(187 days)
Not Found
Yes
The document explicitly states that the device "analyzes cases using an artificial intelligence algorithm" and "specifically, the device uses an artificial intelligence algorithm to analyze images".
No.
The device is described as a software workflow tool that aids in the clinical assessment and prioritization of Chest X-Ray cases by identifying suspicious findings; it does not provide treatment or directly improve a health condition, which are characteristics of a therapeutic device.
No
The document explicitly states multiple times that "The device does not alter the original medical image and is not intended to be used as a diagnostic device. Its results are not intended to be used on a stand-alone basis for clinical decision-making nor is it intended to rule out pneumoperitoneum or otherwise preclude clinical assessment of X-Ray cases." and "The software does not recommend treatment or provide a diagnosis." Its primary aim is for prioritization and triage.
Yes
The device description explicitly states "The HealthPPT solution is a software product" and describes its function as analyzing images and providing notifications to existing hardware (PACS/workstation or standalone desktop application). There is no mention of any accompanying hardware component being part of the device itself.
Based on the provided information, the HealthPPT device is not an In Vitro Diagnostic (IVD).
Here's why:
- IVDs are used to examine specimens derived from the human body. The HealthPPT device analyzes medical images (Chest X-Rays), which are not biological specimens.
- The intended use is for image analysis and workflow prioritization. The device's primary function is to analyze images for suspected findings and prioritize cases for review by a radiologist. It explicitly states it is "not intended to be used as a diagnostic device" and its results are "not intended to be used on a stand-alone basis for clinical decision-making."
- The device works in parallel with standard care. It aids in the workflow but does not replace the radiologist's diagnosis.
The HealthPPT device falls under the category of medical image analysis software, specifically designed to assist in the interpretation and prioritization of radiological images. It is a medical device, but not an IVD.
No
The letter does not explicitly state that the FDA has reviewed and approved or cleared a PCCP for this specific device.
Intended Use / Indications for Use
The HealthPPT device is a software workflow tool designed to aid the clinical assessment of adult frontal Chest X-Ray cases with features suggestive of pneumoperitoneum in the medical care environment. HealthPPT analyzes cases using an artificial intelligence algorithm to identify suspected findings. It makes case-level output available to a PACS/workstation for worklist prioritization or triage. HealthPPT is not intended to direct attention to anomalies other than pneumoperitoneum. Notifications include compressed preview images that are 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. Its results are not intended to be used on a stand-alone basis for clinical decision-making nor is it intended to rule out pneumoperitoneum or otherwise preclude clinical assessment of X-Ray cases.
Product codes (comma separated list FDA assigned to the subject device)
QFM
Device Description
The HealthPPT solution is a software product that automatically identifies suspected findings on chest x-rays (e.g. pneumoperitoneum) and notifies PACS/workstation of the presence of this critical finding in the scan. This notification allows for prioritization of the identified scan and assists clinicians in viewing the prioritized scan before others. The device aim is to aid in prioritization and triage of radiological medical images only.
The software is automatic and is capable of analyzing PA or AP chest x-rays. If a suspected finding is found in a scan, the alert is automatically sent to the PACS/workstation used by the radiologist or to a standalone desktop application in parallel with the ongoing standard of care. The PACS/workstation prioritizes and displays the study through its worklist interface. The ZebrAInsight standalone application includes a compressed preview image meant for informational purposes only and is not intended for diagnostic use.
The HealthPPT device works in parallel to and in conjunction with the standard care of workflow. After a chest x-ray has been performed, a copy of the study is automatically retrieved and processed by the HealthPPT device performs the analysis of the study and returns a notification about the relevant pathology to the PACS/workstation for prioritization. The clinician is then able to review the study earlier than in standard of care workflow.
The software does not recommend treatment or provide a diagnosis. It is meant as a tool to assist in improved workload prioritization of critical cases. The final diagnosis is provided by a radiologist after reviewing the scan itself.
The following modules compose the HealthPPT software for Pneumoperitoneum:
Data input and validation: Following retrieval of a study, the validation feature assessed the input data (i.e. age, modality, view) to ensure compatibility for processing by the algorithm.
Pneumoperitoneum algorithm: Once a study has been validated, the algorithm analyzes the frontal chest x-ray for detection of suspected finding suggestive of pneumoperitoneum.
IMA Integration feature: The study analysis and the results of a successful study analysis is provided to IMA, to then be sent to the PACS/workstation for prioritization.
Error codes feature: In the case of a study failure during data validation or the analysis by the algorithm, an error is provided to the system.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Yes
Input Imaging Modality
Chest X-Ray
Anatomical Site
Chest
Indicated Patient Age Range
adult
Intended User / Care Setting
Radiologist / medical care environment (hospital networks and clinics)
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 data included a retrospective cohort of 216 anonymized Chest X-ray cases from the USA and OUS, including 107 cases positive for Pneumoperitoneum and 109 cases negative for Pneumoperitoneum, as well as confounding imaging factors. The validation data set was truthed (ground truth) by three US Board-Certified Radiologists (truthers).
