurate dose computation increases the probability that disease will be effectively treated and decreases the probability of undesirable side effects. No algorithm produces a perfectly accurate description of dose distribution; all algorithms have limitations, which are generally well understood and documented in scientific literature.

The addition of the Monte Carlo dose calculation algorithm gives users a new option for electron treatment plans. The algorithm represents the state of the art in radiation treatment planning and is widely recognized as the most accurate method currently available for computing the dose delivered by a beam of high-energy electrons.

AI/ML Overview

The provided text describes the XiO RTP System with the addition of an Electron Monte Carlo dose calculation algorithm. While it mentions verification testing and algorithmic accuracy, it does not explicitly define acceptance criteria in a quantitative table or detail a study that directly proves the device meets such criteria through a clinical or reader study.

Here's a breakdown of the available information against your requested points:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not provide a formal table of acceptance criteria or specific quantitative performance metrics beyond stating that XiO "successfully passed verification testing" and that algorithmic testing was performed to "ensure dose calculation accuracy." No specific numerical targets for accuracy or precision are given.

Acceptance Criteria	Reported Device Performance
Not explicitly defined in the provided text. The document states "Pass/fail requirements and results of this testing can be found in the XiO Verification Test Report, which is included in section 18 of this submittal." However, these specifics are not detailed in the provided excerpt.	"XiO successfully passed verification testing." "Algorithm testing was performed to compare calculated against measured doses to ensure dose calculation accuracy."

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

The document states:

"Algorithm testing was performed to compare calculated against measured doses to ensure dose calculation accuracy."
"In addition, clinically oriented validation test cases were written and executed in-house by CMS customer support personnel."

The specific sample size for this "algorithm testing" or these "validation test cases" is not mentioned.
The data provenance (e.g., country of origin, retrospective or prospective) for this testing is not specified. It's implied to be internal data ("in-house by CMS customer support personnel") rather than real-world patient data from specific countries.

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

Number of Experts: The document does not specify a number of experts involved in establishing ground truth for the test set. It mentions "qualified clinicians" review plans and "CMS customer support personnel" executed validation test cases, but it doesn't detail their role in establishing ground truth for an independent test set.
Qualifications of Experts: It refers to "qualified clinicians" and "Dosimetrist or Medical Physicist" as typical users of the system. However, it does not specify the qualifications (e.g., years of experience, board certification) of individuals who might have established ground truth for testing.

4. Adjudication Method for the Test Set

The document does not describe an adjudication method for a test set. The testing mentioned appears to be primarily algorithm verification against measured doses and internal validation cases, not a process involving multiple human reviewers resolving discrepancies.

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

No MRMC comparative effectiveness study was done. The document explicitly states: "Clinical trials were not performed as part of the development of this product." It focuses on algorithm accuracy and internal validation.

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

Yes, a standalone study was done, but not in a formal clinical sense. The "Algorithm testing was performed to compare calculated against measured doses to ensure dose calculation accuracy" is a standalone evaluation of the algorithm's performance against a physical standard. The "clinically oriented validation test cases" also represent an evaluation of the algorithm's output without direct human-in-the-loop performance measurement that would typically be seen in a reader study.

7. Type of Ground Truth Used

The primary type of "ground truth" implied for the algorithm testing is measured doses. This means physical measurements of radiation dose distribution, likely obtained from phantoms or experimental setups, were used as the reference standard against which the Monte Carlo algorithm's calculated doses were compared. The "clinically oriented validation test cases" likely involved scenarios with expected or known outcomes based on physics principles or established clinical practices, rather than pathology or patient outcomes data.

8. Sample Size for the Training Set

The document does not mention a discrete training set sample size. The Monte Carlo algorithm is a physics-based simulation method rather than a machine learning model that would typically have a "training set" in the conventional sense. Its development would involve calibrating physical parameters and validating the underlying physics models, rather than training on a dataset of examples.

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

As the Monte Carlo algorithm is not a typical machine learning model trained on a "training set" of data, the concept of establishing ground truth for a training set in this context is not applicable or described. The "ground truth" for the development of such an algorithm would be based on fundamental physics principles, experimentally validated cross-sections, and particle interaction data, rather than annotated clinical cases.

