(137 days)
Unknown
The description mentions "Semi-automatic lesion segmentation suggestions" and "Semi-automatic lesion labelling suggestions". While these could be implemented using traditional image processing techniques, the term "suggestions" implies a level of inference or prediction that is often associated with AI/ML. However, the document does not explicitly state that AI/ML is used, nor does it provide details about training or test sets, which are typical for AI/ML-based devices. Therefore, it's not possible to definitively confirm or deny the presence of AI/ML based solely on this summary.
No.
The device is described as a "software solution" that assists medical professionals in "viewing, manipulation, storage, annotation, analysis, and comparison of medical images." It is explicitly stated that "AI Metrics is not to be used in mammography" and "does not directly generate any diagnosis or potential findings." Its purpose is to help "assess changes in imaging findings over multiple time-points" and "assess, categorize and document the extent of a disease and/or tumor response to therapy." None of these functions involve directly treating or preventing a disease, which are characteristics of a therapeutic device. It is an image processing and analysis tool for diagnostic support.
No.
The product explicitly states, "It is intended to provide image and related information that is interpreted by a trained professional but does not directly generate any diagnosis or potential findings," and "The medical professional retains the ultimate responsibility for making the pertinent diagnosis based on their standard practices. Al Metrics is a complement to these standard procedures." This indicates that it assists in the diagnostic process by organizing and presenting data but does not make the diagnosis itself.
Yes
The device description explicitly states "AI Metrics is a software only medical device". While it runs on general purpose computing hardware, the device itself is the software application.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to provide information for diagnosis, monitoring, or screening.
- AI Metrics Functionality: AI Metrics is a software solution that processes and analyzes medical images (CT, MR) from within the body. It does not analyze samples taken from the body. Its purpose is to aid in the interpretation and evaluation of these images by trained medical professionals.
- Intended Use: The intended use clearly states it's for "viewing, manipulation, storage, annotation, analysis, and comparison of medical images." It's a workflow automation tool for image analysis, not a diagnostic test performed on biological samples.
- Device Description: The device description reinforces that it's a software-based PACS used for the display and visualization of medical image data.
Therefore, AI Metrics falls under the category of medical imaging software, not in vitro diagnostics.
N/A
Intended Use / Indications for Use
AI Metrics is a software solution intended to be used for viewing, manipulation, storage, annotation, analysis, and comparison of medical images from multiple imaging modalities and/or multiple time points. The application supports images and anatomical datasets, such as CT and MR. AI Metrics is a software only medical device to be deployed via internet software download and installed by trained AI Metrics technicians.
AI Metrics enables visualization of information that would otherwise have to be visually compared disjointedly. AI Metrics provides analytical and workflow automation tools to help the user assess and document the extent of a disease and/or the response to therapy in accordance with user selected standards and assess changes in imaging findings over multiple time-points. Al Metrics supports the interpretation and evaluations and follow up documentation of findings within healthcare institutions, for example, in Radiology, Oncology, and other Medical Imaging environments.
The product is intended to be used as a workflow automation tool by trained medical professionals. It is intended to provide image and related information that is interpreted by a trained professional but does not directly generate any diagnosis or potential findings.
Note: The medical professional retains the ultimate responsibility for making the pertinent diagnosis based on their standard practices. Al Metrics is a complement to these standard procedures. Al Metrics is not to be used in mammography.
Product codes
LLZ
Device Description
Al Metrics is a software based Picture Archiving and Communication System (PACS) used with general purpose computing hardware for the display and visualization of medical image data. It runs on either a native or a virtualized Linux platform. The application supports images and anatomical datasets, such as CT and MR.
Al Metrics is designed as a workflow automation application with analytical tools to help the user assess, categorize and document the extent of a disease and/or tumor response to therapy in accordance with user selected standards (e.g. RECIST 1.1) and assess changes in imaging findings over multiple time-points.
Al Metrics supports the interpretation and evaluation of examinations and follow up documentation of findings within healthcare institutions, for example, in Radiology, Oncology, and other Medical Imaging environments.
Al Metrics functionality provides for communication, storage, processing, rendering, and display of DICOM compliant image data derived from various sources including anatomical datasets (e.g. CT, MRI), navigation through images, selection of regions of interest, generation of information from those regions, evaluation in accordance with user selected standards, and generation of a structured report.
