(100 days)
Rayvolve PTX-PE is a radiological computer-assisted triage and notification software that analyzes chest x-ray images (Postero-Anterior (PA) or Antero-Posterior (AP)) of patients 18 years of age or older for the presence of pre-specified suspected critical findings (pleural effusion and/or pneumothorax).
Rayvolve PTX-PE uses an artificial intelligence algorithm to analyze the images for features suggestive of critical findings and provides study-level output available in DICOM node servers for worklist prioritization or triage.
As a passive notification for prioritization-only software tool within the standard of care workflow, Rayvolve PTX-PE does not send a proactive alert directly to a trained medical specialist.
Rayvolve PTX-PE is not intended to direct attention to specific portions of an image. Its results are not intended to be used on a stand-alone basis for clinical decision-making.
Rayvolve PTX-PE is a software-only device designed to help healthcare professionals. It's a radiological computer-assisted triage and notification software that analyzes chest x-ray imaqes (Postero-Anterior (PA) or Antero-Posterior (AP)) of patients of 18 years of age or older for the presence of pre-specified suspected critical findings (pleural effusion and/or pneumothorax). It is intended to work in combination with DICOM node servers.
Rayvolve PTX-PE has been developed to use the current edition of the DICOM image standard. DICOM is the international standard for transmitting, storing, retrieving, printing, processing, and displaying medical imaging.
Using the DICOM standard allows Rayvolve PTX-PE to interact with existing DICOM node servers (eg .: PACS), and clinical-grade image viewers. The device is designed to run on a cloud platform and be connected to the radiology center's local network. It can also interact with the DICOM Node server.
When remotely connected to a medical center DICOM Node server, the software utilizes Al-based analysis algorithms to analyze chest X-rays for features suggestive of critical findings and provide study-level outputs to the DICOM node server for worklist prioritization. Following receipt of chest X-rays, the software device automatically analyzes each image to detect features suggestive of pneumothorax and/or pleural effusion.
Rayvolve PTX-PE filters and downloads only X-rays with organs determined from the DICOM Node server.
As a passive notification for prioritization-only software tool within the standard of care workflow, Rayvolve PTX-PE does not send a proactive alert directly to a trained health professional. Rayvolve PTX-PE is not intended to direct attention to a specific portion of an image. Its results are not intended to be used on a stand-alone basis for clinical decision-making.
Rayvolve PTX-PE does not intend to replace medical doctors. The instructions for use are strictly and systematically transmitted to each user and used to train them on Rayvolve's use.
AZmed's Rayvolve PTX-PE is a radiological computer-assisted triage and notification software designed to analyze chest x-ray images for the presence of suspected pleural effusion and/or pneumothorax. The device's performance was evaluated through a standalone study to demonstrate its effectiveness and substantial equivalence to a predicate device (Lunit INSIGHT CXR Triage, K211733).
Here's a breakdown of the acceptance criteria and the study proving the device meets them:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for Rayvolve PTX-PE are implicitly derived from demonstrating performance comparable to or better than the predicate device, especially regarding AUC, sensitivity, and specificity for detecting pleural effusion and pneumothorax, as well as notification time. The predicate's performance metrics are used as a benchmark.
| Metric (Disease) | Acceptance Criteria (Implicit, based on Predicate K211733) | Reported Device Performance (Rayvolve PTX-PE) |
|---|---|---|
| Pleural Effusion | ||
| ROC AUC | > 0.95 (Predicate: 0.9686) | 0.9830 (95% CI: [0.9778, 0.9880]) |
| Sensitivity | 89.86% (Predicate) | 0.9134 (95% CI: [0.8874, 0.9339]) |
| Specificity | 93.48% (Predicate) | 0.9448 (95% CI: [0.9239, 0.9339]) |
| Performance Time | 20.76 seconds (Predicate) | 19.56 seconds (95% CI: [19.49 - 19.58]) |
| Pneumothorax | ||
| ROC AUC | > 0.95 (Predicate: 0.9630) | 0.9857 (95% CI: [0.9809, 0.9901]) |
| Sensitivity | 88.92% (Predicate) | 0.9379 (95% CI: [0.9127, 0.9561]) |
| Specificity | 90.51% (Predicate) | 0.9178 (95% CI: [0.8911, 0.9561]) |
| Performance Time | 20.45 seconds (Predicate) | 19.43 seconds (95% CI: [19.42 - 19.45]) |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: The test set for the standalone study consisted of 1000 radiographs for the Pneumothorax group and 1000 radiographs for the Pleural Effusion group. For each group, positive and negative images represented approximately 50%.
