X 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.

Device Description

X Sensor is a digital intraoral sensor which acquires digital intra-oral images. X Sensor 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. X Sensor includes the firmware for the sensor and the previously cleared imaging software "ExDent-I".

AI/ML Overview

The provided text is a 510(k) summary for the X Sensor, a digital dental intraoral sensor. It describes the device's technical characteristics, intended use, and its comparison to a predicate device (EzSensor XHD). However, this document does not contain the detailed information necessary to fully answer your request regarding acceptance criteria and the study proving the device meets these criteria in the context of AI/ML performance.

Specifically, the document focuses on regulatory clearance for a medical device (an X-ray sensor) based on hardware and image quality performance relative to a predicate device, as well as electrical, mechanical, and software safety. It does not mention any AI/ML components or studies evaluating AI/ML performance.

Therefore, many parts of your request, such as those related to AI/ML specific acceptance criteria, sample sizes for AI/ML test and training sets, expert adjudication, MRMC studies, or standalone algorithm performance, cannot be answered from the provided text.

However, I can extract information related to the device's general performance testing and comparison to the predicate device, which serves as a form of "acceptance" for medical device clearance.

Here's what can be extracted and how it relates to your request, with a clear indication of what information is not present:

Acceptance Criteria and Device Performance (General Device Performance)

Based on the document, the "acceptance criteria" appear to be meeting or exceeding the performance of the predicate device (EzSensor XHD) in key technical metrics and demonstrating adequate image quality for diagnostic use.

Acceptance Criterion (Implicit)	Reported Device Performance (X Sensor)
Image Quality (General)	"The performance test result indicates that the X Sensor intra oral sensor performed equally to the EzSensor XHD, the predicated device, as both sensors have the same pixel pitch, thereby providing the same maximum line-pair resolution.""The clinical images obtained from the X Sensor and EzSensor XHD were reviewed and rated comparatively.""The image quality in terms of contrast and resolution are overall similar for the X sensor, the proposed new device and EzSensor XHD, the predicate device.""There are no observable radiographic findings and no quality issues with intra oral diagnostic images provided by both sensors.""The proposed device produces overall better definition and grayscale of bony and soft tissue images.""In conclusion, both the proposed new device and the predicate device produced radiographic images with adequate quality for intra oral diagnosis in terms of resolution and anatomic details."
Detective Quantum Efficiency (DQE) (6 lp/mm)	0.258 (Better than predicate's 0.204)
Modulation Transfer Function (MTF) (3 lp/mm)	0.889 (Better than predicate's 0.685)
Noise Power Spectrum (NPS)	Demonstrated better performance outcome than predicate. (Specific value not provided)
Maximum Resolution (lp/mm)	33.8 (Same as predicate due to same pixel pitch)
Electrical Safety (IEC 60601-1 Series)	Compliance demonstrated.
Electromagnetic Compatibility (IEC 60601-1-2)	Compliance demonstrated.
Software Function (FDA Guidance)	Development followed "Content of Premarket Submissions for Device Software Functions." Provides "basic level of documentation for the firmware."
Cybersecurity (FDA Guidance)	Development, documentation, and testing followed "Cybersecurity in Medical Devices..." guidance.
Pediatric Information (FDA Guidance)	Development followed "Pediatric Information for X-ray Imaging Device Premarket Notifications" guidance.
Mechanical Durability (Drop & Vibration, etc.)	Performed, risks analyzed and mitigated (e.g., stainless-steel frame, soft silicon exterior for USB connector).

Study Information (Based on Available Text)

Sample size used for the test set and the data provenance:
- The document states "The clinical images obtained from the X Sensor and EzSensor XHD were reviewed and rated comparatively."
- Specific sample size for the clinical images reviewed is NOT provided.
- Data provenance (country of origin, retrospective/prospective) is NOT provided. Given it's a 510(k) for a device like an X-ray sensor, the "test set" likely refers to physical images generated during bench testing and some limited clinical image capture, rather than a large dataset for AI/ML validation.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- The document states "The clinical images obtained from the X Sensor and EzSensor XHD were reviewed and rated comparatively."
- The number of experts and their qualifications are NOT specified. This phrasing suggests a qualitative human review of generated images to ensure diagnostic utility.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Adjudication method is NOT specified. The review appeared to be a comparative assessment of image quality.
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 MRMC study was performed or discussed. This device is an X-ray sensor, not an AI-assisted diagnostic tool in the sense of an algorithm interpreting images for a human. It provides the images.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- This is NOT applicable. The "device" is the sensor itself, which captures images. There is no mention of an algorithm that performs standalone diagnostic interpretations.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For the image quality assessment, the "ground truth" seems to be clinical utility/diagnostic adequacy as judged by human review of images generated by both the new device and the predicate device. Quantitative metrics (DQE, MTF, NPS) also served as objective performance measures.
The sample size for the training set:
- NOT applicable/NOT provided. This document describes a medical device, an X-ray sensor, not an AI/ML algorithm that requires a "training set" in the context of machine learning. The "training" for such a device would be its engineering and design optimization.
How the ground truth for the training set was established:
- NOT applicable/NOT provided. As above, there's no mention of a machine learning training set or associated ground truth.

Summary of Limitations:

The provided document is a regulatory submission for an X-ray sensor. It focuses on demonstrating substantial equivalence to a predicate device based on technical specifications, image quality, and regulatory compliance (electrical safety, EMC, software documentation, cybersecurity). It does not describe an AI/ML diagnostic algorithm or any studies related to its performance, and therefore cannot answer the specific questions posed about AI/ML acceptance criteria and validation.

