(132 days)
1012WCA Digital Flat Panel X-Ray Detector is indicated for digital imaging solution designed for human anatomy including head, neck, cervical spine, arm, leg and peripheral (foot, hand, wrist, fingers, etc.). It is intended to replace film based radiographic diagnostic systems and provide a case diagnosis and treatment planning for physicians and other health care professionals. Not to be used for mammography.
1012WCA is a wired/wireless digital X-ray flat panel detector that can acquire radiographic images of human anatomy when used with existing radiographic x-ray systems. The wireless LAN((IEEE 802.11a/g/n) communication signals images captured to the system and improves the user operability through high-speed processing. This X-ray imaging detector consists of a scintillator directly coupled to an a-Si TFT sensor. 1012WCA is designed specifically to be integrated with a console PC system and X-Ray generator to digitalize x-ray images into RAW files. The RAW files can be made to DICOM compatible image files which can be viewed by console SW for a radiographic image diagnosis and analysis.
The document describes the Rayence Co., Ltd. 1012WCA Digital Flat Panel X-ray Detector, which is a modified version of the predicate device Xmaru1210P. The primary aim of the submission is to demonstrate substantial equivalence to the predicate device.
Here's an analysis of the acceptance criteria and the study that proves the device meets them:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state formal "acceptance criteria" in a quantitative sense with pass/fail thresholds. Instead, it aims to demonstrate substantial equivalence to the predicate device. The performance comparison is therefore against the predicate device (Xmaru1210P).
| Characteristic | Acceptance Criteria (Predicate Xmaru1210P) | Reported Device Performance (1012WCA) |
|---|---|---|
| Indications for Use | Same as Xmaru1210P | Same as Xmaru1210P (Digital imaging of human anatomy: head, neck, cervical spine, arm, leg, peripheral. Replaces film-based systems. Not for mammography.) |
| Detector Type | Amorphous Silicon, TFT | Amorphous Silicon, TFT |
| Scintillator | Cesium Iodide | Cesium Iodide |
| Imaging Area | 11 x 13 inches | 11 x 13 inches |
| Pixel matrix | 2080 x 2560 (5.3 million) | 2080 x 2560 (5.3 million) |
| Pixel pitch | 127 µm | 127 µm |
| Resolution | 3.9 lp/mm | 3.9 lp/mm |
| A/D conversion | 14 bit | 16 bit |
| Grayscale | 16384 (14bit) | 65536 (16bit) |
| Preview Image Time | 6.5 seconds | 3 seconds |
| Data output | DICOM 3.0 compatible (various classes) | DICOM 3.0 compatible (various classes) |
| Dimensions | 422 x 403 x 22 mm | 395 x 337 x 18 mm |
| Weight | 3.4 kg | 3.15 kg (incl. battery pack) |
| Application | Portable system | Wireless portable system |
| Image Feature | White box | Black box |
| MTF (Non-clinical) | Baseline performance of Xmaru1210P | While Xmaru1210P performed "better," overall resolution and sharpness of 1012WCA is described as "better" |
| DQE (Non-clinical) | Baseline performance of Xmaru1210P | Better DQE performance than Xmaru1210P at various spatial frequencies |
| NPS (Non-clinical) | Baseline performance of Xmaru1210P | Reduced noise compared to Xmaru1210P, improved accuracy, reduced artifacts |
| Image Quality (Clinical) | Equivalent to Xmaru1210P | Equivalent or better diagnostic image quality compared to Xmaru1210P |
Summary of Study:
The study aimed to demonstrate substantial equivalence between the 1012WCA device and its predicate device, Xmaru1210P, rather than meeting quantitative acceptance criteria defined against an absolute standard. This was achieved through:
- Non-clinical testing: Comparing MTF, DQE, and NPS of both devices using IEC 62220-1 methods.
- Clinical consideration/expert review: Comparing clinical images from both devices by a licensed US radiologist.
2. Sample size used for the test set and the data provenance
- Sample Size for Test Set: Not explicitly stated as a number of images or cases for the clinical expert review. The document mentions "clinical images are taken from both devices" and evaluated "according to age group and anatomical structures." It does not provide a specific count.
