In order to ensure the day to day performance of radiation generating equipment, many quality assurance tests are performed. This testing includes such tests as machine output, beam alignment, distance indicators. In all quality assurance testing a test object or measurement device is used to either validate a system parameter or measure some aspect of system performance. These test objects/devices can easily be classified as one of two types, passive or active. An active device is one that can make a measurement or perform a test without user evaluation or interpretation, while a passive device merely provides an environment or condition for testing, but the result requires the user or operator to make an evaluation and determination. Examples of passive devices are test phantoms or film cassettes.

The Mick Radio-Nuclear Isocentric Beam Checker is a passive device, designed to be placed between the incident radiation beam and a piece of film. Radiographic exposure of the Isocentric Beam Checker results in the production of an image on the film which can then be analyzed by the operator for consistency from the prior test exposure. The Isocentric Beam Checker does not alter, change or moderate the radiation field in any manner. It has radio-opaque objects embedded into it that are visualized on standard x-ray film when inserted in a radiation beam. The inspection of the radio-opaque marks on the film is then used in quality assurance.

Device Description

The Mick Radio-Nuclear Isocentric Beam Checkers are a passive device, designed to be placed between the incident radiation beam and a piece of film. Radiographic exposure of the Isocentric Beam Checker results in the production of an image on the film which can then be analyzed by the operator for consistency from the prior test exposure. The Isocentric Beam Checker does not alter, change or moderate the radiation field in any manner. It has radio-opaque objects embedded into it that are visualized on standard xray film when inserted in a radiation beam. The inspections of the radio-opaque marks on the film are then used in quality assurance.

AI/ML Overview

The provided text is a 510(k) summary for the "Isocentric Beam Checker." This document does not describe a study that establishes acceptance criteria or proves the device meets them. Instead, it describes a device that is a passive quality assurance tool and asserts its substantial equivalence to a predicate device.

Here's why the requested information cannot be extracted from this document:

Nature of the Device: The Isocentric Beam Checker is a passive device. It doesn't have an "algorithm" or "AI" that analyzes images or makes determinations. It provides radio-opaque objects that are visualized on X-ray film, and then a human operator analyzes the film.
Regulatory Context: This is a 510(k) premarket notification, which focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving performance against specific acceptance criteria through a standalone study in the way a novel diagnostic software might.
Contents of the Document: The document outlines the device's classification, intended use, description, and claims substantial equivalence. It explicitly states, "No new issues of safety or effectiveness are introduced by using this device." There is no mention of a performance study with a test set, ground truth, experts, or any of the other details requested for proving device performance in the context of an algorithm or AI. It also notes that "Performance standards for radiologic quality assurance instruments have not been established by the FDA under Section 514 of the Food, Drug and Cosmetic Act."

Therefore, I cannot populate the table or answer the specific questions about acceptance criteria, study details, sample sizes, ground truth, or expert involvement because this information is not present in the provided 510(k) summary.

The document refers to "performance characteristics" in the context of substantial equivalence, but it does not define specific metrics or a study to evaluate them for this particular device.

Summary

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FEB 1 4 2000

K993959
Page 1 of 2

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

October 2, 1999

1. General Provisions

Radiologic Quality Assurance Instrument Common/Usual Name:

Isocentric Beam Checker I/II/III Proprietary Name:

Applicant Name and Address:

Mick Radio-Nuclear Instruments, Inc. 1470 Outlook Avenue Bronx, New York 10465

Name of Predicate Devices: 2.

(1)
l

Manufacturer	K Number
Med Tec, Inc. Iso-Align	Class I exemptionunder registration A743531

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, 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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K992
fage 20

Classification 3.

This device is classified as a class I device according to 21 CFR 892.1940.

Performance Standards 4.

Performance standards for radiologic quality assurance instruments have not been established by the FDA under Section 514 of the Food, Drug and Cosmetic Act.

ડ. Intended Use and Device Description

In order to ensure the day to day performance of radiation generating equipment, many quality assurance tests are performed. This testing includes such tests as machine output, In all quality assurance testing a test object or beam alignment, distance indicators. measurement device is used to either validate a system parameter or measure some aspect of system performance. These test objects/devices can easily be classified as one of two types, passive or active. An active device is one that can make a measurement or perform a test without user evaluation or interpretation, while a passive device merely provides an environment or condition for testing, but the result requires the user or operator to make an evaluation and determination. Examples of passive devices are test phantoms or film cassettes.

6. Biocompatibility

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

7. Summary of Substantial Equivalence

This device is similar in design and construction, utilizes the identical materials, and has the same intended use and performance characteristics to the predicate devices. No new issues of safety or effectiveness are introduced by using this device.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services (HHS). The logo features a stylized caduceus, a symbol often associated with medicine and healthcare, with three wavy lines representing the serpents. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES" is arranged in a circular fashion around the caduceus.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB 1 4 2000

Felix Mick President Mick Radio-Nuclear Instruments, Inc. P.O. Box 99 Bronx, NY 10465

Re:

K993959 Isocentric Beam Checker Dated: November 15, 1999 Received: November 22, 1999 Regulatory class: II 21 CFR 892.5050/Procode: 90 IYE

Dear Mr. Mick:

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 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). 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 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 requirements, 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 the Electronic Product 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 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/odrh/dsma/dsmamain.html".

Sincerely yours,

CAPT Daniel G. Schultz, M.D. Acting 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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Indications for Use

510(k) Number: To be assigned K993959

Device Name: Isocentric Beam Checker

Indications for Use:

In order to ensure the day to day performance of radiation generating equipment, many quality This testing includes such tests as machine output, beam assurance tests are performed. In all quality assurance testing a test object or measurement alignment, distance indicators. device is used to either validate a system parameter or measure some aspect of system performance. These test objects/devices can easily be classified as one of two types, passive or active. An active device is one that can make a measurement or perform a test without user evaluation or interpretation, while a passive device merely provides an environment or condition for testing, but the result requires the user or operator to make an evaluation and determination. Examples of passive devices are test phantoms or film cassettes.

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use: /

Over-The-Counter Use: _ (Per 21 CFR 801.109)

(Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological Devices 510(k) Number_193959

Isocentric Beam Checker 510(k)

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.