(235 days)
Not Found
Yes
The device description explicitly states that it uses "deep-learning-based algorithms" for automatic contouring, which is a form of machine learning.
No.
This device is a software tool used for automated contouring of medical images, which is a part of the treatment planning process for radiation therapy, but it does not directly administer therapy to a patient.
No
Explanation: A diagnostic device identifies or characterizes a disease or condition. This device is a post-processing software that automatically contours DICOM CT imaging data to aid in radiation therapy treatment planning, but it does not diagnose any medical condition.
Yes
The device is explicitly described as "post-processing software" and its functionality is limited to processing DICOM CT data and generating RTSTRUCT outputs. It does not include any hardware components or require specific hardware for its operation beyond a standard computing environment.
Based on the provided information, the QOCA® image Smart RT Contouring System is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: An IVD device is defined as a medical device that is used to perform tests on samples taken from the human body, such as blood, urine, or tissue, to provide information about a person's health.
- QOCA® image Smart RT Contouring System's Function: This device processes medical images (CT scans) to automatically contour anatomical structures (organs at risk). It does not analyze biological samples from the patient.
- Intended Use: The intended use is for post-processing of imaging data for radiation therapy treatment planning, not for diagnostic testing of biological samples.
Therefore, the QOCA® image Smart RT Contouring System falls under the category of medical imaging software or a medical device used in the planning and delivery of medical treatment, rather than an IVD.
No
The provided text does not contain any explicit statement that the FDA has reviewed, approved, or cleared a Predetermined Change Control Plan (PCCP) for this specific device.
Intended Use / Indications for Use
QOCA® image Smart RT Contouring System is a post-processing software intended to automatically contour DICOM CT imaging data using deep-learning-based algorithms.
Contours that are generated by QOCA® image Smart RT Contouring System may be used as input for clinical workflows including external beam radiation therapy treatment planning. QOCA® image Smart RT Contouring System must be used in conjunction with appropriate software such as Treatment Planning Systems and Interactive Contouring applications, to review, edit, and accept contours generated by OOCA® image Smart RT Contouring System. The output of QOCA® image Smart RT Contouring System in the format of RTSTRUCT objects are intended to be used by radiation oncology department.
QOCA® image Smart RT Contouring System does not provide a user interface for data visualization. System settings, user settings, progress status, and other functionalities are managed via a web-based interface.
The software is not intended to automatically detect or contour lesions. Only DICOM images of adult patients are considered to be valid input.
Product codes
QKB
Device Description
QOCA® image Smart RT Contouring System is a post-processing software used to automatically contour DICOM CT imaging data using deep-learning-based algorithms. OOCA® image Smart RT Contouring System contouring workflow supports CT inout data and produces RTSTRUCT outputs. Contours that are generated by QOCA® image Smart RT Contouring System may be used as input for clinical workflows including external beam radiation therapy treatment planning.
The output of QOCA® image Smart RT Contouring System, in the form of RTSTRUCT objects, are intended to be used by radiation oncology department. The output of QOCA® image Smart RT Contouring System must be used in conjunction with appropriate software such as Treatment Planning Systems and Interactive Contouring applications, to review, edit, and accept contours generated by QOCA® image Smart RT Contouring System.
QOCA® image Smart RT Contouring System includes the following functionality:
- Automated contouring of organs at risk (OAR) workflow
- Input - DICOM CT
- Output - DICOM CT (Original), DICOM RTSTRUCT
- Web-based interface of system settings, user settings, and checking progress status
Mentions image processing
Yes
Mentions AI, DNN, or ML
Mentions deep-learning-based algorithms and artificial intelligence algorithm (AI).
Input Imaging Modality
DICOM CT imaging data, CT Images, Non-Contrast CT Images
Anatomical Site
Head, neck, and pelvis regions.
Indicated Patient Age Range
Adult patients (above 22 years old).
Intended User / Care Setting
Radiation oncology department
Description of the training set, sample size, data source, and annotation protocol
During the development of the model, CT images had retrospectively collected from 2000 to 2021 from two hospitals in Taiwan, comprising a total of 317 cases of head and neck images and 351 cases of pelvic images. These images were distributed in an 8:1:1 ratio into Training datasets, Validation datasets, and Test datasets.
The CT images come from the following equipment: GE Discovery CT590 RT, GE Discovery STE, GE Discovery ST, SIEMENS SOMATOM PLUS 4, SIEMENS Sensation 64, PHILIPS Brilliance Big Bore, TOSHIBA Aquilion ONE, TOSHIBA Aquilion/LB. Annotation protocol not specified.
