(41 days)
The ELIAN diagnostic X-ray system is intended for use on adult and pediatric patients radiographic exposure of all body parts and operated by a qualified/trained doctor or technician. NOT intended for Mammography use.
The ELIAN is a digital radiographic image acquisition device. It is a fully integrated image capture and routing system under human operator control. This system may be usable by a technician in a typical radiology environment. The ELIAN system includes a Detector Panel, Soft Ware, Case, Grid, Power Box, Switch Box, Interconnecting Cables, U-arm Mechanical and Generator. The Detector Panel is an indirect conversion device in the form of a rectangular plate in which the input x-ray photons are absorbed in an a-Si layer with CSI. The Power Box functions as a buffer between the Detector Panel and Operating PC while also supplying power to the Detector Panel. The Flugel SW transfers signals between the Detector and X-ray Generator and also indicates the status of the panel using console. Finally, the Flugel SW contains for image data capture and correction of defects on the image data.
The device in question is the ELIAN Digital Diagnostic X-ray System.
1. Acceptance Criteria and Reported Device Performance
The provided document describes a 510(k) submission for substantial equivalence, focusing on comparative performance against predicate devices rather than specific acceptance criteria for standalone performance. However, some performance metrics are reported.
| Metric | Predicate: CXDI-50G (K031447) | New Device: ELIAN (1717SCC) |
|---|---|---|
| MTF (1lp/mm) | 0.50 | 0.49 |
| MTF (2lp/mm) | 0.22 | 0.234 |
| MTF (3lp/mm) | 0.11 | 0.11 |
| MTF (3.5lp/mm) | N/A | 0.083 |
| DQE(0) | 0.1 | 0.22 |
| DQE(1) | 0.25 | 0.35 |
| DQE(2) | 0.17 | 0.275 |
| DQE(3) | 0.09 | 0.14 |
| Pixel Size | 160 x 160 microns | 127 x 127 microns |
| Dynamic Range | 12 bits | 14 bits |
| Spatial Resolution | 3.1 lp/mm | 3.5 lp/mm |
The document states: "The overall test results conclude that ELIAN has outperformed the predicate device Sedecal X-Plus LP Plus Digital (K090238) in terms of modulation transfer function and detective quantum efficiency."
2. Sample Size Used for the Test Set and Data Provenance
The document mentions "Clinical images were provided" but does not specify the sample size for a test set in terms of number of cases or images.
The data provenance is not explicitly stated in terms of country of origin or whether it was retrospective or prospective. It implies a clinical evaluation, but details are absent.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
The document mentions a "clinical study" that compared diagnostic equivalency but does not specify the number of experts used to establish ground truth or their qualifications. It states, "The result of tests demonstrated that ELIAN produces diagnostic images of equivalent quality as the predicate device..." This implies expert assessment, but no details are provided.
4. Adjudication Method for the Test Set
The document does not describe any adjudication method used for the test set.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
An MRMC comparative effectiveness study was not specifically mentioned or detailed. The document alludes to a clinical study to "investigate the diagnostic equivalency of detector panels," where ELIAN's images were compared to those from a predicate device across eight body parts. However, it does not describe a setup to measure the improvement of human readers with AI assistance. The ELIAN system is an X-ray imaging device, not an AI-powered diagnostic tool for interpretation assistance in MRMC studies.
6. Standalone Performance Study
The primary performance studies mentioned are non-clinical, focusing on physical parameters like MTF and DQE, in accordance with IEC 62220-1:2003 Standard. The document states: "The overall test results conclude that ELIAN has outperformed the predicate device Sedecal X-Plus LP Plus Digital (K090238) in terms of modulation transfer function and detective quantum efficiency." This indicates a standalone algorithm-only (device-only, in this case) performance assessment against a standard and a predicate, particularly for image quality metrics.
7. Type of Ground Truth Used
For the non-clinical testing (MTF, DQE), the "ground truth" is established through physical measurements and standards, specifically IEC 62220-1:2003.
For the clinical study, the "ground truth" used for comparison appears to be the diagnostic images produced by the predicate device, with the goal of showing "equivalent quality." This suggests a comparative diagnostic performance rather than an absolute ground truth (e.g., pathology, outcomes data).
8. Sample Size for the Training Set
The document does not mention a training set sample size. The ELIAN system is described as an image acquisition device, not a machine learning or AI algorithm that typically requires a training set for model development.
9. How the Ground Truth for the Training Set Was Established
Since a training set for an AI algorithm is not mentioned, the method for establishing its ground truth is not applicable/provided.
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
January 7, 2016
OSKO, Inc. % Mr. Dave Kim Medical Device Regulatory Affairs Mtech Group 8310 Buffalo Speedway HOUSTON TX 77025
Re: K150506
Trade/Device Name: Elian digital diagnostic x-ray system Regulation Number: 21 CFR 892.1680 Regulation Name: Stationary x-ray system Regulatory Class: II Product Code: KPR Dated: February 23, 2015 Received: February 26, 2015
Dear Mr. Kim:
This letter corrects our substantially equivalent letter of April 08, 2015.