- Data Provenance: The document does not explicitly state the country of origin of the data or whether it was retrospective or prospective.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
The document does not provide details on the number of experts or their specific qualifications (e.g., years of experience as a radiologist) used to establish the ground truth for the test set.
4. Adjudication Method for the Test Set
The document does not describe the adjudication method used for the test set (e.g., 2+1, 3+1, none).
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done
No, a Multi Reader Multi Case (MRMC) comparative effectiveness study was not conducted. The performance assessment was a standalone study evaluating the algorithm's performance only. The document explicitly states: "AZmed conducted a standalone performance assessment for Pneumothorax and Pleural Effusion in worklist prioritization and triage." Therefore, there is no effect size of how much human readers improve with AI vs. without AI assistance reported in this document.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Yes, a standalone performance assessment (algorithm only without human-in-the-loop) was performed. The results presented in the table above and in the "Bench Testing" section are from this standalone evaluation.
7. The Type of Ground Truth Used
The document does not explicitly state the type of ground truth used (e.g., expert consensus, pathology, outcomes data). However, for a diagnostic AI device, it is standard practice to establish ground truth through a panel of qualified medical experts (e.g., radiologists) providing consensus reads, often with access to additional clinical information or follow-up. Given the nature of the findings (pleural effusion and pneumothorax on X-ray), it is highly likely that expert interpretations served as the ground truth.
8. The Sample Size for the Training Set
The document does not specify the sample size used for the training set of the AI model. The provided information focuses on the performance evaluation using an independent test set.
9. How the Ground Truth for the Training Set Was Established
The document does not detail how the ground truth for the training set was established. This information is typically proprietary to the developer's internal development process and is not always fully disclosed in 510(k) summaries.
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March 21, 2025
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 and Human Services logo. To the right of that 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.
AZmed Anthony Joseph QARA Associate 10 Rue d'Uzès Paris, 75002 France
Re: K243808
Trade/Device Name: Rayvolve PTX-PE Regulation Number: 21 CFR 892.2080 Regulation Name: Radiological Computer Aided Triage And Notification Software Regulatory Class: Class II Product Code: QFM Dated: February 17, 2025 Received: February 18, 2025
Dear Anthony Joseph:
We have reviewed your section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (the Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
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Page
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Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (OS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medical
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devices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Jessica Lamb
Jessica Lamb Assistant Director Imaging Software Team DHT8B: Division of Radiologic Imaging Devices and Electronic Products OHT8: Office of Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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| Please type in the marketing application/submission number, if it is known. This textbox will be left blank for original applications/submissions. | K 243808 |
|---|---|
| Please provide the device trade name(s). | Rayvolve (Rayvolve PTX-PE) |
| Please provide your Indications for Use below. |
Rayvolve PTX-PE is a radiological computer-assisted triage and notification software that analyzes chest x-ray images (Postero-Anterior (PA) or Antero-Posterior (AP)) of patients 18 years of age or older for the presence of pre-specified suspected critical findings (pleural effusion and/or pneumothorax).
Rayvolve PTX-PE uses an artificial intelligence algorithm to analyze the images for features suggestive of critical findings and provides study-level output available in DICOM node servers for worklist prioritization or triage.
As a passive notification for prioritization-only software tool within the standard of care workflow, Rayvolve PTX-PE does not send a proactive alert directly to a trained medical specialist.
Rayvolve PTX-PE is not intended to direct attention to specific portions of an image. Its results are not intended to be used on a stand-alone basis for clinical decision-making.
| Please select the types of uses (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/4/Picture/0 description: The image shows the alphanumeric string "K243808" in a simple, sans-serif font. The characters are uniformly sized and spaced, with a clear distinction between the letter "K" and the numerical digits that follow. The text is presented in black against a plain white background, ensuring high contrast and readability.
