The RXS 1000 is an Intraoral Digital X-ray Sensor and is intended to be used by dentists and dental technicians diagnostic diseases of the teeth, jaw and oral structures. Its use is intended for adult subjects.

Device Description

The RXS1000 is intended to acquire real-time, clinical digital intraoral X-ray images using a solidstate imaging sensor. This system consists of the CMOS sensor and software for image display. This system senses the onset of the X-ray exposure and automatically acquires and save the image data to a PC(software).

AI/ML Overview

This document describes the FDA's clearance of the RXS 1000, an intraoral digital X-ray sensor, based on its substantial equivalence to a predicate device (K163282). As such, the document primarily focuses on establishing "substantial equivalence" rather than presenting a detailed study proving the device meets specific acceptance criteria in a clinical performance study.

Therefore, many of the requested elements for a detailed scientific study are not applicable or not explicitly provided within this FDA 510(k) summary document.

Here's an analysis of the provided text based on your request:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly define "acceptance criteria" as pass/fail thresholds for clinical performance but instead focuses on demonstrating equivalence to a predicate device. The performance characteristics are compared between the subject device (RXS 1000) and the predicate device (Apex Dental Sensors Size #1).

Parameter	Acceptance Criteria (Implied by Predicate)	Reported Device Performance (RXS 1000)	Equivalence/Difference
Technological Characteristics
Sensor type	CMOS	CMOS	Equivalent
Scintillator Material	CsI	CsI	Equivalent
Sensor dimension	39 x 25 x 5.3 mm (Predicate)	42 x 26.2 x 6.7 mm	RXS 1000 is larger than predicate device, but patient isn't feel uncomfortable when use.
Image area	30 x 20 mm	30 x 20 mm	Equivalent
Pixel size	20 x 20 µm	20 x 20 µm	Equivalent
Resolution	1500 x 1000 pixels	1500 x 1000 pixels	Equivalent
DQE	More than 20% at 3.5 ln/mm	More than 20% at 3.5 ln/mm	Equivalent
MTF	More than 40% at 5 lp/mm	More than 40% at 5 lp/mm	Equivalent
Cable length	2 m (Predicate)	3 m	For our research, user prefer 3m length cable.
USB interface	USB 2.0 (Predicate)	USB 3.0	USB 3.0 is not only higher transfer data speed, but also can backwards compatibility USB 2.0 interface.
Sensor Input Voltage	DC 5V	DC 5V	Equivalent
Clinical Performance	(Not explicitly defined in terms of specific metrics like sensitivity/specificity)	(Not explicitly defined as a separate study with metrics like sensitivity/specificity)	The document states "RXS 1000's specification is equivalent to predicate device" in conclusion, implying similar clinical performance based on technological equivalence.

2. Sample Size Used for the Test Set and Data Provenance

Sample Size for Test Set: Not applicable. This document is a 510(k) summary demonstrating substantial equivalence based on technological characteristics and adherence to standards, not a clinical trial report with a test set of patient data.
Data Provenance: Not applicable for a clinical test set. The technical specifications listed implicitly refer to characteristics measured on the device itself.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

Not applicable. There is no clinical test set requiring ground truth establishment by experts mentioned in this document.

4. Adjudication Method for the Test Set

Not applicable. There is no clinical test set mentioned.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size of Improvement

No. An MRMC comparative effectiveness study is not mentioned or described in this 510(k) summary. This type of study would typically be performed for AI-enabled diagnostic devices to assess human reader performance with and without AI assistance, which is outside the scope of this particular submission for a digital X-ray sensor itself.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Not applicable. The RXS 1000 is an intraoral digital X-ray sensor, which is a hardware device that acquires images, not an algorithm operating in standalone mode for diagnostic interpretation. Its "performance" relates to image quality and technical specifications of the sensor hardware.

7. The Type of Ground Truth Used

Not applicable for clinical efficacy. The "ground truth" here is implied by the technical specifications of the device itself and its equivalence to a legally marketed predicate. For example, "pixel size 20x20 µm" is a measurable characteristic of the sensor, not a clinical ground truth established by experts or pathology.

8. The Sample Size for the Training Set

Not applicable. The RXS 1000 is a hardware sensor, not a machine learning algorithm that requires a training set of data.

9. How the Ground Truth for the Training Set Was Established

Not applicable. No training set is involved for this type of device.

