The intended use of Acoustic MedSystems, Inc. RadVision Dose Planning and Treatment Systems is to provide patient-specific planning, imaging, and implants or applicator device alignment for treating cancer using radioactive seed implants or HDR afterloader devices. In addition to planning and treatment, RadVision also allows volume and dose calculations, 2D and 3D analomy and dose visualizations, and post treatment seed localization.

RadVision is a general purpose brachytherapy planning system used for prospective and confirmation dose calculations for patients undergoing a course of brachytherapy using either temporary or permanent implants of various radioisotopes.

Device Description

The RadVision system is a brachytherapy dose planning and treatment guidance system. The system consists of a computer, video capture device and software tools. The required software tools are installed in the computer. The system can be used for pre-treatment realtime dose planning in the Operating Room (OR), and for permanent seed implants performing post-implant seed localization assessment and post-implant dose distribution analysis.

AI/ML Overview

The provided document is a 510(k) summary for the RadVision Dose Planning and Treatment System. It focuses on demonstrating substantial equivalence to predicate devices for regulatory clearance and details verification and validation testing of its features. It does not contain information about acceptance criteria or a study proving that the device meets specific performance metrics in a clinical or simulated clinical setting. The document primarily confirms that the software functionalities were tested and passed.

Therefore, for aspects related to "acceptance criteria," "reported device performance," "sample sizes for test and training sets," "data provenance," "number and qualifications of experts," "adjudication method," "MRMC study," "stand-alone study," and "ground truth establishment," the information is not available in the provided text.

Here's a breakdown of what is available and what is not:

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

Not Available. The document states that "RadVision passed all the verification and validation tests successfully," but it does not specify the quantitative or qualitative acceptance criteria for these tests, nor does it provide detailed performance metrics against those criteria. The tests listed are functional and system-level checks rather than performance against pre-defined clinical or dose calculation accuracy thresholds.

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

Not Available. The document does not mention a "test set" in the context of clinical data, nor does it refer to any human subjects or patient data. The "verification and validation testing" refers to software and system testing, not a study involving patient data.

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)

Not Available. As there is no mention of a test set involving human data or expert review, this information is not present.

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

Not Available. This is not applicable as no test set with expert adjudication is described.

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

Not Available. This document describes a brachytherapy dose planning and treatment system, which is a software tool, not an AI-assisted diagnostic tool that would typically undergo MRMC studies comparing human reader performance. There is no mention of AI or human reader improvement.

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

Not Available. While the document describes the functions of the software, it does not present a "standalone" study in the typical sense of evaluating algorithm performance on a dataset against ground truth. The "Verification and Validation test procedures" are functional tests of the software system.

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

Not Available. No "ground truth" in the clinical data sense is mentioned or implied for the testing described. The "verification and validation" likely used predetermined correct outputs for the software functions (e.g., correct dose calculations for given inputs, proper display of images).

8. The sample size for the training set

Not Available. There is no mention of a "training set" or machine learning in the document.

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

Not Available. There is no mention of a "training set" or associated ground truth.

Summary

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Image /page/0/Picture/0 description: The image shows the logo for Acoustic Medsystems. The logo consists of a stylized eye-like symbol on the left, with the words "ACOUSTIC" above "MEDSYSTEMS" on the right. A horizontal line runs through the center of the eye symbol and extends to the right, underlining the words.

K131428
Page 1 of 3

208 Burwash Avenue Savoy, IL 61874

JUL 1 6 2013

Section 5 510(k) Summary

(1)	Date Summary Prepared:	04/29/2013Traditional 510(k) Submission
(2)	Submitter:	Acoustic MedSystems, Inc.208 Burwash AvenueSavoy, IL 61874		Tel:	217-239-0900Fax: 217-239-0905
		Establishment Registration No.: AMS will register following FDA clearance
		Contact Person:	Jennifer WilliamsFDA Official RegulatoryCorrespondente-mail: jwilliams@acousticmed.com
(3)	Device Name:	RadVision
	Common Name:	Brachytherapy Dose Planning and Treatment System
	Classification Name:	21CFR 892.5050 Medical charged particle radiation therapy system, Class II.
	Product Code:	MUJ
	Proprietary Name:	RadVision