Summary

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K092132

July 10, 2009

XiO RTP System -- Monte Carlo Premarket Notification (510(k)) Summary of Safety and Effectiveness

INTRODUCTION

SEP 2 4 2009

This document summarizes the safety and effectiveness information contained within the XiO RTP System - Monte Carlo Premarket Notification (510(k)). The Summary of Safety and Effectiveness contains no confidential or trade secret information and is intended for full public disclosure and distribution.

PREMARKET NOTIFICATION INFORMATION

1. Product Information:
- a. Product Trade Name
- b. Release Version Number
1. Classification Information:
- Classification Name a. system
- b. Common/Usual Name
- Product Classification c.
- d. Product Code
- e. Reference
- f. Review Panel
1. Establishment Information:
- a. Submitter
- b. Submitter Address
- c. Establishment Number
- d. Contact
- Contact Phone e.
- f. Contact Fax

XiO RTP System Monte Carlo added in release 4.50.00

Medical charged-particle radiation therapy

Radiation Treatment Planning System Class II MUJ 21 CFR 892.5050 Radiology

Computerized Medical Systems, Inc. 13723 Riverport Dr. , Suite 100 Maryland Heights, MO 63043 1937649 Kathryn Stinson, RA Associate 314-993-0003 314-993-1175

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PREDICATE DEVICE INFORMATION

The XiO RTP System with Electron Monte Carlo dose calculation algorithm is substantially equivalent to the following devices that the Food and Drug Administration (FDA) has cleared for distribution and are currently being actively marketed in the United States. XiO is substantially equivalent to these products in intended use and safety and effectiveness.

1. XiO RTP System Computerized Medical Systems, Inc. K032762
1. Eclipse Treatment Planning System Varian Medical Systems K071760
1. Oncentra Masterplan Nucletron Corporation K081281

XIO INTENDED USE

DESCRIPTION OF THE PRODUCT

5-2

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structures. The parameters of the plan are output in hard-copy format for later reference placed in the patient file.

LEVEL OF CONCERN

Item 4b of Table 1 in the FDA Guidance document entitled, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices asks, "Does the Software Device control the delivery of potentially harmful energy that could result in death or serious injury, such as radiation treatment systems ... " XiO does not directly control the linear accelerator that delivers the radiation. Once completed, plans are reviewed and approved by qualified clinicians and may be subject to quality assurance practices before treatment actually takes place. There is no automatic link between the XiO software and the linear accelerator. However, should a flaw in the treatment plan escape the notice of the qualified professionals using the XiO system, serious injury or death could result. Therefore, we believe XiO to be of major level of concern.

SUMMARY OF CLINICAL TESTING

Clinical trials were not performed as part of the development of this product. Clinical testing on patients is not advantageous in demonstrating substantial equivalence or safety and effectiveness of the device since testing can be performed such that no human subjects are exposed to risk. Algorithm testing was performed to compare calculated against measured doses to ensure dose calculation accuracy. In addition, clinically oriented validation test cases were written and executed in-house by CMS customer support personnel. The product was deemed fit for clinical use:

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SUMMARY OF NON-CLINICAL TESTING

Verification tests were written and executed to ensure that the system is working as designed. Pass/fail requirements and results of this testing can be found in the XiO Verification Test Report, which is included in section 18 of this submittal. XiO successfully passed verification testing.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

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

SEP 2 4 2009

Ms. Kathryn Stinson Regulatory Affairs Associate Computerized Medical Systems, Inc. 13723 Riverport Dr. Suite 100 MARYLAND HEIGHTS, MISSOURI 63043

Re: K092132

Trade/Device Name: XiO RTP System Regulation Number: 21 CFR 892.5050 Regulation Name: Medical charged-particle radiation therapy system Regulatory Class: II Product Code: MUJ Dated: July 10, 2009 Received: July 15, 2009

Dear Ms. Stinson:

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 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); medical device reporting (reporting of medical

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Page 2 -

device-related adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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.goy/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/MedicalDevices/Resourcesfor You/Industry/default.html

Sincerely yours,

Janine M. Morris

Acting Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indication for Use

510(k) Number (if known):

K092132

Device Name: XiO RTP System

Indication For Use:

X Prescription Use (21 CFR Part 801 Subpart D)

And/Or

Over the Counter Use (21 CFR Part 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

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

210(K)

Division Sign-Off

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.