(24 days)
Edge Air(1417) 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 40(1417) is a wired/wireless digital solid state X-ray detector that is based on flat-panel technology. The wireless LAN (IEEE 802.11a/g/w/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 X-ray images for radiographic diagnosis The RAW files can be further processed as DICOM compatible image files by a separate console SW program (K190866 / Xmaruview V1 (Xmaru Chiroview, Xmaru Podview) / Rayence Co., Ltd.) for a diagnostic analysis.
The provided text describes the Edge Air (1417) Digital Flat Panel X-ray Detector, a device intended to replace film or screen-based radiographic systems for general diagnostic procedures, excluding mammography. The submission argues for substantial equivalence to a predicate device, Edge Air (K172681).
Here's an analysis of the acceptance criteria and the study that proves the device meets them:
1. Table of Acceptance Criteria and Reported Device Performance
The submission primarily focuses on demonstrating substantial equivalence to a predicate device, rather than defining explicit acceptance criteria against a fixed standard. However, the comparisons provided between the proposed device and the predicate device can be interpreted as the performance metrics and their desired "acceptance" (i.e., being similar or equivalent to the predicate).
| Criterion (Implicit Acceptance Target: Similar to Predicate) | Proposed Device (Edge Air (1417)) Performance | Predicate Device (Edge Air) Performance | Outcome |
|---|---|---|---|
| Intended Use | General radiographic system for human anatomy, not for mammography | General radiographic system for human anatomy, not for mammography | Same |
| Detector Type | Amorphous Silicon, TFT | Amorphous Silicon, TFT | Same |
| Scintillator | CsI:TI | CsI:TI | Same |
| Imaging Area | 14 × 17 inches | 17 × 17 inches | Similar (smaller size acknowledged) |
| Pixel Matrix | 2500 × 3052 | 3072 × 3072 | Similar (related to smaller imaging area) |
| Pixel Pitch | 140 μm | 140 μm | Same |
| Resolution | 3.57 lp/mm | 3.57 lp/mm | Same |
| A/D Conversion | 14 / 16 bit | 14 / 16 bit | Same |
| Preview Time | ≤2 | ≤2 | Same |
| MTF (@1lp/mm) | 53.0 (%) | 55.3 (%) | Similar |
| DQE (@0.1lp/mm) | 75.1 (%) | 74.4 (%) | Similar |
| NPS (@0.1lp/mm) | 11.307 | 6.875 | Similar |
| Data Output | DICOM 3.0 | DICOM 3.0 | Same |
| Imaging Software | Xmaruview V1 (K190866) | Xmaruview V1 (K190866) | Same |
| Wireless Specifications | Standard: 802.11 a/g/n/ac compliance | Standard: 802.11 a/g/n/ac compliance | Same |
| Dimensions | 384 × 460 × 15 mm | 460 × 460 × 15 mm | Similar (smaller, as intended) |
| Weight | 3.0 kg (incl. battery) | 3.5 kg (incl. battery) | Similar (lighter, as intended) |
| Application | General radiology system or portable system | General radiology system or portable system | Same |
2. Sample Size Used for the Test Set and Data Provenance
The document mentions "clinical images have been reviewed by a licensed radiologist" for the "clinical consideration test." However, it does not specify the exact sample size (number of images or patients) used for this clinical review or the demographics of the "similar age group and anatomical structures."
The data provenance is implicitly prospective for the clinical images used for comparison, as they involved "taking sample radiographs." The country of origin of the data is not specified.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Only one expert is mentioned: "a licensed radiologist." No specific details about the radiologist's experience (e.g., "10 years of experience") are provided beyond being "licensed" and an "expert opinion."
4. Adjudication Method for the Test Set
The adjudication method appears to be none beyond a single expert's opinion. The text states, "clinical images have been reviewed by a licensed radiologist to render an expert opinion." There is no mention of multiple readers, consensus, or a specific adjudication process for discrepancies.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance
No MRMC comparative effectiveness study was done as described for an AI device. This submission is for a digital flat panel X-ray detector, which is a hardware component for image acquisition, not an AI-powered diagnostic tool. The device itself does not involve AI assistance for human readers in the sense of improving their diagnostic capability. The comparison is for image quality of two different hardware detectors.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Again, this question is not directly applicable to the device under review. The Edge Air (1417) is an X-ray detector, not a standalone algorithm. Its "performance" is measured by physical characteristics (MTF, DQE, NPS) and its ability to produce diagnostic images comparable to a predicate device. The imaging software (Xmaruview V1) is mentioned as a separate 510(k) (K190866), but the submission for the detector itself does not detail standalone performance of an algorithm.
