(189 days)
The DENTIOIII series is intended for dental radiographic examination of the teeth and temporomandibular joints, specifically for panoramic and cephalometric examinations. It is to be used only by dental practitioners and/or radiologists
This equipment is a dental X-ray imaging device used for diagnostic purposes in dental examination. The operating principle of this device is obtaining the panoramic images by rotating the arm to get the recombination data, having the X-ray generator and detector rotate around the patient to irradiate the X-ray, and measuring the penetrated X-ray using the detector. When the X-ray irradiates the teeth area for instance, a large amount of X-ray is attenuated because objects such as bones are highly dense. By contrast, the X-ray permeates more through small molecules with low density such as skin or tissue measuring the X-ray is reconstructed by the software for display and analysis, the anatomical structure can be viewed for the diagnosis purposes. In addition, the Cephalo arm uses the scanning method.
This document is a 510(k) summary for the DENTIOIII series, an Extraoral Source X-Ray System. The summary focuses on establishing substantial equivalence to previously cleared predicate devices, rather than presenting a standalone clinical study to prove new acceptance criteria for an AI/CADe device. Therefore, the information required to directly answer your request about acceptance criteria and study proving device meets those criteria (especially regarding AI performance, human reader improvement, and ground truth establishment methods for large datasets) is not present in this document.
The document primarily addresses the following for comparison with predicate devices:
- Technical characteristics: X-ray tube properties, detector types, pixel size, active area, MTF, DQE, geometry, software, and compliance with electrical safety and radiation protection standards.
- Intended use: Dental radiographic examination of teeth and temporomandibular joints for panoramic and cephalometric images.
However, based on the provided document, here's what can be extracted and inferred, along with explicit statements about missing information for your specific request related to AI/CADe systems:
No AI/CADe Performance Details:
This 510(k) application is for an "Extraoral Source X-Ray System," which is a device for acquiring X-ray images. It is not an AI/CADe device that performs analysis or assists human readers. Therefore, the concepts of "acceptance criteria" and "study proving the device meets acceptance criteria" as they relate to AI/CADe performance (e.g., sensitivity, specificity, human reader improvement, ground truth establishment by experts) are not applicable to this document's content. The "acceptance criteria" discussed implicitly refer to meeting technical specifications and safety standards for an imaging device.
1. A table of acceptance criteria and the reported device performance
The document does not present explicit "acceptance criteria" in the format of pass/fail metrics for a clinical study assessing diagnostic performance of an AI/CADe. Instead, it compares technical specifications of the proposed DENTIOIII series to predicate devices to establish substantial equivalence.
Implicit "Acceptance Criteria" (Technical Specifications for an Imaging Device):
The performance of the device is reported through its technical specifications, compared to predicate devices. These essentially serve as the "performance" data that needs to be "accepted" as substantially equivalent.
| Feature / Metric | Proposed Device (DENTIOIII series) | Predicate Device #1 (K142058) | Predicate Device #2 (K992385) | Predicate Device #3 (K160140) |
|---|---|---|---|---|
| Intended Use | Dental radiographic examination (panoramic, cephalometric) | Similar dental radiographic examination | Similar dental radiographic examination | Dental CT, panoramic, cephalometric imaging |
