(92 days)
The DENTRIa series is a Computed Tomography X-Ray imaging device specialized in diagnosing general dental treatments and orthodontic purpose using Panoramic and Cephalometric images respectively. In addition DENTRIC series is used in the field of Otolaryngology by capturing 360 degree rotation sequence of the head and neck areas, including the ENT and dentomaxillofacial areas for a dental treatment in adult and pediatric dentistry and obtains x-ray images from different angles and calculate through computer-processed to produce 3D x-ray tomographic images. The DENTRIC series used by physicians, dentists, and x-ray technologists.
This Equipment is a Dental X-Ray imaging device used for diagnostic purpose in dental treatment. The operating principle of this device is obtaining the tomographic, and panoramic images by rotating arm to get the recombination data. X-ray generator and detector rotate around the patient to irradiate the X-ray, and penetrated X-ray is measured by the detector. When the X-ray is irradiated on the teeth area for instance, large amount of X-ray is attenuated because objects such as bones are highly dense. On the contrast, X-ray is more permeable to small molecules with low density such as skin or tissue, so more X-ray would pass through the subject. By measuring data obtained from measuring the X-ray is reconstructed by the software to display and analyze the anatomical structure for the diagnosis purposes.
The provided text is a 510(k) summary for the DENTRIa series of computed tomography X-ray systems, which focuses on demonstrating substantial equivalence to a predicate device. It contains information about non-clinical testing for imaging performance but does not describe a study that uses acceptance criteria for algorithm performance (e.g., sensitivity, specificity, or accuracy) against a defined ground truth for a test set, which would typically be present for an AI/ML medical device.
Therefore, I cannot provide a table of acceptance criteria and reported device performance for an AI/ML algorithm or details about a study evaluating its performance in the requested format.
However, I can extract information related to the device's technical performance testing that is present in the document.
1. A table of acceptance criteria and the reported device performance:
As stated above, this document primarily discusses the substantial equivalence of an X-ray imaging device to a predicate device based on technical characteristics and general performance, not the performance of an AI/ML algorithm against clinical acceptance criteria. The document lists technical specifications rather than specific clinical performance criteria for an AI/ML component.
Below is a table summarizing some of the technical performance evaluations mentioned:
| Acceptance Criteria (Measured Technical Performance) | Reported Device Performance (Subject Device) |
|---|---|
| Modulation Transfer Function (MTF) | CT: 57% at 1 lp/mm or 60% at 1 lp/mmPanorama: 57% at 1 lp/mm or 60% at 1 lp/mmCephalo (One-shot): 83.3% at 2 lp/mmCephalo (Scan): 65% at 1 lp/mm |
| Detective Quantum Efficiency (DQE) | CT: 70% at 0 lp/mm or 60% at 1 lp/mmPanorama: 70% at 0 lp/mm or 60% at 1 lp/mmCephalo (One-shot): 38.5% at 0 lp/mmCephalo (Scan): 57% at 1 lp/mm |
| Compliance with IEC 61223-3-4 | Met all requirements of the standard |
| X-ray Tube Voltage Settings | CT: 60-110 kV ±8%Panorama: 60-90 kV ±8%Cephalo (One-Shot): 60-110 kV ±8%Cephalo (Scan): 60-90 kV ±8% |
| X-ray Tube Current Settings | 4-10 mA ±10% |
| Irradiation Time Settings | CT: 8.0-36.0 s ± (5% + 50 ms)Panorama: 1.2-14.0 s ± (5% + 50 ms)Cephalo (One-Shot): 0.5 s to 2.0 s ± (5% + 50 ms)Cephalo (Scan): 2.5-8.0 s ± (5% + 50 ms)Model Scan: 24 s |
| Electrical Safety & Essential Performance | Complies with ES60601-1 |
| Electromagnetic Compatibility (EMC) | Complies with IEC 60601-1-2 |
| Radiation Protection | Complies with IEC 60601-1-3 |
| Dental Extra-Oral X-Ray Equipment Requirements | Complies with IEC 60601-2-63 |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
The document does not describe a test set or data provenance in the context of validating an AI/ML algorithm's clinical performance. The "performance test" section mentions "bench testing" and "image performance testing" conducted according to IEC 61223-3-4 and SSXI (Solid State X-ray Imaging) Devices guidance. These are hardware and imaging physics performance tests, not clinical evaluations with patient data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):
Not applicable. The document does not describe a clinical ground truth establishment process for an AI/ML component.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
Not applicable.