Description of the test set, sample size, data source, and annotation protocol
In the Test datasets, an additional 38 cases from United States public datasets (The Cancer Imaging Archive (TCIA), and Gold Atlas - Male Pelvis (GA)) were included to ensure that the intended patient population in the United States could achieve the expected purpose.
Data collection included 110 head and neck CT images and 110 pelvis CT images, with each anatomical site contributing 50 cases from Taiwan and 60 cases from the United States public dataset, TCIA. These 220 cases are independent of the data used in nonclinical tests and have not been reused.
Demographic distribution of this data:
- Gender: 97 Female (55 Head and Neck; 42 Pelvis), 123 Male (55 Head and Neck; 68 Pelvis).
- Age: Adult (above 22 years old).
- Ethnicity: Data collected from the United States and Taiwan.
- Equipment: GE Discovery ST, GE MEDICAL SYSTEMS LightSpeed Plus, SIEMENS Sensation Open, PHILIPS Brilliance Big Bore, PHILIPS GEMINI TF Big Bore, TOSHIBA Aquilion ONE.
Ground truth annotations were established following CT-based delineation of organs at risk in the head and neck region: DAHANCA, EORTC, GORTEC, HKNPCSG, NCIC CTG, NCRI, NRG Oncology and TROG consensus guidelines and Pelvic Normal Tissue Contouring Guidelines for Radiation Therapy: A Radiation Therapy Oncology Group Consensus Panel Atlas.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Study Type: Retrospective performance study.
Sample Size: 220 cases (110 head and neck CT images and 110 pelvis CT images).
Standalone Performance: The standalone performance of the subject device has been validated in a retrospective performance study on CT data previously acquired for RT treatment planning.
Key Results: The subject device achieved a median DSC > 0.80. Organs not meeting predefined acceptance criteria were excluded from the product's intended use. The system achieved expected performance outcomes regardless of whether contrast was injected.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
The accuracy of the segmentation was evaluated using the DICE similarity coefficient (DSC). Additionally, HD95 (95th percentile of Hausdorff Distance) values are provided for each OAR.
Head and Neck OARs - Model Performance (DSC ± Standard Deviation, HD95 ± Standard Deviation):
- Brain stem: 0.942 (±0.0215), 4.173 (±20.9737)
- Esophagus: 0.875 (±0.0859), 4.694 (±5.5237)
- Mandible: 0.956 (±0.0167), 1.413 (±0.9036)
- Pharyngeal constrictor muscle: 0.820 (±0.0692), 2.232 (±1.3013)
- Spinal cord: 0.931 (±0.0282), 2.330 (±3.3562)
- Thyroid: 0.873 (±0.1756), 3.249 (±5.7852)
- Right eye: 0.956 (±0.0149), 2.038 (±0.9599)
- Left lens: 0.876 (±0.1150), 1.526 (±1.0436)
- Left optic nerve: 0.805 (±0.0849), 3.548 (±3.0927)
- Right parotid: 0.924 (±0.0303), 3.825 (±2.7730)
Pelvis OARs - Model Performance (DSC ± Standard Deviation, HD95 ± Standard Deviation):
- Anorectum: 0.929 (±0.0755), 7.929 (±14.2608)
- Bladder: 0.959 (±0.0912), 4.402 (±9.7696)
- Bowel bag: 0.944 (±0.0338), 11.237 (±8.5063)
- Lumbar spine L5: 0.960 (±0.0648), 5.985 (±31.2018)
- Bilateral seminal vesicles: 0.818 (±0.3178), 3.638 (±6.6927)
- Right iliac: 0.985 (±0.0111), 10.108 (±51.8553)
- Right proximal femur: 0.980 (±0.0195), 13.193 (±68.4094)
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 892.2050 Medical image management and processing system.
(a)
Identification. A medical image management and processing system is a device that provides one or more capabilities relating to the review and digital processing of medical images for the purposes of interpretation by a trained practitioner of disease detection, diagnosis, or patient management. The software components may provide advanced or complex image processing functions for image manipulation, enhancement, or quantification that are intended for use in the interpretation and analysis of medical images. Advanced image manipulation functions may include image segmentation, multimodality image registration, or 3D visualization. Complex quantitative functions may include semi-automated measurements or time-series measurements.(b)
Classification. Class II (special controls; voluntary standards—Digital Imaging and Communications in Medicine (DICOM) Std., Joint Photographic Experts Group (JPEG) Std., Society of Motion Picture and Television Engineers (SMPTE) Test Pattern).
