(61 days)
EzSensor XHD 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 XHD is a digital intraoral sensor which acquires digital intra-oral images. EzSensor XHD acquires intra oral images with a 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. The ergonomic design based on human intraoral anatomy improves patient comfort. EzSensor XHD includes the software (firmware) with MODERATE level of concern.
The provided text is a 510(k) summary for the EzSensor XHD, a digital dental intraoral sensor. It aims to demonstrate substantial equivalence to a predicate device, not necessarily to prove the device meets specific acceptance criteria for a new, unproven technology. Therefore, the traditional concept of "acceptance criteria" and a "study that proves the device meets the acceptance criteria" in the context of a clinical trial with specific performance thresholds is not directly applicable in the way one might expect for a novel AI device.
Instead, the document focuses on demonstrating substantial equivalence to an already legally marketed predicate device (EzSensor Soft, EzSensor Soft i, EzSensor Bio, EzSensor Bio I, Model: 1.0, 1.5, 2.0; K151707). This is achieved by showing that the proposed device has the same indications for use and similar technological characteristics, and that any differences do not raise new questions of safety or effectiveness.
However, we can extract performance specifications and comparative data presented as part of the substantial equivalence claim.
Here's an attempt to structure the information based on your requested format, interpreting "acceptance criteria" as the performance metrics deemed acceptable for demonstrating substantial equivalence to the predicate device, and "study" as the non-clinical and comparative evaluations conducted.
Device Name: EzSensor XHD
Regulatory Product Code: MUH (Extraoral source X-ray system)
Interpretation of "Acceptance Criteria" in the Context of 510(k) Substantial Equivalence:
For a 510(k) submission, "acceptance criteria" are not explicitly defined as pass/fail thresholds against a clinical endpoint for a novel diagnostic. Instead, the "acceptance" is the FDA's determination of substantial equivalence to a predicate device. This is achieved by demonstrating that the new device is as safe and effective as the predicate device. The performance comparisons below serve as the data points to support this claim, rather than a direct set of pre-defined "acceptance criteria" for clinical accuracy or efficacy.
1. Table of Acceptance Criteria (Interpreted as Performance Metrics for Substantial Equivalence) and Reported Device Performance
| Performance Metric (Interpreted as Acceptance Criteria) | EzSensor XHD (Proposed Device) Reported Performance | EzSensor Soft (Predicate Device) Reported Performance | Outcome/Sufficiency for SE Claim |
|---|---|---|---|
| X-ray Converter Type | CsPbBr3 (photoconductor) | Gd2O2S:Tb (fluorescent material) | Different, but deemed not to raise new questions of safety or effectiveness due to similar pixel pitch and demonstrated performance. |
| Detection Type | Direct conversion | Indirect conversion | Different, as above. |
| Sensor Dimension (mm) (Size 1.5) | 41.1 x 30.4 (±10%) | 40.8 x 30.6 (for Size 1.5 of predicate) | Similar |
| Sensor Thickness (mm) | 6.2 | 5 | Slightly thicker, addressed via risk analysis and testing. |
| Available Active Area Size (mm) (Size 1.5) | 23.98 x 33.00 | 23.98 x 33.00 (for Size 1.5 of predicate) | Identical |
| Max. Resolution (lp/mm) | 33.8 (Full Resolution) | Not explicitly stated for predicate in table, but implied to be similar due to same pixel pitch. | Deemed "equally" performing due to same pixel pitch. |
| Pixel Pitch (µm) | 14.8 (Full Resolution) | Implied to be 14.8 (same as proposed device) | Same, supporting "equal" resolution performance. |
| DQE (6 lp/mm) | 0.204 (Full Resolution) | 0.144 | Better performance than predicate. |
| MTF (3 lp/mm) | 0.685 (Full Resolution) | 0.456 | Better performance than predicate. |
| Electrical Safety (IEC 60601-1:2005, AMD1:2012) | Compliance demonstrated | Not explicitly stated but assumed compliant (as predicate) | Compliance shown |
| EMC (IEC 60601-1-2:2014) | Compliance demonstrated | Not explicitly stated but assumed compliant (as predicate) | Compliance shown |
| Image Quality (Subjective Review) | "overall better definition and grayscale of bony and soft tissue images" compared to predicate. | "adequate quality for intra oral diagnosis" as predicate. | Improved/Adequate |
| Overall Safety/Effectiveness | No additional safety risk identified; all risks mitigated to acceptable limits. | Assumed safe and effective (as predicate). | Demonstrated safe and effective. |
2. Sample Sizes Used for the Test Set and Data Provenance
The document describes non-clinical bench testing and a comparative review of clinical images.
- Non-clinical (Bench) Test Set: No specific sample size is given for the non-clinical tests (DQE, MTF, NPS, Electrical, Mechanical, Environmental, EMC). These tests are typically performed on a limited number of manufactured devices/prototypes.
