Aid-U is a software solution intended to be used for storing, zoom-out, retrieving, transmitting, and processing medical images, or outputting them. Aid-U is intended for use as a web- based application and is networked with a PACS server. It enables the display, comparison of CT, MR, PT, US, XA, NM, DX, and SC from other DICOM compliant modalities. Typical users are radiologists, technologists, and clinicians.

Device Description

Aid-U is a medical image transmission device software, of SaaS type (Software as a Service, provided as a service, not as a software installation) or an On-Premise Software type web application (Companies install software in data centers managed by their own facilities) that allows patient medical image data generated by medical imaging devices to be transmitted, stored, managed, and retrieved using standard internet protocols (HTML5).

AI/ML Overview

The provided text is a 510(k) Summary for the device Aid-U. It primarily focuses on demonstrating substantial equivalence to predicate devices based on functional and technical characteristics, as well as adherence to various medical device software standards. However, it does NOT contain specific information regarding clinical performance studies, such as multi-reader multi-case (MRMC) studies, standalone algorithm performance, or detailed acceptance criteria for clinical efficacy.

The document states that "software validation and verification tests" were performed and that "all software specifications meet the acceptance criteria," but it does not define these acceptance criteria in terms of clinical performance metrics (e.g., sensitivity, specificity, AUC) or provide reported device performance against such metrics. It also does not elaborate on the specific study design, sample sizes, ground truth establishment, or expert involvement for clinical evaluation.

Therefore,Based on the provided text, I cannot fulfill most of the requested information regarding acceptance criteria, study details, and performance metrics as these are not present in the document.

Here's what can be extracted and what information is missing:

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

Acceptance Criteria (General Statement): The document states that "all software specifications meet the acceptance criteria." However, it does not specify what these criteria are in terms of clinical performance (e.g., sensitivity, specificity, accuracy for detecting a condition).
Reported Device Performance: No specific clinical performance metrics (e.g., sensitivity, specificity, AUC) are reported. The document focuses on showing technical equivalence and compliance with software standards.

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

Information Not Provided: The document does not mention any test set sample size for clinical performance evaluation, nor does it describe data provenance (country of origin, retrospective/prospective).

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)

Information Not Provided: The text does not refer to the use of experts for establishing ground truth in a performance study.

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

Information Not Provided: There is no mention of an adjudication method for a test set.

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

Information Not Provided: The document does not describe an MRMC study or any information about human reader improvement with or without AI assistance. The device Aid-U is described as a "Medical Image Management and Processing System," not explicitly an AI diagnostic aid that would typically undergo such studies.

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

Information Not Provided: No standalone algorithm performance is reported. The device is described as a system for storing, viewing, and processing medical images.

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

Information Not Provided: There is no mention of the type of ground truth used, as no clinical performance study is detailed.

8. The sample size for the training set

Information Not Provided: No information about a training set size is provided. The document highlights the device's technical specifications and substantial equivalence to existing PACS systems, not a machine learning model developed with a training set.

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

Information Not Provided: No information about ground truth establishment for a training set is provided.

Summary of Device and Study (Based on Provided Text):

Device Name: Aid-U
Device Type: Medical Image Management and Processing System (SaaS or On-Premise Software web application)
Intended Use: Storing, displaying (zoom-in/out), retrieving, transmitting, and processing medical images from various DICOM-compliant modalities (CT, MR, PT, US, XA, NM, DX, SC). Intended for use by radiologists, technologists, and clinicians.
Regulatory Pathway: 510(k) Premarket Notification (K231662)
Basis for Clearance: Substantial Equivalence to predicate devices (Agfa HealthCare's ICIS View K143397 and Novarad Corporation's NovaPACS K171754).
Non-Clinical Tests Mentioned:
- Compliance with DICOM (NEMA PS 3.1 - 3.15, 3.18)
- JPEG 2000 (ISO/IEC 15444-1:2016)
- Software life-cycle processes (IEC 62304:2015)
- Risk management (ISO 14971:2019, IEC TR 80002-1:2009)
- Medical device security (AAMI TIR57:2016)
Conclusion from Non-Clinical Tests: "All software specifications meet the acceptance criteria. It complies with cybersecurity requirements... The results of the hazard analysis, combined with the appropriate preventive measures Taken, indicate the device is of moderate level of concern..."

This documentation is typical for a 510(k) submission for an image management system, which primarily relies on demonstrating functional equivalence and adherence to established standards rather than clinical performance studies focused on diagnostic accuracy or AI assistance.

Summary

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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & 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".

iAID Jooyoung Park Quality Development Manager #1307 6, Wiryeseong-daero, Songpa-gu Seoul. 05544 Korea, South

February 8, 2024

Re: K231662 Trade/Device Name: Aid-U Regulation Number: 21 CFR 892.2050 Regulation Name: Medical Image Management and Processing System Regulatory Class: Class II Product Code: LLZ Dated: January 10, 2024 Received: January 10, 2024

Dear Jooyoung Park:

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" (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

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product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS 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 (OS) 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.

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 medical devices and radiation-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.