0
February 13, 2024
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 & Human Services logo. To the right of that is the FDA logo, which consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, with the word "ADMINISTRATION" underneath.
Quanta Computer Inc. % Joe Wang, Research Specialist No. 188, Wenhua 2nd Rd Guishan Dist. Taoyuan City, 33383 TAIWAN
Re: K231855
Trade/Device Name: QOCA® image Smart RT Contouring System Regulation Number: 21 CFR 892.2050 Regulation Name: Medical Image Management And Processing System Regulatory Class: Class II Product Code: QKB Dated: January 8, 2024 Received: January 8, 2024
Dear Joe Wang:
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/cdrb/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" (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
1
product: and 21 CFR 820.100. Corrective and preventive action. Please note that regardless of whether a change requires premarket review. the OS 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 (QS) 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.
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-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,
Lora Weidner
Lora D. Weidner, Ph.D. Assistant Director Radiation Therapy Team DHT8C: Division of Radiological Imaging and Radiation Therapy Devices OHT8: Office of Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health
2
Indications for Use
510(k) Number (if known) K231855
Device Name
QOCA® image Smart RT Contouring System
Indications for Use (Describe)
QOCA® image Smart RT Contouring System is a post-processing software intended to automatically contour DICOM CT imaging data using deep-learning-based algorithms.
Contours that are generated by QOCA® image Smart RT Contouring System may be used as input for clinical workflows including external beam radiation therapy treatment planning. QOCA® image Smart RT Contouring System must be used in conjunction with appropriate software such as Treatment Planning Systems and Interactive Contouring applications, to review, edit, and accept contours generated by OOCA® image Smart RT Contouring System. The output of QOCA® image Smart RT Contouring System in the format of RTSTRUCT objects are intended to be used
by radiation oncology department.
QOCA® image Smart RT Contouring System does not provide a user interface for data visualization. System settings, user settings, progress status, and other functionalities are managed via a web-based interface.
The software is not intended to automatically detect or contour lesions. Only DICOM images of adult patients are considered to be valid input.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ------------------------------------------------- | -- |
X Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
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3
510(k) Summary
| 5.1. Type of Submission: | Traditional |
|---|---|
| 5.2. Date of Summary: | 01/08/2024 |
| 5.3. Submitter: | Quanta Computer Inc. |
| Address: | No. 188, Wenhua 2nd Rd., Guishan Dist. Taoyuan |
| City 33383, Taiwan (R.O.C) | |
| Phone: | +886-3-327-2345 |
| Contact: | Joe Wang |
| joe_wang@quantatw.com |
5.4. Identification of the Device:
| Proprietary/Trade Name: | QOCA® image Smart RT Contouring System |
|---|---|
| Model Number: | ZSWR901 |
| Review Panel: | Radiology |
| Regulation Name: | Medical Image Management and Processing System |
| Regulation Number: | 21 CFR 892.2050 |
| Product Code: | QKB |
| Device Class: | II |
5.5. Identification of the Predicate Device:
| Predicate Device Name: | AccuContour™ |
|---|---|
| Model Number: | -- |
| 510(k) Number: | K191928 |
| Manufacturer: | Xiamen Manteia Technology LTD. |
| Regulation Number: | 21 CFR 892.2050 |
| Product Code: | QKB |
| Device Class: | II |
4
5.6. Intended Use/Indications for Use of the Device
QOCA® image Smart RT Contouring System is a post-processing software intended to automatically contour DICOM CT imaging data using deep-learning-based algorithms.
Contours that are generated by QOCA® image Smart RT Contouring System may be used as input for clinical workflows including external beam radiation therapy treatment planning. QOCA® image Smart RT Contouring System must be used in conjunction with appropriate software such as Treatment Planning Systems and Interactive Contouring applications, to review, edit, and accept contours generated by QOCA® image Smart RT Contouring System.
The output of QOCA® image Smart RT Contouring System in the format of RTSTRUCT objects are intended to be used by radiation oncology department.
QOCA® image Smart RT Contouring System does not provide a user interface for data visualization. System settings, user settings, progress status, and other functionalities are managed via a web-based interface.
The software is not intended to automatically detect or contour lesions. Only DICOM images of adult patients are considered to be valid input.