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Performance study for triage of time sensitive chest X-Ray cases.
Sample Size: 216 anonymized Chest X-ray cases (107 positive for Pneumoperitoneum, 109 negative).
AUC: 96.75% (95% CI: [94.28%, 99.21%])
Standalone performance:
"balanced sensitivity and specificity" (default) operating point: sensitivity of 92.52% (95% CI: [85.94%;96.16%]) and a specificity of 92.66% (95% CI: [86.18%;96.23%]).
"high-specificity" operating point: sensitivity of 80.37% (95% CL: [71.85%;86.79%]) and a specificity of 97.25% (95% CI: [92.22%;99.06%]).
Key results: All operating points reached their performance goal. The average performance time of the HealthPPT was 4.78 seconds.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
AUC: 96.75% (95% CI: [94.28%, 99.21%])
Sensitivity (Default Operating Point): 92.52% (95% CI: [85.94%;96.16%])
Specificity (Default Operating Point): 92.66% (95% CI: [86.18%;96.23%])
Sensitivity (High-Specificity Operating Point): 80.37% (95% CL: [71.85%;86.79%])
Specificity (High-Specificity Operating Point): 97.25% (95% CI: [92.22%;99.06%])
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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Zebra Medical Vision Ltd. % Shlomit Cymbalista Head of Regulatory Affairs Nano AI Ltd./Shefayim Commercial Center PO Box 25 Sefayim, 6099000 ISRAEL
December 15, 2021
Re: K211803
Trade/Device Name: HealthPPT Regulation Number: 21 CFR 892.2080 Regulation Name: Radiological computer aided triage and notification software Regulatory Class: Class II Product Code: QFM Dated: November 7, 2021 Received: November 10, 2021
Dear Shlomit Cymbalista:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part
1
801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4. Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
For
Thalia T. Mills, Ph.D. Director Division of Radiological Health OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K211803
Device Name HealthPPT
Indications for Use (Describe)
The HealthPPT device is a software workflow tool designed to aid the clinical assessment of adult frontal Chest X-Ray cases with features suggestive of pneumoperitoneum in the medical care environment. HealthPPT analyzes cases using an artificial intelligence algorithm to identify suspected findings. It makes case-level output available to a PACS/workstation for worklist prioritization or triage. HealthPPT is not intended to direct attention to anomalies other than pneumoperitoneum. Notifications include compressed preview images that are 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. Its results are not intended to be used on a stand-alone basis for clinical decision-making nor is it intended to rule out pneumoperitoneum or otherwise preclude clinical assessment of X-Ray cases.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
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510(K) Summary - HealthPPT Nanox AI Ltd.
510(k) Number – K211803
- I. Applicant's Name: Nanox AI Ltd. Shefayim Commercial Center PO Box 25 Shefayim, 6099000 ISRAEL Telephone: +972-9-8827795 Fax: +972-9-8827795
December 13, 2021 Date Prepared:
II. Device
Trade Name: HealthPPT
Classification Name:
QFM - Radiological Computer-Assisted Prioritization Software
Regulation Number: 892.2080
Classification:
Class II, Radiology
III. Predicate Device:
The HealthPPT device is substantially equivalent to the following device:
| Proprietary Name | AIMI-Triage CXR PTX |
|---|---|
| Premarket Notification | K193300 |
| Classification Name | Radiological Computer-Assisted Prioritization Software |
| Regulation Number | 21 CFR 892.2080 |
| Product Code | QFM |
| Regulatory Class | II |
Device Description IV.
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The HealthPPT solution is a software product that automatically identifies suspected findings on chest x-rays (e.g. pneumoperitoneum) and notifies PACS/workstation of the presence of this critical finding in the scan. This notification allows for prioritization of the identified scan and assists clinicians in viewing the prioritized scan before others. The device aim is to aid in prioritization and triage of radiological medical images only.
The software is automatic and is capable of analyzing PA or AP chest x-rays. If a suspected finding is found in a scan, the alert is automatically sent to the PACS/workstation used by the radiologist or to a standalone desktop application in parallel with the ongoing standard of care. The PACS/workstation prioritizes and displays the study through its worklist interface. The ZebrAInsight standalone application includes a compressed preview image meant for informational purposes only and is not intended for diagnostic use.
The HealthPPT device works in parallel to and in conjunction with the standard care of workflow. After a chest x-ray has been performed, a copy of the study is automatically retrieved and processed by the HealthPPT device performs the analysis of the study and returns a notification about the relevant pathology to the PACS/workstation for prioritization. The clinician is then able to review the study earlier than in standard of care workflow.
