(155 days)
Not Found
Yes
The document explicitly states that the software uses "deep learning techniques" and "deep learning algorithms" to analyze chest radiographs and identify suspected malpositioned ETT findings. It also mentions an "Artificial intelligence algorithm". Deep learning is a subset of machine learning and artificial intelligence.
No
Explanation: A therapeutic device is used to treat or cure a disease or condition. This device is a diagnostic tool that assists in identifying malpositioned endotracheal tubes, which is a diagnostic function, not a therapeutic one.
No
The device is a "radiological computer-aided triage and notification software" intended to "assist hospital networks and appropriately trained medical specialists in workflow triage by flagging and communicating suspected positive cases of vertically malpositioned endotracheal tube (ETT)." It is explicitly stated that "EFAI ETTXR is not intended to direct attention to specific portions of an image or to anomalies of an image. Its results are not intended to be used on a stand-alone basis for clinical decision-making nor is it intended to rule out malpositioned ETT or otherwise preclude clinical assessment of chest radiographs." This indicates it's a triage tool, not a diagnostic one.
Yes
The device description explicitly states that the device is a "radiological computer-assisted triage and notification software system" and that it "analyzes chest radiographs and alerts the PACS/RIS workstation". There is no mention of any accompanying hardware components.
Based on the provided information, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- IVDs analyze biological samples: In Vitro Diagnostics are designed to examine specimens taken from the human body, such as blood, urine, tissue, etc., to provide information about a person's health.
- This device analyzes medical images: The EFAI CHESTSUITE XR MALPOSITIONED ETT ASSESSMENT SYSTEM analyzes chest X-ray images. It does not interact with or analyze any biological samples.
The device falls under the category of medical image analysis software or radiological computer-aided triage software. It processes medical images to assist in the workflow and prioritization of cases, not to diagnose or provide information based on biological samples.
No
The provided text does not contain any explicit statement that the FDA has reviewed and approved or cleared a Predetermined Change Control Plan (PCCP) for this specific device.
Intended Use / Indications for Use
EFAI CHESTSUITE XR MALPOSITIONED ETT ASSESSMENT SYSTEM (EFAI ETTXR) is a radiological computeraided triage and notification software indicated for use in the analysis of chest X-ray (CXR) images in adults. The device is intended to assist hospital networks and appropriately trained medical specialists in workflow triage by flagging and communicating suspected positive cases of vertically malpostioned endotracheal twoe (ETT) in relation to the carina. Findings are flagged when the ETT distal tip is assessed as being more than 7 cm above the carina, less than 3 cm above the carina, or when it is below the carina (i.e in the right or left mainstem bronchus). The device assesses solely the vertical position of the ETT distal tip relative to the carina, does not factor patient positioning, and cannot detect esophageal intubation. The device is tested in the single lumen endotracheal tube, while it may trigger a false prioritization alert in the case of properly positioned double lumen ETT.
EFAI ETTXR analyzes cases using algorithms to identify suspected malpositioned ETT findings. It nakes case-level output available to a PACS/workstation for worklist prioritization or trage. EFAI ETTXR is not intended to direct attention to specific portions of an image or to anomalies of an image. Its results are not intended to be used on a stand-alone basis for clinical decision-making nor is it intended to rule out malpositioned ETT or otherwise preclude clinical assessment of chest radiographs.
Product codes (comma separated list FDA assigned to the subject device)
QAS
Device Description
EFAI CHESTSUITE XR MALPOSITIONED ETT ASSESSMENT SYSTEM (EFAI ETTXR) is a radiological computer-assisted triage and notification software system. The software uses deep learning techniques to automatically analyze chest radiographs and alerts the PACS/RIS workstation once images with features suggestive of malpositioned ETT are identified.
Through the use of EFAI ETTXR, a radiologist is able to review studies with features suggestive of malpositioned ETT earlier than in standard of care workflow.
The device is intended to provide a passive notification through the PACS/workstation to the radiologists indicating the existence of a case that may potentially benefit from the prioritization. It does not mark, highlight, or direct users' attention to a specific location on the original chest radiographs. The device aims to aid in prioritization and triage of radiological medical images only.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Yes
Input Imaging Modality
Chest X-ray (CXR) images / Chest X-ray (AP view)
Anatomical Site
Chest
Indicated Patient Age Range
Adults
Intended User / Care Setting
Hospital networks and appropriately trained medical specialists
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
A validation dataset of 940 studies consecutively collected from multiple clinical sites across the United States. Each patient included only one study. None of the studies was used as part of the EFAI ETTXR model development or analytical validation testing.