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:
Not applicable. The submission is for an X-ray imaging device, not an AI/ML software assistance tool for readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. The document describes an X-ray imaging system, which inherently involves human operation and interpretation. The "software validation" section mentions "original software and OTS software as an image viewer" and that the "algorithm type of image reconstruction is FBP (Filtered Back Projection)," but this is about image reconstruction, not a standalone diagnostic AI algorithm.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc):
Not applicable. For the technical performance tests mentioned (MTF, DQE), the "ground truth" would be established physical standards and measurement techniques.
8. The sample size for the training set:
Not applicable. There is no mention of a training set for an AI/ML algorithm.
9. How the ground truth for the training set was established:
Not applicable.
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October 19, 2021
Image /page/0/Picture/1 description: The image contains 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 a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
HDX Will Corp. % Kaon Kim Junior Manager, Regulatory Affairs #105, 106, 201, 202, 203, 204, 38, Osongsaengmyeong 4-ro Osong-eup. Heungdeok-gu Cheongju-si, Chungcheongbuk-do 28161 REPUBLIC OF KOREA
Re: K212254
Trade/Device Name: DENTRIa series (DENTRIα, DENTRI-Cα, DENTRI-Sα) Regulation Number: 21 CFR 892.1750 Regulation Name: Computed tomography x-ray system Regulatory Class: Class II Product Code: OAS Dated: July 20, 2021 Received: July 22, 2021
Dear Kaon 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. 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/cfpmn/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
{1}------------------------------------------------
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 https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) 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 mediation-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) K212254
Device Name DENTRIa series (DENTRIa, DENTRI-Ca, DENTRI-Sa)
Indications for Use (Describe)
The DENTRIa series is a Computed Tomography X-Ray imaging device specialized in diagnosing general dental treatments and orthodontic purpose using Panoramic and Cephalometric images respectively. In addition DENTRIC series is used in the field of Otolaryngology by capturing 360 degree rotation sequence of the head and neck areas, including the ENT and dentomaxillofacial areas for a dental treatment in adult and pediatric dentistry and obtains x-ray images from different angles and calculate through computer-processed to produce 3D x-ray tomographic images. The DENTRIC series used by physicians, dentists, and x-ray technologists.
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
[As required by 21 CFR 807.92]
1. Date Prepared [21 CFR 807.92(a)(1)]
October 14th, 2021
2. Submitter's Information [21 CFR 807.92(a)(1)]
| - Name of Manufacturer: | HDX WILL Corp. |
|---|---|
| - Address: | #105, 106, 201, 202, 203, 204, 38, Osongsaengmyeong4-ro, Osong-eup, Heungdeok-gu, Cheongju-si,Chungcheongbuk-do, 28161, Republic of Korea |
| - Contact Person: | Kaon Kim / Junior Manager |
| - Telephone No.: | +82-43-710-7318 |
| - Fax No.: | +82-43-710-7312 |
| - Email Address: | kaonkim@iwillmed.com |
| - Registration No.: | 3013511605 |
3. Trade Name, Regulation Name, Classification [21 CFR 807.92(a)(2)]
| Device Name | DENTRIa series(DENTRIa, DENTRI-Ca, DENTRI-Sa) |
|---|---|
| Regulation Number | 21 CFR 892.1750 |
| Regulation Name | Computed tomography x-ray system |
| Common/Usual Name | Dental X-ray System |
| Regulatory Class | Class II |
| Product Code | OAS |
| Classification Name | X-Ray, Tomography, Computed, Dental |
| Panel | Radiology |
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4. Identification of Predicate Device(s) [21 CFR 807.92(a)(3)]
The identified predicate devices within this submission are shown as follow;
Predicate device
| - 510(k) Number: | K160140 |
|---|---|
| - Applicant: | HDX WILL Corp. |
| - Device Name: | DENTRIα series (DENTRIα, DENTRI-Cα, DENTRI-Sα) |
| - Regulation Number: | 21 CFR 892.1750 |
| - Regulation Name: | Computed tomography x-ray system |
| - Regulatory Class: | Class II |
| - Product Code: | OAS |
| - Classification Name: | X-Ray, Tomography, Computed, Dental |
There are no significant differences between the DENTRIa series and the predicate device that would adversely affect the use of the product. It is substantially equivalent to these devices in technical characteristics, output characteristics and operation mode.