Image /page/4/Picture/1 description: The image shows the word "azmed" in a dark blue sans-serif font. The letters are closely spaced together, and the "a" and "z" are stylized with a diagonal line running through them. The word is centered and appears to be a logo or brand name.
RAYVOLVE PTX-PE 510K Summary
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Content
| 1. Submitter | 3 |
|---|---|
| 2. Device identification | 3 |
| 3. Predicate device | 3 |
| 4. Device description | 4 |
| 5. Intended use/Indication for use | 5 |
| 6. Substantial equivalence Discussion | 5 |
| 7. Performance data summary | 11 |
| a. Software verification and validation testing | 11 |
| b. Bench Testing | 12 |
| 8. CONCLUSION | 13 |
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1. Submitter
Submitted date: 2025-02-17
| Submitter | AZmed10 Rue d'Uzès75002 Paris, FrancePhone: +33 6 72 19 04 19 |
|---|---|
| Contact person | Anthony JOSEPHQARA Associate10 Rue d'Uzès75002 Paris, FrancePhone: +33 6 72 19 04 19Mail: anthony@azmed.co |
2. Device identification
| Name ofthe Device | Commonor UsualName | Regulatorysection | Classification | ProductCode | Panel |
|---|---|---|---|---|---|
| RayvolvePTX-PE | Rayvolve | 21 CFR892.2080 | Class II | QFM | 90(Radiology) |
3. Predicate device
The legally marketed device for which AZmed is claiming equivalence is identified as follows:
| Manufacturer | Product Name | 510K Number |
|---|---|---|
| Lunit, Inc. | Lunit INSIGHT CXRTriage | K211733 |
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4. Device description
Rayvolve PTX-PE is a software-only device designed to help healthcare professionals. It's a radiological computer-assisted triage and notification software that analyzes chest x-ray imaqes (Postero-Anterior (PA) or Antero-Posterior (AP)) of patients of 18 years of age or older for the presence of pre-specified suspected critical findings (pleural effusion and/or pneumothorax). It is intended to work in combination with DICOM node servers.
Rayvolve PTX-PE has been developed to use the current edition of the DICOM image standard. DICOM is the international standard for transmitting, storing, retrieving, printing, processing, and displaying medical imaging.
Using the DICOM standard allows Rayvolve PTX-PE to interact with existing DICOM node servers (eg .: PACS), and clinical-grade image viewers. The device is designed to run on a cloud platform and be connected to the radiology center's local network. It can also interact with the DICOM Node server.
When remotely connected to a medical center DICOM Node server, the software utilizes Al-based analysis algorithms to analyze chest X-rays for features suggestive of critical findings and provide study-level outputs to the DICOM node server for worklist prioritization. Following receipt of chest X-rays, the software device automatically analyzes each image to detect features suggestive of pneumothorax and/or pleural effusion.
Rayvolve PTX-PE filters and downloads only X-rays with organs determined from the DICOM Node server.
As a passive notification for prioritization-only software tool within the standard of care workflow, Rayvolve PTX-PE does not send a proactive alert directly to a trained health professional. Rayvolve PTX-PE is not intended to direct attention to a specific portion of an image. Its results are not intended to be used on a stand-alone basis for clinical decision-making.
Rayvolve PTX-PE does not intend to replace medical doctors. The instructions for use are strictly and systematically transmitted to each user and used to train them on Rayvolve's use.
5. Intended use/Indication for use
Rayvolve PTX-PE is a radiological computer-assisted triage and notification software that analyzes chest x-ray images (Postero-Anterior (PA) or Antero-Posterior (AP)) of patients of 18 years of age or older for the presence of pre-specified suspected critical findings (pleural effusion and/or pneumothorax).
Rayvolve PTX-PE uses an artificial intelligence algorithm to analyze the images for
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Image /page/8/Picture/0 description: The image shows the word "azmed" in a stylized, sans-serif font. The letters are a dark blue color, and the background is white. The "z" in the word is unique, with a diagonal line that extends beyond the top and bottom of the letter.
features suggestive of critical findings and provides study-level output available in the PACS (or other DICOM storage platforms) for worklist prioritization or triage.
As a passive notification for prioritization-only software tool within the standard of care workflow, Rayvolve PTX-PE does not send a proactive alert directly to a trained medical specialist.
