(239 days)
The SLS-CT is a data gathering device that allows the Radiographic Simulators to process data into tomographic images. The SLS-CT is not a diagnostic tool.
The SLS-CT System manufactured by Bio-Imaging Research (BIR) is a passive add-on option to Philips Medical Systems, Inc.'s existing, legally marketed, Radiotherapy Simulators. The SLS-CT does not control the Simulator x-ray and mechanical functions. The SLS-CT is a data gathering device that allows the Radiographic Simulators to process data into tomographic images. The SLS-CT is not a diagnostic tool.
This document does not contain any information about acceptance criteria or a study proving device performance against such criteria.
The provided text is a "SUMMARY OF SAFETY AND EFFECTIVENESS INFORMATION" for a 510(k) premarket notification. It describes a device (SLS-CT System) that is designed as a passive add-on to existing Radiotherapy Simulators to process data into tomographic images.
Here's what the document does say, and why it doesn't fulfill the request:
- Device Purpose: It explicitly states, "The SLS-CT is not a diagnostic tool." This is crucial because the acceptance criteria and study design usually revolve around diagnostic performance metrics (sensitivity, specificity, accuracy, etc.) when a device is intended for diagnosis.
- Compliance with Standards: It mentions compliance with voluntary standards (IEC601, UL 2601, CSA 601) and adherence to IEEE Software Engineering Standard as a model for software development. These are about safety, quality, and engineering practices, not clinical performance or efficacy.
- Testing Information: It describes "modular testing of the hardware and software," "hazard analysis," "stringent software and hardware design and quality assurance procedures," and "system verification and validation testing...during two Beta tests." This refers to engineering and safety validation, ensuring the system functions as designed and is safe, rather than a clinical study demonstrating its performance on a specific task (like disease detection or image quality for a diagnostic purpose).
- ISO9001 Certification: This relates to the quality management system of the manufacturer, not the performance of the device itself.
To address your request, none of the specific information regarding acceptance criteria, reported performance, sample sizes, expert ground truth, adjudication, MRMC studies, standalone performance, or training data is present in this summary.
It's likely that if such a study were performed (which would be unusual for a non-diagnostic data acquisition device), it would be detailed in a separate section of the 510(k) submission, not this high-level summary. The 510(k) process for a device like this would focus more on demonstrating substantial equivalence to a predicate device regarding its technical specifications and safety, rather than extensive clinical performance studies.
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"SUMMARY OF SAFETY AND EFFECTIVENESS INFORMATION"
for the BIO-IMAGING RESEARCH SLS-CT System 510(k) PREMARKET NOTIFICATION
"This 510(k) Summary of Safety and Effectiveness Information is being submitted in accordance with the requirements of the Safe Medical Devices Act (SMDA) of 1990."
Ronald Baker
Donald Barham Regulatory Affairs Manager Bio-Imaging Research, Inc. 425 Barclay Blvd Lincolnshire, IL 60069
2/26/96
Date
The SLS-CT System manufactured by Bio-Imaging Research (BIR) is a passive add-on option to Philips Medical Systems, Inc.'s existing, legally marketed, Radiotherapy Simulators. The SLS-CT does not control the Simulator x-ray and mechanical functions. The SLS-CT is a data gathering device that allows the Radiographic Simulators to process data into tomographic images. The SLS-CT is not a diagnostic tool.
The SLS-CT System complies with voluntary standards IEC601, UL 2601, and CSA 601. The SLS-CT software was developed utilizing the IEEE Software Engineering Standard as a model.
System and software requirements specifications were developed in concert with Philips Medical Systems. Modular testing of the hardware and software has been performed to the specifications. A hazard analysis of the hardware and software was performed by both Philips Medical Systems and BIR with safeguards instituted. Stringent software and hardware design and quality assurance procedures were adhered to. Stringent system verification and validation testing was performed per documented procedures during two Beta tests, with Beta Test 1 being performed at Philips Medical Systems and Beta Test 2 in a clinical setting. In-house verification and validation was performed by BIR. Operator, System Validation and Maintenance, and Service Manuals, along with Customer Acceptance Test Schedule documents provide the user with clear and concise information thus ensuring the safe and effective operation of the system.
BIR's manufacturing facility strictly adheres to and believes in the FDA's Good Manufacturing Practices. BIR's Quality System is certified to ISO9001 for the design, manufacturing, and service of medical imaging equipment.
§ 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.