Summary

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October 11, 2024

Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: on the left, there is the Department of Health & Human Services logo, and on the right, there is the text "FDA U.S. FOOD & DRUG ADMINISTRATION" in blue. The FDA logo is a symbol of the agency's mission to protect and promote public health through the regulation and supervision of food safety, tobacco, pharmaceuticals, medical devices, and other related products.

Qpix Solutions Inc % Dave Kim Medical Device Regulatory Affairs Mtech Group LLC 7505 Fannin St Suite 610 HOUSTON, TX 77054

Re: K242778

Trade/Device Name: X Sensor (Model: IOS-A151F, HDI-15DGF) Regulation Number: 21 CFR 872.1800 Regulation Name: Extraoral Source X-Ray System Regulatory Class: Class II Product Code: MUH Dated: September 13, 2024 Received: September 13, 2024

Dear Dave 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 (the 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 available 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.

Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device"

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(https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review. the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rue"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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).

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Sincerely,

Smita Kakar

for

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

Submission Number (if known)

K242778

Device Name

X Sensor

(Model: IOS-A15IF, HDI-15DGF)

Indications for Use (Describe)

X 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 801 Subpart C)

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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: September 13, 2024

Submitter's Name, address, telephone number, a contact person:

Submitter's Name :	Qpix Solutions Inc
Submitter's Address:	1001 Aviation Parkway, Ste 200Morrisville, 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:	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:	X Sensor (Model: IOS-A15IF, HDI-15DGF)
Common Name:	Digital Dental Intra Oral Sensor
Regulation number:	21 CFR 872.1800
Classification Name:	Extraoral source X-ray system
Regulatory Class:	Class 2
Product Code:	MUH
Predicate Device :
Manufacturer	: Qpix Solutions Inc
Device	: EzSensor XHD
510(k) Number	: K232255 (Decision Date -09/27/2023)
The Regulation Number	: 21 CFR 872.1800

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Classification Name	: Extraoral Source X-ray System
Regulatory Class	: Class 2
Primary Product Code	: MUH

2. Device Description

3. Indication for use

X 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

X Sensor 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.

While applying the stainless-steel material to the frame, soft silicon material

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surrounds the exterior of the USB connector to protect the sensors from a potential 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	Qpix Solutions Inc
Device's name		X Sensor(Model: IOS-A15IF, HDI-15DGF)	EzSensor XHD
Feature		Image: Proposed Feature	Image: Predicate Feature
510(k) number		-	K232255
X-ray converter		CsPbBr3
Detection type		Direct conversion
Indicationsfor use		Digital Dental Intra Oral Sensor isintended to collect dental x-ray photonsand convert them into electronic impulsesthat may be stored, viewed, andmanipulated for diagnostic use by dentists.	Digital Dental Intra Oral Sensors areintended to collect dental x-rayphotons and convert them intoelectronic impulses that may bestored, viewed and manipulated fordiagnostic use by dentists.
SensorDimension(mm)(±10%)		Size 1.5: 41.1 x 30.4	Size 1.5: 41.1 x 30.4
SensorThickness(mm)		4.8	6.2
Active Area(mm)		Size 1.5: 23.98 x 33.00	Size 1.5: 23.98 x 33.00
USB Module		Integrated USB 2.0 module	Integrated USB 2.0 module
Max. Resolution(lp/mm)		33.8
PixelPitch(μm)	FullResolution	14.8
DQE(6 lp/mm)	FullResolution	0.258	0.204
MTF(3 lp/mm)	FullResolution	0.889	0.685
Typical doserange( $\mu$ Gy)	Incisor & Canine : 300 ~ 500 / Molar: 400 ~ 600
Viewer Software(option)		EzDent-i(K241114)	EzDent-i(K223820)

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510(k) Submission - X Sensor (IOS-A15IF, HDI-15DGF)

ViewerSoftware(option)	510(k) Number	Manufacturer	Comment
EzDent-i	K241114	EWOO SOFT	Dental Imaging Viewer

6.Summary of Performance Testing

The intended use, application of X Sensor is the same as that of the predicate device, EzSensor XHD.

X Sensor is a direct conversion sensor that utilizes a photoconductor (CsPbBr3) and single crystal Silicon as the sensing means whereas EzSensor XHD, the predicate device, utilizes a photoconductor(CsPbBr3) and single crystal Silicon as the sensing means. The performance test result indicates that the X Sensor intra oral sensor performed equally to the EzSensor XHD, 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 X Sensor has better performance outcome than EzSensor XHD, the predicate sensor.

Electrical, mechanical, environmental safety and performance testing were performed according to to IEC 60601-1:2005, IEC 60601-1:2005/AMD1:2012, IEC 60601-1:2005/AMD2:2020 (Medical electrical equipment Part 1:General requirements for basic safety and essential performance). EMC testing was conducted in accordance with standard IEC

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60601-1-2:2014+AMD1:2020.

"Content of Premarket Submissions for Device Software Functions. Guidance for Industry and Food and Drug Administration Staff" was used in the development of the subject device and provide basic level of documentation for the firmware.

"Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions Guidance for Industry and Food and Drug Administration Staff" was used in the development, documentation and testing for the cybersecurity of the subject device.

"Pediatric Information for X-ray Imaging Device Premarket Notifications Guidance for Industry and Food and Drug Administration Staff' guidance was used in the development of the subject device.

The clinical images obtained from the X Sensor and EzSensor XHD were reviewed and rated comparatively.

The image quality in terms of contrast and resolution are overall similar for the X sensor, the proposed new device and EzSensor XHD, the predicate device.

There are no observable radiographic findings and no quality issues with intra oral diagnostic images provided by both sensors.

The proposed device produces overall better definition and grayscale of bony and soft tissue images.

In conclusion, both the proposed new 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 X SENSOR is safe and effective and substantially equivalent to predicate device as described herein.

Regulation Number and Section

§ 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.