The study population contained 49.57% females and 50.43% males, and the mean age of cases was 57.9 years. Cases included White, Black or African American, Hispanic, Asian, Multiracial, and other races or ethnicities. The X-ray images were obtained from manufacturers such as Philips, Canon, Carestream Health, Samsung Electronics, Siemens, and others.
The determination of malpositioned ETT in each case was independently assessed by three U.S. board-certified radiologists, with cases classified as positive for malpositioned ETT. Cases where the ETT was correctly positioned or with no ETT were classified as negative. The reference standard (ground truth) was based on the majority agreement among the three U.S. board-certified radiologists, resulting in 259 positive cases and 681 negative cases (Correctly Positioned ETT: 316, With No ETT: 365).
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Retrospective, blinded, multisite clinical validation study.
Validation dataset of 940 studies.
Standalone performance: sensitivity and specificity of 0.890 (95% CI-0.846-0.923) and 0.935 (95% CI-0.909-0.954) respectively.
The secondary endpoint of the observed system processing time per study is 2.49 minutes (95% CI=2.43-2.56 minutes) on average.
Subgroup analysis across genders, age groups, race or ethnicity groups, and X-ray manufacturer groups demonstrated consistent high performance.
Evaluated performance in cases with other (non-ETT) tubes, lines, and life support devices, lung diseases, image quality issues, post op, and other diseases, showing reliable performance.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Sensitivity: 0.890 (95% CI-0.846-0.923)
Specificity: 0.935 (95% CI-0.909-0.954)
System processing time per study: 2.49 minutes (95% CI=2.43-2.56 minutes)
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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.
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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
Ever Fortune.AI, Co., Ltd. Wang Ti-Hao Chief Technology Officer 8F., No.360, Sec. 1, Jingmao Rd., Beitun Dist. Taichung City, 406040 Taiwan
February 20, 2025
Re: K242821
Trade/Device Name: EFAI Chestsuite XR Malpositioned ETT Assessment System (ETT-XR-100) Regulation Number: 21 CFR 892.2080 Regulation Name: Radiological computer aided triage and notification software Regulatory Class: Class II Product Code: QAS Dated: January 14, 2024 Received: January 14, 2025
Dear Wang Ti-Hao:
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.
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"
1
(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 (QS) 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.
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/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-regulatory
2
assistance/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, PhD Assistant Director Imaging Software Team DHT8B: Division of Radiological Imaging Devices and Electronic Products OHT8: Office of Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
3
Indications for Use
510(k) Number (if known) K242821
Device Name
EFAI CHESTSUITE XR MALPOSITIONED ETT ASSESSMENT SYSTEM (ETT-XR-100)
Indications for Use (Describe)
EFAI CHESTSUITE XR MALPOSITIONED ETT ASSESSMENT SYSTEM (EFAI ETTXR) is a radiological computeraided triage and notification software indicated for use in the analysis of chest X-ray (CXR) images in adults. The device is intended to assist hospital networks and appropriately trained medical specialists in workflow triage by flagging and communicating suspected positive cases of vertically malpostioned endotracheal twoe (ETT) in relation to the carina. Findings are flagged when the ETT distal tip is assessed as being more than 7 cm above the carina, less than 3 cm above the carina, or when it is below the carina (i.e in the right or left mainstem bronchus). The device assesses solely the vertical position of the ETT distal tip relative to the carina, does not factor patient positioning, and cannot detect esophageal intubation. The device is tested in the single lumen endotracheal tube, while it may trigger a false prioritization alert in the case of properly positioned double lumen ETT.
EFAI ETTXR analyzes cases using algorithms to identify suspected malpositioned ETT findings. It nakes case-level output available to a PACS/workstation for worklist prioritization or trage. EFAI ETTXR is not intended to direct attention to specific portions of an image or to anomalies of an image. Its results are not intended to be used on a stand-alone basis for clinical decision-making nor is it intended to rule out malpositioned ETT or otherwise preclude clinical assessment of chest radiographs.
| Type of Use (Select one or both, as applicable) |
|---|
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) |
| ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
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Image /page/4/Picture/0 description: The image shows the logo for Ever Fortune AI. The logo consists of a teal-colored abstract figure with a green globe on top, resembling a person. To the right of the figure, the text "EVER" is displayed above "FORTUNE.AI", both in a teal color that matches the figure. The logo is clean and modern, suggesting a company focused on technology and innovation.