5. Description of the Device [21 CFR 807.92(a)(4)]
This Equipment is a Dental X-Ray imaging device used for diagnostic purpose in dental treatment. The operating principle of this device is obtaining the tomographic, and panoramic images by rotating arm to get the recombination data. X-ray generator and detector rotate around the patient to irradiate the X-ray, and penetrated X-ray is measured by the detector. When the X-ray is irradiated on the teeth area for instance, large amount of X-ray is attenuated because objects such as bones are highly dense. On the contrast, X-ray is more permeable to small molecules with low density such as skin or tissue, so more X-ray would pass through the subject. By measuring data obtained from measuring the X-ray is reconstructed by the software to display and analyze the anatomical structure for the diagnosis purposes.
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1) The DENTRIα series is classified as shown below:
DENTRIα: CT Mode + Panorama Mode + Model Scan Mode
DENTRI-Cα: CT Mode + Panorama Mode + Model Scan Mode + Cephalo Mode (One-shot) DENTRI-Sα: CT Mode + Panorama Mode + Model Scan Mode + Cephalo Mode (Scan)
| MODEL | CT | Panorama | CephaloOne-shot | CephaloScan | Model Scan(Optional) | Cu Filter(Optional) |
|---|---|---|---|---|---|---|
| DENTRIαStitch(Option) | ● | ● | - | - | ● | ● |
| DENTRIαNon-Stitch(Option) | ● | ● | - | - | ● | ● |
| DENTRI-CαStitch(Option) | ● | ● | ● | - | ● | ● |
| DENTRI-CαNon-Stitch(Option) | ● | ● | ● | - | ● | ● |
| DENTRI-SαStitch(Option) | ● | ● | - | ● | ● | ● |
| DENTRI-SαNon-Stitch(Option) | ● | ● | - | ● | ● | ● |
2) Description of the image detectors used.
| Model | DENTRIα, DENTRI-Ca, DENTRI-Sα | DENTRI-Ca | DENTRI-Sα |
|---|---|---|---|
| Contents | CT / Panorama/ Model Scan | Cephalo(One-shot type) | Cephalo(Scan type) |
| Detectormodel | Xineos-1313(Optional) | FLAATZ 330N | Xineos-2301 /Xineos-2301S |
| Manufacturer | Teledyne DALSA | DR Tech | Teledyne DALSA |
| Detector type | CMOS(Complementarymetal oxidesemiconductor) | TFT: a-Se (Thin-Film Transistor,AmorphousSelenium) | CMOS(Complementarymetal oxidesemiconductor) |
| Resolution(pixels) | 1316 x 1312 | 2048 x 1536 | 2304 x 68 |
| Pixel size(um) | 100.1 | 129.0 | 99.0 |
| MTF | 57% at 1 lp/mm | 83.3% at 2 lp/mm | 65% at 1 lp/mm |
| DQE | 70% at 0 lp/mm | 38.5% at 0 lp/mm | 57% at 1 lp/mm |
| Active area(mm) | 131 x 131 | 198 x 264 | 228 x 6.7 |
| A/DConversion | 14 bits | 14 bits | 14 bits |
| FDA 510(k)number | Not Known | Not Known | Not Known |
| 510(k)cleareddeviceincludingcorrespondingdetector as acomponent | 1) System name:DENTRIα,DENTRI-Ca,DENTRI-Sα2) Manufacturer:HDX WILL Corp.3) 510(k)number:K160140 | 1) System name:DENTRIα,DENTRI-Ca,DENTRI-Sα2) Manufacturer:HDX WILL Corp.3) 510(k) number:K160140 | Xineos-2301:1) System name:DENTIOIII,DENTIOIII-S2) Manufacturer:HDX WILL Corp.3) 510(k) number:K181297Xineos-2301S: Notknown |
| TFT: a-Si (Thin-Film Transistor,AmorphousSilicon) | |||
| 1) System name:RCT8002) Manufacturer:Ray Co., Ltd.3) 510(k)number:K192737 |
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6. Indications for Use [21 CFR 807.92(a)(5)]
The DENTRIα series is a Computed Tomography X-Ray imaging device specialized in diagnosing general dental treatments and orthodontic purpose using Panoramic and Cephalometric images respectively. In addition DENTRIα series is used in the field of Otolaryngology by capturing 360 degree rotation sequence of the head and neck areas, including the ENT and dentomaxillofacial areas for a dental treatment in adult and pediatric dentistry and obtains x-ray images from different angles and calculate through computer-processed to produce 3D x-ray tomographic images. The DENTRIα series used by physicians, dentists, and x-ray technologists.
