ClariCT.AI is a software device intended for networking, communication, processing and enhancement of CT images in DICOM format regardless of the manufacturer of CT scanner or model.

Device Description

ClariCT.AI software is intended for denoise processing and enhancement of CT DICOM images when higher image quality and/or lower dose acquisitions are desired. ClariCT.Al software can be used to reduce noises in CT images of the head, chest, and abdomen, in particular in CT images with a lower radiation dose. ClariCT.Al may also improve the image quality of low-dose nondiagnostic Filtered Back Projection images as well as Iterative Reconstruction images. The subject device, ClariCT.Al, added a new module (named Al Marketplace Integration module) to the original cleared device (K183460) to enable installation on the Al Marketplace system. The module integrates the Denoising Processor of the original device into the Al Marketplace system. So ClariCT.Al can be hosted through a third-party Al marketplace that integrates centrally with PACS and seamlessly integrates into the existing IT and modality infrastructure.

AI/ML Overview

The ClariCT.AI device, as described in the 510(k) summary, is a software intended for denoise processing and enhancement of CT images. The submission K212074 focuses on the addition of a new module ("AI Marketplace Integration module") to the previously cleared device (K183460), enabling installation on an AI Marketplace system. This new module allows the device to be hosted through a third-party AI marketplace, integrating with PACS and existing IT infrastructure. The submission asserts that this change has no effect on the safety or efficacy of the device and does not raise any potential safety risks, and that the subject device is identical in performance to the legally marketed predicate device.

Since the submission states that "ClariCT.AI does not require clinical studies to demonstrate substantial equivalence to the predicate devices" and that the subject device is "identical in performance to the legally marketed device (K183460)", it implies that the performance data for K212074 relies on the performance data of the original K183460 submission. However, the provided document does not contain the detailed acceptance criteria or a study proving the device (K212074, or even K183460) meets such criteria, nor does it provide information regarding sample size, data provenance, ground truth establishment, or any comparative effectiveness studies.

Therefore, based solely on the provided text, I cannot provide the requested information in detail. The document primarily focuses on demonstrating substantial equivalence based on the functionality of the new integration module and adherence to general medical device standards.

Here's a breakdown of what can be extracted and what is missing:

1. Table of acceptance criteria and reported device performance:

Acceptance Criteria (Missing): The document states, "Meets the acceptance criteria and is adequate for its intended use," but does not explicitly list these criteria.
Reported Device Performance (Missing): No specific performance metrics (e.g., PSNR, SSIM, radiologists' scores for noise reduction, image quality, diagnostic accuracy improvements) are reported for either the subject or predicate device.

2. Sample size used for the test set and data provenance:

Sample Size (Missing): Not mentioned in the provided text.
Data Provenance (Missing): Not mentioned in the provided text (e.g., country of origin, retrospective/prospective). The document mentions "substantial datasets" were used for testing, but no specifics.

3. Number of experts used to establish the ground truth for the test set and their qualifications:

Missing: This information is not provided in the document.

4. Adjudication method for the test set:

Missing: Not mentioned in the provided text.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and its effect size:

No: The document explicitly states: "ClariCT.AI does not require clinical studies to demonstrate substantial equivalence to the predicate devices." This implies that no MRMC comparative effectiveness study was conducted for this submission (K212074). Given the assertion of identical performance to the predicate, it also suggests such a study wasn't deemed necessary for K183460's clearance either, at least not for the purpose of demonstrating substantial equivalence.

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

Implied Yes, but details missing: The document mentions "performance tests" for the device, which is a software algorithm. However, the specific results of these standalone tests (e.g., quantitative metrics of noise reduction) are not provided. The function is described as "denoise processing and enhancement of CT images."

7. The type of ground truth used:

Missing: Not specified. For a denoising algorithm, ground truth might involve noiseless or extremely low-noise reference images, or expert consensus on image quality. This is not detailed.

8. The sample size for the training set:

Missing: Not mentioned. The device uses "pre-trained deep learning models," but the training set size is not provided.

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

Missing: Not mentioned.