510(k) Summary
General Information 1.
| 510(k) Sponsor | Ever Fortune.AI Co., Ltd. |
|---|---|
| Address | 8F., No.360, Sec. 1, Jingmao Rd., |
| Beitun Dist., | |
| Taichung City 406040, | |
| Taiwan | |
| Applicant | Joseph Chang |
| Contact Information | 886-04-23213838 #216 |
| joseph.chang@everfortune.ai | |
| Correspondence Person | Ti-Hao Wang |
| Contact Information | 886-04-23213838 #168 |
| thothwang@gmail.com | |
| tihao.wang@everfortune.ai | |
| Date Prepared | January, 2025 |
2. Proposed Device
| Proprietary Name | EFAI CHESTSUITE XR MALPOSITIONED ETT ASSESSMENT
SYSTEM (ETT-XR-100) |
|---------------------|------------------------------------------------------------------------|
| Common Name | EFAI ETTXR |
| Classification Name | Radiological computer-assisted triage and notification software |
| Regulation Number | 21 CFR 892.2080 |
| Product Code | QAS |
| Regulatory Class | II |
3. Predicate Device
| Proprietary Name | Briefcase |
|---|---|
| Premarket Notification | K221330 |
| Classification Name | Radiological computer-assisted triage and notification software |
| Regulation Number | 21 CFR 892.2080 |
| Product Code | QAS |
| Regulatory Class | II |
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Image /page/5/Picture/0 description: The image shows the logo for Ever Fortune AI. The logo consists of a stylized human figure in teal with a green network-like design in the head area. To the right of the figure, the text "EVER" is displayed in a larger teal font, with "FORTUNE.AI" underneath in a smaller font, also in teal, with a similar network-like design replacing the "O" in "FORTUNE".
Device Description 4.
EFAI CHESTSUITE XR MALPOSITIONED ETT ASSESSMENT SYSTEM (EFAI ETTXR) is a radiological computer-assisted triage and notification software system. The software uses deep learning techniques to automatically analyze chest radiographs and alerts the PACS/RIS workstation once images with features suggestive of malpositioned ETT are identified.
Through the use of EFAI ETTXR, a radiologist is able to review studies with features suggestive of malpositioned ETT earlier than in standard of care workflow.
The device is intended to provide a passive notification through the PACS/workstation to the radiologists indicating the existence of a case that may potentially benefit from the prioritization. It does not mark, highlight, or direct users' attention to a specific location on the original chest radiographs. The device aims to aid in prioritization and triage of radiological medical images only.
ನ. Intended Use / Indications for Use
EFAI CHESTSUITE XR MALPOSITIONED ETT ASSESSMENT SYSTEM (EFAI ETTXR) is a radiological computer-aided triage and notification software indicated for use in the analysis of chest X-ray (CXR) images in adults. The device is intended to assist hospital networks and appropriately trained medical specialists in workflow triage by flagging and communicating suspected positive cases of vertically malpositioned endotracheal tube (ETT) in relation to the carina. Findings are flagged when the ETT distal tip is assessed as being more than 7 cm above the carina, less than 3 cm above the carina, or when it is below the carina (i.e in the right or left mainstem bronchus). The device assesses solely the vertical position of the ETT distal tip relative to the carina, does not factor patient positioning, and cannot detect esophageal intubation. The device is tested in the single lumen endotracheal tube, while it may trigger a false prioritization alert in the case of properly positioned double lumen ETT.
EFAI ETTXR analyzes cases using deep learning algorithms to identify suspected malpositioned ETT findings. It makes case-level output available to a PACS/workstation for worklist prioritization or triage. EFAI ETTXR is not intended to direct attention to specific portions of an image or to anomalies of an image. Its results are not intended to be used on a stand-alone basis for clinical decision-making nor is it intended to rule out malpositioned ETT or otherwise preclude clinical assessment of chest radiographs.
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Image /page/6/Picture/0 description: The image contains a logo for a company called "EVER FORTUNE.AI". The logo consists of a stylized figure of a person with a green globe on top of their head, and the company name is written in a sans-serif font to the right of the figure. The word "EVER" is in a larger font size than "FORTUNE.AI", and the globe icon is repeated in the word "FORTUNE".