7. The Type of Ground Truth Used
For the non-clinical tests (MTF, DQE, NPS), the ground truth is derived from physical measurements against established standards (IEC 62220-1).
For the "clinical consideration test," the ground truth is expert opinion/comparison by a single licensed radiologist, asserting similarity in image quality ("spatial and soft tissue contrast resolutions for both devices are equivalent"). It's a comparative visual assessment against images from the predicate device by an expert.
8. The Sample Size for the Training Set
The concept of a "training set" is not directly applicable here. This is a hardware device (X-ray detector). The imaging software (Xmaruview V1) might have had a training set if it involved AI, but the submission for the detector does not provide this information. The device's manufacturing and performance are based on engineering design and testing, not machine learning training.
9. How the Ground Truth for the Training Set Was Established
Since there is no "training set" for the X-ray detector itself, this question is not applicable.
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June 29, 2020
Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, with the word "ADMINISTRATION" underneath.
Osko, Inc. % Mr. Hanmaru Chon Regulatory Affairs Manager 8085 NW 90th Street MIAMI FL 33166
Re: K201503
Trade/Device Name: Edge Air (1417) Digital Flat Panel X-ray Detector Regulation Number: 21 CFR 892.1680 Regulation Name: Stationary x-ray system Regulatory Class: Class II Product Code: MQB Dated: June 12, 2020 Received: June 12, 2020
Dear Mr. Chon:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmp/pmn.cfm identifies combination product submissions. 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 of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see
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https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
For
Thalia T. Mills, Ph.D. Director Division of Radiological Health OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K201503
Device Name Edge Air(1417) Digital Flat Panel X-Ray Detector
Indications for Use (Describe)
Edge Air(1417) 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) | |
|---|---|
| X Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
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510(k) Submission Number: K201503
1. Special 510(k) Summary
Product Code:
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: May 29, 2020
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: | Mr. Hanmaru Chon / RA Manager / +1-305-599-7161 |
| Official Correspondent: | Mr. Hanmaru Chon (hanmaru@oskomedical.com) |
| Address: | 8085 NW 90th Street, Miami, Florida 33166, USA |
| Telephone: | +1 305-599-7161 |
| Fax: | +1 305-599-7144 |
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 and Common Name: | Edge Air(1417) Digital Flat Panel X-Ray Detector |
|---|---|
| Classification Name: | 21CFR892.1680 / Stationary x-ray system |
| Product Code: | MQB |
| Product Classification: | Class II |
| Predicate Device | |
| Manufacturer: | OSKO, INC. |
| Device: | Edge Air |
| 510(k) Number: | K172681 |
| Classification Name: | 21CFR892.1680 / Stationary x-ray system |
MQB (Class II)
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2. Device Description
Edge 40(1417) is a wired/wireless digital solid state X-ray detector that is based on flat-panel technology. The wireless LAN (IEEE 802.11a/g/w/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 X-ray images for radiographic diagnosis The RAW files can be further processed as DICOM compatible image files by a separate console SW program (K190866 / Xmaruview V1 (Xmaru Chiroview, Xmaru Podview) / Rayence Co., Ltd.) for a diagnostic analysis.
3. Intended Use
Edge 44(1417) 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 40 (1417) 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 ^*(1417) Digital Flat Panel X-Ray Detector uses the same flat panel x-ray detector as that used in the predicate device Edge Air, K172681, 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 **(1417) detector described in this 510(k) has the same indications for use and similar technical characteristics as the predicate devices, Edge Air of OSKO, INC.
The Edge 4"(1417) detector described in this 510(k) uses the same hardware, firmware and the same version of imaging software Xmaruview V1(K190866), without any change, that the predicate device Edge Air. The only difference from the predicate detector is a smaller size. All other technological characteristics are similar.