| Operation Mode | Panorama, Cephalo (Scan type) | Panorama, Cephalo (One shot/Scan) | Panorama, Cephalo (Option) | CT, Panorama, Cephalo (One shot/Scan) |
| Focal spot size | 0.5 mm | 0.5 mm | 0.5 mm | 0.5 mm |
| Target angle | 5° | 5° | 5° | 5° |
| Total filtration | > 2.8 mmAl | 2.6 mm Al equivalent | > 2.5 mmAl | > 2.5 mmAl |
| Anode material | Tungsten | Tungsten | Tungsten | Tungsten |
| X-ray tube voltage | 60 - 90 kV | 60 - 90 kV | 57 - 85 kV | 60 - 110 kV (depending on mode) |
| X-ray tube current | 4 - 10 mA | 4 - 10 mA | 2 - 16 mA | 4 - 10 mA |
| Irradiation time | Pano: Max 14.2s; Cephalo: Max 8.2s (Normal) / 4.2s (Fast) | Pano: < 14s; Cephalo: < 18s (scan), < 2s (one shot) | Pano: Max 17.6s; Cephalo: 8 - 20s | CT: 8s/24s; Pano: Max 14.2s; Cephalo: < 8.2s (scan), 0.5-2s (one shot) |
| Detector type | Pano: Flat panel (CCD/CMOS); Cephalo: Flat panel (CCD/CMOS) | Pano: Flat panel; Cephalo: CdTe/Amorphous Silicon | Pano: Flat panel (CCD); Cephalo: Flat panel (CCD) | CT: Flat panel; Pano: Flat panel; Cephalo: CCD/Flat panel |
| Pixel size | Pano: 99 µm; Cephalo: 99 µm | Pano: 100 µm; Cephalo: 100 µm (scan), 139 µm (one shot) | Pano: 96x96 µm; Cephalo: 96x96 µm | CT: 100.1/127 µm; Pano: 100.1/127 µm; Cephalo: 27 µm (scan), 129 µm (one shot) |
| Active area (mm) | Pano: 152.0x7.0mm/151.0x6.9mm; Pano/Ceph: 228.0x7.0mm/221.0x6.9mm | Pano: 151.2x6.0mm; Cephalo: 240.0x4.8mm (scan), 427.0x356.0mm/302.0x249.0mm (one shot) | Pano: 138.0x138.0mm; Cephalo: 190.0x190.0mm | CT: 131x131mm/130x130mm; Pano: 6x131mm/3.94x128.78mm; Cephalo: 6.9x221mm (scan), 193x259mm (one shot) |
| MTF @ 1LP/mm | Pano: 70%/65%; Cephalo: 70%/65% | Pano: 70%; Cephalo: 75% (scan), 54% (one shot) | Not known | CT: 57%/55%; Pano: 57%/55%; Cephalo: 70% (scan), 83.3% (one shot) |
| DQE @ 0/1LP/mm | Pano: 57%@1LP/mm or 50%@0LP/mm; Cephalo: 57%@1LP/mm or 50%@0LP/mm | Pano: 50%@1LP/mm; Cephalo: 88%@1LP/mm (scan), 20%@1LP/mm (one shot) | Not known | CT: 70%@0LP/mm or 58%@1LP/mm; Pano: 58%@1LP/mm or 70%@0LP/mm; Cephalo: 50%@0LP/mm (scan), 38.5%@0LP/mm (one shot) |
| SID | Pano: 535mm; Cephalo: 1735mm (Single)/1729mm (Dual) | Not known | Pano: 487mm; Cephalo: 1745mm | CT: 600mm; Pano: 560mm; Cephalo: 1783mm (scan), 1790mm (one shot) |
| Format compatible | DICOM 3.0 | DICOM 3.0 | DICOM 3.0 | DICOM 3.0 |
2. Sample size used for the test set and the data provenance
- Sample Size for Test Set: Not applicable/Not provided. This document does not describe a clinical study for diagnostic performance with a test set of patient cases. It refers to "Non-clinical performance was conducted for imaging performance... both of the predicate devices and proposed device are based on Csi scintillator designed for general radiography." It also mentions "Clinical images were provided as further [evidence] on addition to the combat system works as intended." However, no specific sample size for "test set" from a retrospective or prospective clinical study is given.
- Data Provenance: The document does not specify the country of origin of any "clinical images" or the nature of their collection (retrospective or prospective). The device manufacturer is HDX WILL CORP. from the REPUBLIC OF KOREA.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable. As this is not an AI/CADe device being evaluated for diagnostic performance, there is no mention of experts establishing ground truth for a test set. The "ground truth" for an X-ray imaging system refers to its ability to produce high-quality images that accurately represent the anatomical structures, which is assessed through technical specifications and image quality metrics (MTF, DQE, resolution).
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. No adjudication method is mentioned as there isn't a diagnostic performance study with multiple readers.
