(58 days)
AcroDTI Visualizer is an image processing software that allows the user to calculate and display DTI from diffusion MRI (dMRI) data. This software is intended to be utilized by trained physicians to visually evaluate the DTI index maps.
AcroDTI Visualizer is a software for processing and viewing Diffusion Tensor Imaging (DTI) from dataset of Diffusion Weighted Imaging (DWI) acquired with Magnetic Resonance Imaging (MRI). AcroDTI Visualizer calculates and displays DTI maps which reveal diffusion properties of local tissue. The software displays the DTI maps in axial, coronal, and sagittal views, and is able to adjust the image brightness and contrast to assist visual evaluation.
AcroDTI Visualizer provides support for automated processing of diffusion MRI data in Digital Imaging and COmmunications in Medicine (DICOM) format. The software reads DICOM files in DVD (or CD) exported either from the MR scanner or from a Picture Archiving and Communications System (PACS).
The AcroDTI Visualizer is an image processing software that calculates and displays Diffusion Tensor Imaging (DTI) from diffusion MRI (dMRI) data, intended for visual evaluation by trained physicians. The submission states that performance comparison studies were conducted to support substantial equivalence.
Here's a breakdown of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The document broadly states that "all the software specifications have met the acceptance criteria" and "AcroDTI Visualizer meets the pre-specified acceptance criteria." However, specific quantitative acceptance criteria for performance metrics (e.g., accuracy, sensitivity, specificity, or specific error ranges for DTI calculations) are not detailed in the provided text. The performance is primarily described in terms of "high similarity with the legally marketed devices" in comparative studies.
| Acceptance Criteria (Not Explicitly Stated Quantitatively) | Reported Device Performance |
|---|---|
| Software specifications met | All software specifications have met the acceptance criteria. |
| Safety and effectiveness for intended users/uses/environment | Device is safe and effective as shown by human factors validation testing. |
| High similarity with legally marketed devices | AcroDTI Visualizer has high similarity with legally marketed devices. |
| Verification and validation tests met | AcroDTI Visualizer meets pre-specified acceptance criteria. |
2. Sample Size Used for the Test Set and Data Provenance
The document states, "The performance comparison studies between subject device and legally marketed devices were conducted using qualitative and quantitative methods respectively."
However, the sample size for the test set is not explicitly mentioned. The data provenance is also not specified (e.g., country of origin, retrospective or prospective).
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
The text mentions that "Experienced physicians were recruited to evaluate the performance between subject device and legally marketed devices."
The exact number of experts is not specified, nor are their qualifications (e.g., years of experience, specific sub-specialty).
4. Adjudication Method for the Test Set
The document does not describe any specific adjudication method (e.g., 2+1, 3+1) for establishing ground truth or resolving discrepancies among the experienced physicians.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance
The document describes "performance comparison studies between subject device and legally marketed devices" involving "experienced physicians" to "evaluate the performance." This suggests a comparative study involving readers. However, it does not mention an MRMC study designed to measure the improvement of human readers with AI assistance versus without AI assistance. The AcroDTI Visualizer is described as an "image processing software that allows the user to calculate and display DTI," implying it's a visualization tool rather than an AI-assisted diagnostic aid that directly improves reader performance on a diagnostic task compared to a non-AI workflow. Therefore, an effect size of human readers improving with AI vs. without AI assistance is not applicable or provided.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
The device is positioned as "image processing software that allows the user to calculate and display DTI from diffusion MRI (dMRI) data," and is "intended to be utilized by trained physicians to visually evaluate the DTI index maps." This directly implies a human-in-the-loop scenario. While "software verification and validation testing were conducted," these are typically foundational tests for software functionality and reliability, not a standalone performance evaluation in a diagnostic context. Therefore, a standalone performance study (algorithm only without human-in-the-loop performance) is not explicitly described or implied for a diagnostic claim. The performance comparison was with legally marketed devices, with physicians evaluating the output.
7. The Type of Ground Truth Used
The document indicates that "Experienced physicians were recruited to evaluate the performance between subject device and legally marketed devices." This suggests that the ground truth or "reference standard" for comparison was effectively derived from the evaluations and interpretations of these experienced physicians when using the legally marketed predicate devices, and then comparing the AcroDTI Visualizer's output to that. It is not explicitly stated if pathology, outcomes data, or an independent expert consensus (beyond the comparison itself) was used as an absolute ground truth.
8. The Sample Size for the Training Set
The provided text does not contain any information about a training set or its sample size. The AcroDTI Visualizer appears to be a deterministic image processing and visualization tool (calculates and displays DTI maps) rather than a machine learning model that requires a specific training set to learn from data.