5.7. Device Description
QOCA® image Smart RT Contouring System is a post-processing software used to automatically contour DICOM CT imaging data using deep-learning-based algorithms. OOCA® image Smart RT Contouring System contouring workflow supports CT inout data and produces RTSTRUCT outputs. Contours that are generated by QOCA® image Smart RT Contouring System may be used as input for clinical workflows including external beam radiation therapy treatment planning.
The output of QOCA® image Smart RT Contouring System, in the form of RTSTRUCT objects, are intended to be used by radiation oncology department. The output of QOCA® image Smart RT Contouring System must be used in conjunction with appropriate software such as Treatment Planning Systems and Interactive Contouring applications, to review, edit, and accept contours generated by QOCA® image Smart RT Contouring System.
QOCA® image Smart RT Contouring System includes the following functionality:
- Automated contouring of organs at risk (OAR) workflow ●
- Input - DICOM CT
- Output - DICOM CT (Original), DICOM RTSTRUCT
5
- Web-based interface of system settings, user settings, and checking progress status
QOCA® image Smart RT Contouring System is intended to be used on adults undergoing treatment that requires the identification of anatomical structures in the body considered to be OAR. QOCA® image Smart RT Contouring System is intended to be used in the head, neck, and pelvis regions.
5.8. Comparison of Technological Characteristics with the Predicate Device
QOCA® image Smart RT Contouring System submitted in this 510(k) file is substantially equivalent in intended use, safety and performance to the cleared AccuContour™ (K191928). Differences between the devices cited in this section do not raise any new issue of substantial equivalence.
| Item | Subject Device | Predicate Device | Substantial
Equivalence
Determination | |
|----------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) Number | K231855 | K191928 | -- | |
| Proprietary
Name | QOCA® image Smart
RT Contouring
System | AccuContour™ | -- | |
| Manufacturer | Quanta Computer Inc. | Xiamen Manteia
Technology LTD. | -- | |
| Regulation
Number | 21 CFR 892.2050 | 21 CFR 892.2050 | Same | |
| Product Code | QKB | QKB | Same | |
| Classification | Class II | Class II | Same | |
| Intended
Use/Indication
for Use | QOCA® image Smart
RT Contouring
System is a post-
processing software
intended to
automatically contour
DICOM CT imaging
data using deep-
learning-based
algorithms. | It is used by
radiation oncology
department to
register
multimodality
images and
segment (non-
contrast) CT
images, to generate
needed information | Similar
Both devices utilize
artificial
intelligence
algorithms to
automatically
contour organs at
risk, including the
head and neck, as
well as the pelvis. | |
| Contours that are | for treatment | for radiation | | |
| generated by QOCA® | planning, treatment | treatment planning. | | |
| image Smart RT | evaluation and | | | |
| Contouring System | treatment | | | |
| may be used as input | adaptation. | | | |
| for clinical workflows | | | | |
| including external | | | | |
| beam radiation | | | | |
| therapy treatment | | | | |
| planning. QOCA® | | | | |
| image Smart RT | | | | |
| Contouring System | | | | |
| must be used in | | | | |
| conjunction with | | | | |
| appropriate software | | | | |
| such as Treatment | | | | |
| Planning Systems and | | | | |
| Interactive Contouring | | | | |
| applications, to | | | | |
| review, edit, and | | | | |
| accept contours | | | | |
| generated by QOCA® | | | | |
| image Smart RT | | | | |
| Contouring System. | | | | |
| The output of QOCA® | | | | |
| image Smart RT | | | | |
| Contouring System in | | | | |
| the format of | | | | |
| RTSTRUCT objects | | | | |
| are intended to be | | | | |
| used by radiation | | | | |
| oncology department. | | | | |
| QOCA® image Smart | | | | |
| RT Contouring | | | | |
| System does not | | | | |
| | provide a user
interface for data
visualization. System
settings, user settings,
progress status, and
other functionalities
are managed via a
web-based interface.