- Clinical Image Test Set: The text states, "The clinical images obtained from the EzSsensor XHD and EzSensor Soft were reviewed and rated comparatively." No specific number of images or patients (sample size) is provided for this comparative review.
- Data Provenance: Not explicitly stated, but assumed to be from a controlled in-house setting given the nature of a 510(k) submission primarily relying on bench testing and limited comparative review. The studies are prospective in the sense that they were conducted specifically for this submission, although the images themselves could be from previous patient encounters (retrospective collection).
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
- The document mentions a "comparative review" of clinical images but does not specify the number or qualifications of experts who performed this review or established any form of ground truth for the clinical image set. It simply states the images were "reviewed and rated comparatively" and that "EzSensor XHD produces overall better definition and grayscale of bony and soft tissue images in comparison with EzSensor Soft."
4. Adjudication Method (for the Test Set)
- No adjudication method is described. The comparative review appears to be a qualitative assessment, not a formal quantitative study requiring adjudication of expert readings against a ground truth.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No MRMC comparative effectiveness study was done as described in the provided text. The evaluation was a qualitative comparison of image quality, not a study of human readers' performance with and without AI assistance. The device itself is an imaging sensor, not an AI-assisted diagnostic tool.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance)
- This question is not applicable in the context of this device. The EzSensor XHD is a hardware imaging sensor that collects X-ray photons and converts them to digital images for diagnostic use by dentists. It does not perform an algorithm-only diagnostic task without human interpretation. It is a data acquisition device, not a diagnostic AI.
7. Type of Ground Truth Used
- For the non-clinical performance metrics (DQE, MTF, NPS), the "ground truth" is established by physical measurements and standardized testing protocols performed according to FDA guidance and international standards (e.g., "Guidance for the Submissions of 510(k)'s for Solid State X-ray Imaging Devices").
- For the comparative clinical image review, the "ground truth" is implied to be the expert visual assessment of image quality enabling diagnostic use, compared to an accepted predicate device. There is no mention of pathology, clinical outcomes data, or a multi-expert consensus process for a defined "ground truth" in the sense of disease presence/absence.
8. Sample Size for the Training Set
- The EzSensor XHD is a digital imaging sensor, not an AI/machine learning algorithm that requires a "training set" of data in the typical sense. Therefore, there is no training set as would be understood for an AI device. The device's performance is determined by its physical and electronic design and manufacturing, not by learning from a dataset.
9. How the Ground Truth for the Training Set Was Established
- Not applicable, as there is no training set for this hardware device.
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September 27, 2023
Qpix Solutions Inc. % Mr. Dave Kim Medical Device Regulatory Affairs Mtech Group LLC 7505 Fannin St., Suite 610 HOUSTON TX 77054
Re: K232255
Trade/Device Name: EzSensor XHD Regulation Number: 21 CFR 872.1800 Regulation Name: Extraoral source x-ray system Regulatory Class: Class II Product Code: MUH Dated: July 31, 2023 Received: July 31, 2023
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. 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 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
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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 (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 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.
Lu Jiang
Lu Jiang, Ph.D. Assistant Director Diagnostic X-Ray Systems Team DHT8B: Division of Radiological Imaging Devices and Electronic Products OHT8: Office of 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) K232255
Device Name EzSensor XHD
Indications for Use (Describe)
EzSensor XHD 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 801 Subpart C) |
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1. 510(k) Summary : K232255
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: July 27, 2023
Submitter's Name, address, telephone number, a contact person:
| Submitter's Name : | Qpix Solutions Inc |
|---|---|
| Submitter's Address: | 1001 Aviation Parkway, Ste 200, Morrisville, |
| North Carolina, USA 27560 | |
| Submitter's Telephone: | +1-919-908-6917 |
| Contact person: | Mr. Seungman Yun / CEO / +1-919-908-6917 |
| Official Correspondent: | Dave Kim (davekim@mtechgroupllc.com) |
| Address: | 7505 Fannin St. Suite 610, Houston, TX 77054 |
| Telephone: | +713-467-2607 |
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 XHD |
|---|---|
| Model Name: | IOS-A15IF, HDI-15DGF |
| Common Name: | Digital Dental Intra Oral Sensor |
| Regulatoin number: | 21 CFR 872.1800 |
| Classification Name : | Extraoral source X-ray system |
| Regulatory Class: | CL 2 |
| Product Code: | MUH |
Predicate Device :
| Manufacturer | : Rayence Co., Ltd. |
|---|---|
| Device | : EzSensor Soft, EzSensor Soft i, EzSensor Bio,EzSensor Bio I,Model: 1.0, 1.5, 2.0 |
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| 510(k) Number | : K151707 (Decision Date –07/19/2015) |
|---|---|
| The Regulation Number | : 21 CFR 872.1800 |
| Classification Name | : Extraoral Source X-ray System |
| Regulatory Class | : CL 2 |
| Primary Product Code | : MUH |
2. Device Description
EzSensor XHD is a digital intraoral sensor which acquires digital intra-oral images. EzSensor XHD acquires intra oral images with a 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. The ergonomic design based on human intraoral anatomy improves patient comfort. EzSensor XHD includes the software (firmware) with MODERATE level of concern.