Rayvolve PTX-PE is not intended to direct attention to specific portions of an image. Its results are not intended to be used on a stand-alone basis for clinical decision-making.
Substantial equivalence Discussion 6.
The comparison chart below provides evidence to facilitate the substantial equivalence determination between Rayvolve PTX-PE to the predicate device (K211733) concerning the intended use, technological characteristics, and principle of operation vice and the cited predicate device.
| Comparisonto predicatedevice | Lunit INSIGHT CXR Triage- Predicate (K220164) | Rayvolve PTX-PE -Subject device 510(k) file | Comparison tothe predicate |
|---|---|---|---|
| Device Name | Lunit INSIGHT CXR Triage | Rayvolve | N/A |
| Manufacturer | Lunit, Inc. | AZmed | N/A |
| 510 (k) # | K211733 | K243808 | N/A |
| RegulationNumber | 21 CFR 892.2080 | 21 CFR 892.2080 | Same |
| Class | II | II | Same |
| Product Code | QFM | QFM | Same |
| Device Panel | Radiology | Radiology | Same |
| Level ofConcern | Moderate | Moderate | Same |
| Intended use/ Indicationsfor use | Lunit INSIGHT CXR Triageis a radiologicalcomputer-assisted triageand notification softwarethat analyzes adult chestX-ray images for thepresence of pre-specifiedsuspected critical findings | Rayvolve PTX-PE is aradiologicalcomputer-assisted triageand notification softwarethat analyzes chest x-rayimages (Postero-Anterior(PA) or Antero-Posterior(AP)) of patients 18 years | Equivalent,slight precisionon theintendedpatientpopulation (seethe line'intended |
| Comparisonto predicatedevice | Lunit INSIGHT CXR Triage- Predicate (K220164) | Rayvolve PTX-PE -Subject device 510(k) file | Comparison tothe predicate |
| (pleural effusion and/orpneumothorax). LunitINSIGHT CXR Triage usesan artificial intelligencealgorithm to analyze imagesfor features suggestive ofcritical findings and providescase-level output availablein the PACS/workstation forworklist prioritization ortriage. As a passivenotification forprioritization-only softwaretool within standard of careworkflow, Lunit INSIGHTCXR Triage does not senda proactive alert directly tothe appropriately trainedmedical specialists. LunitINSIGHT CXR Triage is notintended to direct attentionto specific portions of animage. Its results are notintended to be used on astand-alone basis for clinicaldecision-making. | of age or older for thepresence of pre-specifiedsuspected critical findings(pleural effusion and/orpneumothorax).Rayvolve PTX-PE uses anartificial intelligencealgorithm to analyze theimages for featuressuggestive of criticalfindings and providesstudy-level output availablein DICOM Node Serversfor worklist prioritization ortriage.As a passive notification forprioritization-only softwaretool within the standard ofcare workflow, RayvolvePTX-PE does not send aproactive alert directly to atrained medical specialist.Rayvolve PTX-PE is notintended to direct attentionto specific portions of animage. Its results are notintended to be used on astand-alone basis forclinical decision-making. | patientpopulation forthejustification)and for otherDICOMstorageplatforms thesubject device.Other DICOMstorageplatforms areequivalent toPACS.None of thoseprecisionsraise newquestions ofsafety oreffectiveness | |
| Intended user | Appropriately trainedmedical specialists who arequalified to interpret chestradiographs | Healthcare professionals | Equivalent.Healthcareprofessionalsare qualified tointerpret chestradiographs |
| Intendedpatientpopulation | Adults | 18 years of age or older | Equivalent:Our datasetcontainsimages forpatients of |
| Comparisonto predicatedevice | Lunit INSIGHT CXR Triage- Predicate (K220164) | Rayvolve PTX-PE -Subject device 510(k) file | Comparison tothe predicate |
| 18-21 yearsold.Theperformanceresults (seeAppendix 25)shows that theperformancesof RayvolvePTX-PE forpatientsbetween 18and 21 yearsold areequivalent tothe resultsobtained forpatients olderthan 21 yearsold. So, itdoesn't raisenew questionsof safety oreffectiveness,and maintainthe same levelof performancethan thepredicateddevice | |||