- Data Provenance: The images were reviewed by a "licensed US radiologist," implying the data was relevant to clinical practice in the US. No information is given regarding whether the data was retrospective or prospective, or the specific country of origin of the patients whose images were used, beyond the radiologist's location.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Number of Experts: "A licensed US radiologist" (singular, implying one expert).
- Qualifications: "Licensed US radiologist." No further detail regarding years of experience or specialization is provided.
4. Adjudication method for the test set
- Adjudication Method: "An expert opinion" from a single licensed US radiologist was used. This does not describe a formal adjudication method like 2+1 or 3+1, which typically involves multiple readers and a tie-breaking mechanism. With only one expert, there is no need for adjudication.
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
- MRMC Study: No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. The study involved a single expert reviewing images from both devices, not comparing human readers with and without AI assistance (as this is a detector, not an AI diagnostic tool).
- Effect Size of Human Readers with/without AI assistance: Not applicable, as no AI assistance was involved and the study design was not an MRMC comparative effectiveness study in that context.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- This is a digital X-ray detector, not an AI algorithm. Therefore, the concept of "standalone (algorithm only)" performance without human-in-the-loop is not directly applicable in the same way it would be for an AI diagnostic software.
- However, the non-clinical tests (MTF, DQE, NPS) represent an objective "standalone" performance assessment of the detector's physical imaging characteristics, independent of human interpretation. These tests indicated that the 1012WCA demonstrated better DQE and overall resolution/sharpness compared to the predicate, even if MTF alone was slightly lower in some aspects.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- For the clinical evaluation, the "ground truth" was the expert opinion of a licensed US radiologist. It was implicitly that this expert's assessment of image quality and diagnostic utility served as the basis for comparison between the two devices. There is no mention of pathology, outcomes data, or other objective "ground truth" measures for the clinical aspect.
- For the non-clinical bench testing, the ground truth was based on standardized quantitative metrics like MTF, DQE, and NPS, which are derived from physical measurements according to IEC 62220-1.
8. The sample size for the training set
- Not applicable. This device is a digital X-ray detector, not an AI algorithm that requires a "training set" in the machine learning sense. Its performance is based on its physical design and engineering, not learned from data.
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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K123345
Page 1 of 6
MAR 1 2 2013
Special 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: October 22, 2012
Submitter's Name, address, telephone number, a contact person:
| Submitter's Name : | Rayence Co., Ltd. |
|---|---|
| Submitter's Address: | (Seogu-dong, 2F/4F) 14, Samsung Iro 1-gil,Hwaseong-si, Gyeonggi-do, 445-170, Korea . |
| Submitter's Telephone: | +82-31-8015-6459 |
| Contact person: | Mr. Kee Dock Kim / Manager |
| Official Correspondent:(U.S. Designated agent) | Dave Kim (davekim@mtech-inc.net) |
| Address: | 12946 Kimberley Ln, Houston, TX 77079 |
| Telephone: | +713-467-2607 |
| Fax: | +713-464-8880 |
Name of the device, including the trade or proprietary name if applicable, the common or usual name and the classification name, if known:
| Trade/proprietary name: | 1012WCA |
|---|---|
| Common Name: | Digital Flat Panel X-ray Detector |
| Classification Name : | 21CFR 892.1680, Stationary X-ray System,Solid State X-ray Imaging Device, Class2 |
| Product Code: | MQB |
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K123345
Page 2 of 6
Predicate Device :
| Manufacturer | : Rayence Co., Ltd. |
|---|---|
| Device | : Xmaru1210P |
| 510(k) Number | : K101590 (Decision Date - NOV 29. 2010) |
Device Description :
1012WCA is a wired/wireless digital X-ray flat panel detector that can acquire radiographic images of human anatomy when used with existing radiographic x-ray systems. The wireless LAN((IEEE 802.11a/g/n) communication signals images captured to the system and improves the user operability through high-speed processing. This X-ray imaging detector consists of a scintillator directly coupled to an a-Si TFT sensor. 1012WCA is designed specifically to be integrated with a console PC system and X-Ray generator to digitalize x-ray images into RAW files. The RAW files can be made to DICOM compatible image files which can be viewed by console SW for a radiographic image diagnosis and analysis.