Conclusion based on provided text:

The 510(k) summary for ClariCT.AI (K212074) indicates that the device has undergone non-clinical performance testing to comply with international standards and FDA guidance. It asserts that "The test results in this 510(k), demonstrate that ClariCT.AI ... Meets the acceptance criteria and is adequate for its intended use." However, the document does not detail the specific acceptance criteria, the specific performance results against those criteria, or the methodology of any studies (e.g., sample sizes, ground truth establishment, expert involvement) that would prove these claims. The submission primarily focuses on the substantial equivalence of K212074 to its predicate (K183460) by asserting that the new AI Marketplace integration module does not alter its safety or efficacy.

Summary

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July 27, 2021

Image /page/0/Picture/1 description: The image shows the logo for the U.S. Food and Drug Administration (FDA). On the left is the Department of Health and Human Services logo. To the right of that is the FDA logo, which consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, and then the word "ADMINISTRATION" in a smaller font size below that.

ClariPi Inc. % Harry Park President ClariPi USA Inc. 1645 Park Creek Ct. ROCHESTER HILLS MI 48309

Re: K212074

Trade/Device Name: ClariCT.AI Regulation Number: 21 CFR 892.2050 Regulation Name: Medical image management and processing system Regulatory Class: Class II Product Code: LLZ Dated: July 1, 2021 Received: July 2, 2021

Dear Harry 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 (Act) that do not require approval of a premarket approval application (PMA). You mav, 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 avare 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 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-reporting

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combination-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) K212074

Device Name ClariCT.AI

Indications for Use (Describe)

ClariCT.AI is a software device intended for networking, communication, processing and enhancement of CT images in DICOM format regardless of the manufacturer of CT scanner or model.

Type of Use (Select one or both, as applicable)
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X 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 "ClariPi", an AI medical imaging solutions company. The word "Clari" is in bold black font, while the "Pi" symbol is in blue. Below the company name, the words "AI MEDICAL IMAGING SOLUTIONS" are written in a smaller, non-bold font.

510(k) Summary

This 510(k) Summary is being submitted in accordance with the requirements of as required by section 807.92(c).

. SUBMITTER

ClariPi Inc. 3F, 70-15, Ihwajang-gil, Jongno-gu Seoul, Republic of Korea [03088] Tel: +82-2-741-3014 Fax: +82-2-743-3014 Email: claripi@claripi.com

Contact person: Ms. Hyun-Sook Park, CEO Date Prepared: July 01, 2021

II. DEVICE

Name of Device: ClariCT.Al Common or Usual Name: Picture, archive and communications system Classification Name: Medical Image Management and Processing System (21 CFR 892.2050) Regulatory Class: II Product Code: LLZ

III. PREDICATE DEVICE

This predicate has not been subject to a design-related recall. The ClariCT.Al software device, addressed in this premarket notification, is substantially equivalent to the following commercially available software:

Device Classification Name	Medical Image Management and Processing System
510(k) Number	K183460
Device Name	ClariCT.Al
Applicant	ClariPi Inc.3F, 70-15, Ihwajang-gil, Jongno-guSeoul, Korea, Republic of [03088]
Regulation Number	892.2050
Classification Product Code	LLZ
Date Received	12/13/2018
Decision Date	06/13/2019
510k Review Panel	Radiology

IV. DEVICE DESCRIPTION

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Image /page/4/Picture/0 description: The image shows the logo for "Clariπ AI MEDICAL IMAGING SOLUTIONS". The word "Clari" is in bold black font, while the pi symbol is in blue. Below the word "Clariπ" is the text "AI MEDICAL IMAGING SOLUTIONS" in a smaller, thinner font.

510(k) Summary

improve the image quality of low-dose nondiagnostic Filtered Back Projection images as well as Iterative Reconstruction images.

The predicate device is a software application to denoise on CT images, integrated with the clinical environment through DICOM communication on-premise, and runs under the Microsoft Windows platform.