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 such study was done or reported. This device is an X-ray imaging system, not an AI or CADe system for assisting human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- No such study was done or reported. This device is an X-ray imaging system, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not applicable in the context of diagnostic AI. For an X-ray imaging system, the "ground truth" implicitly refers to the physical reality of the objects being imaged and the accuracy of the image acquisition process. This is assessed through phantom imaging, resolution targets, MTF, DQE, and clinical image review by qualified personnel (dental practitioners/radiologists) to ensure diagnostic utility. The document states: "Performance (Imaging performance) testing was conducted according to standard of IEC 61223-3-4. All test results were satisfactory." and "Non-clinical performance was conducted for imaging performance of the proposed detector in accordance with FDA Guidance 'Guidance for the submissions of 510(k)'s for Solid State X-ray Imaging Devices'. Both of the predicate devices and proposed device are based on Csi scintillator designed for general radiography. MTF (Modulation Transfer Function) and DQE (Detective Quantum Efficiency) were tested and measured by IEC 6220-1."
8. The sample size for the training set
- Not applicable/Not provided. This is an imaging device, not an AI/ML algorithm that requires a training set.
9. How the ground truth for the training set was established
- Not applicable/Not provided. No training set for an AI/ML algorithm is discussed.
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Image /page/0/Picture/0 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 the FDA logo, which 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.
November 21, 2018
HDX WILL CORP. Lee Myoung-Joon General Manager #105, 106, 201, 202, 203, 204, 38, Osongsaengmyeong 4-ro Osong-eup, Heungdeok-gu CHEONGJU-SI CHUNGCHEONGBUK-DO 28161 REPUBLIC OF KOREA
Re: K181297
Trade/Device Name: DENTIOIII series (DENTIOIII, DENTIOIII-S) Regulation Number: 21 CFR 872.1800 Regulation Name: Extraoral Source X-Ray System Regulatory Class: Class II Product Code: MUH Dated: September 21, 2018 Received: September 25, 2018
Dear Lee Myoung-Joon:
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.
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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 https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
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/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Hole 2. Mils
for Robert A. 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) K181297
Device Name DENTIOIII series (DENTIOIII, DENTIOIII-S)
Indications for Use (Describe)
The DENTIOIII series is intended for dental radiographic examination of the teeth and temporomandibular joints, specifically for panoramic and cephalome. It is to be used only by dental practitioners and/or radiologists
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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K181297 Page 1/8
510(k) Summary
[As required by 21 CFR 807.92]
1. Date Prepared [21 CFR 807.92(a)(a)]
Sept. 21. 2018
2. Submitter's Information [21 CFR 807.92(a)(1)]
| - Name of Manufacturer: | HDX WILL CORP. |
|---|---|
| - Address: | #105, 106, 201, 202, 203, 204, 38, Osongsaengmyeong 4-ro,Osong-eup, Heungdeok-gu, Cheongju-si, Chungcheongbuk-do28161, Korea |
| - Contact Name: | Myoung-Joon Lee / General Manager |
| - Telephone No.: | +82-43-710-7318 |
| - Fax No.: | +82-43-710-7312 |
| - Email Address: | mjlee@iwillmed.com |
| - Registration No.: | 3013511605 |
3. Trade Name, Regulation Name, Classification [21 CFR 807.92(a)(2)]
| Trade Name | DENTIOIII series (DENTIOIII, DENTIOIII-S) |
|---|---|
| Regulation Number | 21 CFR 872.1800 |
| Regulation Name | Extraoral source x-ray system |
| Regulation Class | II |
| Product Code | MUH |
| Product Code Name | System, X-Ray, Extraoral Source, Digital |
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K181297 Page 2/8
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 #1 - 510(k) Number: K142058 - Applicant: RAY Co., Ltd. - Regulation Name: Extraoral source x-ray system - Product Code: MUH - Device Class: Class II - Device Name: RAYSCAN α-Expert
Predicate device #2
| - 510(k) Number: | K992385 |
|---|---|
| - Applicant: | INSTRUMENTARIUM CORP. |
| - Regulation Name: | Extraoral source x-ray system |
| - Product Code: | MUH |
| - Device Class: | Class II |
| - Device Name: | Orthopantomograph® OP100 D |
Predicate device #3
| - 510(k) Number: | K160140 |
|---|---|
| - Applicant: | HDX WILL CORP. |
| - Regulation Name: | Computed tomography x-ray system |
| - Product Code: | OAS |
| - Device Class: | Class II |
| - Device Name: | DENTRIα series (DENTRIα, DENTRI-Cα, DENTRI-Sα) |
There are no significant differences between the DENTIOIII, DENTIOIII, DENTIOIII-S) and the predicate device that would adversely affect the use of the product.