6. Comparison of Technological Characteristics with Predicate Device
| Feature/
Function | Proposed Device:
EFAI ETTXR | Predicate Device:
BriefCase
(K221330) |
|---------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended
Use/Indication
for Use | EFAI CHESTSUITE XR
MALPOSITIONED ETT
ASSESSMENT SYSTEM (EFAI
ETTXR) is a radiological
computer-aided triage and notification
software indicated for use in the
analysis of chest X-ray (CXR) images
in adults. The device is intended to
assist hospital networks and
appropriately trained medical
specialists in workflow triage by
flagging and communicating
suspected positive cases of vertically
malpositioned endotracheal tube
(ETT) in relation to the carina.
Findings are flagged when the ETT
distal tip is assessed as being more
than 7 cm above the carina, less than 3
cm above the carina, or when it is
below the carina (i.e in the right or left
mainstem bronchus). The device
assesses solely the vertical position of
the ETT distal tip relative to the
carina, does not factor patient
positioning, and cannot detect
esophageal intubation. The device is
tested in the single lumen
endotracheal tube, while it may trigger
a false prioritization alert in the case
of properly positioned double lumen
ETT.
EFAI ETTXR analyzes cases using
deep learning algorithms to identify
suspected malpositioned ETT
findings. It makes case-level output
available to a PACS/workstation for
worklist prioritization or triage. EFAI
ETTXR is not intended to direct
attention to specific portions of an
image or to anomalies of an image. Its
results are not intended to be used on a
stand alone basis for clinical | BriefCase is a radiological
computeraided triage and notification
software indicated for use in the
analysis of frontal chest X-ray (CXR)
images in adults or transitional
adolescents aged 18 and older. The
device is intended to assist hospital
networks and appropriately trained
medical specialists in workflow triage
by flagging and communicating
suspected positive cases of vertically
malpositioned endotracheal tube
(ETT) in relation to the carina.
Findings are flagged when the ETT
distal tip is assessed as being more
than 5 cm above the carina, less than 2
cm above the carina, or when it is
below the carina (i.e in the right or left
mainstem bronchus).
The device assesses solely the vertical
position of the ETT distal tip relative
to the carina, does not factor patient
positioning, and cannot detect
esophageal intubation. The device
does not provide results when the
carina is not well-visualized on the
x-ray image. The device does not
discriminate types of ETTs, as such a
properly positioned double lumen ETT
may trigger a false prioritization alert.
BriefCase uses an artificial
intelligence algorithm to analyze
images and highlight cases with
detected findings on a standalone
application in parallel to the ongoing
standard of care image interpretation.
The user is presented with
notifications for cases with suspected
findings. Notifications include
compressed preview images that are |
| | decision-making nor is it intended to rule out malpositioned ETT or otherwise preclude clinical assessment of chest radiographs. | meant for informational purposes only and not intended for diagnostic use beyond notification. The device does not alter the original medical image and is not intended to be used as a diagnostic device. The results of BriefCase are intended to be used in conjunction with other patient information and based on the user's professional judgment, to assist with triage/prioritization of medical images. Notified clinicians are responsible for viewing full images per the standard of care. |
| User population | Hospital networks and appropriately trained medical specialists | Hospital networks and appropriately trained medical specialists |
| Anatomical region of interest | Chest | Chest |
| Data acquisition protocol | Chest X-ray (AP view) | Frontal Chest X-ray (CXR) |
| Images format | DICOM | DICOM |
| Interference with standard workflow | No. No cases are removed from Worklist or deprioritized. | No. No cases are removed from desktop app or deprioritized |
| Algorithm | Artificial intelligence algorithm with database of images. | Artificial intelligence algorithm with database of images. |
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Image /page/7/Picture/0 description: The image shows the logo for Ever Fortune AI. The logo consists of a stylized human figure in teal with a green circle containing a network of lines and dots as its head. To the right of the figure, the word "EVER" is written in large, teal letters above the words "FORTUNE.AI" in smaller teal letters with a similar green circle containing a network of lines and dots replacing the "O" in "FORTUNE".
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Image /page/8/Picture/0 description: The image contains a logo for a company called "EVER FORTUNE.AI". The logo consists of a stylized figure of a person with a green globe on top of their head. The person is teal. The company name is written in teal next to the figure.
7. Performance Data
Performance of the EFAI ETTXR has been evaluated and verified in accordance with software specifications and applicable performance standards through software verification and validation testing. Additionally, the software validation activities were performed in accordance with IEC 62304:2006/A1:2016 - Medical device software - Software life cycle processes, in addition to the FDA Guidance documents, "Content of Premarket Submissions for Device Software Functions" and "Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions."
