(88 days)
The Saturne Multileaf collimator is intended to be used for radiation therapy.
The Multileaf collimator consists of the collimator assembly, a collimator accessory tray and electron applicators, collimator control and display functions on the Saturne operator console, and a Treatment Preparation Console and film digitizer. The accelerator radiation head and Multileaf collimator are assembled in a rotating gantry fastened to a wall. The existing treatment couch is used to support and position the patient.
I apologize, but the provided text from the GE Medical Systems K910303 submission is a "SUMMARY OF SAFETY AND EFFECTIVENESS" for a Multileaf Collimator Option for radiation therapy systems. This document focuses on the equivalence of the device to predicate devices and does not contain the type of clinical study data, acceptance criteria, or performance metrics typically associated with AI/ML-driven diagnostic or prognostic devices that would allow me to answer your specific questions about acceptance criteria and study details.
The summary primarily states:
- Identifies the product: Multileaf Collimator Option for GE Saturne medical charged-particle radiation therapy systems.
- Compares it to predicate devices: Varian Associates and Philips Medical Systems Multileaf collimators.
- States the conclusion of substantial equivalence: "The Saturne Multileaf collimators are as safe and perform as well as the predicate devices and raise no new questions of safety or effectiveness."
It does not include:
- Acceptance criteria and reported device performance: There are no quantitative performance metrics (e.g., sensitivity, specificity, accuracy, workflow efficiency) or specific acceptance thresholds mentioned.
- Sample size, data provenance, ground truth experts, adjudication methods for a test set.
- Information about Multi-Reader Multi-Case (MRMC) studies or standalone algorithm performance.
- Details on training set size or how ground truth was established for a training set.
Therefore, I cannot extract the requested information from this document. This K910303 document is for a physical medical device (a collimator) and not an AI or software-as-a-medical-device (SaMD) that would typically undergo the kind of performance studies you are asking about.
{0}------------------------------------------------
Image /page/0/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'G' and 'E' intertwined within a circle. There are decorative swirls around the outside of the circle.
GE Medical Svstems
Genera! Electric Company 20 Box 414 Milwaukee. WI 53201
APR 25 1997
SUMMARY OF SAFETY AND EFFECTIVENESS January 9, 1997
This 510(k) summary of safety and effectiveness information is submitted in accordance with the requirements of 21 CFR Part 807.87(h).
Contact: Larry A. Kroger, Ph.D. Phone - 414-544-3894 Fax - 414-544-3863
Identification of Product The Multileaf Collimator Option is a versatile therapy beam collimation system designed for use on GE Saturne medical charged-particle radiation therapy systems. It is manufactured by GE Medical Systems Europe, 283 Rue de la Miniere, 78530 Buc. France and is distributed by GE Medical Systems, Milwaukee, WI.
Marketed Devices The current family of Saturne therapy systems uses rectangular field collimators in combination with external beam blockers to contour the treatment field to the desired shape. The Multileaf collimator will permit the use of irregular treatment field shapes to better conform the treatment field to the desired shape without external beam blockers for some treatments.
Device Description The Multileaf collimator consists of the collimator assembly, a collimator accessory tray and electron applicators, collimator control and display functions on the Saturne operator console, and a Treatment Preparation Console and film digitizer. The accelerator radiation head and Multileaf collimator are assembled in a rotating gantry fastened to a wall. The existing treatment couch is used to support and position the patient.
Indications for Use The Saturne Multileaf collimator is intended to be used for radiation therapy.
Comparison with Predicate Saturne Multileaf collimators perform the same function as Multileaf collimators produced by Varian Associates and Philips Medical Systems, Other device characteristics are either the same or comparable for the various collimator systems.
Conclusion It is the opinion of GE Medical Systems that Saturne Multileaf collimators are substantially equivalent to the named predicate devices based on the similarities in operation and intended use. The Saturne Multileaf collimators are as safe and perform as well as the predicate devices and raise no new questions of safety or effectiveness.
100 Years of Radiology
100 Years of Radiology 1895 - 1995
§ 892.5710 Radiation therapy beam-shaping block.
(a)
Identification. A radiation therapy beam-shaping block is a device made of a highly attenuating material (such as lead) intended for medical purposes to modify the shape of a beam from a radiation therapy source.(b)
Classification. Class II.