ERI Handheld Dental X-Ray System (Model AG100) is intended for the purpose of using it for both adult and pediatric patients by qualified operators (e.g. dentist and/ or radiographer, etc.) regulated by competent authority of each country for producing diagnostic dental X-ray images.

Device Description

It can be used with computed radiography (CR) detection film, digital radiography (DR) detection film or traditional film (dental film) to take intraoral X-rays and provide the information needed by the dentist for diagnosis. As a preoperative, intraoperative, and postoperative evaluation for identifying dental caries or auxiliary root canal treatment, as well as confirming the position of the implant during dental implant surgery. It can take pictures of the front and back teeth, as well as the bite of the back teeth. Applicable objects include adults and children. Due to the medical software included in radiation-emitting device. ERI handheld system is of Moderate level of concern.

AI/ML Overview

The provided text details the 510(k) summary for the ERI Handheld Dental X-ray System (Model AG100), evaluating its substantial equivalence to a predicate device. However, it does not contain information about specific acceptance criteria, reported device performance metrics (e.g., sensitivity, specificity), sample sizes for test sets, data provenance, ground truth establishment, or any comparative effectiveness studies with human readers.

The document focuses on non-clinical test data and performance evaluations.

Here's a breakdown of the available information based on your request:

1. A table of acceptance criteria and the reported device performance:

This information is not provided in the document. The document states that "The function and performance of the AG100 have been evaluated through non-clinical design verification and validation tests" and that "The results of the AG100 performance evaluations demonstrate that the device design is well suited for its intended use." However, it does not specify what those performance evaluations were in terms of acceptance criteria or quantitative performance metrics.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):

This information is not provided. The document states that "Clinical testing has not been conducted on this product," implying that no test set of patient data was used to evaluate its clinical performance. The testing mentioned is "non-clinical design verification and validation tests" and "electrical performance evaluations and usability test," which do not typically involve patient data.

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):

This information is not applicable/provided as no clinical test set with ground truth established by experts was used.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

This information is not applicable/provided as no clinical test set was used.

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:

This information is not applicable/provided. The device is an X-ray system, not an AI diagnostic tool. No AI component or MRMC study is mentioned.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

This information is not applicable/provided. The device itself is an X-ray system, not an algorithm, and the document explicitly states "Clinical testing has not been conducted on this product".

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):

This information is not applicable/provided. As clinical testing was not conducted, no ground truth based on patient diagnoses was established. The performance evaluations were non-clinical.

8. The sample size for the training set:

This information is not applicable/provided. Since clinical testing was not done and the device is not an AI algorithm, there is no mention of a training set of data.

9. How the ground truth for the training set was established:

This information is not applicable/provided for the same reasons as above.

Summary of what is provided regarding testing:

The document lists several international and national standards that testing was performed in accordance with, including:

IEC 62304 (Medical device software - Software life cycle processes)
AAMI ES60601-1 (General Requirements For Basic Safety And Essential Performance)
IEC 60601-1-2 (Electromagnetic Compatibility)
IEC 60601-1-3 (Radiation protection in diagnostic X-ray equipment)
IEC 60601-2-65 (Particular requirements for the basic safety and essential performance of dental intra-oral-X-ray equipment)
IEC 61223-3-4 (Evaluation and routine testing in medical imaging departments - Part 3-4: Acceptance tests - Imaging performance of dental X-ray)
ISO 14971 (Risk management)
ISO 10993 (Biological evaluation of medical devices - Parts 2, 5, 10, 12 for animal welfare, cytotoxicity, irritation/sensitization, and sample preparation)
21 CFR 1020.30 & 1020.31 (Diagnostic x-ray system requirements)

These standards typically define safety, performance, and manufacturing quality requirements for medical devices. The document essentially states that the device was tested to meet these standards through "non-clinical design verification and validation tests," including "electrical performance evaluations and usability test." However, the specific results against particular quantitative acceptance criteria from these tests are not detailed in this summary.

Summary

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April 4, 2022

Image /page/0/Picture/1 description: The image shows the logo for the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health and Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the letters "FDA" in a square and the words "U.S. FOOD & DRUG ADMINISTRATION".

Energy Resources International Co., Ltd. Hsinchu Branch % Ms. Judy Chiang QA&RA Specialist 2F-2, No. 6-1, Sec. 2, Zhengyi Rd Zhubei City. Hsinchu County 30261 TAIWAN

Re: K213282

Trade/Device Name: ERI Handheld Dental X-ray System (Model AG100) Regulation Number: 21 CFR 872.1800 Regulation Name: Extraoral source x-ray system Regulatory Class: Class II Product Code: EHD, MUH Dated: September 27, 2021 Received: October 1, 2021

Dear Ms. Chiang:

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,

Laurel Burk, Ph.D. Assistant Director Diagnostic X-ray Systems Team 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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known) K213282

Device Name

ERI Handheld Dental X-Ray System (Model AG100)

Indications for Use (Describe)

mandheld Dental X-Ray System (Model AG100) is intended for the purpose of using it for both adult and pediatric patients by qualified operators (e.g. dentist and/ or radiographer, etc.) regulated by competent authority of each country for producing diagnostic dental X-ray images.

