The AKTINA "Velos" Constancy Check Device, model 55-145, is intended for use in external beam radiation therapy in a similar way to that of the Tracker Therapy Beam Evaluation System (by Keithley Instruments, Inc.) previously cleared for marketing under K874893.

More specifically, its intended use is for daily, morning checks of machine output by staff technologists, under the supervision of a medical physicist. Not intended as a substitute for machine calibrations or validations of machine beam energy, these checks are quality assurance steps to safeguard accepted standards of good practice in Radiation Oncology.

Device Description

This device is intended to be used as a means of verifying machine output on a daily basis in the delivery of external beam radiation therapy.

"Velos" is designed to operate by either:

being mounted on standard beamblock trays or,
placed on a table, when measurements are needed from various SID's
and functions in an efficient and reliable way through reduction of setup time, remote control readings via CCTV, output constancy checks at all gantry angles (for compliance with TG-43) and fixed geometry for elimination of distance errors.

AI/ML Overview

The provided document is an FDA 510(k) clearance letter and a summary of safety and effectiveness for a medical device called the "Velos Constancy Check Device (CCD), Model 55-145." This document primarily focuses on the device's substantial equivalence to a predicate device and its intended use, rather than detailing a specific study with acceptance criteria and performance metrics of the new device itself.

Therefore, many of the requested details about acceptance criteria, study design, sample sizes, ground truth establishment, and expert involvement are not available in the provided text. The document is about regulatory clearance based on equivalence, not a detailed performance study of the new device against specific, pre-defined acceptance criteria.

However, I can extract the information that is present:

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

This information is not explicitly stated in the provided document. The document focuses on the new device (Velos CCD) being "similar in design and construction, utilizes the same materials, and has the same intended use and performance characteristics" as the predicate device. It doesn't present a table of specific acceptance criteria for the Velos CCD and its measured performance against them.

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

This information is not available in the provided document. No specific test set or study data are presented for the Velos CCD to demonstrate its performance.

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)

This information is not available in the provided document. No specific test set or ground truth establishment process is described.

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

This information is not available in the provided document.

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

There is no indication of an MRMC study or AI-related comparison in the document. The device is a "Constancy Check Device" for external beam radiation therapy, implying it's an objective measurement tool rather than an AI-driven diagnostic aid for human readers.

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

This information is not explicitly stated as a formal study. The device itself is designed as a standalone measurement tool. Its function is to "verify machine output on a daily basis," which implies it provides objective readings without human interpretation in the loop of the measurement itself. However, the document doesn't describe a specific standalone performance study with metrics.

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

This information is not available in the provided document.

8. The sample size for the training set

This information is not applicable and not available in the provided document. The Velos CCD is described as a physical device, not an algorithm that requires a training set.

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

This information is not applicable and not available in the provided document.

Summary of available information:

The provided document, an FDA 510(k) clearance, primarily details the regulatory pathway for the "Velos Constancy Check Device (CCD), Model 55-145." It asserts "substantial equivalence" to a predicate device (Keithly Instruments, Inc., Tracker Therapy Beam Evaluation system, K874893) based on similar design, construction, materials, intended use, and performance characteristics.

Intended Use: "to be used as a means of verifying machine output on a daily basis in the delivery of external beam radiation therapy." More specifically, for "daily, morning checks of machine output by staff technologists, under the supervision of a medical physicist."
Performance Standards: "Performance standards for these devices have not been established by the FDA under Section 514 of the Food, Drug and Cosmetic Act." This indicates that the device did not need to meet FDA-mandated performance standards.
Proof of Performance: The document states that the new device "has the same intended use and performance characteristics" as the predicate device. This "sameness" is the basis for its substantial equivalence, rather than a detailed performance study presented within this document. The description of its function ("functions in an efficient and reliable way through reduction of setup time, remote control readings via CCTV, output constancy checks at all gantry angles (for compliance with TG-43) and fixed geometry for elimination of distance errors") outlines its design advantages and functional capabilities, but not quantified performance against specific criteria.

Summary

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Image /page/0/Picture/1 description: The image shows a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" written around the edge. In the center of the seal is a stylized image of an eagle with its wings spread. The eagle is facing to the right and has three lines representing its wings.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL 29 1937

George Zacharopoulos Certified Radiological Physicist Aktina Medical Physics Corp: . ............................................................................................................................................... 360 North Route 9W Congers, NY 10920

Re: K970384

Velos Constancy Check Device (CCD), -Model 55-145 Dated: June 2, 1997 Received: June 5, 1997 Regulatory class: II 21 CFR 892.5050/Procode: 90 IYE

Dear Mr. Zacharopoulos:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medica! Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). 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 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 QS 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.T) liau 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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x970384

Summary of Safety and Effectiveness Compliance with 513 (i) of the Federal Food, Drug and Cosmetic Act

January 1, 1997

JUL 2 9 1997

1. General Provisions

Common/Usual Name: Constancy Check Device

Velos Constancy Check Device, model 55-145 Proprietary Name:

Applicant Name and Address:

Aktina Medical Physics Corporation 360 North Route 9W Congers, N.Y. 10920

Name of Predicate Devices: 2.

(1) Keithly Instruments, Inc., Tracker Therapy Beam Evaluation system (K874893)

3. Classification

This device is classified as a class II device according to 21 CFR 892.5050

Performance Standards 4.

Performance standards for these devices have not been established by the FDA under Section 514 of the Food, Drug and Cosmetic Act.

5. Intended Use and Device Description

This device is intended to be used as a means of verifying machine output on a daily basis in the delivery of external beam radiation therapy.

6. Biocompatibility

Any statement made in conjunction with this submission regarding substantial equivalence to any other product only relates to whether the product can be lawfully marketed without pre-market approval or reclassification and is not to be interpreted as an admission or used as evidence in patent infringement litigation. As the Commissioner of the FDA has indicated, " ... a determination of substantial equivalence under the Federal Food, Drug, and Cosmetic Act relates to the fact that the product can be lawfully marketed without pre-market approval or reclassification. This determination is not intended to have any bearing whatsoever on the resolution of patent infringement suits." 42 Fed. Reg. 42,520 et seg. (1977).

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No issues of biocompatability are raised with regard to this device.

Summary of Substantial Equivalence 7.

This device is similar in design and construction, utilizes the same This device is simmal in access the same intended use and performance materials, and has the Same intended and issues of safety or characteristics to the produced by using this device.

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P. 02

CDRH DRAERD

Page I of l

510(k) Number if known:	K970384
Device Name:	"Velos" Constancy Check Device

Indications for Use:

"Velos" is designed to operate by either:

being mounted on standard beamblock trays or, ਕ.

placed on a table, when measurements are needed from various SID's b.

and functions in an efficient and reliable way through reduction of setup time, remote control readings via CCTV, output constancy checks at all gantry angles (for compliance with TG-43) and fixed geometry for elimination of distance errors.

Concurrence of CDRH, Office of Device Evaluation(ODE)
-------------------------------------------------------

Prescription Use (Per21 CFR 801.109
	OR
	Over-The-Counter Use ______

(Division Sign-Off)
	(Optional Format 1-2-96)
	LLY
Division of Reproductive, Abdominal, ENT, and Radiological Devices
510(k) Number	K970384

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IP NECDED)

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.