SATURNE MULTILEAF COLLIMATOR

• K Number: K970303
• Device Name: SATURNE MULTILEAF COLLIMATOR
• Manufacturer: GENERAL ELECTRIC CO.
• Date Cleared: 1997-04-25 ( 88 days)
• Product Code: IXI
• Regulation Number: 892.5710
• Type: Traditional
• Panel: RA
• Reference & Predicate Devices: N/A
• Predicate For: N/A

Intended Use

The Saturne Multileaf collimator is intended to be used for radiation therapy.

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.

AI/ML Overview

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:

1. Acceptance criteria and reported device performance: There are no quantitative performance metrics (e.g., sensitivity, specificity, accuracy, workflow efficiency) or specific acceptance thresholds mentioned.
2. Sample size, data provenance, ground truth experts, adjudication methods for a test set.
3. Information about Multi-Reader Multi-Case (MRMC) studies or standalone algorithm performance.
4. 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.

Regulation Number and Section

§ 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.