The Explorer 4D™ Treatment Planning System software is intended for use in preparing treatment plans for patients who have intracranial diseases where neurological radio surgery has been prescribed. The software is used to electronically import CT and MR images to determine the precise location of the target, to define and visualize treatment beam locations, and to visualize dose to the target and other structures.

Device Description

The Explorer 4D™ Treatment Planning System (TPS) provides individual treatment plans for patients undergoing gamma radiation therapy treatment. The TPS provides for the import of patient images and selecting a series of relevant patient images to create a treatment plan. Precise calculation of the dose delivery parameters is supported by the registration of fiducial markers as a reference point between patient images. These images are then annotated with the region of interest (ROI) to be exposed to radiation. Several tools are provided to adjust the ROI based on the desired treatment area, within these regions "shots" (radiation sources) and associated treatment dose levels are defined as they related to a specified collimator size. When the plan definition is completed the operator can save or export the treatment plan.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and supporting study for the Explorer 4D™ Treatment Planning System:

The document describes a 510(k) submission for the Explorer 4D™ Treatment Planning System (version 2.1), primarily focused on demonstrating its substantial equivalence to a predicate device (Explorer 4D™ Treatment Planning System version 2.0). The key difference in the new version is the ability to import MR images in addition to CT images.

The acceptance criteria are implicitly tied to demonstrating that the new feature (MR image import and subsequent treatment planning) performs equivalently to the existing functionality (CT image import) and that the overall system remains safe and effective.

1. Table of Acceptance Criteria and Reported Device Performance

The document doesn't explicitly list "acceptance criteria" with numerical targets in a typical format. Instead, it frames the performance data in terms of "equivalence," particularly regarding the accuracy of dose calculations when using MR images compared to CT images.

Acceptance Criteria Category	Specific Criteria (Implicit from "Performance Data" and "Equivalence Comparison")	Reported Device Performance (Summary from text)
Functional Equivalence	The ability to prepare treatment plans using MR images as well as CT images.	"Functional testing has demonstrated that version 2.1 is safe and effective..."
Accuracy Equivalence	Dose calculation accuracy using MR images should be equivalent to that using CT images.	"...accuracy comparison tests have demonstrated equivalent performance using MR images as obtained using CT images.""Test results have been verified by physicist manual calculations as accurate for CT and MR images."
Safety and Effectiveness	Overall system safety and effectiveness.	"...functional testing has demonstrated that version 2.1 is safe and effective..."

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

Sample Size: The document does not specify a numerical sample size for the test set used in "accuracy comparison tests" or "functional testing." It only states that "all tests were conducted with comparison tests" and "production" (which seems to be a typo/phrase fragment but implies real-world or production-like data).
Data Provenance: Not explicitly stated. The document refers to "MR images instead of CT images" for the new functionality and "comparison tests" between MR and CT results. It does not mention the country of origin or whether the data was retrospective or prospective.

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

Number of Experts: Not specified.
Qualifications of Experts: The document states that "Test results have been verified by physicist manual calculations as accurate for CT and MR images." This implies that qualified physicists were involved in verifying the accuracy, but their specific experience or number is not provided.

4. Adjudication Method for the Test Set

Adjudication Method: Not specified. The verification by "physicist manual calculations" suggests an independent assessment, but the process (e.g., blinded, consensus-based) is not detailed.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

MRMC Study: No, an MRMC comparative effectiveness study was not done or is not reported in this document. The study described focuses on the technical performance and accuracy of the device itself (dose calculations) rather than how human readers' performance with or without AI assistance changes. The device is a treatment planning system, not an AI diagnostic assistant tool for human interpretation.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

Standalone Performance: Yes, the described "accuracy comparison tests" and verification by "physicist manual calculations as accurate for CT and MR images" essentially represent a standalone performance evaluation of the algorithms within the treatment planning system. The goal was to ensure the system's calculations were correct on their own, whether using CT or MR input images.

7. The Type of Ground Truth Used

Ground Truth Type: The ground truth appears to be "physicist manual calculations" of dose, which served as the reference standard against which the device's calculated results (using both CT and MR images) were compared for accuracy.

8. The Sample Size for the Training Set

Training Set Sample Size: Not applicable/Not specified. This document pertains to a 510(k) submission for a treatment planning system, not a machine learning or AI-based device that typically requires a large training set. The system likely uses established physics-based dose calculation algorithms which are validated rather than "trained" in the machine learning sense.

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

Training Set Ground Truth Establishment: Not applicable/Not specified, for the same reasons as #8. The "training" of such a system would involve rigorous engineering and physics validation of its algorithms, rather than training on a dataset with established ground truth.

Summary

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

Image /page/0/Picture/0 description: The image shows the logo for American Radiosurgery. The logo consists of a series of black dots arranged in a semi-circular pattern on the left side of the image. To the right of the dots, the words "AMERICAN RADIOSURGERY" are written in a bold, sans-serif font. The text is aligned horizontally and is the main element of the logo.