Indication for use :
1012WCA Digital Flat Panel X-Ray Detector is indicated for digital imaging solution designed for human anatomy including head, neck, cervical spine, arm, leg and peripheral (foot, hand, wrist, fingers, etc.). It is intended to replace film based radiographic diagnostic systems and provide a case diagnosis and treatment planning for physicians and other health care professionals. Not to be used for mammography.
Summary of the technological characteristics of the device compared to the predicate device:
The 1012WCA SSXI detector described in this 510(k) has the same indications for use and similar technical characteristics as its predicate device, Xmaru1210P flat panel detector, of Rayence Co., Ltd. Table 1 summarizes the technological characteristics of the 1012WCA and Xmaru1210P, the predicate device.
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K123345
Page 3 of 6
.
:
:
| Characteristic | ProposedRayence Co., Ltd.1012WCA | PredicateRayence Co.,Ltd.Xmaru1210P |
|---|---|---|
| 510(k) number | - | K101590 |
| Intended Use | 1012WCA Digital FlatPanel X-Ray Detector isindicated for digital imagingsolution designed for humananatomy including head,neck, cervical spine, arm, legand peripheral (foot, hand,wrist, fingers, etc.).It is intended to replace filmbased radiographicdiagnostic systems andprovide a case diagnosis andtreatment planning forphysicians and other healthcare professionals. Not to beused for mammography. | Xmaru1210P Digital FlatPanel X-Ray Detector isindicated for digital imagingsolution designed for humananatomy including head,neck, spinal column, arm, legand peripheral (foot, hand,wrist, fingers, etc.).It is intended to replace filmbased radiographicdiagnostic systems andprovide a case diagnosis andtreatment planning forphysicians and other healthcare professionals. Not to beused for mammography. |
| Detector Type | Amorphous Silicon, TFT | Amorphous Silicon, TFT |
| Scintillator | Cesium Iodide | Cesium Iodide |
| Imaging Area | 11 x 13 inches | 11 x 13 inches |
| Pixel matrix | 2080 x 2560 (5.3 million) | 2080 x 2560 ( 5.3 million) |
| Pixel pitch | 127 µm | 127 µm |
| Resolution | 3.9 lp/mm | 3.9 lp/mm |
| A/D conversion | 16 bit | 14 bit |
| Grayscale | 65536(16bit) | 16384 (14bit) |
Table 1· Co mparison of 1012WCA and Yr מחוריו
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K123345
Page 4 of 6
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510(k) Submission - 1012WCA
1
| Preview Image | 3 seconds | 6.5 seconds |
|---|---|---|
| Data output | DICOM 3.0 compatible PrintManagement ServiceClass(SCU), Storage ServiceClass(SCU), and othersDICOM Patient CDDICOM Basic Print | DICOM 3.0 compatible PrintManagement ServiceClass(SCU), Storage ServiceClass(SCU), and othersDICOM Patient CDDICOM Basic Print |
| Dimensions | 395 x 337 x 18 mm | 422 x 403 x 22 mm |
| Weight | 3.15 kg (incl. battery pack) | 3.4 kg |
| Application | Wireless portable systemAvailable with upright stand,table, universal stand | Portable systemAvailable with upright stand,table, universal stand |
| Feature | Image: black box | Image: white box |
Table 2: Size Comparison of 1012WCA and Xmaru1210P
| Item | Unit | 1012WCA | Xmaru1210P |
|---|---|---|---|
| Pixel size | μm | 127 x 127 | 127 x 127 |
| Total horizontal andvertical size | mm | 264 x 325 | 264 x 325 |
| Total horizontal andvertical element count | pixels | 2080 x 2560 | 2080 x 2560 |
| Active area horizontaland vertical size | mm | 259 x 320 | 259 x 320 |
| Active area horizontaland vertical elementcount | pixels | 2040 x 2520 | 2040 x 2520 |
| Pixel spacing | um | 127 | 127 |
| Fill factor | % | 65.14 | 65.14 |
| Weight | Kg | 3.15 Kg | 3.4 Kg |
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Summary of Performance Testing:
The wireless/wired 1012WCA flat panel detector is a modified version of Xmarul210P, FDA cleared under the document number K101590. Indications for use, material, form factor, performance, and safety characteristics between 1012WCA and Xmaru1210P, the predicate device are the same. The non-clinical test report and clinical consideration report were prepared and submitted to FDA separately to demonstrate the substantial equivalency between two different detectors. The non-clinical test report contains the MTF, DQE and NPS test results of 1012WCA and Xmaru1210P by using the identical test equipment and same analysis method described by IEC 62220-1 The comparison of the MTF for 1012WCA and Xmaru1210P detector demonstrated that the MTF of the Xmaru1210P detector performed better than 1012WCA. Nevertheless the overall resolution performance and sharpness of 1012WCA is better than Xmaru1210P which results improvement of the ability of the new detector to represent distinct anatomic features within the imaged object. The DQE represents the ability to visualize object details of a certain size and contrast. 