Prescription Use (Part 21 CFR 801 Subpart D)	Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
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Food and Drug AdministrationOffice of Chief Information Officer	Department of Health and Human ServicesPaperwork Reduction Act (PRA) Staff
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Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2023 See PRA Statement below.

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ENERGY RESOURCES INTERNATIONAL CO., LTD. 510(k) Submission AG100

Section 5

510(k) Summary

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Image /page/4/Picture/0 description: The image shows a document with the logo of Energy Resources International Co., Ltd. Hsinchu Branch. The document includes a table with the following information: Product: AG100, 510(k) Summary, page: 5-2, and Version: 2.0. The document appears to be a summary related to the product AG100.

The assigned 510(K) number: K213282 Date Prepared: 09/27/2021

Submitter Information I.

Submitter:
ENERGY RESOURCES INTERNATIONAL CO., LTD. Hsinchu Branch
Address: 2F-2, No.6-1, Sec. 2, Zhengyi Rd., Zhubei City, Hsinchu County 30261,Taiwan(R.O.C.)
Phone Number: +886-3-6585156
Fax Number: +886-3-6585802
Contact Person: Judy Chiang
Email: judy.chiang@eriray.com
Phone Number: +886-3-6585156 ext.112
Fax Number: +886-3-6585802

Subject Device II.

Trade Name: ERI Handheld Dental X-Ray System (Model AG100)

Regulation Name and Classification:

No.	ProductCode	Regulation Name	RegulatoryClass	RegulationNumber	Panel
1	EHD	Extraoral Source X-Ray System	II	872.1800	Radiology
2	MUH	Extraoral Source X-Ray System	II	872.1800	Radiology

III. Predicate Device

510(K) Number	K173319
Manufacturer	Aribex
Device Name	KaVo NOMAD Pro 2 Handheld X-Ray System
Regulation Name	Extraoral Source X-Ray System
Regulation Number	872.1800
Product Code	EHD
Regulatory Class	II

IV. Device Description

As a preoperative, intraoperative, and postoperative evaluation for identifying dental caries or auxiliary root canal treatment, as well as confirming the position of the implant during dental implant surgery. It can take pictures of the front and back teeth, as well as the bite of

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能資國際股份有限公司新竹分公司Energy Resources International Co., Ltd. Hsinchu Branch
Product	AG100	510(k) Summary	page	5-3
			Version	2.0

the back teeth. Applicable objects include adults and children.

Due to the medical software included in radiation-emitting device. ERI handheld system is of Moderate level of concern.

The AG100 device, as well as, the predicate device (Trade Name: KaVo NOMAD Pro 2 Handheld X-Ray System manufactured by Aribex (K173319)) utilize a fixed tube current and voltage (KVp) to achieve their intended use.

v. Indications for Use

VI. Comparison of Technology Characteristics with the Predicate Device

Energy Resources International claims that the AG100 device is substantially equivalent to the KaVo NOMAD Pro 2 Handheld X-Ray System cleared by the FDA in K173319. Energy Resources International claims substantial equivalence because the AG100 has an equivalent intended use, operating principles, and operational specifications as compared to the predicate device.

The specific details regarding the similarities and differences between the AG100 and KaVo NOMAD Pro 2 Handheld X-Ray System have been identified and explained in the Comparison Table, see the following table 3. A summary of these similarities and differences is included below. These differences do not present any new issues related to safety and effectiveness.

Device name	Kavo NOMAD Pro 2 HandheldX-ray system(Predicate Device: K173319)	ERI Handheld Dental X-RaySystem (Model AG100)
Classification,regulationnumber, productcode	Extraoral Source X-ray System,21 CFR 872.1800,EHD	Extraoral Source X-ray System,21 CFR 872.1800,EHD/MUH
Intended Use	The KaVo NOMAD Pro 2Handheld X-ray System isindicated for use only by a trainedand qualified dentist or dentaltechnician for both adult andpediatric subjects as an extraoraldiagnostic dental X-ray source toproduce X-ray images usingintraoral image receptors.	ERI Handheld Dental X-RaySystem (Model AG100) is intendedfor the purpose of using it for bothadult and pediatric patients byqualified operators (e.g. dentist and/or radiographer, etc.) regulated bycompetent authority of each countryfor producing diagnostic dental X-ray images.