5. Description of the Device [21 CFR 807.92(a)(4)]
This equipment is a dental X-ray imaging device used for diagnostic purposes in dental examination. The operating principle of this device is obtaining the panoramic images by rotating the arm to get the recombination data, having the X-ray generator and detector rotate around the patient to irradiate the X-ray, and measuring the penetrated X-ray using the detector. When the X-ray irradiates the teeth area for instance, a large amount of X-ray is attenuated because objects such as bones are highly dense. By contrast, the X-ray permeates more through small molecules with low density such as skin or tissue measuring the X-ray is reconstructed by the software for display and analysis, the anatomical structure can be viewed for the diagnosis purposes. In addition, the Cephalo arm uses the scanning method.
- The DENTIOIII Series are classified as shown below.
▪ DENTIOIII: PANORAMA Mode
▪ DENTIOIII-S: PANORAMA Mode + CEPHALO Mode (SCAN)
- Description of the image detectors used.
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K181297 Page 3/8
| Model | DENTIOIII | DENTIOIII-S | ||
|---|---|---|---|---|
| Contents | Scanning (Pano) | Scanning (Pano /Ceph) | ||
| Detector model | Xineos-1501 | ARGUS-PAN(DM-20-05K10-00-R) | Xineos-2301 | ARGUS - CEPH(DM-20-08K10-00-R) |
| Manufacturer | Teledyne DALSA | Teledyne DALSA | Teledyne DALSA | Teledyne DALSA |
| Detector type | Scanning detector(CMOS) | Scanning detector(CCD) | Scanning detector(CMOS) | Scanning detector(CMOS) |
| Resolution (pixels) | 1536 x 68 | 5580 x 256 | 2305 x 68 | 8160 x 256 |
| Pixel size (um) | 99.0 | 27.0 | 99.0 | 27.0 |
| MTF | 65% at 1LP/mm | 70% at 1LP/mm | 65% at 1LP/mm | 70% at 1LP/mm |
| DQE | 57% at 1LP/mm | 50% at 0LP/mm | 57% at 1LP/mm | 50% at 0LP/mm |
| Active area (mm) | 152.0 x 7.0 mm | 151.0 x 6.9 mm | 228.0 x 7.0 mm | 221.0 x 6.9 mm |
| A/D Conversion | 14 bits | 16 bits | 14 bits | 16 bits |
| FDA 510(k)Number | Not known | Not known | Not known | Not known* |
- Note. Information for detector own 510(K) number or system in which it was cleared 510(k) number.
| Contents | Model | Own 510(K)number | System in which it was cleared 510(k) number. |
|---|---|---|---|
| CEPHALOdetector | ARGUS - CEPH(DM-20-08K10-00-R) | No | 1) System name: DENTRIα series (DENTRIα,DENTRI-Ca, DENTRI-Sa)2) Manufacturer: HDX WILL CORP.3) 510(K) Number: K160140 |
The DENTIOIII series communicates with the Workstation by transmitting data using Ethernet cable and RS232 Cable.