The software does not recommend treatment or provide a diagnosis. It is meant as a tool to assist in improved workload prioritization of critical cases. The final diagnosis is provided by a radiologist after reviewing the scan itself.
The following modules compose the HealthPPT software for Pneumoperitoneum:
Data input and validation: Following retrieval of a study, the validation feature assessed the input data (i.e. age, modality, view) to ensure compatibility for processing by the algorithm.
Pneumoperitoneum algorithm: Once a study has been validated, the algorithm analyzes the frontal chest x-ray for detection of suspected finding suggestive of pneumoperitoneum.
IMA Integration feature: The study analysis and the results of a successful study analysis is provided to IMA, to then be sent to the PACS/workstation for prioritization.
Error codes feature: In the case of a study failure during data validation or the analysis by the algorithm, an error is provided to the system.
V. Intended Use/Indication for Use:
The Zebra HealthPPT device is a software workflow tool designed to aid the clinical assessment of adult frontal Chest X-Ray cases with features suggestive of pneumoperitoneum in the medical care environment. HealthPPT analyzes cases using an artificial intelligence algorithm to identify suspected findings. It makes case-level output available to a PACS/workstation for worklist
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Image /page/5/Picture/0 description: The image contains the logo for NanoXAI. The logo consists of two parts: a stylized graphic on the left and the company name on the right. The graphic is an abstract shape with curved lines in shades of blue and yellow, resembling a stylized flower or butterfly. To the right of the graphic is the company name "NANOXAI" in blue, with the "AI" portion in yellow.
prioritization or triage. HealthPPT is not intended to direct attention to anomalies other than pneumoperitoneum. Notifications include compressed preview images that are 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. Its results are not intended to be used on a stand-alone basis for clinical decision-making nor is it intended to rule out pneumoperitoneum or otherwise preclude clinical assessment of X-Ray cases.
VI. Technological Characteristics Compared to Predicate Device:
The technological characteristics, e.g., overall design, mechanism of action, mode of operation, performance characteristics, etc., and the intended use of the HealthPPT device are substantially equivalent to the predicate device cited above.
| Technological
Characteristics | Proposed Device
HealthPPT | Predicate Device
AIMI-Triage CXR PTX
(K193300) | Summary |
|----------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indication for
Use/Intended Use | The Zebra HealthPPT device
is a software workflow tool
designed to aid the clinical
assessment of adult frontal
Chest X-Ray cases with
features suggestive of
pneumoperitoneum in the
medical care environment.
HealthPPT analyzes cases
using an artificial intelligence
algorithm to identify
suspected findings. It makes
case-level output available to
a PACS/workstation for
worklist prioritization or | The AIMI-Triage CXR
PTX Application is a
notification-only triage
workflow tool for use by
hospital networks and
clinics to identify and
help prioritize chest
X-rays acquired in the
acute setting for review
by hospital radiologists.
The device operates in
parallel to and
independent of standard
of care image
interpretation workflow. | Similar expect for
lesion type |
| | triage. HealthPPT is not
intended to direct attention to
anomalies other than
pneumoperitoneum.
Notifications include
compressed preview images
that are 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. Its results are not | Specifically, the device
uses an artificial
intelligence algorithm to
analyze images for
features suggestive of
moderate to large sized
pneumothorax; it makes
caselevel output available
to a PACS/workstation
for worklist prioritization
or triage. Identification of
suspected cases of
moderate to large sized
pneumothorax is not for
diagnostic use beyond | |
| | intended to be used on a
stand-alone basis for clinical
decision-making nor is it
intended to rule out
pneumoperitoneum or
otherwise preclude clinical
assessment of X-Ray cases. | notification. The
AIMI-Triage CXR PTX
Application is limited to
analysis of imaging data
as a guide to possible
urgency of adult chest
X-ray image review, and
should not be used in lieu
of full patient evaluation
or relied upon to make or
confirm diagnoses.
Notified radiologists are
responsible for engaging
in appropriate patient
evaluation as per local
hospital procedure before
making care-related
decisions or requests. The
device does not replace
review and diagnosis of
the X-rays by
radiologists. The device is
not intended to be used
with plain film X-rays. | |
| Notification-only,
parallel workflow
tool | Yes | Yes | Same |
| User | Radiologist | Radiologist | Same |
| Radiological
images format | DICOM | DICOM | Same |
| Identify patients
with prespecified
clinical condition | Yes | Yes | Same |
| Clinical condition | Pneumoperitoneum | Pneumothorax | Different but as
per the product
classification
definition, both
identify "time
sensitive imaging." |
| Alert to finding | Yes; notification flagged for
review on hospital worklist or
Zebra application | Yes; notification flagged
for review | Similar,
HealthPPT can be
directly integrated
for notification on
the hospital
worklist or on the
Zebra application.