1012WCA demonstrated better DQE performance than Xmaru1210P at various spatial frequencies and provides a higher Signal-to-Noise Ratio (SNR) transfer from the input to the output of a detector as a function of frequency. The reduced noise has improved the accuracy of image and reduced the degree of artifacts for the new detector. Also, the image quality of 1012WCA is greater than Xmaru1210P at the same patient exposure.
To further demonstrate the substantial equivalency of two devices, clinical images are taken from both devices and reviewed by a licensed US radiologist to render an expert opinion. Both test (1012WCA) and control group (Xmaru1210P) are evaluated according to age group and anatomical structures were compared in accordance with the test protocol of diagnostic radiography evaluation procedure.
Based on the non-clinical and clinical consideration and the outcome of an expert review of image comparisons for both devices, we can claim equivalent or better diagnostic image quality of the 1012WCA flat panel detector compared to the predicate device, Xmaru1210P.
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510(k) Submission - 1012WCA
Safety, EMC and Performance Data :
Electrical, mechanical, environmental safety and performance testing according to standard IEC 60601-1:1998+A1:1999+A2:1995(Medical electrical equipment Part 1: General Requirements for Safety) was performed, and EMC testing were conducted in accordance with standard IEC 60601-2 (Medical electrical equipment Part 2: General Requirements for safety - Collateral Standard : Electromagnetic Compatibility Requirements and tests). FCC part 15 subpart B and C, Class A.
All test results were satisfactory.
Conclusions :
The performance data demonstrates that the 1012WCA SSXI detector is as safe and effective as its predicate device, Xmaru1210P. Based on the information in this submission, similarity to the predicate device, and the results of our design control activities, it is our opinion that the 1012WCA flat panel detector is substantially equivalent to the predicate device, Xmaru1210P.
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Image /page/6/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular fashion around the symbol. The logo is black and white.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
March 12, 2013
Rayence Co. Ltd. C/O Dave Kim Mtech Group 12946 Kimberley Lane HOUSTON TX 77079
Re: K123345
Trade/Device Name: Digital Flat Panel X-Ray Detector/1012WCA Regulation Number: 21 CFR 892.1680 Regulation Name: Stationary x-ray system Regulatory Class: II Product Code: MQB Dated: February 8, 2013 Received: February 11, 2013
Dear Mr. Kim:
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. Iisting 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 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.
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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR 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/McdicalDevices/Safetv/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 Small Manufacturers, International and Consumer Assistance 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,
Sm.7)
for
Janine M. Morris 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): K123345
Digital Flat Panel X-ray Detector/1012WCA Device Name:
Indications for Use:
1012WCA Digital Flat Panel X-Ray Detector is indicated for digital imaging solution designed for human anatomy including head, neck cervical spine, arm, leg and peripheral (foot, hand, wrist, fingers, etc.). It is intended to replace film based radiographic diagnostic systems and provide a case diagnosis and treatment planning for physicians and other health care professionals. Not to be used for mammography.
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)
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(Division Sign Off) Division of Radiological Health Office of In Vitro Diagnostic and Radiological Health
K123345 510(k)
Page 1 of
§ 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.