Jessica Lamb

Jessica Lamb, Ph.D. Assistant Director Imaging Software Team DHT8B: Division of Radiologic Imaging Devices and Electronic Products OHT8: Office of Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health

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Indications for Use

510(k) Number (if known) K231662

Device Name Aid-U

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)

ü Prescription Use (Part 21 CFR 801 Subpart D)
□ Over-The-Counter Use (21 CFR 801 Subpart C)

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Image /page/3/Picture/0 description: The image shows the logo for iAID. The logo consists of a 3D cube-like shape on the left, with the letters 'iAID' to the right of the shape. The cube shape is made up of different shades of blue, while the 'i' is gray, the 'A' is blue with a yellow accent, and the 'ID' is gray.

K231662 510(k) Summary

1. Applicant / Submitter

Submitter:	iAID
	#1307 6, Wiryeseong-daero,
	Songpa-gu, Seoul, Republic of Korea [05544]
Contact person (application correspondent):
	- Name : Jooyoung Park
	- Title : Quality Manager
	- Phone number : +82-10-9033-4422
	- E-mail address : chacha4422@gmail.com
Date Prepared:	Feb 07, 2024

2. Proposed Device

Device	System, Image Processing, Radiological
Trade/Device Name	Aid-U
Regulation Number	21 CFR 892.2050
Device Classification Name	Medical Image Management and Processing System
Regulatory Class	Class II
Product Code	LLZ
Classification Panel	Radiology Devices

3. Device Description

4. Indication for use

Aid-U is a software solution intended to be used for storing, zoom-in, zoom-out, retrieving, transmitting, and processing medical images, or outputting them. Aid-U is intended for use as a web- based application and is networked with a PACS server. It enables the display, comparison of CT, MR, PT, US, XA, NM, DX, and SC from other DICOM compliant modalities. Typical

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Image /page/4/Picture/0 description: The image shows the logo for iAid. The logo consists of a blue cube-like shape with the letters "AI" in white on the front. To the right of the cube is the text "iAid" in gray, with the "A" in "iAid" having a green and yellow accent.

users are radiologists, technologists, and clinicians.

5. Technology

Aid-U is a software system that enables health care professionals to access, manipulate in realtime, medical images using any web-browser without installing client software without restrictions of device/location. PACS application program is executed based on Wildfly application server, which is SubSYS-WILDFLY. Based on security communication, logging, DICOM tags stored in DB, and file storage information stored in SubSYS-LDAP, the initialization database SubSYS-POSTGRESOL is used to store, search, and search medical images and meta information. Storage, inquiry and search functions are provided only to authorized users in SubSYS-KEYCLOAK, and unauthorized access is blocked. In addition, it provides a web browser-based PACS/Web viewer UI that can store and search medical images and meta information by interacting with the PACS application program.

6. Predicate Device

Subject Device	Primary Predicate Device	Additional Predicate Device
Aid-U	Agfa HealthCare'sICIS View(K143397)	Novarad CorporationNovaPACS(K171754)
Functionality	Subject Device	Predicate Device	Predicate Device
		Agfa HealthCare's	Novarad Corporation
		ICIS View	NovaPACS
		(K143397)	(K171754)
Device Name	Aid-U	ICIS View	NovaPACS
Classification	Class II	Class II	Class II
Regulatory Number	21 CFR 892.2050	21 CFR 892.2050	21 CFR 892.2050
Product Code	LLZ	LLZ	LLZ
Modalities	CT, MR, PT, US, XA, NM, DX, SC	CR, DX, CT, MR, US,	CT, MR, US, CR/DX, NM, PT, and XA
Communication	Same as predicates	DICOM	DICOM
Indication for Use	Aid-U is a software solution intended to be usedfor storing, zoom-in, zoom-out, retrieving,transmitting, and processing medical images, oroutputting them. Aid-U is intended for use as aweb- based application and is networked with aPACS server. It enables the display, comparisonof CT, MR, PT, US, XA, NM, DX, and SC fromother DICOM compliant modalities. Typicalusers are radiologists, technologists, andclinicians.	ICIS® View is a software application usedfor reference viewing of medical images andassociated reports and, as such, fulfills a keyrole in Agfa HealthCare's Imaging ClinicalInformation System (ICIS). ICIS® Viewenables healthcare professionals, including(but not limited to) physicians, surgeons,nurses, and administrators to receive andview patient images and data from multipledepartments and organizations within onemultidisciplinary viewer. Users may accessthe product directly via a web-browser,select mobile devices, healthcare portal orwithin the Electronic Medical Record(EMR). ICIS® View allows users to performbasic image manipulations andmeasurements (for example window/level,rotation, zoom, and markups). ICIS® Viewcan optionally be configured for Full Fidelitymode, which is intended for diagnostic use,review and analysis of CR, DX, CT, MR,	NovaPACS is intended for the viewing,archiving, analysis, annotation, registration,distribution, editing, fusion, and processingof digital medical images and data acquiredfrom diagnostic imaging devices and allDICOM devices, including mammography.NovaPACS is intended for use by trainedhealthcare professionals, includingradiologists, physicians, technologists,clinicians, and nurses. NovaPACS allows theend user to display, manipulate, archive, andevaluate images.Mobile devices are not intended to replace afull workstation and should be used onlywhen there is no access to a workstation.They are not to be used for mammography orfMRI. Mobile devices are used for diagnosisof medical imagesfrom different modalities including CT, MR,US, CR/DX, NM, PT, and XA. For a list ofcompatible mobile platforms see NovaPACS