The subject device, ClariCT.Al, added a new module (named Al Marketplace Integration module) to the original cleared device (K183460) to enable installation on the Al Marketplace system. The module integrates the Denoising Processor of the original device into the Al Marketplace system. So ClariCT.Al can be hosted through a third-party Al marketplace that integrates centrally with PACS and seamlessly integrates into the existing IT and modality infrastructure.

V. INDICATIONS FOR USE

ClariCT.Al is a software device intended for networking, communication, processing, and enhancement of CT images in DICOM format regardless of the manufacturer of CT scanner or model.

VI. SUBSTANTIAL EQUIVALENCE TABLE

The following information compares the subject device to the predicate. The difference is that the subject device can be integrated into the Al Marketplace system that distributes Docker images in a virtual machine running in a Linux environment. It has no effect on the safety or efficacy of the subject device and does not raise any potential safety risks, and the subject device is identical in performance to the legally marketed device.

Item	Subject DeviceClariCT.AI	Predicate DeviceClariCT.AI (K183460)
IntendedUse	ClariCT.AI, is a software deviceintended for networking,communication, processing andenhancement of CT images inDICOM format regardless of themanufacturer of CT scanner ormodel.	ClariCT.AI, is a software deviceintended for networking,communication, processing andenhancement of CT images inDICOM format regardless of themanufacturer of CT scanner ormodel.
IntendedUser	Radiologists and specialists	Radiologists and specialists
ModalitySupport	CT	CT
NoiseReductionMethod	Noise reduction is performed with theuse of pre-trained deep learningmodels.	Noise reduction is performed with theuse of pre-trained deep learningmodels.
ImageFormat	DICOM	DICOM
ComponentsAndHardwareRequirement	Window Operating System,PC Hardware, CUDA supportedgraphics card or equivalent.	Window or Linux Operating System.PC Hardware supported graphicscard or equivalent.

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510(k) Summary

Image /page/5/Picture/1 description: The image shows the logo for ClariPi, a company that provides AI medical imaging solutions. The logo consists of the word "Clari" in black font, followed by a blue pi symbol. Below the word "ClariPi" is the text "AI MEDICAL IMAGING SOLUTIONS" in a smaller black font. The logo is simple and modern, and it conveys the company's focus on artificial intelligence and medical imaging.

VII. PERFORMANCE DATA

Non-clinical performance testing has been performed on ClariCT.Al, (the subject device) and demonstrates compliance with the following International and FDA-recognized consensus standards and FDA guidance document:

· ISO 14971 Medical devices Application of risk management to medical devices
· NEMA-PS 3.1- PS 3.20 Digital Imaging and Communications in Medicine (DICOM)
Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices issued May 11, 2005.
· Content of Premarket Submissions for Management of Cybersecurity in Medical Devices Guidance for Industry and Food and Drug Administration Staff Document Issued on: October 2, 2014.
· Design Considerations and Pre-market Submission Recommendations for Interoperable Medical Devices issued September 6, 2017.
The subject device was tested in accordance with the internal Verification and Validation processes of ClariPi Inc. Verification and Validation tests have been performed to address intended use, the technological characteristics claims, requirement specifications, and the risk management results.

The test results in this 510(k), demonstrate that ClariCT.Al:

· Complies with the aforementioned international and FDA-recognized consensus standards and
· FDA guidance document, and
· Meets the acceptance criteria and is adequate for its intended use.

Therefore, ClariCT.Al, is substantially equivalent to the currently marketed predicate devices, in terms of safety and effectiveness.

Clinical Testing:

ClariCT.Al does not require clinical studies to demonstrate substantial equivalence to the predicate devices.

VIII CONCLUSIONS

Verification and Validation activities required to establish the safety and effectiveness of ClariCT.Al were performed. Testing involved system-level tests, performance tests, and safety tests from risk analysis. These tests demonstrated the subject device meets predefined functionality requirements.

The subject device and predicate devices are substantially equivalent in the areas of technical characteristics, general function, application, and intended use. Test results with the substantial datasets demonstrate that the subject device is as safe and effective as the predicate devices. Therefore, the subject device is substantially equivalent to the predicate devices.

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).