510(k) Summary

NOW - 5 2010

510(k)	K101220
Submitter/Applicant Name:	American Radiosurgery, Inc.
Address:	16776 Bernardo Center Drive, Suite 203San Diego, CA 92128
Phone number:	858-451-6173
Fax number:	858-487-0662
Contact:	John Clark
Contact person:	Dan Olivier (CCS, Inc.)
Phone number:	(858) 675-8200
Fax number:	(858) 675-8201
Date prepared:	October 30, 2010
Trade name:	Explorer 4D™ Treatment Planning System
Common name:	Radiation Therapy Treatment Planning System
Classification name:	System, Planning, Radiation Therapy Treatment
Classification:	21 CFR Part 892.5050 Class II

Substantial equivalence claimed to:

Substantial equivalence thanks as: "Treament Planning System is functionally and
substantially equivalent to the K093588 Explorer 4D™ Treatment Planning System with the subsumitially equility to import MR as well as CT images. Both systems share the same user interface and dose calculation algorithms; the only difference is the ability to import both CT and MR images.

Description

Precise calculation of the dose delivery parameters is supported by the registration of fiducial markers as a reference point between patient images. These images are then annotated with the region of interest (ROI) to be exposed to radiation. Several tools are provided to adjust the ROI based on the desired treatment area, within these regions "shots" (radiation sources) and associated treatment dose levels are defined as they related to a specified collimator size.

When the plan definition is completed the operator can save or export the treatment plan.

Intended Use

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

The software is used to electronically import CT and MR images to determine the precise location of the target, to define and visualize treatment beam locations, and to visualize dose to the target and other structures.

Substantial Equivalence

Substantial Explorer 4D™ Treatment Planning System include the capability to prepare treatment plans using MR images as well as CT images cleared under submission K093588 (version 2.0). Functional testing has demonstrated that version 2.1 is safe and effective and accuracy comparison tests have demonstrated equivalent performance using MR images as obtained using CT images.

Equivalence Comparison
Item	Device	Predicate
Name	Explorer 4DTM TreatmentPlanning System version 2.1(K101220)	Explorer 4DTM TreatmentPlanning System version 2.0(K093588)
Indications forUse	The Explorer 4DTM TreatmentPlanning System software isintended for use in preparingtreatment plans for patients whohave intracranial diseases whereneurological radio surgery hasbeen prescribed.The software is used toelectronically import CT andMR images to determine theprecise location of the target, todefine and visualize treatmentbeam locations, and to visualizedose to the target and otherstructures.	The Explorer 4DTM TreatmentPlanning System software isintended for use in preparingtreatment plans for patients whohave intracranial diseases whereneurological radio surgery hasbeen prescribed.The software is used toelectronically import CT imagesto determine the preciselocation of the target, to defineand visualize treatment beamlocations, and to visualize doseto the target and otherstructures.
SystemFunctions	The Explorer 4DTM TreatmentPlanning System (TPS) importspatient images to determine theprecise location of the target forgamma irradiation.	The Explorer 4DTM TreatmentPlanning System (TPS) importspatient images to determine theprecise location of the target forgamma irradiation.
Technologicalcharacteristics	Technological characteristicsinclude 3D imaging oftreatment beam locations tovisualize target dose overlaid onCT and MR images.	Technological characteristicsinclude 3D imaging oftreatment beam locations tovisualize target dose overlaid onCT images.
Import data	CT and MR images	CT

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

Equivalence Comparison
Item	Device	Predicate
Data interfaces	TCP/IP network interface	TCP/IP network interface
User access	Secured through identificationcode and password	Secured through identificationcode and password
Safety Features	Requires physician approval oftreatment plans	Requires physician approval oftreatment plans
Non-clinicaltesting	Testing includes functionalcoverage of all requirementsand accuracy comparison testsusing CT and MR images	Testing includes functionalcoverage of all requirements
Test results	Test results have been verifiedby physicist manualcalculations as accurate for CTand MR images	Test results have been verifiedby physicist manualcalculations as accurate for CTimages
Software version	2.1	2.0

Performance Data

Testing for the Explorer 4D™ Treatment Planning System is the same as was performed for the r esting for the Explorer 12 - Freativent Planning System) with the difference that production and of no 9500 Enpress ware version 2.1 using MR images instead of CT images. In an tests were concacted with comparison tests were also conducted showing the results using MR images are equivalent to the results generated using CT images.

production : : : : : : :

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

Image /page/3/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three lines representing its wings and body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle.

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

American Radiosurgery, Inc. c/o Mr. Dan Olivier President Certified Compliance Solutions. Inc. 11665 Avena Place, Suite 203 SAN DIEGO CA 92128

NOV - 5 2010

Re: K101220

Trade Name: Explorer 4DTM Treatment Planning System Regulation Number: 21 CFR §892.5050 Regulation Name: Medical charged-particle radiation therapy system Regulatory Class: II Product Code: MUJ Dated: October 24, 2010 Received: October 25, 2010

Dear Mr Oliver:

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

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

Page 2

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 vours.

Dan

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

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

American Radiosurgery Explorer 4D™ Treatment Planning System Premarket Submission

Indications for Use 4.

510(k) Number: K101220 510(K) Namber : R101220 TM Treatment Planning System

NOV - 5 2010

Indications for Use:

The Explorer 4D™ Treatment Planning System software is intended for use in preparing The Exploier 4D - Treamfell Tiaming System Scoranial diseases where neurological radio surgery has been prescribed.

The software is used to electronically import CT and MR images to determine the precise I he "software" is asour to "elections and visualize treatment beam locations, and to visualize dose to the target and other structures.

Prescription Use (Per 21 CFR 801 Subpart D)

"AND/OR ... .. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

... . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

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

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

Concurrence of CDRH, Office of In Vitro Diagnostics (OIVD)

(Division Sign-Off)

510K K101220

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.