Model 37-185 is used to provide a means of scanning the light field and radiation field generated by radiation therapy machines and presents this data for quality control purposes only. Sequential scans of the light field and the radiation field provides information as to whether the cross hairs in the light field are in the center of the radiation field (per TG-40), the coincidence of the light field to the radiation field, and beam flatness and symmetry. These data aid in the determination of the therapy machine's performance characteristics.

Device Description

The product consists of two main parts; the readout module, and the scanner (data acquisition) module. The readout module is located outside the treatment room while the scanner is positioned on the treatment couch in such a manner as to allow the detectors to transverse the radiation beam as determined by the operator. The readout and the scanner are connected via a single 25 meter (75 foot) shielded cable.

The readout contains a LCD (Liquid Crystal Display) and 8 softkeys providing the operator interface. The readout also includes the microprocessor system, memory, printer interface and computer interface. Connections are provided for the power supply, parallel printer, computer RS-232 interface and the scanner cable.

The scanner module contains a stepper motor and a transport mechanism that moves a light detecting diode and a radiation detecting diode 50 cm, in a straight line to obtain a beam or light field profile during a measurement cycle. There is a fixed radiation detecting diode located in the center of the scanner which acts as a reference to null out any fluctuations in the amplitude of the radiation beam (as a function of time). The stepper motor controller and detector pre-amplifiers are also housed in the scanner assembly. The product includes a separate leveling mechanism to level the scanner module and rotate it 90 degrees.

AI/ML Overview

The provided text describes the Victoreen Model 37-185, a device used for quality control of radiation therapy machines. However, it does not contain detailed information about acceptance criteria, a specific study that proves the device meets those criteria, or the methodology of such a study. The document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device rather than presenting a performance study with detailed acceptance criteria.

Therefore, I cannot directly answer most of your numbered points from the provided input. The information necessary to fill out a table of acceptance criteria and device performance, details about sample size, expert qualifications, ground truth, or MRMC studies is not present.

However, I can extract the available information:

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

Acceptance Criteria: Not explicitly stated in the provided text. The document refers to "quality control purposes only" and obtaining information "as to whether the cross hairs in the light field are in the center of the radiation field (per TG-40), the coincidence of the light field to the radiation field, and beam flatness and symmetry." However, specific numerical or qualitative criteria for these measurements are not provided.
Reported Device Performance: Not explicitly stated in the provided text as a quantifiable study result. The device's function is described: "provides a means of scanning the light field and radiation field... and presents this data." The implication is that it accurately performs these scans, but no performance metrics are given.

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

Not provided.

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 provided.

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

Not provided.

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 MRMC study is mentioned. This device is a quality control tool for radiation therapy machines, not an AI-assisted diagnostic or treatment planning system involving human readers in the context of interpreting patient data.

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

The device itself functions as a standalone measurement tool, providing data for quality control. It's not an "algorithm only" in the modern AI sense, but rather a sensor system. The document does not describe a performance study for its standalone accuracy against a gold standard.

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

Not provided. For a device measuring radiation and light fields, the ground truth would likely be established by conventional, highly accurate physical measurement tools, but this is not detailed.

8. The sample size for the training set

Not applicable/Not provided. This device is a measurement tool, not a machine learning model that typically requires a training set in the AI context.

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

Not applicable/Not provided. (See point 8)

Summary of available information related to performance/validation (from the 510(k) context):

The document states:

The device is "substantially equivalent" to a predicate device (Beam Scan, Model 37-201, 510(k) #K853671A). This implies that its safety and effectiveness are similar to a device already on the market without the need for new extensive clinical trials for performance.
Intended Use: "quality control purposes only."
Functions: "scanning the light field and radiation field generated by radiation therapy machines and presents this data." It provides information on "whether the cross hairs in the light field are in the center of the radiation field (per TG-40), the coincidence of the light field to the radiation field, and beam flatness and symmetry."
The device "does not involve patient contact nor is it used to evaluate patient treatment planning. The patient is not in the room while this product is in use." This context suggests that the primary validation would be technical accuracy and reliability of its measurements rather than direct patient outcome studies.

In conclusion, the provided 510(k) summary focuses on regulatory approval through substantial equivalence and describes the device's function and intended use. It does not contain the detailed performance study information with explicit acceptance criteria, sample sizes, and ground truth methodologies that you requested. Such details would typically be found in a more comprehensive testing report, which is not part of this 510(k) summary.

Summary

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EXHIBIT A

Victoreen, Inc.

K973960

Image /page/0/Picture/3 description: The image shows a logo with three horizontal bars. The top bar is black, the middle bar is white, and the bottom bar is white with the word "VICTOREEN" in black, bold, sans-serif font. The logo is simple and clean, with a focus on the text.

Premarket Notification [510k] Summary as required by section 807.92(c)

IAN I 4 1998

Date Summary was prepared:

September 30, 1997

Submitter's Name

Victoreen, Inc. 6000 Cochran Road Cleveland, Ohio 44139-3395

Contact Person:

Linda S. Nash Director of Regulatory Affairs and Quality Assurance Phone: 440-248-9300 440-248-9301 Fax:

Device Name:

Model 37-185

Classification Name:

Medical charged - particle radiation therapy system

Predicate Device:

Beam Scan, Model 37-201, 510(k) #K853671A

Product Description:

6000 Cochran Road Cleveland, Ohio 44139-3395 (216) 248-9300 FAX (216) 248-9301 DATA (216) 248-9043

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Intended Use:

The Model 37-185 provides a means of scanning the light field and radiation (Function): field generated by radiation therapy machines and presents this data for quality control purposes only. Sequential scans of the light field and the radiation field provides information as to whether the cross hairs in the light field are in the center of the radiation field (per TG-40), the coincidence of the light field to the radiation field, and beam flatness and symmetry. These data aid in the determination of the therapy machine's performance characteristics. The Model 37-185 is intended for use by persons responsible for the proper interpretation of its readings and observing the appropriate safety procedures in the presence of radiation.

As a quality control tool the use of this product does not involve patient contact nor is it used to evaluate patient treatment planning. The patient is not in the room while this product is in use.

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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" arranged around the perimeter. Inside the circle is a stylized symbol that resembles three overlapping human figures or abstract shapes, possibly representing people or services provided by the department.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Linda S.Nash Director of Regulatory Affairs & Quality Assurance Victoreen, Inc. 6000 Cochran Road Cleveland, OH 44139-3395

Dear Ms. Nash:

Re: K973960

Beam Scan Model 37-185 Dated: October 14, 1997 Received: October 16, 1997 Regulatory class: II 21 CFR 892.5050/Procode: 90 LHN 1481 / 1000

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 ise 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, 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 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 vitry diagnostic devices), please contact the Office of Compliance at (301) 594-4613. Additionally, for questions on the promotion 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/cdrl/dsmamain.html", ............................................................................................

Sincerely yours,

h. Tiau 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

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510(k) Number: K973960

Device Name: Model 37-185

Indications for Use:

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

David C. Leyman

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

Prescription Use
(Per 21 CFR 801.109)

Over-The Counter Use

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.