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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.
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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
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forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Michael D'Hara
For
Robert Ochs, Ph.D. Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known)
Device Name
ELIAN Digital Diagnostic X-ray System
Indications for Use (Describe)
The ELIAN diagnostic X-ray system is intended for use on adult and pediatric patients radiographic exposure of all body parts and operated by a qualified/trained doctor or technician. NOT intended for Mammography use.
| Type of Use (Select one or both, as applicable) |
|---|
| Prescription Use (Part 21 CFR 801 Subpart D) |
| Over-The-Counter Use (21 CFR 801 Subpart C) |
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510(k) Summary
This summary of 510(k) safety and effectiveness information is being submitted in accordance with requirements of 21 CFR Part 807.92.
Date 510k summary prepared: February 23, 2015
Submitter's Name, address, telephone number, a contact person:
| 1. Submitter | OSKO, Inc.7260 NW 58th Street, Miami, Florida 33166, USAwww.oskomedical.com |
|---|---|
| -------------- | ------------------------------------------------------------------------------------------------------------------------------ |
| 2. Contact Person | Name: Wang Choi |
|---|---|
| Position: Vice President | |
| E-mail: bioking@medisoneconet.com | |
| Telephone: + 1 305-599-7161 |
Name of the device, including the trade or proprietary name if applicable, the common or usual name and the classification name, if known:
| 3. Device Classification Name | Stationary X-ray System |
|---|---|
| 4. Device Name | ELIANDigital Diagnostic X-Ray System |
| 5. Classification | 21 CFR 892.1680 |
| 6. Product Code | KPR |
| 7. Device Class | 2 |
| 8. Predicate Device | Sedecal X-Plus LP Plus DigitalSedecal, Inc892.1680, Product Code: KPRK090238 (Decision Date - Feb. 27. 2009)CXDI-50GCANON, Inc.892.1680, Product Code: MQBK031447 (Decision Date - May, 21, 2003) |
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9. Device Description
The ELIAN is a digital radiographic image acquisition device. It is a fully integrated image capture and routing system under human operator control. This system may be usable by a technician in a typical radiology environment.
The ELIAN system includes a Detector Panel, Soft Ware, Case, Grid, Power Box, Switch Box, Interconnecting Cables, U-arm Mechanical and Generator. The Detector Panel is an indirect conversion device in the form of a rectangular plate in which the input x-ray photons are absorbed in an a-Si layer with CSI. The Power Box functions as a buffer between the Detector Panel and Operating PC while also supplying power to the Detector Panel. The Flugel SW transfers signals between the Detector and X-ray Generator and also indicates the status of the panel using console. Finally, the Flugel SW contains for image data capture and correction of defects on the image data.
- Intended Use
The ELIAN diagnostic X-ray system is intended for use on adult and pediatric patients for taking diagnostics radiographic exposure of all body parts and operated by a qualified/trained doctor or technician. NOT intended for Mammography use.
- Summary of the Technological Characteristics of the device compared to the Predicate Device
The ELIAN digital diagnostic X-ray system described in this 501K has the similar indications for use and technical characteristics as the predicate device, Sedecal X-Plus LP Plus Digital of Sedecal, Inc. (K090238)
| Feature | New Device:ELIANProduct Code: KPR | Predicate: (K090238)Sedecal X-Plus LP PlusDigitalProduct Code: KPR | Predicate: (K031447)CXDI 50GProduct Code: MQB |
|---|---|---|---|
| Manufacturer | OSKO, Inc | Sedecal, Inc. | Canon Inc. |
| Appearances | Image: OSKO, Inc. | Image: Sedecal, Inc. | Image: Canon Inc. |
| Intended Use | The ELIAN diagnosticX-ray system is intendedfor use on adult andpediatric patients fortaking diagnosticsradiographic exposureof all body parts andoperated by aqualified/trained doctoror technician. NOTintended forMammography use | Intended for use by aqualified/trained doctor ortechnician on both adult andpediatric subjects for takingdiagnostic radiographicexposures of the skull,spinal column, chest,abdomen, extremities, andother body parts.Applications can beperformed with the patientsitting, standing, or lying inthe prone or supine position. | The Canon digitalradiography CXDI-50Gis a portable X-raydigital camera that cantake images of any partof the body. It directlyconverts the X-rayimages captured byLANMIT (Large AreaNew MIS Sensors andTFT) sensor into ahigh-resolution digitalimages. |
| Configuration | U-Arm mount | U-Arm mount | - |
| Electricalsafety | Electrical Safety perIEC-60601. UL listed. | Electrical Safety per IEC-60601. UL listed. | Electrical Safety per IEC-60601. UL listed. |
| PerformanceStandard | 21 CFR 1020.30 | 21 CFR 1020.30 | 21 CFR 1020.30 |
