XPlan-1 is a stereotactic LINAC-based radiation treatment planning system. XPlan-1 localizes lesions to be treated using CT scans, MR scans and digitized angiographic film. XPlan-1 provides a stereotactic planning system, for treatment of tumors < 7 cm in diameter at sites such as base of skull and head. The conformal stereotactic treatments are delivered over multiple fractions.

Device Description

The XPlan-1 system has the same intended use and similar technological characteristics as the commercially available XKnife-3 Stereotactic Radiation Treatment Planning System. Like XKnife-3, the XPlan-1 system includes the same image acquisition, localizing, contouring and beam planning techniques. In addition, XPlan-1 and XKnife-3 both contain methods of QA verification for targeting setup and delivery. XPlan-1 includes modifications of the XKnife-3 system, such as the ability to use conformal collimation devices and a modification to the dose algorithm to account for the use of conformal collimation devices. XPlan-1 also supports the use of the Laser Angio Target Localizer (LATL) as an additional QA check to verify the orientation and position of the LINAC jaws and gantry, the collimator and couch rotation. Like the XKnife-3 use of the Rectilinear Phantom Pointer (RLPP) and Laser Target Localizer Frame (LTLF), XPlan-1 supports the use of the LATL to confirm system alignment at isocenter and to position the patient at isocenter.

XPlan-1 is also substantially equivalent to the commercially available Conformal Radiation Treatment Planning System, FOCUS. Like FOCUS, XPlan-1 supports the use of LINAC jaws, MLCs and wedges to modify the shape and attenuation of the beam. Both XPlan-1 and FOCUS also have the ability to model the total on the target volume and surrounding tissue via a 3D Beam's Eye View and 2D beam visualization. Both systems, also addition to the dose-volume histogram.

AI/ML Overview

The provided document is a 510(k) premarket notification for the XPlan-1 Stereotactic Radiation Treatment Planning System. It primarily focuses on demonstrating substantial equivalence to predicate devices (RSA XKnife-3 System and CMS Focus System), rather than detailing specific acceptance criteria and the results of a primary study.

Therefore, many of the requested details about acceptance criteria, study design, sample sizes, expert involvement, and ground truth establishment are not explicitly present in the provided text. The document refers to "testing" that verifies functionalities, but does not provide the specifics of these tests as a formal study with statistical outcomes.

Here's an attempt to extract the available information and highlight what is missing based on your request:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Inferred from "Safety Summary")	Reported Device Performance (Inferred from "Safety Summary")
Correct aperture generation by beam shaping function	XPlan-1 system testing verifies that the beam shaping function generated the correct aperture.
Correct dose displays in Geometry Viewer and Dose Summary	[XPlan-1 system testing verifies] that the dose displays in the Geometry Viewer and Dose Summary are correct.
Accuracy of PTV generation	[XPlan-1 system testing verifies] that the PTV generation... [is] accurate.
Accuracy of Block and MLC generation	[XPlan-1 system testing verifies] that the... Block and MLC generation... [is] accurate.
Accuracy of DRR display	[XPlan-1 system testing verifies] that the DRR display... [is] accurate.
Accuracy of other new features	[XPlan-1 system testing verifies] that... other new features are accurate.
Functionality of QA verification for targeting setup and delivery	XPlan-1 and XKnife-3 both contain methods of QA verification for targeting setup and delivery.
Support for conformal collimation devices	XPlan-1 includes modifications of the XKnife-3 system, such as the ability to use conformal collimation devices.
Modification to dose algorithm for conformal collimation	XPlan-1 includes a modification to the dose algorithm to account for the use of conformal collimation devices.
Support for Laser Angio Target Localizer (LATL) as QA	XPlan-1 also supports the use of the Laser Angio Target Localizer (LATL) as an additional QA check to verify the orientation and position of the LINAC jaws and gantry, the collimator and couch rotation.
System alignment and patient positioning confirmation (via LATL)	Like the XKnife-3 use of the Rectilinear Phantom Pointer (RLPP) and Laser Target Localizer Frame (LTLF), XPlan-1 supports the use of the LATL to confirm system alignment at isocenter and to position the patient at isocenter.
Support for LINAC jaws, MLCs, and wedges to modify beam	Like FOCUS, XPlan-1 supports the use of LINAC jaws, MLCs and wedges to modify the shape and attenuation of the beam.
Ability to model total volume and surrounding tissue via 3D Beam's Eye View and 2D beam visualization	Both XPlan-1 and FOCUS also have the ability to model the total volume and surrounding tissue via a 3D Beam's Eye View and 2D beam visualization.
Inclusion of dose-volume histogram	Both systems, also addition to the dose-volume histogram.

Note: The document uses phrases like "verifies that..." and "are accurate" to describe performance, without providing quantitative metrics or specific pass/fail criteria for what constitutes "correct" or "accurate" in a statistical sense.

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

Sample Size: Not specified. The document states "XPlan-1 system testing verifies," but does not provide details on the number of cases, patients, or data points used during this testing.
Data Provenance: Not specified. It's unclear if the data used for testing was retrospective or prospective, or its country of origin.