3. Indication for use
EzSensor XHD 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
EzSensor XHD described in this 510(k) has the same indications for use and similar technical characteristics as its predicate device.
These differences do not raise the questions of safety or effectiveness. Based on the laboratory testing results submitted in this 510k, we conclude that the subject device is substantially equivalent to the predicate device.
The potential risks for a new sensor size were analyzed by conducting complete verification for IEC 60601-1 and drop & vibration test which included electronic shock, leakage current, etc...
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While applying the stainless-steel material to the inside of the frame, soft silicon material surrounds the exterior of the USB connector to protect the sensor from external impact. 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 | Proposed | Predicate |
|---|---|---|
| Manufacturer | Qpix Solutions Inc | Rayence Co., Ltd |
| Device name | EzSensor XHD(Model: IOS-A15IF, HDI-15DGF) | EzSensor Soft, EzSensor Soft i,EzSensor Bio, EzSensor Bio i |
| Feature | Image: EzSensor XHD | Image: EzSensor Soft |
| 510(k) number | K232255 | K151707 |
| X-ray converter | CsPbBr3 | Gd2O2S:Tb |
| Detection type | Direct conversion | Indirect conversion |
| Indicationsfor use | EzSensor XHD is intended tocollect dental x-ray photons andconvert them into electronicimpulses that may be stored,viewed, and manipulated fordiagnostic use by dentists. | Digital Dental Intra Oral Sensorsare intended to collect dental x-rayphotons and convert them intoelectronic impulses that may bestored, viewed and manipulatedfor diagnostic use by dentists. |
| Sensor Dimension(mm)(±10%) | Size 1.5: 41.1 x 30.4 | Size "1.0": 37.8 x 26.6Size "1.5": 40.8 x 30.6Size "2.0": 44.0 x 32.5 |
| Sensor Thickness(mm) | 6.2 | 5 |
| Available Active Areasize (mm) | Size 1.5: 23.98 x 33.00 | Size "1.0": 20.01 x 30.01Size "1.5": 23.98 x 33.00Size "2.0": 25.99 x 35.99 |
| USB Module | Integrated USB 2.0 module | Integrated USB 2.0 module |
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| Max. Resolution (lp/mm) | 33.8 | ||
|---|---|---|---|
| PixelPitch(µm) | FullResolution | 14.8 | |
| DQE(6 lp/mm) | FullResolution | 0.204 | 0.144 |
| MTF(3 lp/mm) | FullResolution | 0.685 | 0.456 |
| Typical dose range(µGy) | Incisor & Canine : 300 ~ 500 / Molar: 400 ~ 600 | ||
| Viewer Software (option) | EzDent-I (K223820) | Easydent orEzDent-I (K150747) |
6.Summary of Performance Testing
The indications for use, and application of EzSensor XHD is the same as that of the predicate device, EzSensor Soft.
EzSensor XHD is a direct conversion sensor that utilizes a photoconductor (CsPbBr3) and single crystal Silicon as the sensing means whereas EzSensor Soft, the predicate device, utilizes single crystal Silicon and fluorescent materials (Gd2O2S:Tb) as the sensing means.
The performance test results indicate that the EzSensor XHD intraoral sensor performed equally to the EzSensor Soft, the predicated device, as both sensors have the same pixel pitch, thereby providing the same maximum line-pair resolution. No additional safety risk is identified in the bench test: Non-clinical report.
Non-clinical test was performed according to FDA Guidance "Guidance for the Submissions of 510(k)'s for Solid State X- ray Imaging Devices''.
DQE, MTF, and NPS test results demonstrated that EzSensor XHD has better performance outcome than EzSensor Soft, the predicate sensor.
Electrical, mechanical, environmental safety and performance testing were performed according to IEC 60601-1:2005, AMD1:2012 (Medical electrical equipment Part 1:General requirements for basic safety and essential performance). EMC testing was conducted in accordance with standard IEC 60601-1-2:2014.
The clinical images obtained from the EzSsensor XHD and EzSensor Soft were reviewed and rated comparatively.
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EzSensor XHD produces overall better definition and grayscale of bony and soft tissue images in comparison with EzSensor Soft.
In conclusion, both the proposed device and the predicate device produced radiographic images with adequate quality for intra oral diagnosis in terms of resolution and anatomic details.
7. 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. Qpix Solutions Inc concludes EzSensor XHD is substantially equivalent to EzSensor Soft, the 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.