(100 days)
Not Found
Yes
The document explicitly states that the device "uses an artificial intelligence algorithm" and "utilizes Al-based analysis algorithms".
No
This device is a diagnostic assistance tool that analyzes X-ray images to identify critical findings for worklist prioritization; it does not provide any form of therapy or treatment to the patient.
No
Explanation: The "Intended Use / Indications for Use" section explicitly states "Its results are not intended to be used on a stand-alone basis for clinical decision-making" and "As a passive notification for prioritization-only software tool". This indicates it's for triage and prioritization, not for providing a definitive diagnosis itself.
Yes
The device description explicitly states "Rayvolve PTX-PE is a software-only device". It analyzes existing medical images and provides output to a DICOM node server, indicating it does not include or require proprietary hardware for its primary function.
Based on the provided information, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- IVDs analyze samples taken from the human body. The definition of an IVD typically involves the examination of specimens such as blood, urine, tissue, etc., to provide information about a person's health.
- This device analyzes images of the human body. Rayvolve PTX-PE analyzes chest x-ray images, which are external representations of the internal anatomy, not biological samples taken from the patient.
The device is a software tool that processes medical images for the purpose of triage and notification, which falls under the category of medical imaging software or potentially a medical device software (MDSW), but not an IVD.
No
The letter does not state that the FDA has reviewed and approved or cleared a Predetermined Change Control Plan (PCCP) for this specific device.
Intended Use / Indications 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 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.
Product codes (comma separated list FDA assigned to the subject device)
QFM
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
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.
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.
Input Imaging Modality
chest x-ray images (Postero-Anterior (PA) or Antero-Posterior (AP))
Anatomical Site
Chest/Lung
Indicated Patient Age Range
18 years of age or older
Intended User / Care Setting
Healthcare professionals
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
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%).
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Study Type: Standalone performance assessment
Sample Size: 1000 radiographs in the Pneumothorax group and 1000 radiographs in the Pleural effusion group.
Pneumothorax:
- AUC: 0.9857 (95% Confidence Interval (CI): 0.9809; 0.9901)
- Sensitivity: 0.9379 (95% Confidence interval (CI): 0.9127; 0.9561)
- Specificity: 0.9178 (95% Confidence interval (CI): 0.8911; 0.9561)
- Performance time: 19.43 seconds (95% Cl: 19.42 - 19.45)
Pleural Effusion: - AUC: 0.9830 (95% Confidence Interval (CI): 0.9778; 0.9880)
- Sensitivity: 0.9134 (95% Confidence Interval (CI): 0.8874; 0.9339)
- Specificity: 0.9448 (95% Confidence Interval (CI): 0.9239; 0.9339)
- Performance time: 19.56 seconds (95% Cl: 19.49 - 19.58)
Key results: 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Pneumothorax:
- Sensitivity: 0.9379 (95% Confidence interval (CI): 0.9127; 0.9561)
- Specificity: 0.9178 (95% Confidence interval (CI): 0.8911; 0.9561)
Pleural Effusion: - Sensitivity: 0.9134 (95% Confidence Interval (CI): 0.8874; 0.9339)
- Specificity: 0.9448 (95% Confidence Interval (CI): 0.9239; 0.9339)
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
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.
1
Page
2
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
2
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
3
| 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) |
| ---------------------------------------------------------------------- | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |
|---|
4
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
5
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 |
6
1. Submitter
Submitted date: 2025-02-17
| Submitter | AZmed
10 Rue d'Uzès
75002 Paris, France
Phone: +33 6 72 19 04 19 |
|----------------|--------------------------------------------------------------------------------------------------------------------------------|
| Contact person | Anthony JOSEPH
QARA Associate
10 Rue d'Uzès
75002 Paris, France
Phone: +33 6 72 19 04 19
Mail: anthony@azmed.co |
2. Device identification
| Name of
the Device | Common
or Usual
Name | Regulatory
section | Classification | Product
Code | Panel |
|-----------------------|----------------------------|-----------------------|----------------|-----------------|-------------------|
| Rayvolve
PTX-PE | Rayvolve | 21 CFR
892.2080 | 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 CXR | |
| Triage | K211733 |
7
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
8
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.
