.DECIMAL TISSUE COMPENSATOR/INTENSITY MODULATOR

• K Number: K040804
• Device Name: .DECIMAL TISSUE COMPENSATOR/INTENSITY MODULATOR
• Manufacturer: SOUTHEASTERN RADIATION PRODUCTS, INC.
• Date Cleared: 2004-04-28 ( 30 days)
• Product Code: IXI
• Regulation Number: 892.5710
• Type: Traditional
• Panel: RA
• Reference & Predicate Devices: K940412 , K943224 , K021987 , K880047

Intended Use

.decimal tissue compensator/intensity modulator manufacturing service manufactures the solid filters for missing tissue and intensity modulation for external beam radiation therapy.

Device Description

.decimal tissue compensator / intensity modulator manufacturing service

AI/ML Overview

The provided text does not contain information about specific acceptance criteria and a study demonstrating the device meets those criteria. The document is a 510(k) summary for a "Pre-market Notification" for a medical device called ".decimal tissue compensator / intensity modulator manufacturing service".

Here's a breakdown of what the document does include:

• Premarket Notification (K040804): This is a 510(k) summary, aiming to demonstrate substantial equivalence to previously marketed devices.
• Device Name: .decimal tissue compensator / intensity modulator manufacturing service.
• Intended Use: Manufactures solid filters for missing tissue and intensity modulation for external beam radiation therapy.
• Technological Characteristics: References internal company documents (Device Master Record, Processing Work Order, MSDS sheets) but does not provide details on these characteristics or performance metrics.
• Predicate Devices: A list of previously cleared devices to which this device claims substantial equivalence.
• FDA Clearance Letter: A letter from the FDA stating that the device has been reviewed and determined to be substantially equivalent. This is a regulatory clearance, not a performance study report.

Therefore, I cannot provide the requested information regarding acceptance criteria and a study that proves the device meets them because this information is not present in the provided text.

To answer your request, I would need a document that specifically details:

• Performance metrics (e.g., accuracy, precision, fabrication tolerances).
• Quantitative acceptance criteria for those metrics.
• A written report of a study (validation, verification, clinical trial) that tested the device against these criteria.

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.