9. How the Ground Truth for the Training Set Was Established
Since there is no mention of a training set, the method for establishing ground truth for a training set is not applicable or provided.
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September 9, 2020
Image /page/0/Picture/1 description: The image shows 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 consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, with the word "ADMINISTRATION" underneath.
AcroViz, Inc. % Yung-Chin Hsu Chief Technology Officer Rm. 6, 11F, No. 152, Sec. 1 Zhongxiao E. Rd., Zhongzheng Dist. Taipei. Taiwan 10050 REPUBLIC OF CHINA
Re: K201948
Trade/Device Name: AcroDTI Visualizer Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: Class II Product Code: LLZ Dated: June 20, 2020 Received: July 13, 2020
Dear Yung-Chin Hsu:
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 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,
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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below.
510(k) Number (if known)
Device Name
AcroDTI Visualizer
Indications for Use (Describe)
AcroDTI Visualizer is an image processing software that allows the user to calculate and display DTI from diffusion MRI (dMRI) data. This software is intended to be utilized by trained physicians to visually evaluate the DTI index maps.
| 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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510(k) Summary
| Date | July 3, 2020 |
|---|---|
| ------ | -------------- |
Manufacturer AcroViz Inc. Rm. 6, 11F., No. 152, Sec. 1, Zhongxiao E. Rd., Zhongzheng Dist., Taipei City 10050, Taiwan (R.O.C.)
- Contact Person Yung-Chin Hsu Chief Technology Officer Rm. 6, 11F., No. 152, Sec. 1, Zhongxiao E. Rd., Zhongzheng Dist., Taipei City 10050, Taiwan (R.O.C.) Phone: +886-982-963-908 E-mail: eric.ychsu@acroviz.com
- Device Trade Name AcroDTI Visualizer
- Common Name System, Image Processing, Radiological
- Picture Archiving and Communications System Classification Name
Device Class II
-
Classification Panel Radiology Devices
Product Code LLZ -
Regulation Number 892.2050
Device Description AcroDTI Visualizer is a software for processing and viewing and Technology Diffusion Tensor Imaging (DTI) from dataset of Diffusion Characteristics Weighted Imaging (DWI) acquired with Magnetic Resonance Imaqinq (MRI). AcroDTI Visualizer calculates and displays DTI maps which reveal diffusion properties of local tissue. The software displays the DTI maps in axial, coronal, and sagittal views, and is able to
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adjust the image brightness and contrast to assist visual evaluation.
AcroDTI Visualizer provides support for automated processing of diffusion MRI data in Digital Imaging and COmmunications in Medicine (DICOM) format. The software reads DICOM files in DVD (or CD) exported either from the MR scanner or from a Picture Archiving and Communications System (PACS).
- Indications for Use AcroDTI Visualizer is an image processing software that allows the user to calculate and display DTI from diffusion MRI (dMRI) data. This software is intended to be utilized by trained physicians to visually evaluate the DTI index maps.
Predicate Device(s)
| Predicate Device | Predicate Software | Manufacturer | 510(K) Number |
|---|---|---|---|
| syngo.MR General;syngo.MR Cardiology;syngo.MR Neurology | Softwaresyngo.MRVB20 | Siemens MedicalSolutions USA,Inc. | K163294 |
| Carestream VuePACS | CarestreamVue PACS | CarestreamHealth, Inc. | K170580 |
Performance Data The following performance data were provided in support of the Non-Clinical Tests substantial equivalence determination.
The software for this device was considered as a "moderate" level of concern. Software verification and validation testing were conducted, and documentation was provided as recommended by FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices." The software verification and validation testing results support that all the software specifications have met the acceptance criteria. The human factor engineering file was provided and the human factors validation testing was conducted and showed that the device is safe and effective for the intended users, uses, and use environments.
The performance comparison studies between subject device and legally marketed devices were conducted using qualitative and quantitative methods respectively. Experienced physicians
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were recruited to evaluate the performance between subject device and legally marketed devices. The results show that AcroDTI Visualizer has high similarity with the legally marketed devices and support the substantial equivalence.
The following standards/ guidance applies:
- IEC 62304:2006+AMD1:2015, Medical device software --Software life cycle processes, Ed.1.1
- IEC 82304-1:2016, Health software Part 1: General । requirements for product safety
- Guidance for the Content of Premarket Submissions for -Software Contained in Medical Devices
- -ISO 14971:2019, Medical devices - Application of risk management to medical devices
- -ASTM D4169-16. Standard Practice for Performance Testing of Shipping Containers and Systems
- -IEC 62366-1:2015, Medical devices - Part 1: Application of usability engineering to medical devices
Evaluation was completed following above standards and documents. Conformity to these standards demonstrates that the proposed subject device met the standards' established acceptance criteria for the device. This supports substantial equivalence to its predicates.