| Comparison
to predicate
device | Lunit INSIGHT CXR Triage
- Predicate (K220164) | Rayvolve PTX-PE -
Subject device 510(k) file | Comparison to
the predicate |
|-----------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Name | Lunit INSIGHT CXR Triage | Rayvolve | N/A |
| Manufacturer | Lunit, Inc. | AZmed | N/A |
| 510 (k) # | K211733 | K243808 | N/A |
| Regulation
Number | 21 CFR 892.2080 | 21 CFR 892.2080 | Same |
| Class | II | II | Same |
| Product Code | QFM | QFM | Same |
| Device Panel | Radiology | Radiology | Same |
| Level of
Concern | Moderate | Moderate | Same |
| Intended use
/ Indications
for use | Lunit INSIGHT CXR Triage
is a radiological
computer-assisted triage
and notification software
that analyzes adult chest
X-ray images for the
presence of pre-specified
suspected critical findings | 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 | Equivalent,
slight precision
on the
intended
patient
population (see
the line
'intended |
| Comparison
to predicate
device | Lunit INSIGHT CXR Triage - Predicate (K220164) | Rayvolve PTX-PE -
Subject device 510(k) file | Comparison to
the predicate |
| | (pleural effusion and/or
pneumothorax). Lunit
INSIGHT CXR Triage uses
an artificial intelligence
algorithm to analyze images
for features suggestive of
critical findings and provides
case-level output available
in the PACS/workstation for
worklist prioritization or
triage. As a passive
notification for
prioritization-only software
tool within standard of care
workflow, Lunit INSIGHT
CXR Triage does not send
a proactive alert directly to
the appropriately trained
medical specialists. Lunit
INSIGHT CXR Triage 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. | 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. | patient
population for
the
justification)
and for other
DICOM
storage
platforms the
subject device.
Other DICOM
storage
platforms are
equivalent to
PACS.
None of those
precisions
raise new
questions of
safety or
effectiveness |
| Intended user | Appropriately trained
medical specialists who are
qualified to interpret chest
radiographs | Healthcare professionals | Equivalent.
Healthcare
professionals
are qualified to
interpret chest
radiographs |
| Intended
patient
population | Adults | 18 years of age or older | Equivalent:
Our dataset
contains
images for
patients of |
| Comparison
to predicate
device | Lunit INSIGHT CXR Triage - Predicate (K220164) | Rayvolve PTX-PE -
Subject device 510(k) file | Comparison to
the predicate |
| | | | 18-21 years
old.
The
performance
results (see
Appendix 25)
shows that the
performances
of Rayvolve
PTX-PE for
patients
between 18
and 21 years
old are
equivalent to
the results
obtained for
patients older
than 21 years
old. So, it
doesn't raise
new questions
of safety or
effectiveness,
and maintain
the same level
of performance
than the
predicated
device |
| Targeted
clinical
condition and
anatomy | Pleural effusion,
pneumothorax
Chest/Lung | Pleural effusion,
pneumothorax
Chest/Lung | Same |
| Radiological
images
format | DICOM | DICOM | Same |
| Image
modality | Frontal chest X-ray | Postero-Anterior (PA) or
Antero-Posterior (AP)
chest X-ray | Equivalent.
Inclusion of the
orientation of
the image |
| Comparison
to predicate
device | Lunit INSIGHT CXR Triage - Predicate (K220164) | Rayvolve PTX-PE -
Subject device 510(k) file | Comparison to
the predicate |
| | | | acquisition, but
the
performance
testing (see
appendix 25)
has
demonstrated
that Rayvolve
PTX-PE
achieves
equivalent
accuracy on
both AP and
PA views, so
considering
both views
doesn't raise
new questions
of safety or
effectiveness,
and maintain
the same level
of performance
than the
predicated
device |
| Algorithm for
pre-specified
critical
findings
detection | Al algorithm designed to
detect pleural effusion and
pneumothorax in chest
X-ray images.
Lunit INSIGHT CXR Triage
uses a vendor agnostic
algorithm compatible with
DICOM chest X-ray images. | Al algorithm designed to
detect pleural effusion and
pneumothorax in chest
X-ray images.