Both notifications
operate in parallel |
| | | | with the standard
of care. |
| Independent of
standard of care
workflow | Yes; No cases are removed
from worklist | Yes; No cases are
removed from worklist | Same |
| Modality | Chest X-Ray | Chest X-Ray | Same |
| Artificial
Intelligence
algorithm | Yes | Yes | Same |
| Limited to analysis
of imaging data | Yes | Yes | Same |
| Aids prompt
identification of
cases with
indicated findings | Yes | Yes | Same |
| Preview Image | Presentation of a compressed
preview image for initial
assessment, not meant for
diagnostic purposes.
The device operated in
parallel with the standard of
care, which remains the
default option for all cases. | Presentation of
notification for initial
assessment not meant for
diagnostic purposes. The
device operates in parallel
with the standard of care,
which remains the default
option for all cases. | Similar,
HealthPPT
provides an
additional
compressed image
as a preview only,
not for diagnostic
use. |
| Multiple operating
points | Yes; 2 optional operating
points | No; single operating point | Different, but all
operating points
comply with DEN
170073 Special
control 1(iii). |
| Where results are
received | PACS / Workstation | PACS / Workstation | Same |
A comparison of the technological characteristics with the predicate is summarized below.
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Image /page/6/Picture/0 description: The image contains the logo for NanoX AI. The logo consists of two parts: a stylized graphic on the left and the company name on the right. The graphic is an abstract shape with a grid-like pattern, colored in shades of blue and yellow. The text "NANOXAI" is written in blue, except for the "AI" which is in yellow.
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Image /page/7/Picture/0 description: The image contains the logo for Nanox AI. The logo consists of two parts: a stylized graphic on the left and the text "NANOXAI" on the right. The graphic is a symmetrical design with curved lines, colored in shades of blue and yellow. The text "NANOXAI" is written in a sans-serif font, with "NANOX" in blue and "AI" in yellow.
VII. Performance Data:
Safety and performance of HealthPPT has been evaluated and verified in accordance with software specifications and applicable performance standards through Software Development and Validation & Verification Process to ensure performance according to specifications, User Requirements and Federal Regulations and Guidance documents, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices".
The performance of the HealthPPT device has been validated in a performance study for triage of time sensitive chest X-Ray cases. The data included a retrospective cohort of 216 anonymized Chest X-ray cases from the USA and OUS, including 107 cases positive for Pneumoperitoneum and 109 cases negative for Pneumoperitoneum, as well as confounding imaging factors. The validation data set was truthed (ground truth) by three US Board-Certified Radiologists
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Image /page/8/Picture/0 description: The image contains the logo for NanoX AI. The logo consists of a geometric shape on the left and the text "NANOX AI" on the right. The geometric shape is a stylized representation of a sphere or globe, with a grid-like pattern. The left side of the text is blue, while the right side is yellow.
(truthers). The stand-alone detection accuracy was measured on this cohort respective to the ground truth.
The HealthPPT device detection accuracy met the accuracy performance goals for AUC, and the sensitivity, and specificity for two defined operating points. Overall, the HealthPPT was able to demonstrate an area under the curve (AUC) of 96.75% (95% CI: [94.28%, 99.21%]), which is both comparable to the predicate device, and exceeds the required technical method under the QFM product code. The sensitivity and specificity of the HealthPPT was reported for two operating points. The first "balanced sensitivity and specificity" (default) operating point demonstrated a sensitivity of 92.52% (95% CI: [85.94%;96.16%]) and a specificity of 92.66% (95% CI: [86.18%;96.23%]). The second "high-specificity" operating point reported a sensitivity of 80.37% (95% CL: [71.85%;86.79%]) and a specificity of 97.25% (95% CI: [92.22%;99.06%]). Both operating points reached their performance goal.
In addition, we assessed the time it takes for the HealthPPT device to analyze the study and send a result. The average performance time of the HealthPPT was 4.78 seconds, which is significantly lower than the time reported by the predicate device (20.3 seconds).
VIII. Conclusion
The subject HealthPPT device and the AIMI-Triage CXR PTX (K193300) predicate device are both software-only devices intended to aid in triage of radiological images, independent of and in parallel to the standard of care workflow. Both devices incorporate an artificial intelligence algorithm. The labeling of both devices are limited to the categorization of exams and are not to be used in-lieu of full patient evaluation or relied upon to make or confirm diagnosis.
Both devices operate in parallel to the standard of care workflow in the sense that they do not change the original image, do not provide any marking, and do not remove cases from the standard of care. The minor differences between the subject device and the predicate raise no new issues of safety or effectiveness. In addition, performance testing demonstrates that the HealthPPT performs as intended. The HealthPPT device is therefore substantially equivalent to the AIMI-Triage CXR PTX predicate.