(69 days)
EzSensor Soft [Alternative name : EzSensor Bio] Digital Dental Intra Oral Sensor is intended to collect dental x-ray photons and convert them into electronic impulses that may be stored, viewed and manipulated for diagnostic use by dentists.
EzSensor Soft[Alternative name : EzSensor Bio] Digital Dental Intra Oral Sensor is a device which acquires digital intra oral images. Direct digital systems acquire images with a flexible sensor that is connected to a computer to produce an image almost instantaneously following exposure. The primary advantage of direct sensor systems is the speed with which images are acquired. For patient comfort, the ergonomic design is based on human intraoral anatomy.
The provided document is a 510(k) premarket notification for a dental imaging device, "EzSensor Soft [Alternative name : EzSensor Bio] digital dental image processing system". It compares the new device to a predicate device, "EzSensor". The study primarily focuses on technical performance comparisons and a small-scale image review, rather than a clinical effectiveness study with strict acceptance criteria often seen in AI/CAD device approvals.
Here's an analysis of the acceptance criteria and study findings based on the provided text, while noting the limitations in terms of typical AI/CAD device study requirements:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state formal acceptance criteria in the manner of quantifiable metrics for diagnostic performance (e.g., sensitivity, specificity, AUC targets). Instead, the performance comparison focuses on technical image quality metrics and a qualitative review by a dentist.
Here's a table based on the provided technical characteristics and the stated comparative performance:
| Characteristic | Acceptance Criteria (Implied / Comparator) | Reported Device Performance (EzSensor Soft / EzSensor Bio) |
|---|---|---|
| Image Quality | At least equivalent to the predicate device (EzSensor) in DQE, MTF, NPS. | - DQE (6 lp/mm): 0.199 (Full Resolution & Binning Mode) vs. 0.123 (Predicate). Better performance.- MTF (6 lp/mm): 0.436 (Full Resolution) / 0.464 (Binning Mode) vs. 0.382 (Predicate). Better performance.- NPS: Not explicitly quantified, but stated "outperformed EzSensor". Better performance. |
| Linearity | At least equivalent to the predicate device (EzSensor). | "Very linear and has better linearity than EzSensor in the same dynamic range." Better performance. |
| Contrast-to-Noise Ratio (CNR) | At least equivalent to the predicate device (EzSensor). | "Superior CNR characteristics compared to EzSensor... direct result of Noise improvement." Better performance. |
| Resolution/Sharpness | Images should be similar or moderately superior to EzSensor, presenting no difficulty in evaluating anatomical structures. | "Final images generated by both new and predicate sensors are similar or moderately superior to existing EzSensor (Predicate)." "Images of EzSensor Soft [Alternative name : EzSensor Bio] in full resolution mode is generally more sharper and clearer than EzSensor Soft [Alternative name : EzSensor Bio] in binning mode." |
| Clinical Acceptability | Images present no difficulty in evaluating anatomical structures necessary for correct diagnosis. | "All images present no difficulty in evaluating a range of anatomic structures necessary to provide a correct conclusion..." (based on review by one dentist). |
| Risk Assessment | All risks and hazardous conditions mitigated to acceptable limits. | "All risks and hazardous conditions identified arising from the design change were successfully mitigated and accepted." Risks identified (electronic shock, device failure, misdiagnosis, tissue damage, serious leakage current, sensor fracture/breakage, cable disconnection) analyzed via FMEA and verified with IEC/EN 60601-1 and drop & vibration tests. |
| Software Functionality | Easydent and EzDent i have same functionality and performance. | "Easydent and EzDent i image viewing software have the same functionality and performance." Main difference is UI design and new consulting simulation tool for EzDent i. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Test Set Sample Size: "Total 30 sets of radiographic images were reviewed."
- Data Provenance: Not explicitly stated, but the submission is from Rayence Co. Ltd. in Korea. The context of a premarket notification for a new device suggests these would likely be newly acquired images for testing, making them prospective to the submission. However, this is an inference; it is not explicitly stated. The country of origin for the images is not specified.
