The intended use of the MuCheck software has been extended to include an optional module, Gamma-Knife QA Check to independently verify the dose for single or multiple points that have been previously calculated by the Gamma Knife treatment planning system or other points as determined by the physicist.

Device Description

The Gamma-Knife QA Check Program is a software program that is designed to operate on an IBM compatible personal computer in a Windows environment. It has been designed to onerate either in a stand alone mode independent of the Gammaknife treatment planning grown or to import plans from the GammaKnife treatment planning system. It does not connect to a control any radiation hardware device. Gamma Knife QA Check performs dose calculations to verify the dose calculated by the primary GammaKnife radiation treatment planning system.

AI/ML Overview

The provided K091602 document focuses on the substantial equivalence of the "Mucheck Gamma-Knife QA Check" software to predicate devices. It describes the device's function as a quality assurance tool for verifying dose calculations in Gamma-Knife radiation treatment planning.

However, the document explicitly states:
"Clinical testing was not required to demonstrate substantial equivalence or safety and effectiveness."

This crucial statement means that a formal study demonstrating the device meets specific acceptance criteria based on clinical performance data (like those typically associated with medical imaging or diagnostic AI) was not performed or required for this 510(k) clearance.

Instead, the submission relied on non-clinical verification and validation tests.

Therefore, I cannot provide all the requested information because the nature of this 510(k) submission does not involve:

A table of acceptance criteria and reported device performance based on clinical or comparative studies. The "acceptance criteria" here refer to internal system specifications and matching results with the primary planning system.
Sample size for the test set and data provenance: No clinical test set.
Number of experts and their qualifications for ground truth: No clinical ground truth established.
Adjudication method for the test set: Not applicable.
Multi-reader multi-case (MRMC) comparative effectiveness study: Not performed. This device is a software tool for dose calculation verification, not a diagnostic aid for human readers.
Standalone performance study: The non-clinical tests compared the device's calculations to the primary planning system.
Type of ground truth used: For non-clinical tests, the "ground truth" was the expected calculation results or the results from the primary Gamma-Knife treatment planning system.
Sample size for the training set: As the device performs deterministic dose calculations based on established physics principles, it is highly unlikely to involve a "training set" in the machine learning sense. The software would be developed and verified against known physics models and calculation engines.
How ground truth for the training set was established: Not applicable in the context of a machine learning training set.

Based on the provided document, here's what can be inferred or directly stated regarding performance and verification:

1. Table of Acceptance Criteria and Reported Device Performance (Non-Clinical Focus)

Note: The document only mentions "All system specifications were met" and "test results all matched very closely." It does not provide specific quantitative acceptance criteria or detailed performance metrics in the format of a clinical study. The criteria were likely internal for software verification.

Acceptance Criteria (Inferred/Stated)	Reported Device Performance (as stated in document)
Adherence to system specifications	"All system specifications were met."
Dose calculation accuracy	"The test results all matched very closely." (compared to the primary GammaKnife treatment planning system)
Functional as a QA tool	Designed to "independently verify the dose for single or multiple points" previously calculated by the primary system.

2. Sample size used for the test set and the data provenance:

Test Set Size: Not explicitly stated. The document refers to "non-clinical tests" conducted using "the Gamma-Knife treatment planning system and Gamma-Knife QA Check." This implies a set of test cases or scenarios were run, but the number is not quantified.
Data Provenance: Not applicable in terms of patient data or clinical images. The "data" would be input parameters for dose calculation, derived from configurations or plans within the Gamma-Knife treatment planning system.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not applicable as no clinical ground truth was established by external experts. The verification likely involved internal engineers or physicists ensuring the software's calculations aligned with expected physics models or the predicate device's calculations.

4. Adjudication method for the test set:

Not applicable. This device is a software calculator, not a diagnostic tool requiring expert adjudication.

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:

No, an MRMC comparative effectiveness study was not done. This device is a dose calculation verification software, not an AI-powered diagnostic tool for human readers.

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

Yes, in essence. The "non-clinical tests" evaluated Gamma-Knife QA Check's calculations directly against those of the primary Gamma-Knife treatment planning system. This constitutes an "algorithm only" comparison for its intended function (dose calculation verification).

