(253 days)
The Quix Digital Radiography Upgrade is based on a solid state imaging device and is intended for use in general radiographic examinations and applications wherever conventional film-screen systems may be used, excluding mammography, fluoroscopy, and angiography.
The Quix Digital Radiography Upgrade enables a conventional film-screen X-ray system to perform digital radiography exams by replacing the film-screen and the film-screen bucky with a digital bucky and operator console. The digital bucky incorporates a selenium-based flat panel detector with 16" x 17" imaging area. Images are displayed in approximately 10 seconds after exposure over a wide range of dose settings. The operator console provides local image storage and communicates with other network devices using DICOM 3.0 protocols.
The provided text is a 510(k) summary for the "Quix Digital Radiography Upgrade" device. This document is a premarket notification to the FDA to demonstrate that the device is substantially equivalent to legally marketed predicate devices. It focuses on comparing the new device's technical specifications and intended use against existing products.
Crucially, this document does not contain a study that proves the device meets acceptance criteria in the format typically used for performance claims of AI/ML-based devices (e.g., sensitivity, specificity, AUC, human reader studies).
Instead, the acceptance criteria for this type of device (a digital X-ray system) and the "study" demonstrating its equivalence are based on a comparison of its physical and performance specifications to those of existing, legally marketed predicate devices. The "acceptance criteria" are implied by the performance metrics of the predicate devices.
Here's an attempt to extract and interpret the information based on the provided text, acknowledging the limitations inherent in a 510(k) for a non-AI/ML device:
1. Table of acceptance criteria and the reported device performance
For a device like the Quix Digital Radiography Upgrade, the "acceptance criteria" are implicitly defined by the performance characteristics of its predicate devices. The "reported device performance" is the specifications of the Quix DR Upgrade.
| Item (Performance Characteristic) | Acceptance Criterion (Predicate Device Performance) - Infimed Stingray DR Upgrade (K992794) used as the primary predicate for technical comparison | Reported Device Performance (Quix DR Upgrade) |
|---|---|---|
| Intended Use | Provide diagnostic images for general radiographic use, excluding mammography, fluoroscopy, and angiography. | Provide diagnostic images for general radiographic use, excluding mammography, fluoroscopy, and angiography. |
| Anatomical Sites | General radiography | General radiography |
| Target Population | General population | General population |
| Design | Digital acquisition, electronic processing | Digital acquisition, electronic processing |
| X-ray Converter | Cesium Iodide scintillator, converts X-rays to light | Amorphous selenium, converts X-rays to latent charge image |
| Image Readout | Photodiode and TFT amorphous silicon active matrix array convert light to electrical charge which is readout electronically. | Plasma DR Readout Technology – line scanner sweeps across sensor surface to readout latent charge image. |
| Moving line scanner | No | Yes |
| Performance (Image Processing) | Digital image processing (optimized gray scale) | Digital image processing (optimized gray scale) |
| Imaging Area | 17" x 17" | 16" x 17" |
| Monolithic sensor | No (tiled subarrays) | Yes |
| Pixel array size | 2981 x 3021 (from 510(k)) / 3000 x 3000 (current "chart smart") | 2540 x 2700 |
| Pixel size | 143 $\mu m$ | 160 $\mu m$ |
| Dynamic Range | 14 bits (16,384) | 12 bits (4,096) |
| Connectivity | DICOM 3.0 Compatible | DICOM 3.0 Compatible |
| Image processing time | <8 sec (current "chart smart") (30 sec from 510(k)) | 10 sec |
| Spatial Resolution (1 lp/mm) | 0.7 @ 1 lp/mm | 0.7 @ 1 lp/mm |
| Spatial Resolution (2 lp/mm) | 0.35 @ 2 lp/mm | 0.35 @ 2 lp/mm |
| Spatial Resolution (3 lp/mm) | 0.15 @ 3 lp/mm | 0.1 @ 3 lp/mm |
Note on Acceptance Criteria: The "acceptance criteria" are effectively met if the new device's performance characteristics are considered equivalent to or comparable with the predicate device, especially for key aspects like intended use, anatomical sites, target population, and diagnostic image quality (as implied by spatial resolution, dynamic range, etc.). Some parameters, like pixel size or dynamic range, may differ but are justified as not raising new questions of safety or effectiveness.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not describe a specific clinical test set or dataset in the manner of an AI/ML study. The "test set" here refers to the device itself and its specifications. The comparison is based on the technical specifications of the new device against the known specifications of existing predicate devices.
Therefore, there is:
- No specific sample size for a test set of images/patients.