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)
- Number of Experts: "a licensed dentist" (singular).
- Qualifications: "a licensed dentist." No information on years of experience or specialization is provided.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Adjudication Method: "none". The document states "Based on the reviewer's conclusion," indicating a single reviewer's assessment without a consensus or adjudication process.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- MRMC Study: No. This document describes a medical device (digital dental x-ray sensor), not an AI/CAD system. Therefore, an MRMC study comparing human readers with and without AI assistance is not applicable and was not performed. The study described is a technical comparison of the image sensor and a qualitative review of images by a single dentist.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Standalone Study: Not applicable. This is not an AI/CAD algorithm. The device is an image acquisition sensor. There is no algorithm operating standalone on diagnostic tasks.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Type of Ground Truth: The "ground truth" for the image review consisted of the qualitative assessment by a single "licensed dentist" regarding the difficulty in evaluating anatomical structures and the sharpness/clearness of images. This is best characterized as expert opinion/review by a single expert. It is not objective ground truth like pathology or outcomes data.
8. The sample size for the training set
- Training Set Sample Size: Not applicable. As this is an image acquisition hardware device (sensor) and not an AI/machine learning algorithm, there is no "training set" in the context of AI. The device's performance is based on its physical and electronic design and confirmed through bench testing.
9. How the ground truth for the training set was established
- Ground Truth for Training Set: Not applicable, as there is no training set for an AI algorithm.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
March 10, 2015
Rayence Co. Ltd. % Mr. Dave Kim Medical Device Regulatory Affairs Mtech Group 8310 Buffalo Speedway HOUSTON TX 77025
Re: K143753
Trade/Device Name: EzSensor Soft [Alternative name : EzSensor Bio] digital dental image processing system Regulation Number: 21 CFR 872.1800 Regulation Name: Extraoral source x-ray system Regulatory Class: II Product Code: MUH Dated: February 16, 2015 Received: February 23, 2015
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,
Robert A Ochs
Robert Ochs, Ph.D. Acting Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: December 31, 2013 See PRA Statement on last page.
510(k) Number (if known) K143753
Device Name
EzSensor Soft [Alternative name : EzSensor Bio] digital dental image processing system
Indications for Use (Describe)
EzSensor Soft [Alternative name : EzSensor Bio] Digital Dental Intra Oral Sensor is intended to collect dental x-ray photons and convert them into electronic impulses that may be stored, viewed and manipulated for diagnostic use by dentists.
Type of Use (Select one or both, as applicable)
|× Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 807 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
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1. 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: February 16, 2015
Submitter's Name, address, telephone number, a contact person:
| Submitter's Name : | Rayence Co., Ltd. |
|---|---|
| Submitter's Address: | 14, Samsung 1-ro 1-gil, Hwaseong-si, Gyeonggi-do, Korea |
| Submitter's Telephone: | +82-31-8015-6459 |
| Contact person: | Mr. Kee Dock Kim / RA Team Manager / +82-31-8015-6459 |
| Official Correspondent: | Dave Kim (davekim@mtech-inc.net) |
| (U.S. Designated 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: | EzSensor Soft [Alternative name : EzSensor Bio] |
|---|---|
| Common Name: | Digital Dental Intra Oral Sensor |
| Regulatoin number: | 21 CFR 872.1800 |
| Regulation name: | Extraoral source X-ray system |
| Product Code: | MUH |
| Predicate Device : | |
| Manufacturer | : Rayence Co., Ltd. |
| Device | : EzSensor |
| 510(k) Number | : K090526 (Decision Date – DEC. 2. 2009) |
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2. Device Description
EzSensor Soft[Alternative name : EzSensor Bio] Digital Dental Intra Oral Sensor is a device which acquires digital intra oral images. Direct digital systems acquire images with a flexible sensor that is connected to a computer to produce an image almost instantaneously following exposure. The primary advantage of direct sensor systems is the speed with which images are acquired. For patient comfort, the ergonomic design is based on human intraoral anatomy.