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Product	AG100	page 5-4Version 2.0
Source to skin distance	20 cm	20 cm
Cone diameter	6 cm	6 cm
Backscatter radiation protection	6.75" dia. Pb-filled acrylic plastic scatter shield	153mm(6.02") dia. Pb-filled acrylic plastic scatter shield
Exposure switch	Trigger located on handset	Trigger located on front top
	Electrical
Energy Source	Rechargeable 21.6 V DC Li-ion battery core pack	Rechargeable 14.4 V DC Li-polymer battery core pack
Capacity	1.7 A-hr	2.4 A-hr (34.56Wh)
Casing	Hard shell case	Hard shell case
Recharge capability	70% remaining capacity after 300 cycles	After 300 cycles, more than 70%
Exposure Time	0.02 – 1.0 seconds in 0.01 increments	0.1 – 2.0 seconds in 0.01 increments
mA	2.5 mA fixed	0.6 mA fixed
kVp	60 kVp fixed	60 kVp fixed
Duty Cycle	1:60	maximum 60 sec after previous shot
Electrical Safety Standards	AAMI ES60601-1:2005/(R)2012 And A1:2012	ANSI AAMI ES60601-1:2005/(R)2012 and A1:2012, C1:2009/(R)2012 and A2:2010/(R)2012 (Consolidated Text)
EMI Standards	IEC60601-1-2 Ed. 4	IEC60601-1-2:2014 Ed. 4
	X-ray Performance
Performance Standard	21 CFR 1020.30, 1020.31; IEC60601-1-3; IEC60601-2-65	21 CFR 1020.30, 1020.31; IEC 60601-1-3 Edition 2.1; IEC 60601-2-65 Edition 1.1 CONSOLIDATED VERSION; IEC 61223-3-4 First edition

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Image: Energy Resources International Co., Ltd. Hsinchu Branch logo
Product	AG100	510(k) Summary	page	5-5
			Version	2.0

Hence, the subject device is similar to the predicate device in terms of the indications for use and technological application.

VII. Non-clinical Test Data

Testing was performed in accordance with the following international standards:

IEC 62304 Edition 1.1 [2015-06] Medical device software - Software life cycle processes
ANSI AAMI ES60601-1:2005/(R)2012 and A1:2012, C1:2009/(R)2012 and A2:2010/(R)2012 (Consolidated Text) Medical Electrical Equipment - Part 1: General Requirements For Basic Safety And Essential Performance (IEC 60601-1:2005, MOD)
IEC 60601-1-2 Edition 4.0 [2014-02] Medical Electrical Equipment - Part 1-2: General Requirements For Basic Safety And Essential Performance - Collateral Standard: Electromagnetic Compatibility - Requirements And Tests
IEC 60601-1-3 Edition 2.1 [2013-04] Medical electrical equipment - Part 1-3: General requirements for basic safety and essential performance - Collateral Standard: Radiation protection in diagnostic X-ray equipment
IEC 60601-2-65 Edition 1.1 [2017-05] Medical electrical equipment - Part 2-65: Particular requirements for the basic safety and essential performance of dental intra-oral-X-ray equipment
IEC 61223-3-4 First edition [2000-03] Evaluation and routine testing in medical imaging departments - Part 3-4: Acceptance tests - Imaging performance of dental X-ray
ISO14971 Third Edition [2019-12] Medical devices - Applications of risk management to medical devices
ISO10993-2 Second edition [2006-07-15] Biological Evaluation of medical devices - Part 2: Animal welfare requirements
ISO10993-5 Third edition [2009-06-01] Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity
ISO10993-10 Third Edition [2010-08-01] Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization
ISO10993-12 Fourth edition [2012-07-01] Biological evaluation of medical devices - Part 12: Sample preparation and reference materials
21 CFR 1020.30: Diagnostic x-ray system and their major components
21 CFR 1020.31: Radiographic Equipment

VIII. Clinical Performance Data

The function and performance of the AG100 have been evaluated through non-clinical design verification and validation tests. Testing included electrical performance evaluations and usability test. The results of the AG100 performance evaluations demonstrate that the device design is well suited for its intended use. Clinical testing has not been conducted on this product, and successful bench testing results should be sufficient in demonstrating substantial equivalence for the AG100 handheld system.

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117	能資國際股份有限公司新竹分公司Energy Resources International Co., Ltd. Hsinchu Branch
Product AG100		page	5-6
	510(k) Summary	Version	2.0

IX. Conclusions

The Energy Resources International AG100 has the same intended use and same basic technology as the predicate device, thus is able to achieve the same effectiveness and safety as the predicate device. The AG100 contains in some combination similar features and design as the predicates. Other differences include device design such as exposure time, size and user interface. The subject device is substantially equivalent to the predicate device with its intended use, mechanical and electrical performance as described.

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.