(18 days)
The Altris IMS is a standalone, browser-based software application intended for use by healthcare professionals to import, store, manage, display, and measure data from ophthalmic diagnostic instruments, including patient data, diagnostic data, clinical images and information, reports, and measurement of DICOM-compliant images. The device is also indicated for manual labeling and annotation of retinal OCT scans.
Altris IMS is a cloud-based software program to assist healthcare professionals, specifically Eye Care Practitioners (ECPs) with OCT interpretation. Altris IMS utilizes commonly available internet browsers to locally manage and review data which is uploaded to an Amazon AWS cloud-based server. Its intended use is to import, store, manage, display, analyze and measure data from ophthalmic diagnostic instruments, including patient data, diagnostic data, clinical images and information, reports, and measurement of DICOM-compliant images. The platform allows the user to manually annotate areas of interest in the images, calculate the layer thickness and volume from annotated images and present the progression of the measurements. Altris IMS also provides a tool for linear distance measuring of ocular anatomy and ocular lesion distances. The platform supports DICOM format files. Altris IMS is focused on the center sector of the retina. Altris IMS does not perform optic nerve analysis. Altris IMS has tools for manual area of interest image segmentation and labeling/annotation for healthcare professionals to use and review for their own diagnosis. The Subject device neither performs any diagnosis, nor provides treatment recommendations. It is solely intended to be used as a support tool by trained healthcare professionals. The software does not use artificial intelligence or machine learning algorithms. The Subject device is a client-server model. It utilizes a local user/client internet browser-based (frontend) interface used to upload, manage, annotate, and review imaging data. Data is stored and processed on a remote web-based server (backend).
The provided text does not contain detailed information about the acceptance criteria or a specific study that proves the device meets those criteria for the Altris IMS. The document is a 510(k) summary for a medical device (Altris IMS) seeking FDA clearance, focusing on demonstrating substantial equivalence to a predicate device rather than outright performance claims.
However, based on the information provided, we can infer some aspects and highlight what is missing.
The Altris IMS is a software application for managing and displaying ophthalmic diagnostic data, including manual labeling and annotation of retinal OCT scans. It explicitly states it does not use AI or ML algorithms and does not perform diagnosis or provide treatment recommendations.
Given this, the performance data section is likely to focus on the software's functionality, accuracy of manual measurements, and data handling, rather than diagnostic accuracy or clinical effectiveness in a medical sense.
Here's an attempt to answer your questions based on the provided text, and where information is missing, it will be noted:
1. A table of acceptance criteria and the reported device performance
The document does not provide a formal table of acceptance criteria or specific quantitative performance metrics like sensitivity, specificity, accuracy, or measurement error rates. The "Performance Data" section states: "Due to the difficulty in evaluating this type of software, no direct performance bench testing of software to an established standard was performed."
Instead, performance was demonstrated through:
- Software Verification
- Software Validation
- Comparative Software measurement study with the K170164 Reference device.
Without the actual study report, specific performance numbers are unavailable. The goal was to prove the device "performs as intended similarly to the Predicate device."
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
The document mentions "a Comparative Software measurement study with the K170164 Reference device." However, it does not provide details on:
- The sample size of images/cases used in this comparative study.
- The data provenance (country of origin, whether it was retrospective or prospective data).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)
Given the device allows for "manual labeling and annotation of retinal OCT scans" by "healthcare professionals," and it does not use AI/ML for diagnosis, the "ground truth" for the comparative measurement study would likely involve comparing the device's manual measurement capabilities against the reference device or perhaps against expert manual measurements performed independently.
The document does not specify the number of experts or their qualifications involved in establishing any form of "ground truth" or reference measurements for the comparative study.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
The document does not describe any adjudication method used for establishing ground truth or conducting the comparative measurement study.
