RADIOCAMERAS PATIENT POSITIONING SYSTEM by SURGICAL NAVIGATION TECHNOLOGIES, INC.

The RadioCameras™ System is indicated for use with a Linear Accelerator to perform Stereotactic Radiosurgery or Radiotherapy on cranial lesions. The RadioCameras™ System provides precise positioning of the treatment target at the Linear Accelerator's isocenter.

Device Description

This submission describes a system that is intended to be used to place patients at the isocenter of a linear accelerator for stereotactic radiosurgery or radiotherapy procedures. The RadioCameras™ System uses optical tracking of infrared markers as the method of locating the position of the patient. The RadioCameras™ System consists of a high resolution linear CCD camera array, computer workstation, an optical Positioner, and an optical calibration jig.

AI/ML Overview

The provided text is a 510(k) summary and an FDA clearance letter for the RadioCameras™ Patient Positioning System. It describes the device's purpose and general claims of substantial equivalence butdoes not contain any information about acceptance criteria, specific performance metrics, or details of a study demonstrating its performance.

Therefore, I cannot fulfill your request for:

A table of acceptance criteria and reported device performance.
Sample size used for the test set or data provenance.
Number of experts used or their qualifications.
Adjudication method.
MRMC comparative effectiveness study results or effect size.
Standalone performance study details.
Type of ground truth used.
Sample size for the training set.
How ground truth for the training set was established.

The document only states that the device "was shown to be substantially equivalent to other commercially available patient positioning systems" for its intended use, which is general information about regulatory clearance rather than a detailed performance study.

Summary

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K980750

510(k) Summary

RadioCameras™ Patient Positioning System

I. Surgical Navigation Technologies Company: 530 Compton St. Broomfield, CO 80020 (303) 439-9709

RadioCameras™ Patient Positioning System Product Name: II.

This submission describes a system that is intended to be used to place patients at III. the isocenter of a linear accelerator for stereotactic radiosurgery or radiotherapy procedures. The RadioCameras™ System uses optical tracking of infrared markers as the method of locating the position of the patient. The RadioCameras™ System consists of a high resolution linear CCD camera array, computer workstation, an optical Positioner, and an optical calibration jig.
IV. The RadioCameras™ System was shown to be substantially equivalent to other commercially available patient positioning systems for use in conjunction with linear accelerator-based stereotactic radiosurgery and radiotherapy.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY 2 0 1998

Roger White Group Director Quality Systems and Regulatory Affairs Surgical Navigation Technologies 530 Compton Street Broomfield. Colorado 80020

Re:

K980750 RadioCameras™ Patient Positioning System Dated: February 24, 1998 Received: February 26, 1998 Regulatory class: II 21 CFR 892.5050/Procode: 90 IYE

Dear Mr. White:

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 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 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 requirements, as set forth in the Quality System Regulation (OS) 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 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/dsmaldsmamain.html".

Sincerely yours,
Kilian Yi

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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Page 1 __ of _ 1

510(k) Number (if known):

Device Name: _________________________________________________________________________________________________________________________________________________________________

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. Gypson

(Division Sign-Off) Division of Reproductive, Abdominal, EN and Radiological Dev 510(k) Number.

Prescription Use_ (Per 21 CFR 801.109)

Over-The-Counter Use _____________

(Optional Format 1-2-96)

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.