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-at-risk, 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 Proton Spot Scanning. XiO provides the user with the ability to choose between multiple dose calculation algorithms, selecting the algorithm most appropriate for the given clinical scenario.

AI/ML Overview

The provided K102216 submission for the XiO RTP System with Proton Spot Scanning focuses on the safety and effectiveness of a radiation treatment planning system. Therefore, the "acceptance criteria" and "device performance" in this context refer to the accuracy of the dose calculation algorithm and the successful execution of verification tests, rather than typical clinical performance metrics like sensitivity, specificity, or AUC which are common for diagnostic AI devices.

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

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Criteria / Test Type	Reported Device Performance
Dose Calculation Accuracy	Comparison of calculated vs. measured doses.	Algorithm testing performed to ensure dose calculation accuracy. (Implies successful comparison, though specific metrics not detailed.)
System Functionality	Verification tests (Pass/Fail requirements for system working as designed).	XiO successfully passed verification testing.
Clinical Suitability	Clinically oriented validation test cases, executed in-house.	Product deemed fit for clinical use.

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."
"Clinically oriented validation test cases were written and executed in-house by CMS customer support personnel."

This indicates the test sets were synthetically created or derived from experimental measurements in a lab setting (for algorithm performance) and internal validation cases rather than patient data.

Sample Size: Not explicitly stated for either the algorithm testing or the clinically oriented validation test cases. It is implied there were sufficient cases to validate the algorithms and system functionality.
Data Provenance: The data for algorithm testing would likely be from physical measurements in a lab (e.g., phantom studies) against which the calculated doses are compared. The "clinically oriented validation test cases" were "written and executed in-house" by the manufacturer (CMS customer support personnel), suggesting simulated clinical scenarios or predefined test inputs mirroring real-world conditions, rather than primary patient data.
Retrospective or Prospective: Both types of testing (algorithm and validation test cases) are described as retrospective analyses or internal validation exercises on predefined scenarios/data, not prospective studies on real patients.

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

Number of Experts: Not explicitly stated.
Qualifications of Experts: The ground truth for dose calculation accuracy would be established by dosimetrists or medical physicists who perform the physical measurements of radiation dose distributions in a lab setting. The "clinically oriented validation test cases" were executed by "CMS customer support personnel," which might include individuals with dosimetric or clinical application knowledge, but their specific qualifications are not detailed beyond "customer support personnel." Given the "Major Level of Concern" for this device, a qualified medical physicist would likely have overseen or been involved in the interpretation of algorithm accuracy.

4. Adjudication Method for the Test Set

Not applicable in the conventional sense for a typical AI diagnostic device. The "ground truth" for this device is the measured physical dose or the correct output based on system specifications for verification tests. Discrepancies would be resolved by re-measurement, re-analysis, or debugging, not by expert consensus adjudication of human interpretation.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size

No. An MRMC study is not relevant for this type of device (a radiation treatment planning system). The device assists human readers (dosimetrists/medical physicists) in planning treatments but does not present images for interpretation in a diagnostic context. Its primary function is calculation and display of dose distributions.

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

Yes, in essence. The "algorithm testing" performed to compare calculated against measured doses is a standalone performance assessment of the core dose calculation engine. This evaluates the algorithm's accuracy independent of a human user's input or interpretation after the calculation.

7. The Type of Ground Truth Used

Algorithm Testing: Measured physical dose distributions (e.g., from phantom studies, ion chamber measurements, film dosimetry). This is a form of empirical measurement/experimental data.
Verification Tests: The expected correct system behavior and output as defined by the system's design specifications. This can be considered definitive system specification ground truth.
Clinically Oriented Validation Test Cases: Predefined correct treatment plans or expected outcomes based on established clinical practice and physics principles. This combines elements of expert consensus (on what constitutes a correct plan) and physics-based ground truth.

8. The Sample Size for the Training Set

Not applicable. This document describes a traditional software upgrade to a radiation treatment planning system, not a machine learning or AI algorithm that requires a "training set" in the common sense. The "training" of such a system involves the development and calibration of physics-based dose calculation algorithms against physical models and experimental data, not supervised learning from a dataset of labeled clinical cases.

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

Not applicable. As noted above, this is not an AI/ML device that uses a "training set" in the context of supervised learning. The underlying physics models and algorithms are developed based on established scientific principles, physical measurements, and mathematical formulations, which constitute their "ground truth" or foundational knowledge.

Summary

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K102216

August 4, 2010

XiO RTP System - Proton Spot Scanning Premarket Notification (510(k)) Summary of Safety and Effectiveness

OCT " 1 2010

INTRODUCTION

This document summarizes the safety and effectiveness information contained within the XiO RTP System - Proton Spot Scanning 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
- Submitter Address b.

C. Establishment Number

Contact d.
Contact Phone e.
t. Contact Fax

XiO RTP System Proton Spot Scanning added in release 4.61

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 Specialist 314-993-0003 314-993-1175

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PREDICATE DEVICE INFORMATION

The XiO RTP System with Proton Spot Scanning functionality 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. K092132
1. Eclipse Treatment Planning System Varian Medical Systems K091492

XIO INTENDED USE

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 i 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.

DESCRIPTION OF THE PRODUCT

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 Proton Spot Scanning. 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

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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.

CMS received 510(k) clearance for the addition of proton planning capability to XiO in 2002. This feature extends proton planning functionality, giving the user the ability to create proton treatment plans that involve a series of small proton beams for which dose and monitor units are calculated and displayed individually. This allows users to create intensity modulated radiation therapy (IMRT) plans with protons, as discussed in more detail in section 11 of this submission. The proton spot scanning feature includes a new pencil beam dose calculation algorithm.

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.

5-3

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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 submission. XiO successfully passed verification testing.

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Image /page/4/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes entwined around it. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular fashion around the caduceus symbol. The text is in all capital letters.

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

Ms. Kathryn Stinson Regulatory Affairs Specialist Computerized Medical Systems, Inc. 13723 Riverport Drive, Suite 100 MARYLAND HEIGHTS MO 63043

OCT 1 2010

Re: K102216

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 and LHN Dated: August 4, 2010 Received: August 6, 2010

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 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 (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.

If 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,

Signature

David G. Brown, Ph.D. Acting 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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Indication for Use

510(k) Number (if known): K10 2216

Device Name: XiO RTP System

Indication For Use:

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 Hevice Evaluation (ODE) (2)

Muband D. Rhm for David G. Brown
Division Sign Off

Division Sign-Off

510(k): K102216

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.