(275 days)
Intended for use in general human radiography imaging similar to the optically coupled CCD based device cleared under 510(k) number K974863. Not to be used for mammography.
The Xplorer 1000 is an optical based digital x-ray imager. It works by converting incident x-ray energy to visible light by use of fluorescent screen. The visible light is deflected by a mirror to a high resolution CCD camera that produces a digital image. The device trigger mechanism ensures that image is captured when the x-ray beam is turned on. The device does not require any connection to the x-ray generator.
Here's a breakdown of the acceptance criteria and study as described in the provided documents for the Xplorer 1000 Digital X-ray Imager:
Acceptance Criteria and Reported Device Performance
The core acceptance criterion for the Xplorer 1000 was to demonstrate equivalence to its predicate devices: the IMIX DIGITAL THORAX SYSTEM (K974863) and conventional radiographic film (21 CFR 892.1840). This equivalence was assessed in terms of intended use and radiographic performance.
Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria Category/Measure | Acceptance Criteria (Implicit for Predicate Equivalence) | Reported Xplorer 1000 Performance |
|---|---|---|
| Intended Use | General human radiography (same as predicates) | General human radiography |
| Radiographic Performance | ||
| Spatial Resolution (microns at 100% MTF) | At least 200 microns (IMIX) or <100 microns (Film) | 127 microns |
| Qualitative Imaging of Bone Detail (e.g., trabeculae) | Equivalent to conventional film | Found equivalent by radiologists |
| Overall Image Quality | Equivalent to conventional film | Found equivalent by radiologists |
Study Details
Here's a detailed breakdown of the studies conducted:
2. Sample size used for the test set and the data provenance:
- Non-clinical testing (Spatial Resolution): Not explicitly stated, but "line pair resolution targets and radiological phantoms" were used. These are typically standardized, manufactured objects rather than patient data.
- Clinical testing (Image Quality): 20 human subjects were x-rayed.
- Data Provenance: Not explicitly stated, but likely prospective given the clinical testing involved x-raying subjects "both conventionally and with the Xplorer 1000." The country of origin is not mentioned.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Non-clinical testing: Not explicitly stated, but for qualitative imaging of bone detail, "radiologists" were involved. The number is not specified, nor are their specific qualifications beyond being radiologists.
- Clinical testing: 3 radiologists. Their specific qualifications (e.g., years of experience) are not provided.
4. Adjudication method for the test set:
- Clinical testing: "The results were examined by a panel of 3 radiologists and found equivalent to film." This suggests a consensus-based approach, but the specific adjudication method (e.g., unanimous agreement required, majority vote) is not detailed. It does not appear to be a 2+1 or 3+1 method.
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:
- No, an MRMC comparative effectiveness study was not explicitly done in the way typically understood for AI-assisted reading. The study aimed to show equivalence between a digital imager and film, not to demonstrate human reader improvement with AI assistance. The device is a digital X-ray imager, not an AI diagnostic tool.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Yes, in a sense, the device's inherent "performance" (e.g., spatial resolution) was evaluated independently of human interpretation. The spatial resolution reported (127 microns) is a standalone measurement of the device's capability. However, this is not a standalone AI algorithm performance as the device itself is an imager, not an AI for diagnosis.
7. The type of ground truth used:
- Non-clinical testing (Spatial Resolution): Standardized resolution targets and phantoms.
- Clinical testing (Image Quality): The "ground truth" was essentially the subjective evaluation of image quality and anatomical detail (bone detail, trabeculae) by a panel of radiologists, comparing the Xplorer 1000 images to images obtained using conventional film. This is expert consensus on image quality rather than a definitive medical diagnosis or pathology.
8. The sample size for the training set:
- Not applicable. The Xplorer 1000 is an optical-based digital X-ray imager, not a machine learning or AI device that requires a "training set." It converts X-ray energy to visible light and captures it with a CCD camera.
9. How the ground truth for the training set was established:
- Not applicable, as there is no training set for this type of device.
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CONFIDENTIAL
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2.1 Summary for Public Disclosure
Submitter Robin Winsor Director - Regulatory Affairs # 151, 2340 Pegasus Way NE Calgary, Alberta T2E 8M5 Canada Tel: (403) 251 9939 Fax: (403) 251 1771 E-mail: rwinsor@xrayimaging.com
Date summary was prepared
August 24, 1999
Name(s) of the device
| Trade name | Xplorer 1000 Digital X-ray Imager |
|---|---|
| Common name | Digital X-ray Imager |
Classification name Solid State X-ray Imager
Identification of predicate device(s)
Equivalency is based on the IMIX DIGITAL THORAX SYSTEM (K974863) and conventional radiographic film (21 CFR 892.1840).
