(76 days)
The SOMATOM Plus 4 CT Scanner is intended to produce crosssectional images of the body by computer reconstruction of X-ray transmission data from either the same axial plane taken at different angles or spiral planes* taken at different angles.
- The axial planes resulted from the continuous rotation of detectors and X-ray tube and the simultaneous translation of the patient.
The SOMATOM Plus 4 with Somaris 4/B30 software is a whole body computed tomography X-ray scanner, which features a continuously rotating tube-detector system and functions according to the fan beam principle.
The provided text is a 510(k) Summary for the Siemens SOMATOM Plus 4 Computed Tomography (CT) Scanner with Somaris 4/B30 Software, submitted in 1996. This document describes the device, its intended use, and argues for its substantial equivalence to previously cleared devices.
*However, the document does not contain any information regarding acceptance criteria, device performance studies, sample sizes, ground truth establishment, expert qualifications, adjudication methods, or MRMC studies.
Therefore, I cannot populate the table or answer the specific questions about performance studies. The 510(k) summary focuses on demonstrating equivalence to predicate devices based on design and technological characteristics, not on presenting detailed performance data from a specific study and acceptance criteria.
Key takeaway from the document regarding performance:
- Improved Low Contrast Resolution and Reduced Noise: The document states that the addition of an optional solid-state detector, which has a higher conversion efficiency than the previous xenon detector, "improves low contrast resolution and reduces image noise." This is a qualitative statement about performance improvement, but no specific metrics, acceptance criteria, or study data are provided to quantify this improvement.
In summary, based only on the provided text, the requested information about acceptance criteria and detailed study data is not available.
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FEB 1 0 1997 Attachment 12
510(k) Summary
Siemens SOMATOM Plus 4 Computed Tomography (CT) Scanner with Somaris 4/B30 Software
Submitted by:
Siemens Medical Systems, Inc. 186 Wood Avenue South Iselin, NJ 08830
November 25, 1996
This 510(k) summary of safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR $807.92.
Contact Person: 1.
Ms. Jing Zhang Phone: (908)321-4927 Fax: (908)321-4841
Device Name and Classification: 2.
Trade Name: Classification Name: Classification Panel: CFR Section: Device Class: Device Code:
SOMATOM Plus 4 CT Scanner Computed Tomography X-ray System Radiology 21 CFR §892.1750 Class II 90IAK
3. Intended Use:
The SOMATOM Plus 4 CT Scanner is intended to produce crosssectional images of the body by computer reconstruction of X-ray transmission data from either the same axial plane taken at different angles or spiral planes* taken at different angles.
* The axial planes resulted from the continuous rotation of detectors and X-ray tube and the simultaneous translation of the patient.
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SIEMENS
র. Substantial Equivalence:
The new SOMATOM Plus 4 CT Scanner is substantially equivalent to the following devices in commercial distribution:
5. Device Description:
The SOMATOM Plus 4 with Somaris 4/B30 software is a whole body computed tomography X-ray scanner, which features a continuously rotating tube-detector system and functions according to the fan beam principle.
6. Summary of Technological Characteristics of the Device Compared to the Predicate Device:
The SOMATOM Plus 4 operating with Somaris 4/B30 software has the same technological characteristics as the predicate Plus 4 operating with Somaris 4/B20 software, except the addition of an optional solid state detector. The change from xenon detector to solid state detector does not change the overall design and operation of the Plus 4 scanner. Since the solid state detector has a higher conversion efficiency, the low contrast resolution is improved and the image noise is reduced.
Kathleen Rutherford
Kathleen Rutherford
Kathleen Rutherford Manager, Regulatory Submissions Siemens Medical Systems, Inc.
§ 892.1750 Computed tomography x-ray system.
(a)
Identification. A computed tomography x-ray system is a diagnostic x-ray system intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from the same axial plane taken at different angles. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II.