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7. Determination of Substantial Equivalence
Summary of technological characteristics of the device compared to the predicate device. [21 CFR 807.92(a)(6)]
| Applicant | HDX WILL Corp. | HDX WILL Corp. | SE Note | |
|---|---|---|---|---|
| Device Name | DENTRIα series(DENTRIα, DENTRI-Ca, DENTRI-Sa) | DENTRIα series(DENTRIα, DENTRI-Ca, DENTRI-Sa) | ||
| Subject Device | Predicate Device | - | ||
| 510(k) Number | K212254 | K160140 | - | |
| Common/UsualName | Dental X-ray System | Dental X-ray System | - | |
| RegulationNumber | 892.1750 | 892.1750 | - | |
| Product Code | OAS | OAS | - | |
| Class | Class II | Class II | - | |
| Model | DENTRIα, DENTRI-Ca, DENTRI-Sa | DENTRIα, DENTRI-Ca, DENTRI-Sa | - | |
| Indications forUse | The DENTRIα series is a ComputedTomography X-Ray imaging devicespecialized in diagnosing generaldental treatments and orthodonticpurpose using Panoramic andCephalometric images respectively. Inaddition DENTRIα series is used in thefield of Otolaryngology by capturing 360degree rotation sequence of the headand neck areas, including the ENT anddentomaxillofacial areas for a dentaltreatment in adult and pediatricdentistry and obtains x-ray images fromdifferent angles and calculate throughcomputer-processed to produce 3D x-ray tomographic images. The DENTRIαseries used by physicians, dentists, andx-ray technologists. | The DENTRIα series is a ComputedTomography X-Ray imaging devicespecialized in diagnosing generaldental treatments and orthodonticpurpose using Panoramic andCephalometric images respectively. Inaddition DENTRIα series is used in thefield of Otolaryngology by capturing 360degree rotation sequence of the headand neck areas, including the ENT anddentomaxillofacial areas for a dentaltreatment in adult and pediatricdentistry and obtains x-ray images fromdifferent angles and calculate throughcomputer-processed to produce 3D x-ray tomographic images. The DENTRIαseries used by physicians, dentists, andx-ray technologists. | Same | |
| Operation Mode | 1. CT2. Panorama3. Cephalo1) One-Shot type2) Scan type4. Model Scan | 1. CT2. Panorama3. Cephalo1) One-Shot type2) Scan type | Similar | |
| X-ray tube assembly | ||||
| X-ray tubeassemblyoptions | PXD-140CT(Optional) | WDG90(Optional) | - | |
| X-ray tube | OPX/105 (C.E.I.) | OX/115-05 (C.E.I.) | Similar | |
| Target angle | 5° | 15° | Similar | |
| Focal spot sizeaccording to IEC60336, measured | 0.5 mm | 0.5 mm | Same | |
| Inherent filtrationaccording to IEC 60522 | 0.5 mmAl | 0.5 mmAl | 0.5 mmAl | Same |
| Anode material | Tungsten | Tungsten | Tungsten | Same |
| Total filtration ofX-ray tubeassembly | > 2.5 mmAl | > 2.5 mmAl + 0.5 mmCu (Optional) | > 2.5 mmAl | Similar |
| Range of X-rayTube Voltagesettings | PXD-140CT(Optional)1. CT60-110 kV ±8%2. Panorama60-90 kV ±8%3. Cephalo1) One-Shot type60-110 kV ±8%2) Scan type60-90 kV ±8% | WDG90 (Optional)1. CT60-90 kV ±8%2. Panorama60-90 kV ±8%3. Cephalo1) One-Shot type60-90 kV ±8%2) Scan type60-90 kV ±8% | 1. CT60-110 kV ±8%2. Panorama60-90 kV ±8%3. Cephalo1) One-Shot type60-110 kV ±8%2) Scan type60-90 kV ±8% | Same |