- No data provenance mentioned in terms of country of origin or retrospective/prospective nature of a clinical image dataset.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not applicable and not provided in this type of 510(k) submission. Ground truth, in the context of AI/ML device evaluation, usually refers to the verified diagnosis or condition of a patient based on expert review or pathology. For a digital radiography system, the "ground truth" is the physical performance characteristics of the device itself (e.g., resolution measurements, dose response curves), which are measured using standard physics and engineering methods, not expert clinical interpretation of images from a test set.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This is not applicable and not provided. Adjudication methods are used in clinical studies where multiple human readers assess a case and their interpretations are then consolidated to establish a robust ground truth or measure inter-reader agreement. This 510(k) does not describe such a clinical study.
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
There was no MRMC comparative effectiveness study described for this device. This document pertains to a new digital X-ray capture system, not an AI-assisted diagnostic tool. Therefore, there's no mention of human reader improvement with or without AI assistance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is not applicable. The device is a digital radiography upgrade, effectively a hardware system for acquiring X-ray images, not a standalone AI algorithm. Its performance is inherent in the image acquisition and processing capabilities it provides.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for demonstrating substantial equivalence for this device category relies on technical specifications and physical performance measurements (e.g., spatial resolution, dynamic range, image processing speed, pixel size) of the Quix DR Upgrade compared to predicate devices. There is no mention of expert consensus on clinical findings, pathology, or outcomes data in this submission.
8. The sample size for the training set
This is not applicable and not provided. This device is a digital X-ray capture system and does not involve AI/ML technology that would have a "training set" of data.
9. How the ground truth for the training set was established
This is not applicable and not provided for the same reasons as point 8.
{0}------------------------------------------------
JUN - 7 2006
Section 10 Administrative Requirements
510(k) Summary of Safety and Effectiveness
- Submitter :
EDGE MEDICAL DEVICES Ltd. 25 Hatasia St. P.O. Box 2126 Raanana 43654 lsrael Contact: Vered Scharf vscharf@edge-medical.com Eli Shalev eshalev@edge-medical.com 972-9-7413675 September, 2005
-
- Device Name:
| Classification Name: | Solid State X-ray Imaging Device |
|---|---|
| Common/Usual Name | Flat Panel Digital Imager |
| Proprietary Name | Quix Digital Radiography Upgrade |
-
- Equivalent Devices:
| ProprietaryName: | AGFA CP-B 200screen / AGFA CP-BUNew film | Fuji CR 5501D | Infimed Stingray DRSystem |
|---|---|---|---|
| 510(k) Numbers: | exempt from 510(k) | K993861 | K992794 |
| Common Name: | Analog Screen-Filmsystem | Computed RadiographySystem | Digital RadiographySystem |
| Regulatory Class: | Class I (screen and film) | Class II | Class II |
| ClassificationPanel: | Radiology | Radiology | Radiology |
| Product Code: | 892.1960 (screen)892.1840 (film) | 901XW 892.1900 | 90MQB 892.1650 |
4. Device Description:
The Quix Digital Radiography Upgrade enables a conventional film-screen X-ray system to perform digital radiography exams by replacing the film-screen and the film-screen bucky with a digital bucky and operator console. The digital bucky incorporates a selenium-based flat panel detector with 16" x 17" imaging area. Images are displayed in approximately 10 seconds after exposure over a wide range September, 2005 510(k) Premarket Notification Submission
{1}------------------------------------------------
of dose settings. The operator console provides local image storage and communicates with other network devices using DICOM 3.0 protocols.
- క్. Statement of Intended Use:
The Quix Digital Radiography Upgrade is based on a solid state imaging device and is intended for use in general radiographic examinations and applications wherever conventional film-screen systems may be used, excluding mammography, fluoroscopy, and angiography.
Comparison to substantially equivalent devices: റ.
AGFA CP-B 200 screen / AGFA CP-BU New film Fuji Computed Radiography System K893861 Infimed Stingray Digital Radiography System K992774
The following chart depicts the comparison characteristics.