| Targetedclinicalcondition andanatomy | Pleural effusion,pneumothoraxChest/Lung | Pleural effusion,pneumothoraxChest/Lung | Same |
| Radiologicalimagesformat | DICOM | DICOM | Same |
| Imagemodality | Frontal chest X-ray | Postero-Anterior (PA) orAntero-Posterior (AP)chest X-ray | Equivalent.Inclusion of theorientation ofthe image |
| Comparisonto predicatedevice | Lunit INSIGHT CXR Triage- Predicate (K220164) | Rayvolve PTX-PE -Subject device 510(k) file | Comparison tothe predicate |
| acquisition, buttheperformancetesting (seeappendix 25)hasdemonstratedthat RayvolvePTX-PEachievesequivalentaccuracy onboth AP andPA views, soconsideringboth viewsdoesn't raisenew questionsof safety oreffectiveness,and maintainthe same levelof performancethan thepredicateddevice | |||
| Algorithm forpre-specifiedcriticalfindingsdetection | Al algorithm designed todetect pleural effusion andpneumothorax in chestX-ray images.Lunit INSIGHT CXR Triageuses a vendor agnosticalgorithm compatible withDICOM chest X-ray images. | Al algorithm designed todetect pleural effusion andpneumothorax in chestX-ray images.Rayvolve PTX-PE uses avendor agnostic algorithmcompatible with DICOMchest X-ray images. | Same |
| Wheregeneratedresults arestored | PACS/Workstation | PACS/Workstation | Same |
| Comparison to predicate device | Lunit INSIGHT CXR Triage - Predicate (K220164) | Rayvolve PTX-PE - Subject device 510(k) file | Comparison to the predicate |
| Computational platform | Lunit INSIGHT CXR Triage is designed as a softwaremodule that can bedeployed on severalcomputing and X-rayimaging platforms such asradiological imagingequipment, PACS, OnPremise or On Cloud. | Rayvolve PTX-PE isdesigned as a softwaremodule that can bedeployed on severalcomputing and X-rayimaging platforms such asradiological imagingequipment, PACS, OnPremise or On Cloud. | Same |
| Device outputin case ofpositivedetection | When deployed on otherradiological imagingequipment Lunit INSIGHTCXR Triage automaticallyruns after image acquisitionand prioritizes and displaysthe analysis result throughthe worklist interface ofPACS/workstation.No markup on originalimage. Secondary captureof the finding.Upon image acquisitionfrom other radiologicalimaging equipment (e.g.X-ray systems), anon-device, tehcnologistnotification indicating whichcases were flagged by LunitINSIGHT CXR Triage inPACS, is generated 15minutes after interpretationby the user.The on device notification iscontextual and does notprovide any diagnostic | When deployed on otherradiological imagingequipment RayvolvePTX-PE automaticallyruns after imageacquisition and prioritizesand displays the analysisresult through the worklistinterface ofPACS/workstation.No markup on the originalimage. Secondary captureof the device will indicatethe presence of findingssuspicious ofpneumothorax or pleuraleffusion.Upon image acquisitionfrom other radiologicalimaging equipment (e.g,X-ray systems), a passivenotification indicating whichstudies were flagged byRayvolve PTX-PE isgenerated.The notification is | Same |
| Comparisonto predicatedevice | Lunit INSIGHT CXR Triage- Predicate (K220164) | Rayvolve PTX-PE -Subject device 510(k) file | Comparison tothe predicate |
| information. It is notintended to inform anyclinical decision,prioritization, or action to thetechnologist. | contextual and does notprovide any diagnosticinformation. It is notintended to inform anyclinical decision,prioritization, or action. | ||
| Notification(i.e., recipienttiming andmeans ofnotification) | Passive notification.Images with suspicion ofpleural effusion and/orpneumothorax are flaggedin PACS/workstation | Passive notification.Images with suspicion ofpneumothorax and/orpleural effusion are flaggedinPACS/workstation/DICOMviewer. | Equivalent:DICOMviewers are thesoftware thatallow to openthe Dicom fileson theworkstations, itdoesn't raisenew questionsof safety oreffectiveness |
