(290 days)
This program can be utilized for all traditional and accepted gamma camera applications. It is expected that its benefits will be realized primarily when the system is being used to acquire tomographic studies. The intended use of the gamma camera system is unchanged by this program.
This product is an optional software program available for the Toshiba DI-series devices. It is intended to give a user the ability to acquire scatter data during acquisitions, then remove the unwanted scatter data from the processed image data. Based on the Triple Energy Window method of Compton - Scatter Correction, this program calculates the location and amount of scatter data in each pixel and subtracts it from the patient data.
The provided text is a 510(k) summary for a software program called "Scatter Correction Volume Software for Toshiba Gamma Cameras, Model NSSC-020A". This document focuses on demonstrating substantial equivalence to a predicate device and outlining the software's functionality rather than presenting a detailed clinical study with specific acceptance criteria and performance metrics.
Therefore, the requested information regarding acceptance criteria, device performance, study details, ground truth establishment, expert qualifications, adjudication methods, and MRMC studies cannot be extracted from the provided text. The document describes the software's purpose (removing scatter data from gamma camera images using the Triple Energy Window method) and states that the intended use of the gamma camera system remains unchanged, implying that the software is not introducing new clinical claims that would necessitate such detailed performance studies in this specific 510(k) submission.
The document states:
- "This product is computational only and does not affect the physical characteristics of the host device."
- "Determination of and correction for Compton-scatter effects are well understood and documented in peer-reviewed scientific publications."
- "Due to the absence of new intended uses, it follows that the overall safety and effectiveness of the gamma camera system is not changed by this program."
These statements suggest that the FDA's clearance for this software was likely based on its computational nature and the established scientific principles of scatter correction, rather than a clinical trial demonstrating improved diagnostic accuracy or specific performance against defined acceptance criteria.
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DEC 23 1996
510(k) Summary
17960948
Javad Sevedzadeh. Director of Regulatory Affairs Submitted by: Toshiba America Medical Systems, Inc. 2441 Michelle Drive Tustin, CA 92681 Tel .: 714-730-5000 Contact: Mark Stauffer. Regulatory Affairs Specialist Toshiba America Medical Systems, Inc. Tel.: 714-730-5000
Date:
March 6, 1996
· Device Name
Scatter Correction Volume Software for Toshiba Gamma Cameras, Model NSSC-020A
Common name: Gamma Camera Processing Software
Classification name: Emission Computed Tomography System
· Predicate Device
Toshiba GCA-7200A (K931297/A)
· Description of Device
This product is an optional software program available for the Toshiba DI-series devices. It is intended to give a user the ability to acquire scatter data during acquisitions, then remove the unwanted scatter data from the processed image data. Based on the Triple Energy Window method of Compton - Scatter Correction, this program calculates the location and amount of scatter data in each pixel and subtracts it from the patient data.
· Intended Uses
This program can be utilized for all traditional and accepted gamma camera applications. It is expected that its benefits will be realized primarily when the system is being used to acquire tomographic studies. The intended use of the gamma camera system is unchanged by this program. Toshiba believes that users will find the T.E.W method to be beneficial when performing dual-nuclide acquisitions, by enhancing the system's ability to detect the energy peaks of each
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nuclide without interference from the other nuclide. This determination is left to the user, however, and no specific claims regarding dual nuclide uses are being made. Due to the absence of new intended uses, it follows that the overall safety and effectiveness of the gamma camera system is not changed by this program.
• Comparison of technological characteristics
There is no change to the technology of the host device when the optional program Scatter Correction Volume, or T.E.W., is applied. This product is computational only and does not affect the physical characteristics of the host device. Determination of and correction for Comptonscatter effects are well understood and documented in peer-reviewed scientific publications.
N/A