- Substantial Equivalence The subject device has same indications for use, technology, operation principle and technical characteristics with the predicate device(s). Verification activities were performed on subject device and all tests were verified to meet the required acceptance criteria. The verification tests demonstrate that the differences in the device do not affect the indications for use of the device or raise any unsolved issues. There are no significant differences between subject device and the predicate device(s) that would adversely affect the use of the product. We conclude that subject device is substantially equivalent to predicate devices.
- Conclusion In all verification and validation tests, AcroDTI Visualizer meets the pre-specified acceptance criteria that are considered essential for its indications for use and is considered substantially equivalent to the predicate devices.
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| Subject Device | Predicate Device | Primary Predicate Device | |
|---|---|---|---|
| Device Name | AcroDTI Visualizer | syngo.MR General;syngo.MR Cardiology;syngo.MR Neurology | Carestream Vue PACS |
| 510(k) | K201948 | K163294 | K170580 |
| Applicant | AcroViz Inc. | Siemens Medical Solutions USA, Inc. | Carestream Health, Inc. |
| RegulationNumber | 892.2050 | 892.2050 | 892.2050 |
| Product code | LLZ | LLZ/ LNH | LLZ |
| Classification | II | II | II |
| Prescription orOTC use | Prescription | Prescription | Prescription |
| Indications forUse | AcroDTI Visualizer is an imageprocessing software that allows the userto calculate and display DTI fromdiffusion MRI (dMRI) data. This softwareis intended to be utilized by trainedphysicians to visually evaluate the DTIindex maps. | The software comprising the syngo.MR post-processing applications is post-processingsoftware/applications to be used for viewingand evaluating the designated imagesprovided by a magnetic resonancediagnostic device. All of the softwareapplications comprising the syngo. MR post-processing applications have their ownindications for use | The Carestream Vue PACS is an imagemanagement system whose intended use isto provide completely scalable local and widearea PACS solutions for hospital and relatedinstitutions/sites, which will archive,distribute, retrieve and display images anddata from all hospital modalities andinformation systems. The system is to beused by trained professionals including but |
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| syngo.MR General is a syngo based post- processing software for viewing, manipulating and evaluating MR images. | not limited to, physicians and medical technicians. The system contains interactive tools in order to ease the process of analyzing and comparing three dimensional (3D) images. It is a single system that integrates review, dictation and reporting tools to create a productive work environment for the radiologists and physicians. |
|---|---|
| syngo.MR Cardiology is a syngo based post- processing software for viewing, manipulating and evaluating MR cardiac images. | |
| syngo.MR Neurology is a syngo based post-processing software for viewing, manipulating, and evaluating MR neurological images. | The system contains a Perfusion module with interactive tools to analyze and compare Computed Tomography Perfusion (CTP) and MR Perfusion (MRP) images of adult patients. Blood perfusion parameters are automatically calculated and displayed as a set of perfusion maps and perfusion tables. The perfusion tables include the calculation of parameters related to tissue flow (perfusion) and tissue blood volume. The system contains a Diffusion Module with interactive tools to ease the process of analyzing and comparing MR Diffusion Weighted images (DWI) and MR Diffusion Tensor Imaging (DTI) of adult patients. This module is used to visualize local water diffusion properties from the analysis of diffusion- weighted MRI data. |
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| The system supports Subtraction withinteractive tools to aid with the analysis ofDigital Subtraction Angiography (DSA)images in both interventional radiology andcardiology. Subtraction automaticallysubtracts a mask from contrast frames of anX-Ray Angiography study for visualization ofvascular anatomy and pathology of adultpatients. | |||
|---|---|---|---|
| PhysicalCharacteristics | Software package | Software package | Software package |
| Data Source | MR Images | MR Images | MR Images |
| Technologyand Output | - visualize local water diffusion properties- offers the Diffusion Tensor Imaging(DTI) maps including FractionalAnisotropy (FA) ADC/Mean Diffusivity(MD), Axial Diffusivity (AD), RadialDiffusivity (RD), Dxx, Dyy, Dzz, Dxy,Dxz, Dyz and color FA | - visualize local water diffusion properties- offers the capability to generateTENSOR data together with all otherdiffusion maps (including b0, ADC,TraceW, FA, AD, RD) from raw diffusionseries. | - visualize local water diffusion properties- offers Diffusion Tensor Imaging of thefollowing types Fractional Anisotropy(FA), Relative Anisotropy (RA), VolumeRatio (VR), ADC/Mean Diffusivity(ADC), Axial Diffusivity (AD), andRelative Diffusivity (RD). |
§ 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).