(88 days)
The SMARTSPOT enhances the quality of the fluoroscopy image, enables acquisition and display of high resolution (1024 x 1024 pixels) radiographic images and gives the user the possibility to perform advanced studies involving image digital subtraction, such as Roadmapping and DSA, that were not possible with conventional techniques.
Fields of application of the system are: gastrointestinal examinations, interventional procedures, peripheral angiography studies, urology examinations and other routine fluoroscopy studies.
The SMARTSPOT is a high resolution digital system for Digital Spot Imaging in Radiography/Fluoroscopy (R/F) X-ray rooms. It is designed to reduce (and even replace) the use of cassette filming and 105 mm spot cameras, and in this way reduce overall patient radiation exposure and examination time.
The system is based on a computer workstation running Windows NT as the operating system. The other main components are: a high resolution CCD camera, an advanced video processor, operation room and control room monitors, X-ray and TV interfaces, Hardcopy Laser Camera interface and a 2 GBytes internal hard disk.
This 510(k) summary does not contain information about acceptance criteria or a study proving the device meets acceptance criteria in the way typically expected in modern regulatory submissions for AI/ML devices. The "SMARTSPOT" device from CMT Medical Technologies Ltd. (K961307) is a high-resolution digital imaging system, not an AI/ML device in the contemporary sense. The document primarily focuses on its intended use, comparison to a predicate device, and safety information based on general medical device standards.
Here's an analysis based on the provided text, highlighting the absence of the requested information:
Analysis of Provided Information:
The document describes the SMARTSPOT as a "high resolution digital system for Digital Spot Imaging," designed to "reduce (and even replace) the use of cassette filming and 105 mm spot cameras, and in this way reduce overall patient radiation exposure and examination time." Its primary function is to "enhance the quality of the fluoroscopy image, enable acquisition and display of high resolution (1024 x 1024 pixels) radiographic images and gives the user the possibility to perform advanced studies involving image digital subtraction, such as Roadmapping and DSA."
The comparison to the predicate device (S&S Inficon Inc.'s FC 2000, K911454) states: "Both systems have the same intended use. They have almost identical features, same spatial resolution and same digitization depth." The main difference highlighted is the camera type (digital CCD vs. Pick-up tube), with CCD cameras noted for "comparable spatial resolution and dynamic range" and outperforming in "cost-effectiveness and long term stability."
Absence of Requested Information:
The provided 510(k) summary does not contain any of the following information relevant to acceptance criteria or a study proving performance as typically understood for AI/ML devices:
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A table of acceptance criteria and the reported device performance: There are no specific quantitative performance metrics (e.g., sensitivity, specificity, AUC) or defined acceptance thresholds for such metrics presented. The document states a general goal of "enhancing image quality" and enabling higher resolution, but no measurable criteria are given.
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Sample size used for the test set and the data provenance: No test set is described, nor is any sample size, country of origin, or whether the data was retrospective/prospective.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts: No ground truth establishment for a test set is mentioned because no test set analysis is presented.
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Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable as no test set analysis is described.
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If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This is not an AI-assisted diagnostic device. The comparison is between a new digital imaging system and existing conventional methods (cassette filming, 105mm spot cameras) or a predicate digital imaging system. The "effect" described is primarily related to image quality, resolution, and procedural efficiency (reduced radiation, examination time), not human reader performance with AI.
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If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable. This is an imaging hardware and software system, not an AI algorithm.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable as no specific performance evaluation based on ground truth is described.
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The sample size for the training set: Not applicable as it's not an AI/ML device that undergoes training on image data in the described manner.
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How the ground truth for the training set was established: Not applicable.
Summary Conclusion based on the document:
The 510(k) summary for the SMARTSPOT device (K961307) focuses on establishing substantial equivalence to a predicate device (FC 2000, K911454) based on similar intended use, features, spatial resolution, and digitization depth, while highlighting improvements in technology (CCD camera) and efficiency. It does not provide the type of detailed performance data, acceptance criteria, ground truth methodology, or study design typically associated with AI/ML devices, as those concepts were not applicable to this type of device and regulatory submission in 1996. The "study" mentioned is primarily related to compliance with general medical device safety standards (IEC 601-1) and internal "beta testing to meet specifications," rather than a clinical performance study with defined endpoints and statistical analysis as would be expected for a diagnostic AI.