| Generator | High frequency | High frequency | - |
| X-ray tube | Toshiba (E7252X) usedfor the marketed device:K133782 | - | - |
| Collimator | Manual(Daesung) | Manual(Ralco) orAutomatic (Huestis) | - |
| Imageacquisition | Digital 1717SCC ( K122173)-Type: Wired.Acquisition Software:flugel (Private label product for XmaruView1,K102078) | DigitalCANON CXDI Panels, multiple models: 50C, 50G, 40Cand 40G | CXDI-50G(K031447) |
| DetectorDimensions | 17" x 17" | 19.3" x 18.8" | |
| MTF | 0.49 (1lp/mm), 0.234(2lp/mm), 0.11(3lp/mm),0.083(3.5lp/mm) | 0.50 (1lp/mm), 0.22(2lp/mm), 0.11(3lp/mm) | |
| DQE | DQE(0) - 0.22, DQE(1)-0.35, DQE(2)-0.275,DQE(3)-0.14 | DQE(0) – 0.1, DQE(1)-0.25, DQE(2)-0.17,DQE(3)-0.09 | |
| Pixel Size | 127 x 127 microns | 160x160 microns | |
| DynamicRange | 14 bits | 12 bits | |
| SpatialResolution | 3.5 lp/mm | 3.1 lp/mm |
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12. Comparison discussion:
The model Sedecal X-Plus LP Plus Digital and CANON CXDI 50G are the primary predicate device. The subject device and predicate device are substantially equivalent, having the same intended use, configuration, electrical safety, performance standard, collimator and image acquisition. The differences are pixel size, dynamic range and spatial resolution only. Both subject device and predicate device are categorized in product code KPR : equivalence between these models is evident.
There are similar characteristics between ELIAN and its predicate devices. The similarities ELIAN and the predicate device are listed below.
A few differences are as follows.
These differences do not raise any new questions of safety or effectiveness.
- Differences in Dimensions
Dimensions of 1717SCC is 17X17" and that of CXDI-5 0G is 19.3X18.8". But it has no effect on efficiency and safety.
- Differences in Pixel size
Pixel size of 1717SCC is 127 x 127 microns and that of CXDI-50G is 160 x 160 microns. But it has no effect on efficiency and safety.
- Differences in Spatial Resolution
Spatial Resolution of 1717SCC is 3.5 lp/mm and that of CXDI-50G is 3.1 lp/mm. But it has no effect on efficiency and safety.
- Differences in Non Clinical Performance
The MTF and DQE performance of the 1717 SCC digital flat panel for ELIAN are consistently higher than CDXI-50G equipped by Sedecal X-Plus LP Plus Digital.
In summary, both detectors are similar in terms of the capacity of transferring the modulation of the input signal at a given spatial frequency to its output, a useful measure of true or effective resolution.
Higher DQE values of 1717SCC. compared to CDXI-50G. indicate that less radiation is needed to achieve identical image quality; increasing the DQE and leaving radiation exposure constant will improve image quality.
- Different image viewing software
1717SCC digital flat panel is compatible with the imaging software used with the submitted device is 'flugel' and it is identical to the XmaruView V1., cleared under K102078.
In conclusion, the ELIAN is substantially equivalent to predicate devices.
13. Summary of Non-Clinical Testing
The performance of Detector can be evaluated by DQE and MTF according to IEC 62220-1:2003 Standard. DQE & MTF have been tested by acquiring the X-ray image with designated devices.
The overall test results conclude that ELIAN has outperformed the predicate device Sedecal X-Plus LP Plus Digital (K090238) in terms of modulation transfer function and detective quantum efficiency.
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Moreover, ELIAN has been tested in accordance with Safety (IEC 60601-1; 2005 + A1 (2012)), EMC (EN60601-1-2:2007 / AC : 2010 (IEC60601-1-2:2007)), IEC 60601-2-54 (First Edition) : 2009 and DICOM standards (NEMA PS 3.1-3.20:2011).
14. Summary of Clinical Testing
Clinical study is to investigate the diagnostic equivalency of detector panels with the same a-Se technology and same pixel sizes. We've tested for eight body parts (Chest, Shoulder, L-Spine_L, L-Spine_AP, Hand, Forearm, Foot and Knee) compared to the predicate device. The result of tests demonstrated that ELIAN produces diagnostic images of equivalent quality as the predicate device Sedecal X-Plus LP Plus Digital of Sedecal, Inc. (K090238).
"Clinical images were provided; these images were not necessary to establish substantial equivalence based on the modifications to the device but they provide further evidence in addition to the laboratory performance data to show that the complete system works as intended."
15. Functional and Safety Testing
The ELIAN has been evaluated as per FDA's "Guidance for the Submission of 510(k)s for Solid State X-ray Imaging Devices" and has shown good performance, substantially equivalent to the predicate device.
The ELIAN has also met applicable Electro Magnetic Compatibility (EMC) requirements.
- Conclusion
The ELIAN is substantially equivalent to the Predicate Device in design and performance.
- Manufacturing Facility
OSKO, INC.
7260 NW 58th Street, Miami, Florida, 33166 USA Establishment Registration Number: 301066640
§ 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.