7. The type of ground truth used:

For the non-clinical tests, the "ground truth" was effectively:
- Expected scientific/physics calculations: The software's output was compared against established radiation physics models.
- Predicate device's calculations: The results were compared to the primary GammaKnife treatment planning system (which itself would have been verified and validated).

8. The sample size for the training set:

Not applicable. This device performs deterministic calculations based on algorithms for radiation dose, not machine learning that requires a "training set" of data.

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

Not applicable. As it's not a machine learning model, there is no "training set" or corresponding ground truth establishment in that context. The "ground truth" for the software's development and internal validation would stem from established radiation physics principles and previous, validated dose calculation methods.

Summary

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K091602

1-2

JUN 18 2009

510(k) Safety and Effectiveness Summary

Submitter:	Oncology Data Systems, Inc.1601 S.W 89th, Ste. E-100Oklahoma City, Ok. 73159tel. (405) 680-5222fax (405) 680-5444
Contact:Date:	Vince RuminerMay 18, 2009
Trade Name:	Mucheck Gamma-Knife QA Check
Common Name:	Dose Validation Software
Classification Panel:	Radiology
Classification Name:	Medical Charged Particle Radiation TherapySystem(Accessory)21 CFR 892.5050 (class II)
Performance Standards:	none established under section 514

Substantial Equivalence:

Device Name	510(K) Number
MuCheck Monitor Unit Validation (V4 for IMRT)	K012227
MuCheck Monitor Unit Validation (V7 for Brachy)	K061152
Leksell GammaPlan	K061540

Description:

Substantial Equivalence Summary:

Intended Use:

The intended use for the Gamma-Knife QA Check program is the same as for the predicate devices: to calculate a dose for the purpose of validating a dose previously calculated by a the

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K09/602

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primary GammaKnife treatment planning system The intended use is as a quality assurance tool only and not as a treatment planning device.

In a radiation therapy department quality assurance is an important part of patient care. The ability to provide a secondary check for the primary dose calculation is part of good treatment protocol as well being a recommendation by Task Group 40. Gamma Knife QA Check provides this very important quality assurance function.

Technological Characteristics:

The technological characteristics are the same as for the predicate devices. Gamma-Knife OA Check was designed to operate in a windows environment using both mouse and keyboard.

Non-clinical tests:

Verification and validation test plans were completed in accordance with Oncology Data Systems procedures and GMP guidelines. A Hazard Analysis was completed and hazards were resolved as appropriate. All system specifications were met and testing performed to demonstrate substantial equivalence. The non-clinical tests were conducted using the GammaKnife treatment planning system and Gamma-Knife QA Check. The test results all matched very closely which supports the claim of substantial equivalence. See Figure 6.0 in section 6 for comparison summary.

Summary of Clinical Testing:

Clinical testing was not required to demonstrate substantial equivalence or safety and effectiveness.

Conclusions:

Based upon the technological characteristics, intended use, and non-clinical tests, Gamma Knife QA Check is substantially equivalent to the predicate device. The documentation submitted for review supports this claim.

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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 consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA" around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three curved lines. The symbol is black, and the text is also in black.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

ﻳﻤﻜﻨ

JUN 18 2009

Oncology Data Systems, Inc. % Mr. Mark Job Responsible Third Party Official Regulatory Technology Services 1394 25th Street NW BUFFALO MN 55313

Re: K091602

Trade/Device Name: MuCheck V8 Regulation Number: 21 CFR 892.5050 Regulation Name: Medical charged-particle radiation therapy system Regulatory Class: II Product Code: IYE Dated: June 1, 2009 Received: June 3, 2009

Dear Mr. Job:

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. Insting 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 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

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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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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/cdrl/mdr/ 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Larry Morris

Janine M. Morris Acting Director, Division of Reproductive. Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

99/607 510(k) Number (if known):

Device Name: MuCheck V8

Indications For Use:

MuCheck is an independent computer based verification of the monitor unit or dose calculated by the primary radiation treatment planning system.

Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR

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

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Camufo Rorxes

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

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.