Rayvolve PTX-PE uses a
vendor agnostic algorithm
compatible with DICOM
chest X-ray images. | Same |
| Where
generated
results are
stored | 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 |
| Computationa
l platform | Lunit INSIGHT CXR Triage is designed as a software
module that can be
deployed on several
computing and X-ray
imaging platforms such as
radiological imaging
equipment, PACS, On
Premise or On Cloud. | Rayvolve PTX-PE is
designed as a software
module that can be
deployed on several
computing and X-ray
imaging platforms such as
radiological imaging
equipment, PACS, On
Premise or On Cloud. | Same |
| Device output
in case of
positive
detection | When deployed on other
radiological imaging
equipment Lunit INSIGHT
CXR Triage automatically
runs after image acquisition
and prioritizes and displays
the analysis result through
the worklist interface of
PACS/workstation.
No markup on original
image. Secondary capture
of the finding.
Upon image acquisition
from other radiological
imaging equipment (e.g.
X-ray systems), an
on-device, tehcnologist
notification indicating which
cases were flagged by Lunit
INSIGHT CXR Triage in
PACS, is generated 15
minutes after interpretation
by the user.
The on device notification is
contextual and does not
provide any diagnostic | When deployed on other
radiological imaging
equipment Rayvolve
PTX-PE automatically
runs after image
acquisition and prioritizes
and displays the analysis
result through the worklist
interface of
PACS/workstation.
No markup on the original
image. Secondary capture
of the device will indicate
the presence of findings
suspicious of
pneumothorax or pleural
effusion.
Upon image acquisition
from other radiological
imaging equipment (e.g,
X-ray systems), a passive
notification indicating which
studies were flagged by
Rayvolve PTX-PE is
generated.
The notification is | Same |
| Comparison
to predicate
device | Lunit INSIGHT CXR Triage - Predicate (K220164) | Rayvolve PTX-PE -
Subject device 510(k) file | Comparison to
the predicate |
| | information. It is not
intended to inform any
clinical decision,
prioritization, or action to the
technologist. | contextual and does not
provide any diagnostic
information. It is not
intended to inform any
clinical decision,
prioritization, or action. | |
| Notification
(i.e., recipient
timing and
means of
notification) | Passive notification.
Images with suspicion of
pleural effusion and/or
pneumothorax are flagged
in PACS/workstation | Passive notification.
Images with suspicion of
pneumothorax and/or
pleural effusion are flagged
in
PACS/workstation/DICOM
viewer. | Equivalent:
DICOM
viewers are the
software that
allow to open
the Dicom files
on the
workstations, it
doesn't raise
new questions
of safety or
effectiveness |
| Performance
level - Timing
of notification | The average time taken by
the device to analyze the
study and send a
notification to the worklist is
20,76 seconds for pleural
effusion and 20.45 seconds
for pneumothorax | The average time taken by
the device to analyze the
study and send a
notification to the worklist is
19.56 seconds for pleural
effusion and 19.43
seconds for pneumothorax | Equivalent
The
performance
results of the
subject device
are slightly
better than the
results for the
predicate
device, so it
doesn't raise
new questions
of safety or
effectiveness. |
| Performance
level -
accuracy of
classification | Pleural Effusion
ROC AUC > 0.95
AUC: 0.9686 (95% CI:
[0.9547,0.9824])
Sensitivity 89.86% (95% CI:
[86.72, 93.00]) | Pleural Effusion
ROC AUC > 0.95
AUC: 0.9830 (95% CI:
[0.9778, 0.9880])
Sensitivity 0.9134 (95% CI:
[0.8874, 0.9339]) | Equivalent
The
performance
results of the
subject device
are slightly
better than the |
| Comparison
to predicate
device | Lunit INSIGHT CXR Triage - Predicate (K220164) | Rayvolve PTX-PE -
Subject device 510(k) file | Comparison to
the predicate |
| | Specificity 93.48% (95% Cl:
[91.06, 95.91])
Pneumothorax
ROC AUC > 0.95
AUC: 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])
Pneumothorax
ROC AUC > 0.95
AUC: 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 the
predicate
device, so it
doesn't raise
new questions
of safety or
effectiveness. |
9
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
12
azmed
13
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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Image /page/16/Picture/0 description: The image shows the word "azmed" in a stylized, sans-serif font. The letters are a dark blue color. The "a" and "z" are connected by diagonal lines, creating a unique visual element.
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.