(30 days)
Edge Air Digital Flat Panel X-Ray Detector is indicated for digital imaging solution designed for general radiographic system for human anatomy. It is intended to replace film or screen based radiographic system in all general purpose diagnostic procedures. Not to be used for mammography.
Edge Air is a wired/wireless digital solid state X-ray detector that is based on flat-panel technology. The wireless LAN (IEEE 802.11a/g/n/ac) communication signals images captured to the system and improves the user operability through high-speed processing. This radiographic image detector and processing unit consists of a scintillator coupled to an a-Si TFT sensor. This device needs to be integrated with a radiographic imaging system. It can be utilized to capture and digitalize Xray images for radiographic diagnosis The RAW files can be further processed as DICOM compatible image files by a separate console SW program (K160579 / Xmaru View V1 and Xmaru PACS/ Rayence Co., Ltd.) for a diagnostic analysis.
This document describes the equivalence of the OSKO, INC. Edge Air Digital Flat Panel X-ray Detector to a predicate device, the Rayence Co., Ltd. 1717WCC. The focus is on demonstrating that the Edge Air performs similarly to the predicate device, rather than establishing novel acceptance criteria for improved diagnostic accuracy.
Here's a breakdown of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
Since this is a substantial equivalence submission, the "acceptance criteria" are primarily based on demonstrating similar performance to the predicate device. The performance metrics are reported in terms of comparison.
| Acceptance Criteria (Comparison to Predicate) | Reported Device Performance (Edge Air vs. 1717WCC) |
|---|---|
| Intended Use | Same |
| Detector Type | Same (Amorphous Silicon, TFT) |
| Scintillator | Same (CsI:T1) |
| Imaging Area | Same (17 x 17 inches) |
| Pixel Matrix | Same (3072 X 3072) |
| Pixel Pitch | Same (140 um) |
| Resolution | Same (3.9 lp/mm) |
| A/D Conversion | Same (14 / 16 bit) |
| Preview Time | Same (<2 seconds) |
| MTF (@1lp/mm) | 58% (Edge Air) vs. 56% (1717WCC) - Similar |
| DQE (@0.1lp/mm) | 77.5% (Edge Air) vs. 80% (1717WCC) - Similar |
| Data Output | Same (RAW, convertible to DICOM 3.0 by console S/W) |
| Imaging Software | Same (Xmaru View 1 / Xmaru PACS, Version 2.0.0) |
| Wireless Specifications | Same |
| Dimensions | Same (460 × 460 × 15 mm) |
| Weight | Same (3.5 kg, incl. battery) |
| Application | Same (General Radiology system or Wireless/Wired portable system) |
| Overall Diagnostic Image Quality | "Edge Air is similar to the same view obtained from a similar patient with the predicate device, 1717WCC. In general, the spatial and soft tissue contrast resolutions for both devices are equivalent. Specially, the soft tissues on extremity films were seen with better clarity." |
| Electrical, Mechanical, Environmental Safety | Satisfactory (according to IEC 60601-1:2005 and IEC 60601-1-2:2007) |
2. Sample Size Used for the Test Set and Data Provenance
The document mentions "talking sample radiographs of similar age group and anatomical structures" for the clinical image review. However, the specific sample size of images or patients for the test set is not explicitly stated.
The data provenance for the clinical images is not explicitly stated in terms of country of origin, but it is implied to be for human anatomy and diagnostic procedures. It is a prospective comparison of images taken with the Edge Air and the predicate device.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts
One expert was used for the clinical image review. The expert is described as a "licensed radiologist." No specific details about years of experience are provided.
4. Adjudication Method for the Test Set
The adjudication method appears to be a single expert review. The licensed radiologist reviewed images from both the Edge Air and the predicate device to render an opinion on their similarity and diagnostic image quality. There is no mention of multiple readers or consensus methods.
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, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This submission is for a digital flat panel X-ray detector, which is a hardware device for image acquisition, not an Artificial Intelligence (AI) diagnostic tool. Therefore, the concept of human readers improving with or without AI assistance is not applicable here.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
Yes, in essence, standalone performance was assessed through non-clinical tests.
The non-clinical tests (MTF, DQE, NPS) are measures of the device's inherent imaging performance characteristics without human interpretation. These tests were conducted by "using the identical test equipment and same analysis method described by IEC 6220-1." The comparison against the predicate device's specifications serves as the standalone performance evaluation.
7. The Type of Ground Truth Used
For the non-clinical tests (MTF, DQE, NPS), the ground truth is based on standardized physical measurements as described by IEC 6220-1.
For the clinical image review, the ground truth is based on expert opinion/consensus by a licensed radiologist regarding the visual similarity and diagnostic quality of the images. This is a form of expert consensus, although only one expert is mentioned.