| Performancelevel - Timingof notification | The average time taken bythe device to analyze thestudy and send anotification to the worklist is20,76 seconds for pleuraleffusion and 20.45 secondsfor pneumothorax | The average time taken bythe device to analyze thestudy and send anotification to the worklist is19.56 seconds for pleuraleffusion and 19.43seconds for pneumothorax | EquivalentTheperformanceresults of thesubject deviceare slightlybetter than theresults for thepredicatedevice, so itdoesn't raisenew questionsof safety oreffectiveness. |
| Performancelevel -accuracy ofclassification | Pleural EffusionROC AUC > 0.95AUC: 0.9686 (95% CI:[0.9547,0.9824])Sensitivity 89.86% (95% CI:[86.72, 93.00]) | Pleural EffusionROC AUC > 0.95AUC: 0.9830 (95% CI:[0.9778, 0.9880])Sensitivity 0.9134 (95% CI:[0.8874, 0.9339]) | EquivalentTheperformanceresults of thesubject deviceare slightlybetter than the |
| Comparisonto predicatedevice | Lunit INSIGHT CXR Triage- Predicate (K220164) | Rayvolve PTX-PE -Subject device 510(k) file | Comparison tothe predicate |
| Specificity 93.48% (95% Cl:[91.06, 95.91])PneumothoraxROC AUC > 0.95AUC: 0.9630 (95% Cl:[0.9521,0.9739])Sensitivity 88.92% (95% Cl:[85.60,92.24])Specificity 90.51% (95% Cl:[88.18,92.83]) | Specificity 0.9448 (95% Cl:[0.9239, 0.9339])PneumothoraxROC AUC > 0.95AUC: 0.9857 (95% Cl:[0.9809,0.9901])Sensitivity 0.9379 (95% Cl:[0.9127,0.9561])Specificity 0.9178 (95% Cl:[0.8911,0.9561]) | results for thepredicatedevice, so itdoesn't raisenew questionsof safety oreffectiveness. |
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azmed
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Image /page/10/Picture/0 description: The image shows the word "azmed" in a dark blue sans-serif font. The letters are closely spaced together, and the "a" and "z" are connected by a diagonal line. The word is centered and takes up most of the frame.
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azmed
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azmed
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ozmed
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Table 1: Comparison between predicate and subject devices
AZmed claims the substantial equivalence of Rayvolve PTX-PE with the predicate Lunit INSIGHT CXR Triage (K211733) based on the functional principle of the software algorithms, the same technological characteristics, and the intended use of the software.
7. Performance data summary
Software verification and validation testing a.
The device's software development, verification and validation have been carried out in accordance with FDA guidelines. The software was tested against the established software design specification for each test plan to assure the device performances as intended. The device hazard analysis was completed and risk control implemented to mitigate identified hazards. The testing results support that all the software specifications have met the acceptance criteria of each module and interaction of processes. Rayvolve PTX-PE device passes all the testing and supports the claims of substantial equivalence with the predicate.
Validation activities included a usability study of Rayvolve under normal conditions for use. The study demonstrated:
- Non-invasive usability because users' habits are unchanged, -
- Comprehension of the instructions for use provided with the device. -
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b. Bench Testing
AZmed conducted a standalone performance assessment for Pneumothorax and Pleural Effusion in worklist prioritization and triage.
The clinical performance is evaluated considering the following factors:
- The interpretative process is a concurrent read -
- । The physical characteristic of Rayvolve PTX-PE mark is a header containing information on the presence or absence of a pathology, known as Pneumothorax or Pleural Effusion.
- -The users are healthcare professionals
The sample size was composed of 1000 radiographs in the Pneumothorax group and 1000 radiographs in the Pleural effusion group. Positive and negative images represent 50% of the sample (+/- 5%).