| Range of X-rayTube Currentsettings | 4-10 mA ±10% | 4-10 mA ±10% | 4-10 mA ±10% | Same |
| Range ofIrradiation Timesettings | 1. CT8.0-36.0 s ± (5 % + 50 ms)2. Panorama1.2-14.0 s ± (5 % + 50 ms)3. Cephalo1) One-Shot type0.5 s to 2.0 s ± (5 % + 50 ms) (in 0.5 sincrements)2) Scan type2.5-8.0 s ± (5 % + 50 ms)4. Model Scan24 s | 1. CT(Normal)8 s or 24 s ± 10 %2. Panorama14 s and less ± 10 %3. Cephalo1) One shot type0.5, 1, 1.5, 2 s ± 10 %2) Scan type8.2 s and less ± 10 % | Similar | |
| Image Properties | ||||
| Detector type | 1. CTCMOS or TFT:a-Si2. PanoramaCMOS or TFT:a-Si3. Cephalo1) One-shot typeTFT:a-Se2) Scan typeCMOS | 1. CTFlat panel2. PanoramaFlat panel3. Cephalo1) One shot typeFlat panel2) Scan typeCCD | Similar | |
| Pixel size | 1. CT100.1 um or 119 um2. Panorama100.1 um or 119 um3. Cephalo1) One-shot type129.0 um2) Scan type99.0 um | 1. CT:100.1 or 127 μm2. Panorama:100.1 or 127 μm3. Cephalo1) One shot type:129 μm2) Scan type:27 μm | Similar | |
| Active area(mm) | 1. CT131 x 131 or149.464 x 149.4642. Panorama6 x 130 or | 1. CT:131 x 131 mm or130 x 130 mm2. Panorama:6 x 131 mm or | Similar | |
| 6 x 149.5 | 3.94 x 128.78 mm | |||
| 3. Cephalo | 3. Cephalo | |||
| 1) One-shot type | 1) One shot type: | |||
| 198 x 264 | 193 x 259 mm | |||
| 2) Scan type | 2) Scan type: | |||
| 6.7 x 228 | 6.9 x 221 mm | |||
| 1. CT: | 1. CT: | |||
| - 57% at 1 lp/mm or | - 57% at 1 Lp/mm or | |||
| - 60% at 1 lp/mm | - 55% at 1 Lp/mm | |||
| 2. Panorama: | 2. Panorama: | |||
| MTF | - 57% at 1 lp/mm or- 60% at 1 lp/mm | - 57% at 1 Lp/mm or- 55% at 1 Lp/mm | Similar | |
| 3. Cephalo | 3. Cephalo | |||
| 1) One shot type | 1) One shot type: | |||
| - 83.3% at 2 lp/mm | - 83.3% at 2 Lp/mm | |||
| 2) Scan type: | 2) Scan type: | |||
| - 65% at 1 lp/mm | - 70% at 1 Lp/mm | |||
| 1. CT: | 1. CT: | |||
| - 70% at 0 lp/mm or- 60% at 1 lp/mm | - 70% at 0 Lp/mm or- 58% at 1 Lp/mm | |||
| 2. Panorama: | 2. Panorama: | |||
| DQE | - 70% at 0 lp/mm or- 60% at 1 lp/mm | - 70% at 0 Lp/mm or- 58% at 1 Lp/mm | Similar | |
| 3. Cephalo | 3. Cephalo | |||
| 1) One shot type | 1) One shot type: | |||
| - 38.5% at 0 lp/mm | - 38.5% at 0 Lp/mm | |||
| 2) Scan type: | 2) Scan type: | |||
| - 57% at 1 lp/mm | - 50% at 0 Lp/mm | |||
| Geometry | ||||
| 1. CT | 1. CT | |||
| 600 mm | 600 mm | |||
| 2. Pano | 2. Panorama | |||
| Source ImageDistance(SID) | 560 mm | 560 mm | Similar | |
| 3. Cephalo | 3. Cephalo | |||
| 1) One-Shot Ceph1792 mm | 1) One shot type1790 mm | |||
| 2) Scan Ceph1,782 mm | 2) Scan type1783 mm | |||
| FormatCompatible | DICOM 3.0 Format compatible | DICOM 3.0 Format compatible | Same |
a) Technological Characteristics
in the central Xray beam
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HDX WILL Corp.