In summary, the provided document, a 510(k) summary for an intraoral digital X-ray sensor, focuses on demonstrating substantial equivalence to a predicate device primarily through technical specifications and compliance with relevant standards (IEC 60601-1, IEC 60601-1-2, ISO 14971). It does not contain information about a clinical performance study with acceptance criteria, test sets, ground truth establishment by experts, or AI algorithm performance typically found for software-as-a-medical-device (SaMD) or AI-enabled diagnostic tools.

Summary

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September 15, 2021

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Rolence Enterprise Inc. % Ben Chang QA Associate Manager 18-3 Lane 231 Pu Chung Rd., Chungli Taovuan, 32083 TAIWAN

Re: K202369

Trade/Device Name: RXS 1000 Regulation Number: 21 CFR 872.1800 Regulation Name: Extraoral source x-ray system Regulatory Class: Class II Product Code: MUH Dated: July 14, 2021 Received: August 6, 2021

Dear Ben Chang:

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

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801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (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,

. for

Thalia T. Mills, Ph.D. Director Division of Radiological Health OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K202369

Device Name RXS 1000

Indications for Use (Describe)

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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Submitter's Information:

Firm Name: Rolence Enterprise Inc. Address: 18-3 Lane 231 Pu Chung Rd., Chungli, Taoyuan, Taiwan Phone: +886-3-4631999 FAX: +886-3-4631997

Contact Person:

Contact: Ben Chang Position: QA Associate Manager E-mail: ben@rolence.com.tw Phone: +886-3-4631999 FAX: +886-3-4631997

Date of Summary Preparation: 2020/7/28

Device Information:

510(k) Number: K202369 Trade Name (Model Name): RXS 1000 Common Name: Intraoral Digital X-ray Sensor Classification Name: System, X-Ray, Extraoral Source, Digital Classification: Class II per 21 CFR 872.1800 Product Code: MUH Classification Panel: Dental

Predicate Device Information:

510(k) Number: K163282 Trade Name: Apex Dental Sensors Size #1 Common Name: Intraoral Digital X-ray Sensor Classification Name: System, X-Ray, Extraoral Source, Digital Classification: Class II per 21 CFR 872.1800 Product Code: MUH Classification Panel: Dental

Device Description:

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Indication for Use:

The RXS 1000 is intended to be used by dentists and dental technicians diagnostic diseases of the teeth, jaw and oral structures. Its use is intended for adult subjects.

Technological Characteristics:

Parameter	Subject Device	Predicate Device	Equivalent orDifference
Model Name	RXS 1000	Apex Dental Sensors Size#1	N/A
K Number	K202369	K163282	N/A
Manufacturer	Rolence Enterprise Inc.	Masterlink LLC	N/A
Classification Name	System, X-Ray, ExtraoralSource, Digital	System, X-Ray, ExtraoralSource, Digital	Equivalent
Classification	Class II21 CFR 872.1800	Class II21 CFR 872.1800	Equivalent
Product Code	MUH	MUH	Equivalent
Classification Panel	Dental	Dental	Equivalent
Indications for use	The RXS 1000 is intendedto be used by dentists anddental techniciansdiagnostic diseases of theteeth, jaw and oralstructures. Its use isintended for adult subjects.	The Apex Dental Sensorsis intended to be used for aradiographic examinationby a dental professional toassist in the diagnosing ofdiseases of the teeth, jawand oral structures.	Equivalent
Sensor type	CMOS	CMOS	Equivalent
Scintillator Material	CsI	CsI	Equivalent
Sensor dimension	42 x 26.2 x 6.7 mm	39 x 25 x 5.3 mm	RXS 1000 islarger thanpredicatedevice, butpatient isn't feeluncomfortablewhen use.
Image area	30 x 20 mm	30 x 20 mm	Equivalent
Pixel size	20 x 20 μm	20 x 20 μm	Equivalent
Resolution	1500 x 1000 pixels	1500 x 1000 pixels	Equivalent
DQE	More than 20% at 3.5ln/mm	More than 20% at 3.5ln/mm	Equivalent
MTF	More than 40% at 5 lp/mm	More than 40% at 5 lp/mm	Equivalent
Cable length	3 m	2 m	For ourresearch, userprefer 3m lengthcable.
USB interface	USB 3.0	USB 2.0	USB 3.0 is notonly highertransfer dataspeed, but alsocan backwardscompatibilityUSB 2.0interface.
Sensor Input Voltage	DC 5V	DC 5V	Equivalent

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Summary of Testing:

RXS 1000 applied IEC standards for IEC 60601-1 and IEC 60601-1-2. Risk management was according to ISO 14971. Performance testing, software documentation conducted were according to FDA guidance.

Conclusion:

Except the dimension and USB cable length, RXS 1000's specification is equivalent to predicate device.

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.