8. The Sample Size for the Training Set
The document specifies the Edge Air detector "uses the same flat panel x-ray detector as that used in the predicate device, K162519, and that no changes were necessary to either the hardware or firmware of the device." It also states it uses the "same version of imaging software Xmaru View 1 / Xmaru PACS (K160579)."
Given that this is a 510(k) submission for a device demonstrating substantial equivalence to a predicate, and the hardware and software are identical to the predicate, there is no mention of a separate "training set" for the Edge Air device's image processing. The underlying technology (detector and software) would have been "trained" or developed during the creation of the predicate device and the imaging software (K160579). The context here is not an AI algorithm that requires a distinct training set for this specific submission.
9. How the Ground Truth for the Training Set Was Established
As explained above, this submission does not explicitly discuss a new "training set" for the Edge Air device. The device leverages existing, established hardware and software from the predicate. Therefore, the question of how a training set's ground truth was established for the Edge Air is not applicable in this document's context, as it's not a new AI-driven diagnostic system requiring novel training data. The "ground truth" for the predicate device and its associated software would have been established during their respective development and clearance processes.
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
October 6, 2017
OSKO, INC. % Mr. Dave Kim Medical Device Regulatory Affairs Mtech Group 8310 Buffalo Speedway HOUSTON TX 77025
Re: K172681
Trade/Device Name: Edge Air Digital Flat Panel X-ray Detector Regulation Number: 21 CFR 892.1680 Regulation Name: Stationary x-ray system Regulatory Class: II Product Code: MQB Dated: August 29, 2017 Received: September 6, 2017
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, 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 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 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/Resourcesfor You/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 Edge Air Digital Flat Panel X-ray Detector
Indications for Use (Describe)
Edge Air Digital Flat Panel X-Ray Detector is indicated for digital imaging solution designed for general radiographic system for human anatomy. It is intended to replace film or screen based radiographic system in all general purpose diagnostic procedures. Not to be used for mammography.
| 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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1. Traditional 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: September 29, 2017
Submitter's Name, address, telephone number, a contact person:
| Submitter's Name: | OSKO, Inc. |
|---|---|
| Submitter's Address: | 8085 NW 90th Street, Miami, Florida 33166, USA |
| Submitter's Telephone: | +1-305-599-7161 |
| Contact Person: | Ms. Vivian Garcia / RA Manager / +1-305-599-7161 |
| Official Correspondent: | Dave Kim (davekim@mtech-inc.net) (U.S. Agent) |
| Address: | 8310 Buffalo Speedway, Houston, TX 77025 |
| Telephone: | +713-467-2607 |
| Fax: | +713-583-8988 |
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: | EdgeAir | |
|---|---|---|
| Common Name: | Digital Flat Panel X-ray Detector | |
| Classification Name: | 21CFR892.1680 / Stationary x-ray system | |
| Product Code: | MQB | |
| Product Classification: | Class II | |
| Predicate Device: | ||
| Manufacturer: | Rayence Co., Ltd. | |
| Device: | 1717WCC | |
| 510(k) Number: | K162519 | |
| Classification Name: | 21CFR892.1680 / Stationary x-ray system | |
| Product Code: | MQB (Class II) |
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2. Device Description
Edge Air is a wired/wireless digital solid state X-ray detector that is based on flat-panel technology. The wireless LAN (IEEE 802.11a/g/n/ac) communication signals images captured to the system and improves the user operability through high-speed processing. This radiographic image detector and processing unit consists of a scintillator coupled to an a-Si TFT sensor. This device needs to be integrated with a radiographic imaging system. It can be utilized to capture and digitalize Xray images for radiographic diagnosis The RAW files can be further processed as DICOM compatible image files by a separate console SW program (K160579 / Xmaru View V1 and Xmaru PACS/ Rayence Co., Ltd.) for a diagnostic analysis.
3. Intended Use
Edge Air Digital Flat Panel X-Ray Detector is indicated for digital imaging solution designed for general radiographic system for human anatomy. It is intended to replace film or screen based radiographic system in all general-purpose diagnostic procedures. Not to be used for mammography.
4. Summary of Design Control Risk Management
The Edge Air Digital Flat Panel X-Ray Detector is developed for the purpose of portable imaging. The risk and the hazardous impact of the device modification were analyzed with FMEA method. The specific risk control and protective measures to mitigate the risks from the modification were reviewed and implemented in the new product design phase. The overall assessment concluded that all risks and hazardous conditions identified arising from the design change were successfully mitigated and accepted.
The Edge Air Digital Flat Panel Detector uses the same flat panel x-ray detector as that used in the predicate device, K162519, and that no changes were necessary to either the hardware or firmware of the device.