Legally Marketed Predicate Devices: (4)

Burdette Medical Systems, Inc. Interplant, 510(k) number K982696 dated 1 April 1999

Varian Medical Systems BrachyVision 6.0, 510(k) number K992762 dated 03 March 2000

Varian Medical Systems VariSeed 7.1, 510(k) number K030534 dated 21 May 2003

Telephone: 217-239-0900 Facsimile: 217-239-0905

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K131428
Page 2 of 3

Description of Acoustic MedSystems, Inc. RadVision Dose Planning and (5) Treatment System:

(6) Intended Use:

The intended use of Acoustic MedSystems. Inc. RadVision Dose Planning and Treatment Systems is to provide patient-specific planning, imaging, and implants or applicator device alignment for treating cancer using radioactive seed implants or high dose radiation (HDR) afterloader devices. In addition to planning and treatment, RadVision allows volume and dose calculations. 2D and 3D anatomy and dose visualizations, as well as post treatment seed localization.

(6) Performance Testing:

The computer systems that will be used to install RadVision for commercial distribution to customers are required to be tested and meet the following standards:

IEC 60601-1-1 .
IEC 60601-1-2 .
IEC 60601-1-3 .
IEC 60601-1-4 .

Verification and Validation test procedures were prepared considering the technological characteristics of the predicate devices. Non-clinical testing of RadVision was conducted for the following characteristics:

Computer systems and software .
Administration, Patient management and Help support .
Calibration of template positioning and images to template registration �
Equipment set identifications and specifications (associates all . equipment/instrumentation as configured for set up for implants)
. Image acquisition, import, display (2D and 3D) from various modalities (ultrasound, MR, CT Fluoroscopy)
. Contouring and anatomical identification
Identification and loading of radiation source and placement with image quidance (low . dose radiation (LDR) and HDR)
. Dose calculation (LDR and HDR)
. Printing reports

Verification and validation testing was performed using RadVision Dose Planning and Treatment System. RadVision passed all the verification and validation tests successfully.

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K131421
Page 3 of 3

Based on verification and validation test results and analysis of similarities and differences between the technological characteristics of the devices, RadVision is substantially equivalent to the stated predicate devices without raising new safety and/or efficacy issues.

Technological Characteristics: (7)

The intended use statement of RadVision is respectfully similar to the intended use statement of the predicate devices. RadVision is a Brachytherapy treatment planning software compatible with both LDR and HDR delivery systems, whereas Interplant and VariSeed 7.1 are for LDR and Varian BrachyVision 6.0 for HDR. There are no substantial differences between RadVision and Interplant and Variseed 7.1 for permanent seed implant functions and between RadVision and Varian BrachyVision for HDR functions.

The level of concern for RadVision software is major: FDA considers software contained in radiation therapy devices to be Major level of concern. RadVision is not intended for diagnostic purposes, nor will it control the delivery of the treatment plan to the patient.

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Image /page/3/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. Inside the circle is a stylized symbol featuring three parallel lines that curve and merge into a single, wavy line at the bottom.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

July, 16, 2013

Acoustic MedSystems, Inc. % Ms. Jennifer Williams Official Regulatory Correspondent 208 Burwash Avenue SAVOY IL 61874

Re: K131428

Trade/Device Name: RadVision Regulation Number: 21 CFR 892.5730 Regulation Name: Radionuclide brachytherapy source Regulatory Class: II Product Code: KXK. MUJ Dated: April 29. 2013 Received: May 22, 2013

Dear Ms. Williams:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind vou, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA). it may be subject to 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) 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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Page 2 - Ms. Williams

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638 2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Michael D. O'Hara

for

Janine M. Morris Director, Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known): K131428

Device Name: RadVision

Indications for Use:

Burdette Medical Systems, IncInterplant	Varian Medical SystemsBrachyVision 6.0	Varian Medical SystemsVariSeed 7.1
K982696	K992762	K030534

Prescription Use (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)

Michael D. O'Hara

(Division Sign Off) Division of Radiological Health Office of In Vitro Diagnostic and Radiological Health

510(k)_K131428

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.