The user controls these functions with a system of interactive menus and semi-automated or manual workflow automation tools, including:
- Manual annotation tools for users to select regions of interest (ROIs), ●
- Semi-automatic lesion segmentation suggestions for user-selected ROIs,
- Automatic measurement and display of long and short axis of segmented lesions,
- . Automatic tabulation and summation of measurements,
- Semi-automatic lesion labelling suggestions for anatomical location (organ, body region, . and laterality),
- . Automatic calculation of quantitative and qualitative metrics using annotation data in accordance with the selected criteria, and
- Automatic generation of a structured report that includes the annotation data and ● calculated quantitative and qualitative metrics presented in a graph, table, key images, and structured text report.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Yes (AI Metrics, AI Metrics is a software solution)
Input Imaging Modality
CT and MR
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Trained medical professionals / healthcare institutions, for example, in Radiology, Oncology, and other Medical Imaging environments.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
Al Metrics has successfully undergone extensive verification and validation testing to ensure that all requirements for the software were met per FDA Guidance. The software design and development process followed the ISO 62304 standard. The software was tested against the established Software Design Specifications and passed all required tests. A Risk Management Report was completed which identified and verified the mitigation of all required hazards in compliance with ISO 14971 standard. Quality management systems follow the ISO 13485 standard. These results provide objective evidence that the outputs of the software design activity meet all of the specified requirements for that activity.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
December 22, 2020
AI Metrics, LLC % Yujan Shrestha, M.D. CTO Innolitics. LLC 1101 West 34th Street #550 AUSTIN TX 78705
Re: K202229
Trade/Device Name: AI Metrics Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: Class II Product Code: LLZ Dated: November 11, 2020 Received: November 13, 2020
Dear Dr. Shrestha:
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
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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-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 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,
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) K202229
Device Name AI Metrics
Indications for Use (Describe)
AI Metrics is a software solution intended to be used for viewing, manipulation, storage, annotation, analysis, and comparison of medical images from multiple imaging modalities and/or multiple time points. The application supports images and anatomical datasets, such as CT and MR. AI Metrics is a software only medical device to be deployed via internet software download and installed by trained AI Metrics technicians.
AI Metrics enables visualization of information that would otherwise have to be visually compared disjointedly. AI Metrics provides analytical and workflow automation tools to help the user assess and document the extent of a disease and/or the response to therapy in accordance with user selected standards and assess changes in imaging findings over multiple time-points. Al Metrics supports the interpretation and evaluations and follow up documentation of findings within healthcare institutions, for example, in Radiology, Oncology, and other Medical Imaging environments.
The product is intended to be used as a workflow automation tool by trained medical professionals. It is intended to provide image and related information that is interpreted by a trained professional but does not directly generate any diagnosis or potential findings.
Note: The medical professional retains the ultimate responsibility for making the pertinent diagnosis based on their standard practices. Al Metrics is a complement to these standard procedures. Al Metrics is not to be used in mammography.
| 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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Image /page/3/Picture/0 description: The image shows the logo for AI Metrics. The logo has the letters "AI" in light blue with a plus sign above the letters. To the right of the letters is the word "METRICS" in gray.
5. 510(k) Summary
In accordance with 21 CFR 807.92, the following summary of information in the 510(k) submission is provided.
5.1 Identification of the Submitter
| Submitter: | Al Metrics LLC
432 Renaissance Dr. Hoover, AL 35226
Phone: 205-573-3332
Website: www.aimetrics.com |
|------------------|-------------------------------------------------------------------------------------------------------------|
| Primary Contact: | Dr. Andrew Smith, Founder
Email: andrew@aimetrics.com
Phone: (769) 610-6235 |
| Company Contact: | Bob Jacobus, COO
Email: bob@aimetrics.com
Phone: (205) 639-8618 |
| Date Prepared: | September 9, 2020 |
5.2 Identification of the product
| Trade Name: | AI Metrics |
|---|---|
| Common Name: | Image Processing Software |
| Classification: | Picture Archiving and Communications System per 21 CFR 892.2050 |
| Review Panel: | Radiology |
| Device Class: | Class II |
| Product Code: | LLZ |
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Image /page/4/Picture/0 description: The image shows the logo for AI Metrics. The logo consists of the letters "AI" in light blue, with a plus sign above the letters. To the right of the letters is the word "METRICS" in gray. There is a light blue line above the word "METRICS".