Ever Fortune.AI conducted a retrospective, blinded, multisite clinical validation study with the proposed device EFAI ETTXR with a pre-determined primary and secondary endpoint and performance goals to evaluate the performance of the EFAI ETTXR in identifying malpositioned Endotracheal Tube (ETT) from chest x-ray images on a validation dataset of 940 studies consecutively collected from multiple clinical sites across the United States. Each patient included only one study. None of the studies was used as part of the EFAI ETTXR model development or analytical validation testing.
The study population contained 49.57% females and 50.43% males, and the mean age of cases was 57.9 years. Cases included White, Black or African American, Hispanic, Asian, Multiracial, and other races or ethnicities. The X-ray images were obtained from manufacturers such as Philips, Canon, Carestream Health, Samsung Electronics, Siemens, and others.
The determination of malpositioned ETT in each case was independently assessed by three U.S. board-certified radiologists, with cases classified as positive for malpositioned ETT. Cases where the ETT was correctly positioned or with no ETT were classified as negative. The reference standard (ground truth) was based on the majority agreement among the three U.S. board-certified radiologists, resulting in 259 positive cases and 681 negative cases (Correctly Positioned ETT: 316, With No ETT: 365). Primary endpoints were sensitivity and specificity with an 80% performance goal.
The observed results of the standalone performance validation study demonstrated that EFAI ETTXR by itself, in the absence of any interaction with a clinician, can provide case-level notifications with features suggestive of malpositioned ETT with satisfactory results. The performance evaluation conducted exclusively on AP view showed EFAI ETTXR demonstrated a sensitivity and specificity of 0.890 (95% CI-0.846-0.923) and 0.935 (95% CI-0.909-0.954) respectively, which is substantially equivalent to the predicate device (BriefCase, K221330). The secondary endpoint of the observed system processing time per study is 2.49 minutes (95% CI=2.43-2.56 minutes) on average and was significantly less than the pre-specified performance goal.
In addition, the results of the subgroup analysis, which included different genders, age groups, race or ethnicity groups, and X-ray manufacturer groups, demonstrated that EFAI ETTXR consistently performed high performance, underscoring its reliability and effectiveness across diverse subgroups. Furthermore, we also evaluated the device's performance in cases with other (non-ETT) tubes, lines, and life support devices, lung diseases (cavitary lung lesions, lung abscesses, lung masses, nodules, pleural effusion, pneumothorax, and pulmonary edema), image quality issues (poor patient's position, artifact present, field of view issues, and
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missing anatomy), post op (surgery or implants), and other diseases to assess the impact of these potential confounding factors. The device consistently performed reliably across these circumstances.
In conclusion, the results demonstrate that the EFAI ETTXR device is determined to be substantially equivalent in safety and effectiveness to the predicate device.
8. Safety & Effectiveness
EFAI ETTXR has been designed, verified and validated in compliance with 21 CFR, Part 820.30 requirements. The device has been designed to meet the requirements associated with ISO 14971:2019 Medical devices - Application of risk management to medical devices. The EFAI ETTXR performance has been validated using retrospective data from case data and through the use of Reader comparison analysis.
Substantial Equivalence 9.
The indications for use statement for the subject device is substantially similar to the cleared indications for use statement for BriefCase (K221330). Both the subject and predicate devices are used for triaging chest radiographs by identifying suspected malpositioned endotracheal tubes (ETTs) relative to the carina. Both devices include specific criteria for ETT positioning and provide similar support for clinical decision-making.
Both devices target the same user population, focus on the chest as the anatomical region of interest, utilize chest X-rays (CXR) as the data acquisition protocol, support notifications as a parallel workflow tool, and use DICOM format for images. They also employ similar artificial intelligence algorithms for analyzing images. Regarding interference with standard workflow, neither device removes or deprioritizes cases from the workflow.
EFAI ETTXR has minor technical differences compared to the predicate device. The predicate device provides preview images within their notification while the proposed device provides notification as a text based JSON file. However, both devices are designed to provide case-level outputs for triage and prioritization purposes and intended to be used in conjunction with full images, thus no new risks or safety issues arise.
10. Conclusion
Based on the information submitted in this premarket notification, and based on the indications for use, technological characteristics, and performance testing, the EFAI ETTXR raises no new questions of safety and effectiveness and is substantially equivalent to the predicate device in terms of safety, efficacy, and performance.