5. Summary of the technological characteristics of the device compared to the predicated device:
The Edge Air detector described in this 510(k) has the same indications for use and similar technical characteristics as the predicate devices, 1717WCC of Rayence Co., Ltd
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510(k) Submission - Edge Air
The Edge Air detector described in this 510(k) uses the same hardware, firmware and the same version of imaging software Xmaru View 1 / Xmaru PACS (K160579), without any change, that are used by the predicate device, 1717WCC.
Xmaru View 1 FDA 510(k) information is as follows:
| Item | DeviceClassificationName | Device name | 510(k)number | Applicant |
|---|---|---|---|---|
| FDA510(k) | System, ImageProcessing,Radiological | Xmaru View V1 andXmaru PACS, Medicalimage processingsoftware | K160579 | Rayence Co.,Ltd. |
5.1 Comparison Table
| Characteristic | ProposedOSKO, INC.Edge Air | PredicateRayence Co., Ltd.1717WCC | |
|---|---|---|---|
| Feature | Image: OSKO, INC. Edge Air | Image: Rayence Co., Ltd. 1717WCC | |
| 510(k) number | K176281 | K162519 | |
| Intended Use | Edge Air Digital Flat Panel X-Ray Detector is indicated fordigital imaging solutiondesigned for generalradiographic system for humananatomy. It is intended toreplace film or screen basedradiographic system in allgeneral-purpose diagnosticprocedures. Not to be used formammography. | 1717WCC Digital Flat Panel X-Ray Detectors are indicated fordigital imaging solutiondesigned for generalradiographic system for humananatomy. It is intended toreplace film or screen basedradiographic system in allgeneral-purpose diagnosticprocedures. Not to be used formammography. | Same |
| Detector Type | Amorphous Silicon, TFT | Amorphous Silicon, TFT | Same |
| Scintillator | CsI:T1 | CsI:T1 | Same |
| Imaging Area | 17 x 17 inches | 17 x 17 inches | Same |
| Pixel Matrix | 3072 X 3072 | 3072 X 3072 | Same |
| Pixel Pitch | 140 um | 140 um | Same |
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510(k) Submission - Edge Air
| Resolution | 3.9 lp/mm | 3.9 lp/mm | Same |
|---|---|---|---|
| A/DConversion | 14 / 16 bit | 14 / 16 bit | Same |
| Preview Time | <2 | <2 | Same |
| MTF(@1lp/mm) | 58 (%)*Result value from Non-Clinical Report | 56 (%) | Similar |
| DQE(@0.1lp/mm) | 77.5 (%)* Result value from Non-Clinical Report | 80 (%) | Similar |
| Data Output | RAW*The RAW files are convertibleinto DICOM 3.0 by consoleS/W | RAW*The RAW files are convertibleinto DICOM 3.0 by consoleS/W | Same |
| ImagingSoftware | Xmaru View 1 / Xmaru PACS(Version 2.0.0) | Xmaru View 1 / Xmaru PACS(Version 2.0.0) | Same |
| WirelessSpecifications | -Standard: 802.11 a/g/n/ac complianceWithout DFS (5.25GH to 5.35GHzand5.47 to 5.725) Band-Peak Rate:1300Mbps-Frequency: 2.4 GHz / 5 GHz-Bandwith: 20MHz / 40MHz / 80MHz-MIMO: 3 x 3 | -Standard: 802.11 a/g/n/ac complianceWithout DFS (5.25GH to 5.35GHzand5.47 to 5.725) Band-Peak Rate:1300Mbps-Frequency: 2.4 GHz / 5 GHz-Bandwith: 20MHz / 40MHz / 80MHz-MIMO: 3 x 3 | Same |
| Dimensions | 460 × 460 × 15 mm | 460 × 460 × 15 mm | Same |
| Weight | 3.5 kg (incl. battery) | 3.5 kg (incl. battery) | Same |
| Application | General Radiology system orWireless/Wired portable systemAvailable with upright stand,table, universal stand | General Radiology system orWireless/Wired portable systemAvailable with upright stand,table, universal stand | Same |
| AddedOptionalComponents | Battery & Battery ChargerInterface Cox IrDA module | Battery & Battery ChargerInterface Cox IrDA module | Same |
The Edge Air Digital Flat Panel Detector is identical to the wireless hardware and . functionality of the predicate device, 1717WCC.
Maximum wireless signal rate derived from IEEE standard specifications. Actual data throughput will vary. Network conditions and environmental factors, including volume of network traffic, building materials and construction, and network overhead, lower actual data throughput rate.
5.2 Scintillator Layer
The scintillator (a phosphor that produces scintillations) layer of the Edge Air detector is described as below.
