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.

Optionally, the user may elect to generate plans using Dynamic Conformal Arc Therapy capability. Dynamic Conformal Arc Therapy is a treatment modality in which the gantry rotates in an arc (or multiple arcs) over user-specified angles while the leaves of a multileaf collimator (MLC) continually reshape the beam to conform to the targer.

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) a) the target volume to be treated and b) critical structures which must not receive above a certain level of radiation, on these diagnostic images.

Based on the prescribed dose, 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 then produces a display of radiation dose distribution within the patient, indicating not only doses to the target volume but to surrounding tissue and structures. The "best" plan satisfying the prescription is then selected, one that maximizes dose to the target volume while minimizing dose to surrounding healthy volume. The parameters of the plan are output in hard-copy format for later reference and for placement in the patient file.

This Premarket Notification addresses the addition of support for Dynamic Conformal Therapy. Dynamic Conformal is a treatment modality in which radiation beams are continuously shaped to conform to a target while the gantry rotates and the beam is on. In XiO, the user chooses the target, defines structures to avoid, optional margin(s), and treatment angles. XiO then plans a treatment over a specified arc and with specified beam increments, with the leaves of the multi-leaf collimator (MLC) continually reshaping the beam to conform to the target. The target receives a homogenous dose while the structures designated as "avoidance structures" are avoided absolutely.

Dose calculation is performed using existing, validated algorithms within XiO. Determination of dose at the specified angles is calculated in the same way as conventional and asymmetric arc beams; the calculated dynamic beam dose distribution is determined as the sum of multiple fixed beam dose distributions across the specified arc.

AI/ML Overview

This submission describes the XiO Radiation Treatment Planning System with the added functionality of Dynamic Conformal Therapy. The information provided heavily emphasizes the regulatory process and comparisons to predicate devices rather than detailed performance studies with acceptance criteria.

Here's an analysis based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The provided text does not explicitly state specific acceptance criteria in terms of numerical thresholds for dose calculation accuracy or clinical outcomes. Instead, it focuses on the device's ability to calculate dose and conform to targets.

Acceptance Criteria (Implied)	Reported Device Performance
Accurate dose calculation for Dynamic Conformal beams.	"Algorithm test cases were written and executed to ensure that the system is calculating dose correctly for Dynamic Conformal beams." The results of this testing are apparently found in the "XiO Dynamic Conformal Algorithm Test Report, included in section 9 of this submittal." (This report itself is not included in the provided text, so specific performance metrics or thresholds are unknown). The text also states, "Dose calculation is performed using existing, validated algorithms within XiO."
Ability to conform to the target via dynamic MLC reshaping.	The system allows the user to "choose the target, define structures to avoid, optional margin(s), and treatment angles." XiO then "plans a treatment over a specified arc... with the leaves of the multi-leaf collimator (MLC) continually reshaping the beam to conform to the target." "The target receives a homogenous dose while the structures designated as 'avoidance structures' are avoided absolutely."
Generation of treatment plans for external beam radiation therapy.	The system "will calculate and display... two- or three-dimensional radiation dose distributions within a patient for a given treatment plan set-up." (This is a general function of the RTP system, not specific to the new Dynamic Conformal feature, but applies to its output).

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

Test Set Sample Size: Not explicitly stated. The document mentions "Algorithm test cases were written and executed." The number of these test cases is not specified.
Data Provenance: The testing was "executed in-house by CMS customer support personnel." This suggests simulated or internally generated data rather than real patient data. The country of origin is implicitly the US, where Computerized Medical Systems, Inc. is located. It was a retrospective evaluation against defined test cases.

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

Number of Experts: Not specified. The "Algorithm test cases were written and executed" and "Clinically oriented validation test cases were written and executed" by "CMS customer support personnel." It's unclear if these personnel are qualified medical experts (e.g., medical physicists, dosimetrists) or if external experts were involved in establishing the ground truth for these test cases.
Qualifications of Experts: Not explicitly stated. While the system's users are described as "typically a Dosimetrist or Medical Physicist," it doesn't confirm if these roles or similarly qualified individuals generated the test cases or the ground truth for them.

4. Adjudication Method for the Test Set

Adjudication Method: Not specified. Since the testing involved "algorithm test cases" and "clinically oriented validation test cases," it's likely a comparison against predetermined correct outputs for those cases rather than an adjudication process involving multiple human observers reviewing complex real-world interpretations.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No, an MRMC comparative effectiveness study was not done. The text explicitly states: "Actual testing in a clinic was not performed as part of the development of this feature." It also adds that such testing "is not required to demonstrate substantial equivalence or safety and effectiveness of the device." Therefore, there is no effect size reported for human readers improving with AI vs. without AI assistance.

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

Yes, a standalone study was done, as far as the algorithm's performance is concerned. The text highlights "Algorithm test cases were written and executed to ensure that the system is calculating dose correctly for Dynamic Conformal beams." This "algorithm test" would represent a standalone evaluation of the core calculation engine's accuracy against predefined inputs and expected outputs, without direct human intervention in each calculation step.