3) Laser
The laser is used for patient positioning and is class 1. This technical characteristic is as follows:
| LM-6501RS (Option1) | P9-655-5L (Option2) | |
|---|---|---|
| Optical output | 1 mW or less | 1 mW or less |
| Wavelength | 655 nm ± 5 nm | 655 nm ± 6 nm |
| Line type | Accurate Straight | Accurate Straight |
| Form of beam output | Gaussian | Gaussian |
6. Indications for Use [21 CFR 807.92(a)(5)]
The DENTIOIII series is intended for dental radiographic examination of the teeth and temporomandibular joints, specifically for panoramic and cephalometric examinations. It is to be used only by dental practitioners and/or radiologists
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W HDXWILL
#105, 106, 201, 202, 203, 204, 38, Osongsaengmyeong 4-ro, Osong-eup, Heungdeok-gu, Cheongju-si, Chungcheongbuk-do, 28161, Korea, Tel: +82-43-710-7318/ Fax: +82-43-710-7312
K181297 Page 4/8
7. Determination of Substantial Equivalence
The DENTION series is substantially equivated predicate devices with respect of the companison of technical features. The subject device was fund to be equivalent to predicate devices with regarding to dechnical characteristics. The table below presents comparisons for each origations of technological characteristics of the device compared to the predicate devices. [21 CFR 807.92(a)(6)]
| Proposed Device | Predicate Device #1 | Predicate Device #2 | Predicate Device #3 | |
|---|---|---|---|---|
| K Number | K181297 | K142058 | K992385 | K160140 |
| Model | DENTIOIII series· DENTIOIII· DENTIOIII-S | RAYSCAN α- Expert· RAYSCAN α -P· RAYSCAN α -SC· RAYSCAN α -OCL· RAYSCAN α -OCS | Orthopantomograph® OP100 D | DENTRIα series· DENTRIα· DENTRI-Cα· DENTRI-Sα |
| Manufacturer | HDX WILL CORP. | RAY Co., Ltd. | INSTRUMENTARIUM CORP. | HDX WILL CORP. |
| Indications for Use | The DENTIOIII series is intendedfor dental radiographic examinationof the teeth and temporomandibularjoints, specifically for panoramicand cephalometric examinations. Itis to be used only by dentalpractitioners and/or radiologists | The RAYSCAN α - Expert DentalX-Ray System is an extraoralsource dental panoramic andoptional cephalometric X-raysystem intended to produce X-raysfor dental radiographic examinationand diagnosis of diseases of theteeth, jaw, and oral structures. | Orthopantomograph® OP100 D isintended to be used for producingdiagnostic X-ray radiograph ofdentition, TM-joints and other oralstructures. | The DENTRIα series is a ComputedTomography X-Ray imaging devicespecialized in diagnosing generaldental treatments and orthodonticpurpose using Panoramic andCephalometric images respectively.In addition, DENTRIα series isused in the field of Otolaryngologyby capturing 360 degree rotationsequence of the head and neckareas, including the ENT anddentomaxillofacial areas for adental treatment in adult andpediatric dentistry, and obtains x-ray images from different anglesand calculate though computer-processed to produce 3D x-raytomographic images. The |
| Proposed Device | Predicate Device #1 | Predicate Device #2 | Predicate Device #3 | |
| DENTRIα series is used by physicians, dentists, and x-ray technologists. | ||||
| Operation Mode | 1) Panorama2) Cephalo• Scan type | 1) Panorama2) Cephalo• One shot type• Scan type | 1) Panorama2) Cephalo (Option) | 1) CT2) Panorama3) Cephalo• One shot type• Scan type |
| X-ray tube assembly | ||||
| X-ray tube | D-054S | Not known | D-051S | OPX/105 (C.E.I. X-ray tube) |
| Focal spot size | 0.5 mm | 0.5 mm | 0.5 mm | 0.5 mm |
| Target angle | Target angle 5° | Target angle 5° | Target angle 5° | Target angle 5° |
| Total filtration of X-ray tube assembly | > 2.8 mmAl | 2.6 mm Al equivalent | > 2.5 mmAl | > 2.5 mmAl |
| Anode material | Tungsten | Tungsten | Tungsten | Tungsten |
| range of X-ray tube voltage settings | 60 - 90 kV | 60 - 90 kV | 57 - 85 kV | 1) CT: 60 - 110 kV2) Panorama: 60 - 90 kV3) Cephalo• Scan type:60 - 90 kV• One shot type: 60 - 110 kV |
| range of X-ray tube current settings | 4 - 10 mA | 4 - 10mA | 2 - 16 mA | 4 - 10mA |