5.3 Predicate Device to which Equivalence is claimed
| Device Name: | mint Lesion |
|---|---|
| Manufacturer: | Mint Medical GmbH Germany |
| 510(k) Number: | K142647 |
| Product Code: | LLZ |
| Classification: | Picture Archiving and Communications System per 21 CFR 892.2050 |
5.4 Device Description
Al Metrics is a software based Picture Archiving and Communication System (PACS) used with general purpose computing hardware for the display and visualization of medical image data. It runs on either a native or a virtualized Linux platform. The application supports images and anatomical datasets, such as CT and MR.
Al Metrics is designed as a workflow automation application with analytical tools to help the user assess, categorize and document the extent of a disease and/or tumor response to therapy in accordance with user selected standards (e.g. RECIST 1.1) and assess changes in imaging findings over multiple time-points.
Al Metrics supports the interpretation and evaluation of examinations and follow up documentation of findings within healthcare institutions, for example, in Radiology, Oncology, and other Medical Imaging environments.
Al Metrics functionality provides for communication, storage, processing, rendering, and display of DICOM compliant image data derived from various sources including anatomical datasets (e.g. CT, MRI), navigation through images, selection of regions of interest, generation of information from those regions, evaluation in accordance with user selected standards, and generation of a structured report.
The user controls these functions with a system of interactive menus and semi-automated or manual workflow automation tools, including:
- Manual annotation tools for users to select regions of interest (ROIs), ●
- Semi-automatic lesion segmentation suggestions for user-selected ROIs,
- Automatic measurement and display of long and short axis of segmented lesions,
- . Automatic tabulation and summation of measurements,
5
Image /page/5/Picture/0 description: The image shows the logo for AI Metrics. The logo consists of the letters "AI" in light blue, with a plus sign above the "I". To the right of "AI" is the word "METRICS" in gray. A light blue line is above the word "METRICS".
- Semi-automatic lesion labelling suggestions for anatomical location (organ, body region, . and laterality),
- . Automatic calculation of quantitative and qualitative metrics using annotation data in accordance with the selected criteria, and
- Automatic generation of a structured report that includes the annotation data and ● calculated quantitative and qualitative metrics presented in a graph, table, key images, and structured text report.
Al Metrics software has been extensively tested on Linux systems by members of the development and quality control teams. A hazard analysis has been conducted and all risks have been determined to be acceptable. The release candidate version of the software passed all tests considered critical in terms of patient safety and demonstrated an overall acceptable performance.
5.5 Intended Use
Al Metrics is a software solution intended to be used for viewing, manipulation, communication, storage, annotation, analysis, and comparison of medical images from multiple imaging modalities and/or multiple time points. The application supports images and anatomical datasets, such as CT and MR. AI Metrics is a software only medical device to be deployed via internet software download and installed by trained Al Metrics technicians.
Al Metrics enables visualization of information that would otherwise have to be visually compared disjointedly. Al Metrics provides analytical and workflow automation tools to help the user assess and document the extent of a disease and/or the response to therapy in accordance with user selected standards and assess changes in imaging findings over multiple time-points. Al Metrics supports the interpretation and evaluation of examinations and follow up documentation of findings within healthcare institutions, for example, in Radiology, Oncology, and other Medical Imaging environments.
The product is intended to be used as a workflow automation tool by trained medical professionals. It is intended to provide image and related information that is interpreted by a trained professional but does not directly generate any diagnosis or potential findings.
Note: The medical professional retains the ultimate responsibility for making the pertinent diagnosis based on their standard practices. Al Metrics is a complement to these standard procedures. Al Metrics is not to be used in mammography.
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Image /page/6/Picture/0 description: The image shows the logo for AI Metrics. The logo consists of the letters "AI" in a light blue color, with a plus sign above the letters. To the right of the letters "AI" is the word "METRICS" in gray. A horizontal line is above the word "METRICS".