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

Number of Experts: Not specified.
Qualifications: Not specified.

4. Adjudication Method for the Test Set

Adjudication Method: Not specified. There is no mention of expert review, consensus methods (e.g., 2+1, 3+1), or any other adjudication process.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

MRMC Study: No. This document describes a radiation treatment planning system, not an AI-assisted diagnostic or interpretation tool for human readers. Therefore, an MRMC study comparing human reader performance with and without AI assistance is not applicable to the outlined purpose of this device.

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

Standalone Performance Study: The document refers to "XPlan-1 system testing" to verify various functions like beam shaping, dose display, and PTV/MLC generation. This implies a form of standalone testing of the algorithm's outputs. However, specific performance metrics (e.g., accuracy percentages, error margins) from such a standalone study are not provided. The "Safety Summary" paragraph could be interpreted as a High-Level summary of a standalone performance evaluation, but lacks the granular detail of a formal study report.

7. The Type of Ground Truth Used

Type of Ground Truth: Not explicitly stated. For a treatment planning system, ground truth would typically involve comparisons against established physics models, phantom measurements, or expert-defined optimal plans. The document broadly mentions "accuracy" and "correctness," which suggests a comparison to some reference, but the nature of that reference (e.g., a gold standard derived from established physics, or expert consensus on ideal plan parameters for specific cases) is not detailed.

8. The Sample Size for the Training Set

Sample Size for Training Set: Not applicable/Not specified. This device is described as a "Stereotactic Radiation Treatment Planning System" which uses algorithms to calculate and plan, rather than an AI/Machine Learning system that typically requires a distinct "training set." The system likely relies on physics-based models and established dosimetry principles, not data-driven learning from a training set in the modern sense.

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

Ground Truth for Training Set: Not applicable/Not specified, for the same reasons as #8. If the system incorporates any machine learning, this information is not provided. Given the 1997 date of the document, it's highly unlikely that "training set" as understood in current AI contexts applies here.

Summary

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Summary of Safety and Effectiveness

K972905

OCT 28 1997

OCT 28 1997
General Information
Classification:	Class II
Common Name:	Stereotactic Radiation Treatment Planning System
Device Trade Name:	XPlan-1
Intended Uses:	Computer planned LINAC-based stereotacticradiotherapy procedures
Predicate Device:	RSA XKnife-3 System and CMS Focus System
Establishment Name and Address:	Radionics Software Applications, Inc.22 Terry AvenueBurlington, MA 01803
Contact Name and Phone:	Renee J. Thibeault or Linda Jalbert, (617) 272-1233
Establishment Registration Number:	1222895
Performance Standard:	None established under Section 514

Substantial Equivalence Determination

A summary of the information contained in this premarket notification that addresses safety and effectiveness follows.

Safety Summary

RSA XPlan-1 system testing verifies that the beam shaping function generated the correct aperture and that the dose displays in the Geometry Viewer and Dose Summary are correct. Further, it verifies that the PTV generation, Block and MLC generation, DRR display and other new features are accurate.

General Safety and Effectiveness

The device labeling contains instructions for use. It includes indications for use, cautions, warnings and user quality assurance procedures. The training and installation sessions provide assurance that the user understands all aspects of the XPlan-1 System; mechanical, computer and software, plus its intended functionality. This information promotes safe and effective use of the device.

Description of the Device and the Basis for Substantial Equivalence

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XPlan-1 and FOCUS also have the ability to model the total on the taget.
volume and surrounding tissue via a 3D Beam's Eye View and 2D beam visualization.
Both systems, also addition to the dose-volume histogram.

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Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the department's name around the perimeter. In the center of the circle is an abstract symbol that resembles a stylized caduceus or a representation of human figures.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Renee J. Thibeault Radionics Software Applicants, Inc. 22 Terry Avenue Burlington, MA 01803-2516

Re:

K972905 Xplan-1 Stereotactic Radiation Treatment Planning System Dated: August 5, 1997 Received: August 6, 1997 Regulatory class: II OCT 28 1997 21 CFR 892.5050/Procode: 90 IYE

Dear Ms. Thibeault:

We have reviewed your Section 510K) notification of intent to market the device and we have determined the device is substantially equivalent for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, 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 and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class III (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic OS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under Radiation Control provisions, or other Federal laws or regulations.

This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4613. Additionally, for question 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" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours.

H. William Yu

Lillian Yin, Ph.D. Director, Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

The following are the indications for use of the XPlan-1 system:

XPlan-1 is a stereotactic LINAC-based radiation treatment planning system. XPlan-1 A Flail-T IS a steleolacite Ell Tre Oase Tacianon Cleiting and digitized angiographic film.
Iocalizes lesions to be treated using CT scans, MR scans and digitized angiographi XPlan-1 provides a stereotactic planning system, for treatment of turnors < 7 cm in
XPlan-1 provides a stereotactic planning system, for treatment of turns of creation AF lan-1 provides a sices of skull and head. The conformal stereotactic chameler at sites Juen as on are delivered over multiple fractions.

Givind A. Slegyson

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

Prescription Use (Per 21 CFR 801.109)

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.