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510(k) Submission – Edge Air
| Item | DeviceClassificationName | Device name | 510(k)number | Applicant |
|---|---|---|---|---|
| FDA510(k) | System, ImageProcessing,Radiological | Xmaruview V1 (XmaruChiroview, XmaruPodview) | K190866 | Rayence Co.,Ltd. |
Xmaruview V1 FDA 510(k) information is as follows:
5.1 Comparison Table
| Proposed | Predicate | ||
|---|---|---|---|
| Characteristic | OSKO, INC.Edge Air(1417) | OSKO, INC.Edge Air | |
| Feature | Image: Proposed OSKO, INC. Edge Air(1417) | Image: Predicate OSKO, INC. Edge Air | |
| 510(k) number | K172681 | Same | |
| Intended Use | Edge Air(1417) Digital Flat Panel X-Ray Detector is indicated for digitalimaging solution designed forgeneral radiographic system forhuman anatomy. It is intended toreplace film or screen basedradiographic system in all general-purpose diagnostic procedures. Notto be used for mammography. | Edge Air Digital Flat Panel X-RayDetector is indicated for digitalimaging solution designed forgeneral radiographic system forhuman anatomy. It is intended toreplace film or screen basedradiographic system in all general-purpose diagnostic procedures.Not to be used for mammography. | Same |
| Detector Type | Amorphous Silicon, TFT | Amorphous Silicon, TFT | Same |
| Scintillator | CsI:TI | CsI:TI | Same |
| Imaging Area | 14 × 17 inches | 17 × 17 inches | Similar |
| Pixel Matrix | 2500 × 3052 | 3072 × 3072 | Similar |
| Pixel Pitch | 140 μm | 140 μm | Same |
| Resolution | 3.57 lp/mm | 3.57 lp/mm | Same |
| A/DConversion | 14 / 16 bit | 14 / 16 bit | Same |
| Preview Time | ≤2 | ≤2 | Same |
| MTF(@1lp/mm) | 53.0 (%)*Result value from Non-ClinicalReport | 55.3 (%)*Result value from Non-ClinicalReport | Similar |
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510(k) Submission - Edge Air
| DQE(@0.1lp/mm) | 75.1 (%)*Result value from Non-ClinicalReport | 74.4 (%)*Result value from Non-ClinicalReport | Similar |
|---|---|---|---|
| NPS(@0.1lp/mm) | 11.307*Result value from Non-ClinicalReport | 6.875*Result value from Non-ClinicalReport | Similar |
| Data Output | DICOM 3.0 | DICOM 3.0 | Same |
| ImagingSoftware | Xmaruview V1 | Xmaruview V1 | 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 | 384 × 460 × 15 mm | 460 × 460 × 15 mm | Similar |
| Weight | 3.0 kg (incl. battery) | 3.5 kg (incl. battery) | Similar |
| Application | General radiology system orportable system | General radiology system orportable system | Same |
| AddedOptionalComponents | Battery & Battery Charger, PowerSupply | Battery & Battery Charger, PowerSupply, Interface Cox IrDAmodule | Similar |
. The Edge ^*(1417) Digital Flat Panel X-ray Detector is identical to the wireless hardware and functionality of the predicate device, Edge Air. 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 4"(1417) detector is described as below.
| Proposed | Predicate | |
|---|---|---|
| CsI(Cesium Iodide) | Edge $Air$ (1417) | EdgeAir |
5.3 Recommended Generator Specification
The subject detector Edge Air(1417) does not connect to the x-ray generator. The subject detector is compatible with any x-ray system operating at 40 to 150 KVp and 0.1 to 1000 mAs
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6. Summary of Performance Testing compared with predicate device
The Edge 44(1417) Digital Flat Panel X-Ray Detector has the same indications for use, material, form factor, performance, and safety characteristics compared to the predicate device, Edge Au.
The non-clinical test and clinical consideration test for the Edge Ait have been performed to demonstrate the substantial equivalency of the subject devices compared to the predicate device, Edge A. The non-clinical test report contains the MTF, DQE and NPS test results of Edge 44"(1417) by using the identical test equipment and same analysis method described by IEC 62220-1.
The comparative result of the MTF and DQE test for Edge ^(1417) detector with respect to the predicate demonstrated that the MTF and DQE of the subject devices performed same with the predicate device, Edge Air. 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 Air(1417) detector demonstrated that the performed almost same with Edge Air.
To further demonstrate the substantial equivalency of the Edge **(1417), clinical images have been reviewed by a licensed radiologist to render an expert opinion. The test subject (Edge Air(1417)) and the predicate device (Edge Air) 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.
After a broad review of plain radiographic images taken with the Edge Air(1417), the image obtained with the Edge 4"(1417) is similar to the same view obtained from a similar patient with the predicate device, Edge 44. 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 All(1417), 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
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- -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 4"(1417) is substantially equivalent in comparison with Edge Air, 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.