- · Excellent image quality based on advanced CMOS technology
- · Sensor's ergonomic shape is more comfortable for the human oral structure
- · Lower dose exposure (compared to film sensor)
- Enhanced durability
- Easy-to-use USB interface
3. Indication for use
EzSensor Soft [Alternative name : EzSensor Bio] Digital Dental Intra Oral Sensor is intended to collect dental x-ray photons and convert them into electronic impulses that may be stored, viewed and manipulated for diagnostic use by dentists.
4. Summary of Design Control Risk management
The risks 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.
5. Summary of the technological characteristics of the device compared to the predicate device
The EzSensor Soft [Alternative name : EzSensor Bio] Digital Dental Intra Oral Sensor described in this 510(k) has the same indications for use and similar technical characteristics as its predicate device, EzSensor of Rayence Co., Ltd.
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5. 1 Feature
The mechanical design for each device is different as following.
Image /page/6/Figure/2 description: The image shows two diagrams of the EzSensor. The top diagram is labeled "Proposed: EzSensor Soft [Alternative name: EzSensor Bio]" and shows a USB port labeled A, a component labeled B, and a sensor labeled C. The bottom diagram is labeled "Predicate: EzSensor" and also shows a USB port labeled A, an interface board labeled B, and a sensor labeled C.
Differences
| Proposed | Predicate |
|---|---|
| B 1) Improved the user grip by designing the interface board housing slim to reduce the possibility of dropping the sensor.2) The holder for the sensor housting makes it easily portable. | The interface board is larger. |
| C Soft silicon material surrounds the moudule to reduce the discomfort when it is positioned inside the mouth compared to the predicate device. | The aluminum case caused a pain and discomfort when it was placed inside the mouth of a patient. |
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EzSensor Soft [Alternative name : EzSensor Bio] The potential risks (electroic shock, device failure, misdiagnosis, tissue damage, serious leakage current, etc...) were analyzed by conducting complete verification for IEC/EN 60601-1 and drop & vibration test. (Completed the risk analysis for A,B,C above).
While applying the sensor exterior with soft silicon material reduced the oral discomfort or pain, additional risk analysis was conducted to mitigate the potential risks that may arise with respect to leakage current, sensor fracture or breakage, and cable disconnection. The risk mitigation measures were satisfactory to manage the new risks identified and the residual risks were within acceptable limits.
| Characteristic | ProposedRayence Co., Ltd.EzSensor Soft[Alternative name : EzSensor Bio] | PredicateRayence Co., Ltd.EzSensor | |
|---|---|---|---|
| Feature | Image: EzSensor Soft | Image: EzSensor | |
| 510(k) number | K150212 | K090526 | |
| Indicationsfor use | EzSensor Soft[Alternative name : EzSensor Bio]Digital Dental Intra Oral Sensor isintended to collect dental x-rayphotons and convert them intoelectronic impulses that may bestored, viewed and manipulated fordiagnostic use by dentists. | EzSensor, an Intra-oral ImagingSystem, is intended to collect dentalx-ray photons and convert theminto electronic impulses that maybe stored, viewed, and manipulatedfor diagnostic use by dentists. | |