| range of irradiation time settings | 1) PanoramaMax 14.2 s2) Cephalo• Scan type:Max 8.2 s (Normal) / 4.2 s (Fast) | 1) Panorama:below 14sec2) Cephalo• Scan type: below 18sec• One shot type: below 2sec | 1) PanoramaMax 17.6 s2) Cephalo8 - 20 s | 1) CT(Normal):8 s or 24 s2) Panorama:Max 14.2 s3) Cephalo• Scan type: 8.2 s and less• One shot type:0.5, 1, 1.5, 2 s |
| Detector type | 1) Panorama• Flat panel (CCD or CMOS) | 1) Panorama• Flat panel | 1) Panorama• Flat panel (CCD) | 1) CT: Flat panel2) Panorama: Flat panel |
| Proposed Device | Predicate Device #1 | Predicate Device #2 | Predicate Device #3 | |
| 2) Cephalo· Scan type:Flat panel (CCD or CMOS) | 2) Cephalo· Scan type:CdTe Direct flat panel sensor· One shot type: AmorphousSilicon | 2) Cephalo· Scan type:Flat panel (CCD) | 3) Cephalo· Scan type: CCD· One shot type: Flat panel | |
| Pixel size | 1) Panorama: 99 µm2) Cephalo:99 µm | 1) Panorama: 100 µm2) Cephalo· Scan type: 100 µm· One shot type: 139 µm | 1) Panorama: 96 x 96 µm2) Cephalo· Scan type: 96 x 96 µm | 1) CT: 100.1 or 127 µm2) Panorama: 100.1 or 127 µm3) Cephalo· Scan type: 27 µm· One shot type: 129 µm |
| Active area (mm) | 1) Pano· 152.0 x 7.0 mm or151.0 x 6.9mm2) Pano/Ceph· Scan type:228.0 x 7.0 mm or221.0 x 6.9 mm | 1) Panorama:· 151.2 x 6.0 mm2) Cephalo· Scan type:240.0 x 4.8 mm· One shot type:427.0 x 356.0 mm or302.0 x 249.0 mm | 1) Panorama:· 138.0 x 138.0 mm/ 1440 pixels2) Cephalo· 190.0 x 190.0 mm / 1980 pixels | 1) CT:· 131 x 131 mm or· 130 x 130 mm2) Panorama:· 6 x 131 mm or· 3.94 x 128.78 mm3) Cephalo· Scan type: 6.9 x 221 mm· One shot type:193 x 259 mm |
| MTF | 1) Panorama:· 70 % at 1LP/mm or65% at 1LP/mm2) Cephalo· Scan type:70 % at 1LP/mm or65% at 1LP/mm | 1) Panorama:· 70 % at 1LP/mm2) Cephalo· Scan type:75 % at 1LP/mm· One shot type:54 % at 1LP/mm | Not known | 1) CT: 57% or 55% at 1LP/mm2) Panorama:· 57% or 55% at 1LP/mm3) Cephalo· Scan type:70% at 1LP/mm· One shot type:83.3% at 2 LP/mm |
| DQE | 1) Panorama:· 57% at 1LP/mm or· 50% at 0LP/mm | 1) Panorama:· 50 % at 1LP/mm2) Cephalo | Not known | 1) CT:· 70% at 0 LP/mm or |
| Proposed Device | Predicate Device #1 | Predicate Device #2 | Predicate Device #3 | |
| 2) Cephalo• Scan type:57% at 1LP/mm or50% at 0LP/mm | • Scan type:88 % at 1LP/mm• One shot type:20 % at 1LP/mm | • 58% at 1 LP/mm2) Panorama:• 58% at 1 LP/mm or• 70% at 0 LP/mm3) Cephalo• Scan type:50% at 0 LP/mm• One shot type:38.5% at 0 LP/mm | ||
| Geometry | ||||
| Source Image Distance(SID) | 1) Panorama: 535mm2) Cephalo• 1735 mm (Single detector type)• 1729mm (Dual detector type) | Not known | 1) Panorama:19.2 inches / 487 mm2) Cephalo68.7 inches / 1745 mm | 1) CT: 600 mm2) Panorama: 560 mm3) Cephalo:• Scan type:1783 mm• One shot type: 1790 mm |
| Formatcompatible | DICOM 3.0 Format compatible | DICOM 3.0 Format compatible | DICOM 3.0 Format compatible | DICOM 3.0 Format compatible |
[Table of Comparison of Proposed Device to Predicate Device]
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W HDXWILL
#105, 106, 201, 202, 203, 204, 38, Osongsaengmyeong 4-ro, Osong-eup, Heungdeok-gu, Cheongju-si, Chungcheongbuk-do, 28161, Korea, Tel: +82-43-710-7318/ Fax: +82-43-710-7312
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W HDXWILL
#105, 106, 201, 202, 203, 204, 38, Osongsaengmyeong 4-ro, Osong-eup, Heungdeok-gu, Cheongju-si, Chungcheongbuk-do, 28161, Korea, Tel: +82-43-710-7318/ Fax: +82-43-710-7312
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Justification to Support Substantial Equivalence
Although the clectors wed differ with predicate including image proposed device is enough to perform each mode with respect to the finctional aspects. The clinical data shows that the DENTIOII series is effective . Clinical inages were provided as further on addition to the combet system works as intended. As licenses or clinical daggoses of the images, it might be proved that the region of interests. Therefore, these technological differences of detectors used do not raise different questions of safety and effectiveness to diagnosis.
