(64 days)
The PCR 5.2 System is a digital film processing system for reading and then digitizing X-ray images from reusable imaging plates which have been exposed in conventional radiographic examination devices. The digitized X-ray images can then be viewed, stored, post-processed and printed. The Philips PCR system can be used in all conventional RAD/RF examination situations, except for mammography. PCR is suitable for routine RAD exams as well as specialist areas, like intensive care units, trauma departments and pediatric departments.
A PCR system consists of an image reader, one or more PCR User Terminals, and an Easy Vision PCR Printstation or optional EasyVision RAD workstation.
Imaging plates are exposed via conventional X-Ray devices. The imaging plates used in PCR systems are coated with a luminescent material which acts as an x-ray detector. It stores the x-ray image in the form of excited charge carriers. An exposed imaging plate is loaded into the image reader of the PCR system and the image stored on the imaging plate is scanned with a laser and converted to digital data. The digital X-ray image data is then routed to the EasyVision PCR Printstation or optional EasyVision RAD workstation for image processing, viewing, storing and/or printing to film if the workstations are connected to a compatible laser imager. The PCR User Terminal is used for the scheduling of patients and exams.
The PCR User Terminal consists of a Pentium-based PC, a keyboard, an operator terminal with function keys, and an optional bar-code reader. PCR User Terminals may be interconnected via standard ethernet.
Three image reader types, currently AC2, AC3 and 9000, can be connected to the system in order to meet different requirements based on image plate size and throughput.
The EasyVision PCR Printstation is a workstation that provides image storage, display, printing and processing functions using a SUN computer. The optional EasyVision RAD workstation is also a SUN computer that provides the same functions as the Printstation but it also provides more storage capability and additional post-processing functions. Both workstations are able to export digital images to the network via the DICOM protocol.
Digital image data from the image readers are processed based on selection of either an UnSharp Masking (UM) algorithm or a Dynamic Range Reconstruction (DRR) algorithm.
This 510(k) summary for the Philips Computed Radiography (PCR) 5.2 system describes a device that digitizes X-ray images. The primary focus of the document is on establishing substantial equivalence to a predicate device and outlining its functions. Consequently, the document does not contain details about specific acceptance criteria, a dedicated study proving device performance against those criteria, or many of the specific study design elements you requested.
Here's an attempt to answer your questions based only on the provided text:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state quantitative acceptance criteria or report specific device performance metrics in comparison to such criteria. Instead, it focuses on demonstrating compliance with general electrical safety and communication standards, and substantial equivalence to a predicate device.
The "Performance Standards" section notes:
"This device complies with the relevant national and international standards for electrical safety (UL-1950. IEC-601-1, and IEC-950) as well as the international standard for electromagnetic compatibility (IEC-601-1-2) and the ACR/NEMA DICOM Version 3.0 digital imaging communication standard."
The "Substantial Equivalence Information" section implies performance is acceptable if it's "substantially equivalent" to previously cleared devices. Specifically, it notes that the new DRR algorithm is "substantially equivalent" to the Unsharp Mask (UM) algorithm and the Dynamic Range Control (DRC) algorithm. It states: "Processing with DRR improves low contrast resolution."
Therefore, we can infer the implied acceptance criteria are:
- Compliance with cited electrical safety and EMC standards.
- Compliance with DICOM 3.0 standards.
- Substantial equivalence in performance to the predicate device (Philips PCR ACe system) and its associated algorithms (UM and DRC for image processing), with an improvement in low contrast resolution with the new DRR algorithm.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not provide any information regarding a test set, its sample size, or data provenance. The assessment appears to be based on engineering comparisons and references to existing cleared devices rather than a new clinical performance study.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This information is not available in the provided text. There is no mention of ground truth establishment by experts for a test set.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not available in the provided text.
5. 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
The document does not describe a multi-reader multi-case (MRMC) comparative effectiveness study. This device is an "Automatic Radiographic Film Processor" (Computed Radiography system), which digitizes X-ray images. While it performs "Image Processing" with algorithms like DRR, it is not described as an "AI" system in the contemporary sense, nor is there any mention of a study evaluating improvements in human reader performance with or without its assistance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
The document does not detail a standalone performance study. It describes the system's functions (image reading, processing, viewing, printing, storage, export) and emphasizes its equivalence to predicate devices. The claim "Processing with DRR improves low contrast resolution" is a statement about the algorithm's effect, but not presented as the result of a formal standalone performance study with metrics.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The document does not describe the establishment or use of ground truth for evaluating the device's image processing capabilities. The primary evaluation method seems to be through comparison and demonstration of "substantial equivalence" of its technological characteristics (including algorithms) to previously cleared devices.
8. The sample size for the training set
The document does not mention any training set size. As the device involves image processing algorithms like UnSharp Masking and Dynamic Range Reconstruction, these algorithms would have been developed and tuned, but the text does not refer to a "training set" in a machine learning context.
9. How the ground truth for the training set was established
Not applicable, as no training set is mentioned in the context of device evaluation.
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Image /page/0/Picture/0 description: The image shows the Philips logo. The logo consists of the word "PHILIPS" in capital letters above a shield-like shape. Inside the shield, there are two stars and two wavy lines, creating a stylized representation of the sky and water. The logo is simple and iconic, representing the brand's identity.
Image /page/0/Picture/1 description: The image shows the word "PHILIPS" in a bold, sans-serif font. Below the word "PHILIPS" is the handwritten text "K964124". The text is in black and the background is white.