| SensorDimension(mm) | Size "1.0": 37.5 x 26.5Size "2.0": 43.5 x 32.5 | Size "1.0": 35.7 x 25.2Size "1.5": 38.7 x 29.2 | |
| Sensor Thickness | 5 | 4.9 | |
| Active Area(mm) | Size "1.0": 20 x 30Size "2.0": 25.99 x 35.99 | Size "1.0": 20.02 x 30.03Size "1.5": 24.08 x 31.85 | |
| Pixel Pitch(μm) | 14.8 | 35 | |
| SB Module | Integrated USB 2.0 module | Integrated USB 2.0 module | |
| Full Resolution | 14.8 | 35 |
5. 2 Characteristic
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| Pixel Pitch(μm) | Binning Mode | 29.6 | |
|---|---|---|---|
| DQE (6 lp/mm) | Full Resolution | 0.199 | |
| Binning Mode | 0.199 | 0.123 | |
| MTF (6 lp/mm) | Full Resolution | 0.436 | 0.382 |
| Binning Mode | 0.464 | ||
| Typical doserange(μGy) | Incisor & Canine : 300 ~ 500 / Molar: 400 ~ 600 | ||
| Active Pixel Array | Size 1.0: 1352 x 2028 pixels(30 x 20 mm)676 x 1014 pixels @ binning modeSize 2.0: 2432 x 1756 pixels(35.99 x 25.99 mm)1216 x 878 pixels @ binning mode | Size 1.0: 572 x 858 pixels(20.02 x 30.03 mm)Size 1.5: 686 x 944 pixels(24.01 x 33.04 mm) |
5. 3 Viewer Software
| Characteristic | ProposedRayence Co., Ltd.EzSensor Soft[Alternative name : EzSensor Bio] | PredicateRayence Co., Ltd.EzSensor |
|---|---|---|
| Viewer Software | Easydent & EzDent i | Easydent |
This device is operated using viewer software. With the identical hardware configuration, the model name is distinguished by the type of image viewing software available. The software functions include the patient information management, image capture, and viewer for captured images.
| Viewer Software | 510(k) Number | Manufacturer |
|---|---|---|
| Easydent | - | Rayence Co., Ltd. |
| EzDent i | K131594 | EWOO SOFT |
Easydent and EzDent i image viewing software have the same functionality and performance. The main difference is the design of the user interface (UI) and new consulting simulation tool for EzDent i. EzDent i requires a fee based license registration for the right to use whereas Easydent is provided free of charge.
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5.4 Difference for Easydent and EzDent i
| Easydent | EzDent i | |
|---|---|---|
| Function | PatientViewAcquisitionConsultationReport | PatientViewAcquisitionConsultationReportLicense |
| The initialscreen shot | Image: Easydent initial screen | Image: EzDent i initial screen |
| ImageAcquisitionscreen | Image: Easydent acquisition screen | Image: EzDent i acquisition screen |
5.5 Features added to EzDent i
5.5.1. Acquisition_ CONSULT Tab
Acquisition_ CONSULT Tab is a consulting tool and provides a video simulation of the treatment process with the acquired images in sequence.
Image /page/9/Picture/5 description: The image shows a dental software interface with a focus on dental imaging and treatment planning. On the left, there is a panel with options like 'Favorites' and 'Recent List', suggesting image organization features. The central part of the interface displays a dental X-ray, while the right side shows a 3D model of a tooth undergoing a root canal procedure. At the bottom, there is a timeline or sequence of images related to the root canal treatment, indicating a step-by-step guide or visual aid for dental professionals.
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5.5.2. License
EzDent i requires a fee based license registration for the right to use whereas EasyDent is provided free of charge.