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Non-Clinical Test Summary
The DENTIOIII series complies with international standards for electromagnetic compatibility. The following data were provided in support of the substantial equivalence determination:
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- Electrical Safety, Electromagnetic Compatibility and Performance:
The DENTIOIII series comply with the electrical safety and electromagnetic compatibility requirements established by the standards.
- Electrical Safety, Electromagnetic Compatibility and Performance:
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· Electrical Basic Safety and Essential Performance requirements in accordance with IEC 60601-1:2005/AMD1:2012
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· Electromagnetic Compatibility Testing in accordance with IEC 60601-1-2:2007
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· Radiation Protection In Diagnostic X-Ray Equipment requirements of IEC 60601-1-3:2008/AMD1:2013
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" Dental Extra-Oral X-Ray Equipment requirements of IEC 60601-2-63:2012
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· Acceptance Tests Imaging Performance of Dental X-Ray requirements of IEC 61223-3-4:2000
Bench testing was used to assess whether or not the parameter measured required for describing functionalities related to imaging properties of the dental X-ray device and patient dosage satisfies the designated tolerance. Performance (Imaging performance) testing was conducted according to standard of IEC 61223-3-4. All test results were satisfactory. The manufacturing facility is in conformance with the relevant EPRC standards as specified in 21 CFR 1020.30, 31 and the records are available for review.
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- Software Validation
The DENTIOIII series use original software. The DENTIOIII series contains MODERATE level of concern software. Software was designed and developed according to a software development process and was verified and validated. Software information is provided in accordance with FDA guidance: "The content of premarket submissions for software contained in medical devices, on May 11, 2005."
- Software Validation
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- Biocompatibility
A biocompatibility study is not necessary.
- Biocompatibility
4) SSXI Report
Non-clinical performance was conducted for imaging performance of the proposed detector in accordance with FDA Guidance "Guidance for the submissions of 510(k)'s for Solid State X-ray Imaging Devices". Both of the predicate devices and proposed device are based on Csi scintillator designed for general radiography. MTF (Modulation Transfer Function) and DQE (Detective Quantum Efficiency) were tested and measured by IEC 6220-1. Base on the Non-clinical test results, even though the used detector differs in term of the pixel size and active area, the diagnostic image quality of the detector is equal or better than those of the predicate device and there is no significant difference in efficiency and safety.
8. Conclusion [21 CFR 807.92(b)(3)]
Based on the comparison of intended use, technological characteristics and performance specifications, the DENTIOIII series is safe and effective and substantially equivalent to the predicate devices.
§ 872.1800 Extraoral source x-ray system.
(a)
Identification. An extraoral source x-ray system is an AC-powered device that produces x-rays and is intended for dental radiographic examination and diagnosis of diseases of the teeth, jaw, and oral structures. The x-ray source (a tube) is located outside the mouth. This generic type of device may include patient and equipment supports and component parts.(b)
Classification. Class II.