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
Given that the device "does not use artificial intelligence or machine learning algorithms" and "neither performs any diagnosis, nor provides treatment recommendations," an MRMC study comparing human readers with AI vs. without AI assistance would be irrelevant and was not performed. The study mentioned is a "Comparative Software measurement study" which likely focuses on the accuracy or consistency of the manual measurement tools provided by the software.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Since the device "does not use artificial intelligence or machine learning algorithms," and its primary functions are data management, display, and manual annotation/measurement, the concept of an "algorithm only" standalone performance is not applicable in the typical sense of AI diagnostic devices. The software supports human-in-the-loop actions.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the "Comparative Software measurement study," the "ground truth" would most likely be a comparison of measurements obtained using the Altris IMS's manual tools against those obtained using the K170164 Reference device, which is an imaging system with storage/management software and supports image annotation and measurement. It could also involve comparing against expert manual measurements using established clinical standards. The document does not explicitly state the type of ground truth used beyond "measurement validation."
8. The sample size for the training set
Since the device "does not use artificial intelligence or machine learning algorithms," there is no concept of a training set in the machine learning sense for this device.
9. How the ground truth for the training set was established
As there is no training set (due to the absence of AI/ML), there is no ground truth established for a training set.
In summary, the provided FDA 510(k) summary focuses on demonstrating substantial equivalence based on indications for use and technological principles, supported by general software verification and validation, and a comparative measurement study. It explicitly states the device does not employ AI/ML, which changes the nature of the performance data required compared to an AI-powered diagnostic device. The document lacks the specific quantitative performance metrics, sample sizes, and expert details typically found in studies validating AI/ML-driven medical devices.
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July 31, 2023
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Altris, Inc. % Prithul Bom Most Responsible Person Regulatory Technology Services, LLC 1000 Westgate Drive, Suite 510k Saint Paul, Minnesota 55114
Re: K232088
Trade/Device Name: Altris IMS Regulation Number: 21 CFR 892.2050 Regulation Name: Medical image management and processing system Regulatory Class: Class II Product Code: NFJ Dated: July 13, 2023 Received: July 13, 2023
Dear Prithul Bom:
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,
Elvin Y. Ng -S
Elvin Ng Assistant Director DHT1A: Division of Ophthalmic Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices 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) K232088
Device Name Altris IMS
Indications for Use (Describe)
The Altris IMS is a standalone, browser-based software application intended for use by healthcare professionals to import, store, manage, display, and measure data from ophthalmic diagnostic instruments, including patient data, diagnostic data, clinical images and information, reports, and measurement of DICOM-compliant images. The device is also indicated for manual labeling and annotation of retinal OCT scans.
| 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 Altris, Inc Altris IMS 7/12/2023
ADMINISTRATIVE INFORMATION
| Manufacturer Name: | Altris, Inc.125 South Clark Street17th FloorChicago, Illinois 60603 | Regulatory Consultant: | Aclivi, LLC3250 Brackley DriveAnn Arbor, MI 48105 |
|---|---|---|---|
| Telephone: | +1 773 382 8709 | +1 (810) 360-9773 | |
| Official ContactEmail: | Andrey Kuropyatnyk, Directorandrey@altris.ai | Chris Brown, Manageracliviconsulting@gmail.com |
DEVICE NAME AND CLASSIFICATION
| Trade/Proprietary Name: | Altris IMS |
|---|---|
| Classification Name: | System, Image Management, Ophthalmic |
| Classification Regulations: | 21 CFR 892.2050 |
| Device Class: | Class II |
| Product Code: | NFJ |
| Review Panel: | Ophthalmic |
PREDICATE DEVICE INFORMATION
The Subject device is highly similar in Indications for Use, and technological/design principles to the following legally marketed Predicate device:
| 510(k) | Predicate Device Name | Company Name |
|---|---|---|
| K211715 | RetinAl Discovery | RetinAl Medical AG |
| 510(k) | Reference Device Name | Company Name |
|---|---|---|
| K170164 | 3D OCT-1 Maestro | Topcon Corporation |
DEVICE DESCRIPTION
Altris IMS is a cloud-based software program to assist healthcare professionals, specifically Eye Care Practitioners (ECPs) with OCT interpretation. Altris IMS utilizes commonly available internet browsers to locally manage and review data which is uploaded to an Amazon AWS cloud-based server. Its intended use is to import, store, manage, display, analyze and measure data from ophthalmic diagnostic instruments, including patient data, diagnostic data, clinical images and information, reports, and measurement of DICOM-compliant images. The platform allows the user to manually annotate areas of interest in the images, calculate the layer thickness and volume from annotated images and present the progression of the measurements. Altris IMS also provides a tool for linear distance measuring of ocular anatomy and ocular lesion distances. The platform supports DICOM format files.