6. Proposed Labeling- Changes in comparison to the predicate device
| Proposed | Predicate |
|---|---|
| Rayence Co., Ltd.EzSensor Soft[Alternative name : EzSensor Bio] | Rayence Co., Ltd.EzSensor |
| Rayence Co.,Ltd.14, Samsung 1-ro 1-gil, Hwaseong-si,Gyeonggi-do, Korea www.rayence.com | Rayence Co., Ltd.14, Samsung 1-ro 1-gil, Hwaseong-si,Gyeonggi-do, Korea www.rayence.com |
|---|---|
| • Product Name : Medical Image Processing Unit | • Product Name : Medical Image Processing Unit |
| • Model Name : EzSensor Soft | • Model Name : EzSensor |
| • Rating : 5V, 500mA | |
| SN | SN |
| REF | REF R-USM-701 |
| IP Class:IPX0 | |
| This equipment complies with IEC 60601-1, IEC 60601-1-2 and 21CFR Subchapter J | |
| EC REP | EC REP |
| VATECH Dental Manufacturing Ltd.Chancery House, St. Nicholas Way, Sutton, SM1 1JB UKTel: +44-208-652-1990 Fax: +44-208-652-1909Made in KOREA | VATECH Dental Manufacturing Ltd.Chancery House, St. Nicholas Way, Sutton, SM1 1JB UKTel: +44-208-652-1990 Fax: +44-208-652-1909Made in KOREA |
| Rayence Co.,Ltd14, Samsung 1-ro 1-gil, Hwaseong-si,Gyeonggi-do, Korea www.rayence.com |
|---|
| • Product Name : Medical Image Processing |
| • Model Name : EzSensor Bio |
| • Rating : 5V, 500mA |
| SN |
| REF |
| EC REP |
| VATECH Dental Manufacturing Ltd.Chancery House, St. Nicholas Way, Sutton, SM1 1JB UKTel: +44-208-652-1990 Fax: +44-208-652-1909Made in KOREA |
7.Summary of Performance Testing
The intended use, application and detector type of EzSensor Soft[Alternative name : EzSensor Bio] is the same as that of the predicate device, EzSensor Soft[Alternative name : EzSensor Bio] and EzSensor use the same amorphous silicon alley and materials for fluorescent as the sensing means. The performance test result indicates that the EzSensor Soft[Alternative name : EzSensor Bio] detector outperformed EzSensor (the predicated device ) in terms of DQE, MTF, and NPS. No additional safety risk is identified in the bench test: SSXI report.
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With a smaller measured pixel size of EzSensor Soft, both in full resolution and in 2x2 binning mode, DQE, MTF, and NPS test demonstrated that EzSensor Soft has better performance results than EzSensor, the predicate sensor.
Especially, the response of EzSensor Soft (alternatively, EzSensor Bio) as a function of X-ray exposure is very linear and has better linearity than EzSensor in the same dynamic range.
The EzSensor Soft intra oral sensor improved the noise performance and superior CNR characteristics compared to EzSensor, the predicate device. Lower the contrast-to-noise ratio (CNR), it is less able to represent a fine shade of the lesion. The superior CNR performance of EzSensor Soft compared to EzSensor is the direct result of the Noise improvement.
The pixel pitch of EzSensor Soft(Proposed) is smaller than one for EzSensor(Predicate) and the difference between the resolution is expected to be large. However, final images generated by both new and predicate sensors are subject to post processing (image enchangement) image optimization with the noise improvement and maximization of signal-to-noise ratio. Therefore the new sensor images are similar or moderatly superior to existing EzSensor (Predicate).
Total 30 sets of radiographic images were reviewed by a licensed dentist. Based on the reviewer's conclusion, EzSensor Soft[Alternative name : EzSensor Bio] (Full Resolution Mode) more closely matches EzSensor. In addition, images of EzSensor Soft[Alternative name : EzSensor Bio] in full resolution mode is generally more sharper and clearer than EzSensor Soft[Alternative name : EzSensor Bio] in binning mode.
All images present no difficulty in evaluating a range of antomic structures necessary to provide a correct conclusion while minimizing radiation exposure to patients.
Clinical images were provided; these images were not necessary to establish substantial equivalence based on the modifications to the device. However they provide further evidence in addition to the laboratory performance data to show that the complete system works as intended.
9. Conclusions
In accordance with the Federal Food, Drug and Cosmetic Act, 21 CFR Part 807 and based on the information provided in this premarket notification. Rayence Co., Ltd. concludes that EzSensor Soft [Alternative name : EzSensor Bio] is safe and substantially equivalent to predicate device as described herein.
§ 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.