7. The Type of Ground Truth Used

Type of Ground Truth: The ground truth for the "Algorithm test cases" would likely be pre-calculated, theoretical, or established results from known physics principles or established algorithms for radiation dose calculation under specific, controlled parameters. For "Clinically oriented validation test cases," the ground truth would similarly be pre-defined correct treatment plans or dose distributions established by medical physicists/dosimetrists for those specific clinical scenarios. It is not pathology, expert consensus on patient images, or outcomes data.

8. The Sample Size for the Training Set

Training Set Sample Size: Not applicable/Not provided. Radiation Treatment Planning (RTP) systems like XiO, particularly from this era (2003), typically rely on deterministic physical algorithms for dose calculation rather than machine learning models that require training data sets in the conventional sense. The "algorithms" mentioned are likely physics-based models rather than AI models.

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

Ground Truth for Training Set: Not applicable. As mentioned above, this system likely operates on deterministic algorithms rather than machine learning, so there isn't a "training set" or corresponding ground truth in the AI context. The algorithms themselves would have been developed and validated against established physics principles and possibly empirical measurements (though those details are not in this summary).

Summary

{0}------------------------------------------------

6 $327 62 510(k) Summary of Safety and Effectiveness XiO Radiation Treatment Planning System Dynamic Conformal

Submitter Name:	Computerized Medical Systems, Inc.
Submitter Address:	1145 Corporate Lake DriveSt. Louis, MO 63132-1716
Submitter Phone:	314 993 0003
Submitter Fax:	314 993 0075
Contact Person:	Michael A. Parsons - Director - Quality Assuranceand Regulatory Affairs orKathryn Stinson - Regulatory Affairs Associate
Date Summary Prepared:	September 2003
Device Trade Name:	XiO Radiation Treatment Planning System
Device Common Name:	Radiation Treatment Planning System
Device Classification:	System, Simulator, Radiation Therapy per21CFR892.5840
Substantial Equivalence:	BrainLAB BrainSCAN Conformal RT Module,K9713673D Line DMLC IV – ERGO, K001163

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) a) the target volume to be treated and b) critical structures which must not receive above a certain level of radiation, on these diagnostic images.

Page 4-1

{1}------------------------------------------------

Kp32762 510(k) Summary of Safety and Effectiveness XiO Radiation Treatment Planning System Dynamic Conformal Page 2 of 3

Device Intended Use:

The XiO RTP System will continue to be 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, cither two- or three-dimensional radiation dose distributions within a patient for a given treatment plan sct-up.

{2}------------------------------------------------

032762

510(k) Summary of Safety and Effectiveness XiO Radiation Treatment Planning System Dynamic Conformal Page 3 of 3

Summary of Technological Characteristics Compared to Predicate Devices: Like the XiO Dynamic Conformal feature, the predicate devices are used to generate plans for treatments that use a combination of rotational radiation beams and dynamic MLCs to conform the beam to the target while the gantry rotates and the beam is on.

Both predicate devices (BrainSCAN RTP System with Conformal RT Module and ERGO) are sold with companion micro-MLCs that are directly controlled by the RTP software. The XiO system does not include an MLC and does not directly control the MLC leaves. Instead, XiO exports the leaf positions to any standard linac MLC.

Detailed comparison information can be found in Section 6 of this submittal.

Summary of Clinical Testing: Actual testing in a clinic was not performed as part of the development of this feature. Clinical testing is not required to demonstrate substantial equivalence or safety and effectiveness of the device. Clinically oriented validation test cases were written and executed in-house by CMS customer support personnel.

Summary of Non-Clinical Testing: Algorithm test cases were written and executed to ensure that the system is calculating dose correctly for Dynamic Conformal beams. Results of this testing can be found in the XiO Dynamic Conformal Algorithm Test Report, included in section 9 of this submittal.

{3}------------------------------------------------

Image /page/3/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal features an abstract design resembling an eagle or bird in flight, composed of three curved lines. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular pattern around the emblem.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC - 2 2003

Mr. Michael A. Parsons Director, Quality Assurance and Regulatory Affairs Computerized Medical Systems, Inc. 1145 Corporate Lake Drive Suite 100 ST LOUIS MO 63132

Re: K032762 Trade/Device Name: XiO RTP System with Dynamic Conformal Arc Therapy Regulation Number: 21 CFR 892.5050 Regulation Name: Medical charged particle radiation therapy system Regulatory Class: II Product Code: IYE and MUJ Dated: September 4, 2003

Received September 5, 2003

Dear Mr. Parsons:

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 such 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 (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.

{4}------------------------------------------------

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 Part 801), please contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of the 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" (21CFR Part 807.97) you may obtain. 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 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

{5}------------------------------------------------

Statement of Indication for Use

510(k) Number: K032762

Device Name: XiO RTP System with Dynamic Conformal Arc Therapy

Indication for 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 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.

Concurrence of the Center for Devices and Radiological Health,
Office of Device Evaluation (ODE)

Prescription Use		OR per 21 CFR 801.109	Over the Counter Use ________
------------------	-----------------------------------------------------------------	-----------------------	-------------------------------

Signature

(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices

510(k) Number	K032762
---------------	---------

Computerized Medical Systems - XiO Radiation Treatment Planning System Dynamic Conformal 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.