Description of the device
The Xplorer 1000 is an optical based digital x-ray imager. It works by converting incident x-ray energy to visible light by use of fluorescent screen. The visible light is deflected by a mirror to a high resolution CCD camera that produces a digital image. The device trigger mechanism ensures that image is captured when the x-ray beam is turned on. The device does not require any connection to the x-ray generator.
Intended Use
The Xplorer 1000 is a digital x-ray imager intended as a replacement for x-ray film for general human radiography.
June 1, 2000 IMAGING DYNAMICS CORPORATION Xplorer 1000 Digital X-ray Image
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Comparison of device characteristics to predicate
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| Feature | Xplorer 1000 | IMIX | Film / Screen |
|---|---|---|---|
| 510(k)/Regulation | Pending | K974863 | 892.1840 |
| Intended Use | General Human Radiography | ||
| Fluorescent screento convert x-rays tolight | Yes | Yes | Yes |
| Mirror to separatex-rays from light | Yes | Yes | No |
| Lens to focus light | Yes | Yes | No |
| CCD to captureimage | Yes | Yes | No |
| Spatial Resolution(microns) at 100%MTF | 127 | 200 | <100 |
Non-clinical testing
The Xplorer 1000 uses a fluorescent screen of the type used in film / screen radiography to convert x-rays to light. This light is then captured by a high resolution CCD sensor.
To verify the spatial resolution and determine its equivalence to film, tests were performed using line pair resolution targets and radiological phantoms. Resolution was found to exceed the standards set by the American College of Radiologists and, qualitatively, imaging of bone detail, particularly trabeculae, was found equivalent by radiologists.
Clinical testing
In an image quality study, 20 human subjects were x-rayed both conventionally and with the Xplorer 1000. A range of anatomy was covered representative of general radiography. The results were examined by a panel of 3 radiologists and found equivalent to film.
Conclusion
Imaging Dynamics concludes that the Xplorer 1000 Digital X-ray Imager is equivalent to the Imix Digital Thorax System (K974863) and conventional radiographic film (21 CFR 892.1840) based upon the following criteria:
- the Xplorer 1000 has the same intended use as the predicate devices; and, .
- the Xplorer 1000 has radiographic performance equivalent to the predicate devices.
June 1 . 2000 IMAGING DYNAMICS CORPORA Xplorer 1000 Digital X-ray In
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Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the department's name around the perimeter. Inside the circle is an abstract symbol that resembles a stylized caduceus, a symbol often associated with medicine and healthcare. The symbol consists of three curved lines that converge to form a shape reminiscent of a human figure.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN - 2 2000
Robin Winsor Director-Regulatory Affairs Imaging Dynamics Corporation 151, 2340 Pegasus Way, NE Calgary, Alberta Canada T2E 8M5
Re:
K992955 Xplorer 1000 Dated: April 21, 2000 Received: April 24, 2000 Regulatory class: II 21 CFR 892.1630/Procode: 90 MQB
Dear Mr. Winsor:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the vice is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce pror to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that mansou in kerotato schilder stime of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include manike the annual registration, isting 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 ir your dontols. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice r ans oo ood. 7 Costantany of the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under Radiation Control provisions, or other Federal laws or regulations.
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of r mo to the mailer 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4591. Additionally, for question and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Daniel G. Schultz, M.D. Captain, USPHS Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure(s)
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2.3 Indications for Use Statement
Ver/ 3 - 4/24/96 Applicant: Imaging Dynamics Corporation 510 (k) Number (if known): K992955 Device Name: Xplorer 1000 Digital X-ray Imager Indications For Use:
Intended for use in general human radiography imaging similar to the optically coupled CCD based device cleared under 510(k) number K974863.
Not to be used for mammography.
PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrance of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109)
(Per 21 CFR 801.109) (Optional Format 1-2-96)
David H. Seymore
(Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological Devices 510(k) Number
June 1, 2000 IMAGING DYNAMICS CORPORATION Xplorer 1000 Digital X-ray Imager
§ 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.