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Altris IMS is focused on the center sector of the retina. Altris IMS does not perform optic nerve analysis. Altris IMS has tools for manual area of interest image segmentation and labeling/annotation for healthcare professionals to use and review for their own diagnosis.
The Subject device neither performs any diagnosis, nor provides treatment recommendations. It is solely intended to be used as a support tool by trained healthcare professionals. The software does not use artificial intelligence or machine learning algorithms.
The Subject device is a client-server model. It utilizes a local user/client internet browser-based (frontend) interface used to upload, manage, annotate, and review imaging data. Data is stored and processed on a remote web-based server (backend).
INDICATIONS FOR USE
The Altris IMS is a standalone, browser-based software application intended for use by healthcare professionals to import, store, manage, display, and measure data from ophthalmic diagnostic instruments, including patient data, diagnostic data, clinical images and information, reports, and measurement of DICOM-compliant images. The device is also indicated for manual labeling and annotation of retinal OCT scans.
EQUIVALENCE TO MARKETED DEVICE
Overall, the Subject device is highly similar to the Predicate device with respect to Indications for Use and technological principles. The Comparison tables below compare Indications for Use and Technological Characteristics of the Subject device and Predicate device.
| Device | Indications for Use Statement |
|---|---|
| Subject DeviceAltris IMSAltris, Inc. | The Altris IMS is a standalone, browser-based software application intended for use by healthcareprofessionals to import, store, manage, display, analyze and measure data from ophthalmic diagnosticinstruments, including patient data, diagnostic data, clinical images and information, reports, andmeasurement of DICOM-compliant images. The device is also indicated for manual labeling andannotation of retinal OCT scans. |
| Predicate DeviceRetinAl DiscoveryRetinAl Medical AGK211715 | The RetinAl Discovery is a standalone, browser-based software application intended for use by healthcareprofessionals to import, store, manage, display, analyze and measure data from ophthalmic diagnosticinstruments, including: patient data, diagnostic data, clinical images and information, reports, andmeasurement of DICOM-compliant images. The device is also indicated for manual labeling andannotation of retinal OCT scans. |
| Reference Device3D OCT-1 MaestroTopcon CorporationK170164 | The 3D OCT-1 Maestro with new line CCD has the following intended use and indications for use:The Topcon 3D OCT-1 Maestro is a non-contact, high resolution tomographic and biomicroscopic imagingdevice that incorporates a digital camera for photographing, displaying and storing the data of the retinaand surrounding parts of the eye to be examined under Mydriatic and non-Mydriatic conditions.The 3D OCT-1 Maestro is indicated for in vivo viewing, axial cross sectional, and three-dimensionalimaging and measurement of posterior ocular structures, including retina, retinal nerve fiber layer, maculaand optic disc as well as imaging of anterior ocular structures.It also includes a Reference Database for posterior ocular measurements which provide for thequantitative comparison of retinal nerve fiber layer, optic nerve head, and the macula in the human retinato a database of known normal subjects. The 3D OCT-1 Maestro is indicated for use as a diagnostic deviceto aid in the diagnosis, documentation and management of ocular health and diseases in the adultpopulation. |
Indications for Use Statement (IFUS)
The wording of the Indications for Use Statement (IFUS) of the Subject device is highly similar to that of the Predicate device, differing only in device name. This does not change the intended use of the devices to import, store, manage, display, analyze and measure data from ophthalmic diagnostic instruments.
The wording of the Indications for Use Statement (IFUS) of the Subject device is similar to that of the Reference device. The Reference device includes imaging equipment and additional imaging measurement and comparison
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features. This does not change the fundamental intended use of the devices to store, manage, display, analyze and measure data from ophthalmic diagnostic instruments.