5.6 Substantial Equivalence Comparison to the Predicate Device
The following tables summarize the intended use and technological characteristics of Al Metrics and the predicate device mint Lesion.
| Intended Use | Subject (Al Metrics) | Predicate (K142647) |
|---|---|---|
| Thin client medical image viewer. | Yes. | Yes. |
| Software only medical device deployed within | ||
| a customer's IT infrastructure or on virtualized | ||
| server technology. | Yes. | Yes. |
| Application supports anatomical datasets, | ||
| such as CT and MR. | Yes. | Yes. Also supports |
| functional datasets. | ||
| To be used for viewing, manipulation, | ||
| communication, storage, 3D-visualization and | ||
| comparison of medical images from multiple | ||
| imaging modalities and/or multiple time points. | Yes. | Yes. |
| Provides tools to help the user assess and | ||
| document the extent of a disease and/or the | ||
| response to therapy in accordance with user | ||
| selected standards. | Yes. | Yes. |
| Supports the interpretation and evaluation of | ||
| examinations and follow up documentation of | ||
| findings within healthcare institutions, for | ||
| example, in Radiology, Oncology, and other | ||
| Medical Imaging environments. | Yes. | Yes. Includes |
| Nuclear Medicine | ||
| environments. | ||
| The medical professional retains the ultimate | ||
| responsibility for making the pertinent | ||
| diagnosis based on their standard practices. | ||
| The software is a complement to these | ||
| standard procedures. | Yes. | Yes. |
| Not be used in mammography. | Yes. | Yes. |
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Image /page/7/Picture/0 description: The image shows the logo for AI Metrics. The logo has the letters AI in light blue with a crosshair symbol over the letters. The word METRICS is in gray and to the right of the letters AI.
| Technological Characteristic | Subject (Al Metrics) | Mint Lesion (K142647) |
|---|---|---|
| Design | ||
| Software-based Picture Archiving and Communication System (PACS) used with general purpose computing hardware. | Yes. | Yes. |
| Operating system / Run environment | Windows 64 / native or virtualized Microsoft Windows platform. | Linux / native or virtualized Linux platform. |
| Software delivery method | CD ROM/DVD or internet. | Internet software download. |
| Features and Functionality | ||
| Image navigation tools (pan, zoom, scroll, window/level) | Yes. | Yes. |
| Measurement tools (linear, ROI, HU) | Yes. | Yes. |
| Automatic long and short axis calculations | Yes. | Yes. |
| User controls functions with a system of interactive menus and tools | Yes. | Yes. |
| Semi-automatic lesion segmentation tools | Yes. | Yes. |
| Anatomical location labelling tools | Yes. | Yes. |
| Display output of measurements and anatomical location information | Yes. | Yes. |
| Tabulation and summation of measurements, lesion categorization and standard evaluation in accordance with selected criteria | Yes. | Yes. |
| Longitudinal lesion analysis | Yes. | Yes. |
| Image co-registration for viewing images | ||
| from different time points | Yes. | Yes. |
| Report generation | Yes. | Yes. |
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Image /page/8/Picture/0 description: The image shows the logo for AI Metrics. The logo has the letters "AI" in light blue with a crosshair symbol over the letters. To the right of the letters is the word "METRICS" in gray.
Al Metrics has the same intended use as the predicate device. Al Metrics does not support functional datasets such as PET. In addition to the shared indications for use in radiology and oncology, the predicate device also includes indications for use in nuclear medicine environments. Al Metrics does not support functional datasets and therefore does not have indications for use in nuclear medicine environments. We believe these differences do not raise different questions of safety and effectiveness.
Al Metrics and the predicate device are substantially equivalent in the categories of technical characteristics and features. We believe the differences in operating systems and software delivery methods do not raise different questions of safety and effectiveness. The software delivery method itself will undergo verification and validation activities to ensure it does not adversely affect the safety and effectiveness of the device.
5.7 Summary of Studies
Al Metrics has successfully undergone extensive verification and validation testing to ensure that all requirements for the software were met per FDA Guidance. The software design and development process followed the ISO 62304 standard. The software was tested against the established Software Design Specifications and passed all required tests. A Risk Management Report was completed which identified and verified the mitigation of all required hazards in compliance with ISO 14971 standard. Quality management systems follow the ISO 13485 standard. These results provide objective evidence that the outputs of the software design activity meet all of the specified requirements for that activity.
5.9 Conclusion
Al Metrics has the same intended use and technological characteristics as the predicate device. Any differences between Al Metrics and the predicate device do not raise different questions of safety and effectiveness. The result of all testing conducted was found acceptable to support the claim of substantial equivalence.