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CIVIL
MEDICAL TECHNOLOGIES LTD
JU - 1 1996
510(k) Summary of Safety and Effectiveness
Submitter Information
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Submitter: CMT Medical Technologies Ltd. MATAM, Haifa 31905 Israel
Establishment Reg .: 9680763 -
Contact: Imre Farkash Quality Assurance Manager
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Summary Date: April 21, 1996
Name of Device and Classification
Proprietary Name: SMARTSPOT
Common Name: High Resolution Digital Imaging System
Classification: Accessory to 21 CFR 892.1650, Class II
Predicate Device
Manufacturer: S & S Inficon Inc.
Predicate Name: FC 2000
510(k) number: K911454
Description of the Device
The SMARTSPOT is a high resolution digital system for Digital Spot Imaging in Radiography/Fluoroscopy (R/F) X-ray rooms. It is designed to reduce (and even replace) the use of cassette filming and 105 mm spot cameras, and in this way reduce overall patient radiation exposure and examination time.
The system is based on a computer workstation running Windows NT as the operating system. The other main components are: a high resolution CCD camera, an advanced video processor, operation room and control room monitors, X-ray and TV interfaces, Hardcopy Laser Camera interface and a 2 GBytes internal hard disk.
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Intended Use
The SMARTSPOT enhances the quality of the fluoroscopy image, enables acquisition and display of high resolution (1024 x 1024 pixels) radiographic images and gives the user the possibility to perform advanced studies involving image digital subtraction, such as Roadmapping and DSA, that were not possible with conventional techniques.
Fields of application of the system are: gastrointestinal examinations, interventional procedures, peripheral angiography studies, urology examinations and other routine fluoroscopy studies.
Comparison to the Predicate
Both systems have the same intended use. They have almost identical features, same spatial resolution and same digitization depth.
Both systems are computer controlled devices, although different platforms and different operating systems but both in the mainstream of today's computer technology. The main and almost only relevant difference is the TV camera used: the SMARTSPOT integrates a digital CCD camera vs. the Pick-up tube type used by the predicate device. CCD cameras are already widely used in fluoroscopic digital devices. These cameras show a comparable spatial resolution and dynamic range as the pick-up tube counterparts but thev outperform them in terms of cost-effectiveness and long term stability.
Safety information
The device is designed to comply at least with the minimum response requirements stated in the initial Hazard Analysis included in this notification, and with voluntary international standard IEC 601-1 for medical electrical equipment regarding both its safety (part 1) and electromagnetic compatibility (part 2) requirements.
After completion of the pre-production series, the device will be submitted for compliance tests with the above mentioned requirements in a certified laboratory. Prior to commercial distribution, the system will be ß tested to meet specifications including safety requirements.
Conclusion
We conclude that, once finished the development and testing phase as described, the SMARTSPOT will be as safe and effective as the predicate device.
Atalhafi
Imre Farkash Quality Assurance Manager
April 21, 1996
date
te
§ 892.2050 Medical image management and processing system.
(a)
Identification. A medical image management and processing system is a device that provides one or more capabilities relating to the review and digital processing of medical images for the purposes of interpretation by a trained practitioner of disease detection, diagnosis, or patient management. The software components may provide advanced or complex image processing functions for image manipulation, enhancement, or quantification that are intended for use in the interpretation and analysis of medical images. Advanced image manipulation functions may include image segmentation, multimodality image registration, or 3D visualization. Complex quantitative functions may include semi-automated measurements or time-series measurements.(b)
Classification. Class II (special controls; voluntary standards—Digital Imaging and Communications in Medicine (DICOM) Std., Joint Photographic Experts Group (JPEG) Std., Society of Motion Picture and Television Engineers (SMPTE) Test Pattern).