VISITRAK, VERSION 1, RELEASE 1 by MATH RESOLUTIONS, LLC.

This product is to be used by radiation therapy oncologist or staff under their direction to locate the position relative to the patient of the isocenter of a treatment beam on a gantry mounted radiation therapy treatment machine. Some internal marker must be visible on both a radiograph of the patient taken at the time of treatment and the images used for the treatment plan in order to use this software to align the marker image on the radiograph with the plan to find the proper patient support system coordinates. Only a translation along the couch lateral, longitudinal, and height directions are considered and solved for. Possible rotations or repositioning of the patient are not considered.

Device Description

VisiTrak is a radiation therapy localization software system that assist in aiming the radiation beam. This software uses functions from System 2100, a Radiological Image Display System, 510(k) K993530, and Dosimetry Check, a treatment plan delivery testing system, 510(k) K010225.

The following functions are included in VisiTrak:

(1) Means to download a treatment plan from a treatment planning system, to include a stackable image set (such as the CT scans used to generate the plan), beam geometry, and optional regions of interest outlines. [This function from Dosimetry Checkl
(2) Means to define and trace a marker that is visible in the stackable image set. [This function from System 2100]
(3) Means to draw the markers on two dimensional plane images and three dimensional perspective room views.
(4) Means to read in radiographic images made of the patient in the treatment position on the gantry mounted treatment machine.
(5) Means to define the geometry for each radiographic image, i.e., in the treatment machine coordinates.
(6) Means to project the defined markers onto the radiographic images.
(7) Means to manually select couch coordinates to match up the images of the markers on the radiographs with the projected marker images.
(8) Means to trace the images of the markers on the radiographs.
(9) Means to solve for the best estimate of the couch coordinates that will align the projected and traced marker images.
Means to display the couch coordinates for each treatment beam using the (10) couch position found in (7) or (9) above.

AI/ML Overview

The provided text is a 510(k) summary for VisiTrak, a radiation therapy localization software system. While it describes the device's functions and intended use, it does not contain information about specific acceptance criteria, a study proving performance against those criteria, or the detailed methodological information requested.

Therefore, many of the requested points cannot be answered from the provided document.

Here's a breakdown of what can and cannot be extracted:

1. A table of acceptance criteria and the reported device performance

Cannot be answered from the text. The document does not define specific acceptance criteria (e.g., accuracy thresholds, precision measurements) or present a table of results from a performance study.

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)

Cannot be answered from the text. The document mentions the device "mathematically solves for the x, y,z coordinates" and projects markers, but it does not describe any specific testing or validation study with a test set.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)

Cannot be answered from the text. There is no mention of a test set, ground truth establishment, or experts involved in such a process.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set

Cannot be answered from the text. No adjudication method is described as no test set or expert review process is detailed.

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

Cannot be answered from the text. The document describes a software system that assists in aiming radiation beams, performing calculations and projections. It does not mention any MRMC comparative effectiveness study, nor does it quantify human reader improvement with or without AI assistance. The device's function is more about precision and alignment calculation than interpretive human assistance.

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

Cannot be answered from the text. The document describes the software's functionality, which includes both automated projection/solving and manual selection/tracing by users ("Means to manually select couch coordinates," "Means to trace the images of the markers"). It doesn't explicitly state whether a standalone algorithm-only performance test was conducted. The nature of the device suggests it's an human-in-the-loop tool.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

Cannot be answered from the text. No ground truth type is specified, as no performance study or test set is described.

8. The sample size for the training set

Cannot be answered from the text. The document does not describe any machine learning or AI models that would require a training set, nor does it mention a training set size. The device is described as mathematically solving coordinates and projecting images based on geometric definitions.

9. How the ground truth for the training set was established

Cannot be answered from the text. Since no training set or machine learning components are mentioned, the establishment of ground truth for a training set is not discussed.

Summary

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Image /page/0/Picture/1 description: The image shows the logo and contact information for Math Resolutions, LLC. The logo includes the word "Math" above the word "Resolutions" with an integral symbol on the left. The contact information includes a website, address (5975 Gales Lane, Columbia, MD 21045), phone number (410-997-9578), and email address (WendelDRenner@comcast.net).

File: vtksum.doc

Contact Person: Wendel Dean Renner, President of Math Resolutions, LLC Date: March 17, 2005

510(k) Summary

The trade name is VisiTrak. A common name is imaged guided radiation therapy. Regulatory Class is II.

A predicate device is Acculoc from Northwest Medical Physics Equipment, 21031 67th Ave. West, Lynnwood, WA 98036, 510(k) K970464. VisiTrak and Acculoc both mathematically solves for the x, y,z coordinates of the couch so that the projected image of a designated marker and the radiographic image of the same marker coincide on orthogonal views.

The following functions are included in VisiTrak:

(1) Means to download a treatment plan from a treatment planning system, to include a stackable image set (such as the CT scans used to generate the plan), beam geometry, and optional regions of interest outlines. [This function from Dosimetry Checkl
(2) Means to define and trace a marker that is visible in the stackable image set. [This function from System 2100]
(3) Means to draw the markers on two dimensional plane images and three dimensional perspective room views.
(4) Means to read in radiographic images made of the patient in the treatment position on the gantry mounted treatment machine.
(5) Means to define the geometry for each radiographic image, i.e., in the treatment machine coordinates.

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(6) Means to project the defined markers onto the radiographic images.
(7) Means to manually select couch coordinates to match up the images of the markers on the radiographs with the projected marker images.
(8) Means to trace the images of the markers on the radiographs.
(9) Means to solve for the best estimate of the couch coordinates that will align the projected and traced marker images.
Means to display the couch coordinates for each treatment beam using the (10) couch position found in (7) or (9) above.

The intended use of the device is by radiation oncologist and their therapy technicians and physicist to solve for the couch coordinates for each radiation therapy treatment of a radiation therapy patient to properly align the isocenter of the treatment machine with the isocenter location within the planning image set (typically CT) that was planned on a radiation therapy treatment planning system. Some internal marker must be visible on both radiographs of the patient taken at the time of treatment and the sectional images used for the treatment plan.

Document Approved by: Wendel Dean Renner Title: President of Math Resolutions, LLC

Signature:

Date: March 17, 2005

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized image of an eagle with three lines representing its wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Wendel Dean Renner President Math Resolutions, LLC 5975 Gales Lane COLUMBIA MD 21045

Re: K050372 Trade/Device Name: VisiTrak Regulation Number: 21 CFR 892.5050 Regulation Name: Medical charged-particle radiation therapy system Regulatory Class: II Product Code: IYE Dated: February 11, 2005 Received: February 14, 2005

Dear Mr. Renner:

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 (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 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.

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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 this letter:

21 CFR 876.xxxx	(Gastroenterology/Renal/Urology)	240-276-0115
21 CFR 884.xxxx	(Obstetrics/Gynecology)	240-276-0115
21 CFR 892.xxxx	(Radiology)	240-276-0120
Other		240-276-0100

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincercly yours,

Nancy C. Hogdon

Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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VisiTrak File: vtinduse.doc

510(k) Number: K050372

Device Name: VisiTrak

Indications for Use:

Document Approved by: Wendel Dean Renner Title: President, Math Resolutions, LLC

Signature: U. Handel Dean Kinner

scription Use

Date:

Jauric bhagdon
(Division Sign-Off)

(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number K050312

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.