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510(k) Submission – Edge Air
| Proposed | Predicate | |
|---|---|---|
| CsI(Cesium Iodide) | Edge Air | 1717WCC |
5.3 Added Optional Components
| Components | Description |
|---|---|
| Battery & Battery ChargerImage: Battery and battery charger | Sources of electricity |
| Mobile Battery ChargerImage: Mobile battery charger | |
| Interface BoxImage: Interface box | 1) Connector to synchronize the detector and its generator.2) Data transfer and battery charge while the detector is in use(Connect between the detector and Interface Box), Up tothree detectors can be connected.3) Transmitting an image/command between the detector andPC.4) Wireless AP. |
| IrDA moduleImage: IrDA module | Sharing function for PC and the detector. |
5.4 Recommended Generator Specification
| Model | Manufacture | Specification | ||
|---|---|---|---|---|
| CMP 200 | Communications & PowerIndustries | 32kW | 40kW | 50kW |
| kVp | 40-125 | 40-150 |
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510(k) Submission - Edge Air
| mA | 10-400 | 10-500 | 10-630 | ||
|---|---|---|---|---|---|
| EDITOR HFe 501 | Rontgenwerk Bochum | kVp | 40-150 | ||
| mA | 10-630 | ||||
| UD150L-40E/40F | Shimadzu | kVp | 40-150 | ||
| mA | @100 kVp- 500(320) | ||||
| @80 kVp- 630(400) | |||||
| PXR-321B | POSKO, m Co.,Ltd. | kVp | 125/150 | ||
| mA | 500 |
Image /page/8/Picture/2 description: The image shows a caution sign. The sign is a white square with a black dashed border. Inside the square, there is a black triangle with an exclamation point inside. Below the triangle, the word "CAUTION" is written in black, bold letters.
To our best knowledge, the detector is compatible with the X-rav generators with the specifications described above.
If you have questions regarding the compatibility issue for other generators which are not listed above, please contact your OSKO, Inc. representative.
6. Summary of Performance Testing compared with predicate device
The Edge Air Digital Flat Panel X-Ray Detector has the same indications for use, material, form factor, performance, and safety characteristics compared to the predicate device, 1717WCC. The non-clinical test and clinical consideration test for the Edge 41 have been performed to demonstrate the substantial equivalency of the subject devices compared to the predicate device, 1717WCC. The non-clinical test report contains the MTF, DOE and NPS test results of Edge Air by using the identical test equipment and same analysis method described by IEC 6220-1.
The comparative result of the MTF and DOE test for Edge 4" detector with respect to the predicate demonstrated that the MTF and DQE of the subject devices performed same with the predicate device, 1717WCC. The MTF and DQE represent the ability to visualize object details of a certain size and contrast. The comparable performance of the MTF and DQE for the Edge An detector demonstrated that the performed almost same with 1717WCC.
To further demonstrate the substantial equivalency of the Edge Art, clinical images have been reviewed by a licensed radiologist to render an expert opinion. The test subject (Edge Air) and the predicate device (1717WCC) have been evaluated and compared by talking sample radiographs of similar age group and anatomical structures in accordance with the test protocol of diagnostic radiography evaluation procedure.
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After a broad review of plain radiographic images taken with the Edge Air, the image obtained with the Edge Air is similar to the same view obtained from a similar patient with the predicate device, 1717WCC. In general, the spatial and soft tissue contrast resolutions for both devices are equivalent. Specially, the soft tissues on extremity films were seen with better clarity. Based on the non-clinical and clinical consideration test and the outcome of a comparative review by an expert for the Edge Air, the sponsor can claim the substantial equivalency between the subject
device and the predicate device in terms of diagnostic image quality.
The manufacturing facility is in conformance with the design control procedure requirements and the relevant EPRC standards as specified in 21 CFR 802.30 and the records are available for review.
Note: Clinical images were provided: even though these images are not necessary to establish substantial equivalence based on the modifications to the device, they provide additional evidence in addition to bench testing data to show that the complete system works as intended.
7. Summary for any testing in the submission:
Electrical, mechanical, environmental safety and performance testing according to standard IEC 60601-1:2005 (3rd Edition) + CORR. 1:2006 + CORR. 2:2007 + A1:2012 (Medical electrical equipment Part 1: General requirements for basic safety and essential performance) was performed, and EMC testing were conducted in accordance with standard IEC 60601-1-2:2007.
The Non-clinical consideration & performance test have been conducted according to the following FDA Guidance.
- Performance Standards for Ionizing Radiation Emitting Products, 21 CFR 1020 -
- -Diagnostic x-ray systems and their major components, 21 CFR 1020.30
- Radiographic Equipment, 21 CFR 1020.31 -
- FDA Guidance for the Submission of 510(k)s for Solid State X-ray Imaging Devices -
- -FDA Guidance titled "Content of Premarket Submissions for Management of Cybersecurity in Medical Devices"
All test results were satisfactory.
8. Conclusion:
In accordance with the Federal Food, Drug and Cosmetic Act, 21 CFR Part 807 and based on the information provided in this premarket notification OSKO, INC. concludes that Edge Air is substantially equivalent in comparison with 1717WCC, the predicate device as described herein.
§ 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.