DEC 1 8 1995
Philips Medical Systems
4 October 1996
510(K) Summary
In accordance with the requirements of the Safe Medical Device Act, Philips Medical Systems North America Company herewith submits a 510(K) summary of safety and effectiveness for the following device.
| CLASSIFICATION NAME: | Automatic Radiographic Film Processor(Class II, Tier 2, 21CFR 892.1900) |
|---|---|
| COMMON/USUAL NAME: | Computed Radiography System |
| TRADE/PROPRIETARY NAME: | Philips Computed Radiography (PCR) 5.2 |
| ESTABLISHMENT NO .: | 1217116 |
| CONTACT PERSON: | Peter Altman, Director of Regulatory Affairs |
PERFORMANCE STANDARDS:
This device complies with the relevant national and international standards for electrical safety (UL-1950. IEC-601-1, and IEC-950) as well as the international standard for electromagnetic compatibility (IEC-601-1-2) and the ACR/NEMA DICOM Version 3.0 digital imaging communication standard.
SYSTEM DESCRIPTION:
A PCR system consists of an image reader, one or more PCR User Terminals, and an Easy Vision PCR Printstation or optional EasyVision RAD workstation.
Imaging plates are exposed via conventional X-Ray devices. The imaging plates used in PCR systems are coated with a luminescent material which acts as an x-ray detector. It stores the x-ray image in the form of excited charge carriers. An exposed imaging plate is loaded into the image reader of the PCR system and the image stored on the imaging plate is scanned with a laser and converted to digital data. The digital X-ray image data is then routed to the EasyVision PCR Printstation or optional EasyVision RAD workstation for image processing, viewing, storing and/or printing to film if the workstations are connected to a compatible laser imager. The PCR User Terminal is used for the scheduling of patients and exams
The PCR User Terminal consists of a Pentium-based PC, a keyboard, an operator terminal with function keys, and an optional bar-code reader. PCR User Terminals may be interconnected via standard ethernet.
Three image reader types, currently AC2, AC3 and 9000, can be connected to the system in order to meet different requirements based on image plate size and throughput.. The image readers are manufactured by Fuji Photo Film Co. Ltd. The AC2 has been granted a 510(k) clearance. Refer to accession number K896050A. The AC3 has been granted a 510(k) clearance. Refer to accession number K944046. The 9000 has been granted a 510(k) clearance. Refer to accession number K951373.
Philips Medical Systems North America Company 710 Bridgeport Avenue Shelton, CT 06484-4708 Tel: (203) 926-7674 Fax: (203) 929-6099
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Image /page/1/Picture/1 description: The image shows the Philips logo, which consists of the word "PHILIPS" in bold, sans-serif font above a shield-like emblem. The emblem features a globe-like shape with wavy lines across the middle, resembling water or sound waves. There are also four stars placed around the globe, two on the top and two on the bottom.
SYSTEM DESCRIPTION: (cont'd)
The EasyVision PCR Printstation is a workstation that provides image storage, display, printing and processing functions using a SUN computer. The optional EasyVision RAD workstation is also a SUN computer that provides the same functions as the Printstation but it also provides more storage capability and additional post-processing functions. Both workstations are able to export digital images to the network via the DICOM protocol. These workstations have been granted a 510(k) clearance. Refer to accession number K953095. Digital image data from the image readers are processed based on selection of either an UnSharp Masking (UM) algorithm or a Dynamic Range Reconstruction (DRR) algorithm. The DRR algorithm is a processing feature of the PCR 5.2 system not previously available on other computed radiography systems such as the predicate device PCR ACe which uses an Unsharp Masking algorithm. The DRR algorithm provides higher transparency in radiological dense areas. The result is a display which shows more information and thus avoids alterations to the presentation parameters which would otherwise be necessary. Processing with DRR improves low contrast resolution.
| Function | Description |
|---|---|
| Demographic Data Entry | For each image, demographic data identifying the patient anddescribing the examination are entered. |
| Image Plate Reading | An image stored on a stimulated phosphor image plate is readand digitized. |
| Demographic Data Linking | Linking of demographic data to the appropriate image plate. |
| Image Processing | Spatial enhancement and contrast enhancement algorithms areapplied to digitized raw images. |
| Viewing | Images may be viewed on a monitor in order to check forappropriate positioning and other examination details. |
| Printing | Images may be routed to a laser hardcopy unit. |
| Export | Images may be exported to other digital imaging systems, suchas viewing stations or archives. |
| Storage | Images may be stored locally on optical disk. |
PCR 5.2 System functions are listed in the table below
INTENDED USE:
The PCR 5.2 System is a digital film processing system for reading and then digitizing X-ray images from reusable imaging plates which have been exposed in conventional radiographic examination devices. The digitized X-ray images can then be viewed, stored, post-processed and printed. The Philips PCR system can be used in all conventional RAD/RF examination situations, except for mammography. PCR is suitable for routine RAD exams as well as specialist areas, like intensive care units, trauma departments and pediatric departments.
SUBSTANTIAL EQUIVALENCE INFORMATION:
The Philips PCR 5.2 system is a modification of, and considered substantially equivalent to the Philips PCR ACe system manufactured by Philips Medical Systems based on a comparison of the technological characteristics of the PCR 5.2 system to those of the PCR ACe system. The PCR ACe system has been granted a 510(k) clearance. Refer to accession number K915237. Also, the image processing algorithm called Dynamic Range Reconstruction (DRR) used with PCR 5.2 is considered substantially equivalent to the Unsharp Mask (UM) algorithm implemented by Fuji and used with the image reader for the PCR ACe system and it is also substantially equivalent to the Dynamic Range Control (DRC) algorithm also implemented by Fuji and used on the 9000 image reader. The DRC algorithm has been granted a 510(k) clearance as part of the 9000 image reader. Refer to accession number K951373.
§ 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).