		US images and medical reports. ICIS® ViewFull Fidelity is not intended to replace fulldiagnostic workstations and should only beused when there is no access to aworkstation. ICIS® View full fidelity is notintended for the display of digitalmammography images for diagnosis.	Diagnostic Viewer User Manual. WhileNovaPACS full workstation provides toolsto assist the healthcare professionaldetermine diagnostic viability, it is the user'sresponsibility to ensure quality, displaycontrast, ambient light conditions, and toconfirm image compressionratios are consistent with the generallyaccepted standards of the clinicalapplication.NovaPACS is intended for providinganalysis and visualization of functional MRIdata of the human brain, presenting derivedproperties and parameters in a clinicallyuseful context.
Window Level	Same as primary predicate	Yes	Yes
User Authentication	Same as primary predicate	Yes	Yes
Network Access	Web browser connects toexisting PACS	Web browser connects toexisting PACS	Workstation, andNovaWeb Web Viewer.
Transfer/Storage/Displayof Medical Images	Same as primary predicate	Yes	Yes
Pan/Zoom	Same as primary predicate	Yes	Yes
Measurement	Same as primary predicate	Yes	Yes
Annotation	Same as primary predicate	Yes	Yes

7. Determination of Substantial Equivalence

Aid-U has the same intended use, principle of operation, and similar technological features to the predicate devices ICIS (K143397) and NovaPACS (K171754).

There might be slight differences in features and menu, but these differences between the predicate devices and the proposed device do not raise any new or potential safety risks to the user or patient and questions of safety or effectiveness. Based on the results of software validation and verification tests, we conclude that the proposed device is substantially equivalent to the predicate devices.

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Image /page/5/Picture/0 description: The image shows the logo for iAID. The logo consists of a blue cube-like shape with the letters 'AI' on the left side. To the right of the cube is the text 'iAID' in gray and blue.

Comparison Table:

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Image /page/6/Picture/0 description: The image shows the logo for iAID. The logo consists of the letters "Ai" in blue and the letters "AID" in gray. The "i" in "iAID" is lowercase, while the other letters are uppercase.

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Image /page/7/Picture/0 description: The image shows the logo for iAID. The logo consists of a blue 3D cube with the letters "AI" on the left side of the image. To the right of the cube are the letters "iAID" in gray, with a small yellow accent on the "A". The logo is simple and modern, and the colors are eye-catching.

8. Summary of Non-Clinical Test

Non-clinical tests were conducted for the device Aid-U during product development.

. NEMA PS 3.1 - 3.15, 3.18 (2016). Digital Imaging and Communication in Medicine (DICOM)
. ISO/IEC 15444-1:2016 (JPEG 2000)
IEC 62304:2015, Medical devices software Software life-cycle processes .
. ISO 14971:2019 Medical devices - Application of risk management to medical devices
. IEC TR 80002-1:2009, Medical device software -- Part 1: Guidance on the application of ISO 14971 to medical device software
. AAMI TIR57:2016, Principles for medical device security-Risk management

The risk analysis was completed, verification and validation tests were performed to support the claim of substantial equivalence, and the test results support that all software specifications meet the acceptance criteria. It complies with cybersecurity requirements by implementing processes to prevent unauthorized access, modification, misuse, or refusal to use information stored, accessed, or transmitted by medical devices.

9. Safety and Effectiveness Information:

Software specifications, design descriptions, hazard analysis, and labeling information are submitted in support of this premarket notification. The device labeling contains instructions for use with cautions to provide for safe and effective use of the device. The results of the hazard analysis, combined with the appropriate preventive measures Taken, indicate the device is of moderate level of concern, as per the Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices (May 11, 2005).

10. Conclusion

The new device Aid-U and predicate device are substantially equivalent in the areas of technical characteristics, general functions, application, and intended use. The new device does not introduce a fundamentally new scientific technology, and the nonclinical tests demonstrate that the device is as safe and effective as the predicate devices currently on the market.

Regulation Number and Section

§ 892.2050 Medical image management and processing system.

(a)
Identification. A medical image management and processing system is a device that provides one or more capabilities relating to the review and digital processing of medical images for the purposes of interpretation by a trained practitioner of disease detection, diagnosis, or patient management. The software components may provide advanced or complex image processing functions for image manipulation, enhancement, or quantification that are intended for use in the interpretation and analysis of medical images. Advanced image manipulation functions may include image segmentation, multimodality image registration, or 3D visualization. Complex quantitative functions may include semi-automated measurements or time-series measurements.(b)
Classification. Class II (special controls; voluntary standards—Digital Imaging and Communications in Medicine (DICOM) Std., Joint Photographic Experts Group (JPEG) Std., Society of Motion Picture and Television Engineers (SMPTE) Test Pattern).