| Technological Characteristics | |||
|---|---|---|---|
| Parameter | Subject DeviceAltris IMSAltris, Inc. | Predicate DeviceRetinAl DiscoveryRetinAl Medical AGK211715 | Reference Device3D OCT-1 MaestroTopcon CorporationK170164 |
| Reason for Predicate | n/a | Ophthalmic software to import, store,manage, display, analyze and measuredata from ophthalmic diagnosticinstruments | Measurement comparison |
| Device | System, image management,ophthalmic | System, image management,ophthalmic | Tomography, Optical Coherence |
| Trade Name | Altris IMS | RetinAl Discovery | 3D OCT-1 Maestro |
| Regulation # | 21 CFR 892.2050 | 21 CFR 892.2050 | 21 CFR 886.1570 |
| Regulation Name | Medical Image Management andProcessing System | Medical Image Management andProcessing System | Ophthalmoscope |
| Product Code | NFJ | NFJ | OBO |
| Classification | Class II | Class II | Class II |
| User Population | Trained medical professionals | Trained medical professionals | Trained medical professionals |
| Device Type | Software only | Software only | Imaging system withstorage/management software |
| Operating System | Internet Web Browser-based• Google Chrome: Version v.88 and later• Mozilla Firefox: Version v.89 and later• Opera: Version v.74 and later• Apple Safari: Version v.15 and later | Internet Web Browser-based• Browsers and versions not specified | PC-based with dedicated software• Operating system not specified |
| Data and SupportedFormats | DICOM-compliant files from anophthalmic device (Scanning LaserOphthalmoscope, Fundus photographs,Optical Coherence Tomography unit,etc.) | DICOM-compliant files from anophthalmic device (Scanning LaserOphthalmoscope, Fundus photographs,Optical Coherence Tomography unit,etc.) | DICOM-compliant files (based ondevice labeling) and different types ofscans and photography protocols |
| Supported Machines | DICOM-compliant devices | DICOM-compliant devices | DICOM-compliant devices |
| Image Annotation andMeasurement | Yes | Yes | Yes |
| Sharing | Share images with current layout withanother user via shareable link | Share images with current layout withanother user via shareable link | Not defined in device labeling |
| Biocompatible | n/a | n/a | n/a |
| Sterility | n/a | n/a | n/a |
| OTC or Rx | Rx | Rx | Rx |
The Subject and Predicate devices are highly similar standalone browser-based software devices intended to display, and annotate previously acquired images of the eye in order to streamline review of such images by healthcare professionals. Neither the Subject or Predicate devices are used to offer capture components or are used directly to acquire images. The Subject device can be used on a variety of web browsers (i.e., Google Chrome, Mozilla Firefox, Opera, Apple Safari). The Predicate device also operates with an internet web browser interface but has not provided specific browser and version information in public facing documents. Internet web browsers are ubiquitous and regularly updated, so use of a specific browser or browser version number does not impact evaluation of device similarities as the browser is simply the interface to the Subject device and numerous options exist for users. Therefore, the Subject and Predicate are highly similar in the use of a web-browser interface. The Subject and Predicate device feature highly similar capabilities of manual measurement and annotation of OCT imaging.
The K170164 Reference device does not share the same regulation or product code as the Subject device as it is a combined imaging and image management device with the imaging device as the primary product code. Both the Subject and Reference devices are operated from a computer, but the Reference device has a dedicated software program rather than a web-browser based interface. Both the Subject and Reference devices support image annotation and measurement from DICOM-compliant imaging systems and both work with a variety of photography formats. Differences between the Subject and K170164 Reference device software formats do not change the intended uses to import, store, manage, display, analyze and measure data from ophthalmic diagnostic instruments. The Reference device is included in support of comparative
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measurement validation of the Subject device. The use of Predicate device as a standalone, web-browserbased program supports the Subject device web-browser-based program configuration.
Software validation and verification and validation were used to demonstrate the Subject device performs as intended similarly to the Predicate device.
PERFORMANCE DATA
Due to the difficulty in evaluating this type of software, no direct performance bench testing of software to an established standard was performed.
The following non-clinical performance tests were performed to assist in establishing similarity with the Predicate device and suitability for intended use:
- Software Verification
- . Software Validation
- Comparative Software measurement study with the K170164 Reference device.
CONCLUSION
Overall, the Indications for Use statement for the Subject and Predicate devices is highly similar.
Overall, the Technological Characteristics of the Subject device are highly similar to the Predicate device.
The conclusions drawn from the nonclinical tests demonstrate that the proposed Subject device is as safe, as effective, and performs as well as the legally marketed Predicate device, according to 807.92(b)(3).
Overall, the Altris IMS software is substantially equivalent to the Predicate device.
§ 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).