Image /page/9/Picture/1 description: The image contains a logo for HDX Will. The logo features a green and blue square with a white "W" inside, followed by the text "HDX Will" in a bold, blue font. The text is slightly slanted to the right, giving the logo a dynamic appearance.
05, 106, 201, 202, 203, 204, 38, Osongsaengmyeong 4-ro, Osong-eup, Heungdeok-gu, Cheongiu-si. Chunacheongbuk-do. 28161. Republic of Korea TEL: +82=43-710-7318 FAX: +82-43-710-7312
b) Substantial Equivalence Discussion
The DENTRIα series is substantially equivalent to the predicate device identified above with respect to intended use, principles of operation, and technological characteristics. From the information provided in table above, it is understood that the subject device does not introduce any new technology and/or indications of use. Therefore, the DENTRIα series is considered substantially equivalent to the predicate device.
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8. Non-Clinical Test Summary
The DENTRIa series is verified and validated according to the FDA design control requirements, 21 CFR 820. The subject device had been subjected to the applicable safety and performance testing before release to ensure the device meets all its specifications. The quality assurance measures applied to the design and development of the subject device include, but not limited to risk analysis, verification and validation, product specifications and design reviews.
1) Thermal, electrical, mechanical safety & Electromagnetic Compatibility
The DENTRIa series complies with the electrical safety and electromagnetic compatibility requirements established by the standards below:
- Electrical Basic Safety and Essential Performance requirements in accordance with ES60601-1
- Electromagnetic Compatibility Testing in accordance with IEC 60601-1-2
- Radiation Protection In diagnostic X-Ray Equipment requirements of IEC 60601-1-3
- Dental Extra-Oral X-Ray Equipment requirements of IEC 60601-2-63
The manufacturing facility is in conformance with the relevant EPRC standards as specified in 21 CFR 1020.30, and 1020.31. The records are available for review.
2) Software Validations
The DENTRIa series utilizes original software and OTS software as an image viewer. The DENTRIα series contains MODERATE level of concern software. Software was designed and developed according to a software development process and was verified and validated.
The algorithm type of image reconstruction is FBP (Filtered Back Projection).
Software information is provided in accordance with FDA guidance: "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices, issued on May 11, 2005."
Cybersecurity information is provided in accordance with FDA guidance: "Content of Premarket Submissions for Management of Cybersecurity in Medical Devices, issued on October 2, 2014"
3) Biocompatibility
A biocompatibility test is not necessary when considering the device's characteristics.
4) Performance Test
Bench testing was used to assess whether the parameter measured required for describing functionalities related to the dental X-ray device's imaging properties meet the criteria under the designated tolerance.
lmage performance testing was conducted according to IEC 61223-3-4 standard. The test results show that the DENTRIα series met all requirements of the standard.
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5) SSXI (Solid State X-ray Imaging) Devices Report
Non-clinical performance was conducted for imaging performance of the proposed detector in accordance with FDA guidance: "Guidance for the Submission of 510(k)s for Solid State X-ray Imaging Devices, issued on September 1, 2016". MTF (Modulation Transfer Function) and DQE (Detective Quantum Efficiency) were tested, measured, and compared with the detectors of the predicate devices in terms of detector type, pixel size, active area, MTF and DQE, the diagnostic image quality of the detector is equal or better than those of the predicate devices based on the Non-clinical test results. Therefore, there are no significant differences in the safety and performance of the detectors.
9. Conclusion [21 CFR 807.92(b)(3)]
In conclusion, the conducted tests, as well as all verification and validation activities, demonstrate that the design specifications and technological characteristics of the DENTRIα series meet applicable requirements and standards for its safety and effectiveness for the intended use. The testing and validation activities conducted demonstrate that any differences between the subject device and the predicate devices do not raise new or different questions of safety or effectiveness compared to the predicate devices. Therefore, the DENTRIα series is substantially equivalent to the predicate devices.
§ 892.1750 Computed tomography x-ray system.
(a)
Identification. A computed tomography x-ray system is a diagnostic x-ray system intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from the same axial plane taken at different angles. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II.