The results of the standalone study demonstrated that Rayvolve PTX-PE :
- Detects pneumothorax with high sensitivity (0.9379, 95% Confidence interval -(CI): 0.9127; 0.9561), high specificity (0.9178. 95% Confidence interval (CI): 0.8911; 0.9561) and high area under the Curve (AUC) of the Receiver Operating Characteristic (ROC) (0.9857, 95% Confidence Interval (CI): 0.9809; 0.9901) and with a performance time of 19.43 seconds (95% Cl: 19.42 - 19.45)
- Detects pleural effusion with high sensitivity (0.9134, 95% Confidence Interval -(CI): 0.8874; 0.9339), high specificity (0.9448, 95% Confidence Interval (CI): 0.9239; 0.9339) and high area under the Curve (AUC) of the Receiver Operating Characteristic (ROC) (0.9830, 95% Confidence Interval (CI): 0.9778; 0.9880) and with a performance time of 19.56 seconds (95% Cl: 19.49 - 19.58)
The results of the standalone study demonstrated that Rayvolve PTX-PE detects pneumothorax and pleural effusion with high AUC, sensitivity, and specificity for all the following variables: age, gender, ethnicity, device projection views, patient position (upright or supine), institutions, and additional conditions.
8. CONCLUSION
Both the subject device (Rayvolve PTX-PE) and the predicated device are computer-assisted triage and notification software that analyzes frontal chest x-ray images for the presence of pre-specified suspected critical findings (pleural effusion and/or pneumothorax. They both accept as input radiographs in DICOM format, use AI algorithms to detect pleural effusion and pneumothorax in chest X-rays and send back the same type of output and notifications in case of positive detection. The differences in the indication for use, including the differences in the patient
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population, the difference in the intended users, and the precision in the image modality for the subject device, do not raise different questions of safety and effectiveness. The results of the standalone performance assessment demonstrate that Rayvolve PTX-PE performs according to the specifications and meets user needs and intended use.
Therefore, Rayvolve PTX-PE and the predicate Lunit INSIGHT CXR Triage (K211733) are substantially equivalent.
§ 892.2080 Radiological computer aided triage and notification software.
(a)
Identification. Radiological computer aided triage and notification software is an image processing prescription device intended to aid in prioritization and triage of radiological medical images. The device notifies a designated list of clinicians of the availability of time sensitive radiological medical images for review based on computer aided image analysis of those images performed by the device. The device does not mark, highlight, or direct users' attention to a specific location in the original image. The device does not remove cases from a reading queue. The device operates in parallel with the standard of care, which remains the default option for all cases.(b)
Classification. Class II (special controls). The special controls for this device are:(1) Design verification and validation must include:
(i) A detailed description of the notification and triage algorithms and all underlying image analysis algorithms including, but not limited to, a detailed description of the algorithm inputs and outputs, each major component or block, how the algorithm affects or relates to clinical practice or patient care, and any algorithm limitations.
(ii) A detailed description of pre-specified performance testing protocols and dataset(s) used to assess whether the device will provide effective triage (
e.g., improved time to review of prioritized images for pre-specified clinicians).(iii) Results from performance testing that demonstrate that the device will provide effective triage. The performance assessment must be based on an appropriate measure to estimate the clinical effectiveness. The test dataset must contain sufficient numbers of cases from important cohorts (
e.g., subsets defined by clinically relevant confounders, effect modifiers, associated diseases, and subsets defined by image acquisition characteristics) such that the performance estimates and confidence intervals for these individual subsets can be characterized with the device for the intended use population and imaging equipment.(iv) Stand-alone performance testing protocols and results of the device.
(v) Appropriate software documentation (
e.g., device hazard analysis; software requirements specification document; software design specification document; traceability analysis; description of verification and validation activities including system level test protocol, pass/fail criteria, and results).(2) Labeling must include the following:
(i) A detailed description of the patient population for which the device is indicated for use;
(ii) A detailed description of the intended user and user training that addresses appropriate use protocols for the device;
(iii) Discussion of warnings, precautions, and limitations must include situations in which the device may fail or may not operate at its expected performance level (
e.g., poor image quality for certain subpopulations), as applicable;(iv) A detailed description of compatible imaging hardware, imaging protocols, and requirements for input images;
(v) Device operating instructions; and
(vi) A detailed summary of the performance testing, including: test methods, dataset characteristics, triage effectiveness (
e.g., improved time to review of prioritized images for pre-specified clinicians), diagnostic accuracy of algorithms informing triage decision, and results with associated statistical uncertainty (e.g., confidence intervals), including a summary of subanalyses on case distributions stratified by relevant confounders, such as lesion and organ characteristics, disease stages, and imaging equipment.