| Item | Current Device | Predicate Device | Predicate Device | Predicate Device |
|---|---|---|---|---|
| Device | Quix DR Upgrade | AGFA CP-B 200 screen / AGFA CP-BU New film | Fuji CR System | Infimed Stingray DR Upgrade |
| 510(k) Number | exempt from 510(k) | K993861 | K992794 | |
| Intended Use | Provide diagnostic images for general radiographic use | Same | Same | Same |
| Anatomical Sites | General radiography | Same | Same | Same |
| Target Population | General population | Same | Same | Same |
| Design | Digital acquisition, electronic processing | Analog acquisition, chemical processing | Digital acquisition, electronic processing | Digital acquisition, electronic processing |
| X-ray Converter | Amorphous selenium, converts X-rays to latent charge image | Fluorescent screen, converts X-rays to light | Photostimulable phosphor imaging plate converts X-rays to stable exited states of the material | Cesium lodide scintillator, converts X-rays to light |
| Image Readout | Plasma DR Readout Technology – line scanner sweeps across sensor surface to readout latent charge image. | Silver halide film | Mechanical scanner sweeps Laser across phosphor surface to readout latent stored image. | Photodiode and TFT amorphous silicon active matrix array convert light to electrical charge which is readout electronically. |
| Moving line scanner | Yes | No | Yes | No |
| Performance | Digital image processing (optimized gray scale) | Chemical processing (fixed gray scale) | Digital image processing (optimized gray scale) | Digital image processing (optimized gray scale) |
| Imaging area | 16" x 17" | 14" x 17" | 14" x 17" | 17" x 17" |
| Monolithic sensor | Yes | Yes | Yes | No (tiled subarrays) |
| Pixel array size | 2540 x 2700 | N/A | 2140 x 2140 | 2981 x 3021 (from 510(k))3000 x 3000 (current "chart smart") |
September, 2005
510(k) Premarket Notification Submission
{2}------------------------------------------------
| Item | Current Device | Predicate Device | Predicate Device | Predicate Device |
|---|---|---|---|---|
| Device | Quix DR Upgrade | AGFA CP-B 200 screen/ AGFA CP-BU New film | Fuji CR System | Intimed Stingray DR Upgrade |
| Pixel size | $160 \mu m$ | $<100 \mu m$ | 200 $\mu m$ in standard mode100 $\mu m$ in high density mode | $143 \mu m$ |
| Dynamic Range | 12 bits (4,096) | Approximately x50 | 10 bits (1,024) | 14 bits (16,384) |
| Connectivity | DICOM 3.0 Compatible | N/A | DICOM 3.0 Compatible | DICOM 3.0 Compatible |
| Image processing time | 10 sec | 90 sec | 3-5 minutes per image | 30 sec (from 510(k))<8 sec (current "chart smart") |
| Spatial resolution | 0.7 @ 1lp/mm0.35 @ 2lp/mm0.1 @ 3lp/mm | N/A | Standard mode:0.65 @ 1lp/mm0.3 @ 2lp/mm0.1 @ 3lp/mmHigh density mode:0.8 @ 1lp/mm0.5 @ 2lp/mm0.3 @ 3lp/mm | 0.7 @ 1lp/mm0.35 @ 2lp/mm0.15 @ 3lp/mm |
:
10-3
510(k) Premarket Notification Submission
{3}------------------------------------------------
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird-like figure with three curved lines representing its body and wings. The logo is surrounded by text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.
Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850
JUN -7 2006
Vered Scharf, Ph.D. R&D Manager EDGE Medical Devices Ltd. 25 Hatasiya P.O. Box 2126 Raanana Ind. Zone, 43654 ISRAEL
Re: K052661
Trade/Device Name: Quix Digital Radiography Upgrade Regulation Number: 21 CFR §892.1650 Regulation Name: Image-intensified fluoroscopic x-ray system Regulatory Class: II Product Code: MQB Dated: April 20, 2006 Received: May 2, 2006
Dear Dr. Scharf:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Image /page/3/Picture/10 description: The image shows a circular logo with the text "1906-2006" at the top. Below this text is a large, bold "FDA" and the word "Centennial" in a smaller font. There are three stars below the word "Centennial". The logo is surrounded by a dotted circle.
Protecting and Promoting Public Health
{4}------------------------------------------------
Page 2 -
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter:
| 21 CFR 876.xxx | (Gastroenterology/Renal/Urology | 240-276-0115 |
|---|---|---|
| 21 CFR 884.xxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 894.xxx | (Radiology) | 240-276-0120 |
| Other | 240-276-0100 |
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150
or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Nancy C Hodgdon
Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
{5}------------------------------------------------
Indication for Use Statement
510(k) Number (if known): K 05 266 ا
Quix Digital Radiography Upgrade Device Name: _
Indications for Use:
The Quix Digital Radiography Upgrade is based on a solid state imaging device and is intented for use The Quix Digital Radiography Opplications wherever conventional firm-screen systems may
in general radiographic examinations and applications wherever conventional film-scree in general radiographic examinations and applications with the many ography.
be used, excluding mammography, fluoroscopy, and angiography.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Nancy Brogdon
Division Sign-Off
and Ra 510(k) Num
Prescription Use
September, 2005
V
510{k} Premarket Notification Submission
40-5
§ 892.1680 Stationary x-ray system.
(a)
Identification. A stationary x-ray system is a permanently installed diagnostic system intended to generate and control x-rays for examination of various anatomical regions. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II (special controls). A radiographic contrast tray or radiology diagnostic kit intended for use with a stationary x-ray system only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.