The software is not
intended to
automatically detect or
contour lesions. Only
DICOM images of
adult patients are
considered to be valid
input. | | | |
| Operating System | Windows | Windows | Same | |
| Algorithm | Deep Learning | Deep Learning | Same | |
| Segmentation of
Organ at Risk in
the Anatomic
Regions | Brain stem,
Esophagus, Mandible,
Pharyngeal,
Constrictor Muscle
(PCM), Spinal cord,
Thyroid, Right eye,
Light eye, Right lens,
Left lens, Right optic
nerve, Left optic
nerve, Right parotid,
Left parotid,
Anorectum, Bladder,
Bowel bag, Lumbar
spine L5, Bilateral
seminal vesicles,
Right iliac, Left iliac. | Head and Neck,
Thorax, Abdomen,
and Pelvis | Similar
The subject device
contains head and
neck, and pelvis. | |
| Left proximal femur | | | | |
| Compatible
Modality | CT Images | Non-Contrast CT
Images | Similar
The subject device
and the predicate
device are both
compatible only
with CT images for
the segmentation
feature. The
predicate device
claims to handle
only non-contrast
CT images, while
the subject device
can be used with
both contrast and
non-contrast CT
images. | |
| Compatible
Scanner Models | No specific
requirement for the
scanner model, it is
recommended to use
multi-detector CT
(MDCT) equipment
with more than 16
slices for Radiation
Therapy Simulation
CT, and DICOM
compliance required. | No Limitation on
scanner model,
DICOM 3.0
compliance
required. | Similar
The Subject Device
and Predicate
Device are
substantially
equivalent in their
requirements for
DICOM
compliance,
ensuring
interoperability and
standardization in
medical imaging
data. The Subject
Device
recommends a | |
| | | | scanner with more | |
| | | | than 16 slices | |
| | | | specifically for | |
| | | | Radiation Therapy | |
| | | | Simulation CT to | |
| | | | provide detailed | |
| | | | imaging necessary | |
| | | | for accurate therapy | |
| | | | planning. | |
| Compatible
Treatment
Planning System | No Limitation on TPS
model, DICOM
compliance required. | No Limitation on
TPS model,
DICOM
3.0compliance
required. | Same | |
| | Contraindications | Adult use only. | There are no
known specific
situations that
contraindicate the
use of this device. | Similar
The subject device
is designed for
adult use, and there
are no known
specific situations
that contraindicate
its usage. |
| | Segmentation
Performance | The segmentation
performance was
validated using private
datasets from Taiwan
and public datasets
was collected from
various sources,
including the USA.
The datasets were
obtained from major
vendors such as GE,
Siemens, Philips, and
TOSHIBA. The | The segmentation
performance was
validated using
datasets from
China and the USA
using three major
vendors (GE,
Siemens and
Philips). The
segmentation
accuracy is
evaluated using
DICE similarity | Same |
6
7
K231855
8
9
10
| accuracy of the
segmentation was
evaluated using the
DICE similarity
| coefficient (DSC). | coefficient (DSC). |
|---|---|
| ----------------------------------------------------------------------------------------------------- | -------------------- |
Similarity and Difference
The subject device has the similar intended use and features to the predicate device. Both devices are intended to aid user to contour the organ-at-risk (OAR) by artificial intelligence algorithm. And they are not intended to be used on a stand-alone basis for clinical decisionmaking or clinical diagnosis.
The primary difference between the subject and predicate devices lies in their "Compatibility with Scanner Models" and "Imaging Modalities". However, the subject device's approach to presenting results aligns with that of the predicate device. Furthermore, both devices meet the requirements for DICOM compliance, ensuring interoperability and standardization in medical imaging data. Notably, the subject device recommends the use of a multi-detector CT scanner with more than 16 slices for radiation therapy simulation CT, enabling detailed imaging essential for precise therapy planning. Both devices exclusively support CT images for the segmentation feature. While the predicate device is limited to non-contrast CT images, the subject device can handle both contrast and noncontrast CT images. Therefore, it will not affect the substantial equivalence.
5.9. Performance Data
The subject device, QOCA® image Smart RT Contouring System has been evaluated and verified in accordance with software specifications and applicable performance standards to ensure performance.
The subject device has undergone software validation activities in accordance with IEC 62304: 2006/A1:2016 - Medical device software - Software life cycle processes, Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices, Content of Premarket submissions for Devices Software Functions and Content of Premarket Submission for Management of Cybersecurity in Medical Devices.
The performance of the subject device has been evaluated and verified in accordance with software specifications and applicable performance standards through software verification
11
and validation testing.
Nonclinical Tests
During the development of the model, CT images had retrospectively collected from 2000 to 2021 from two hospitals in Taiwan, comprising a total of 317 cases of head and neck images and 351 cases of pelvic images. These images were distributed in an 8:1:1 ratio into Training datasets, Validation datasets, and Test datasets.
In the Test datasets, an additional 38 cases from United States public datasets (The Cancer Imaging Archive (TCIA), and Gold Atlas - Male Pelvis (GA)) were included to ensure that the intended patient population in the United States could achieve the expected purpose.
The CT images come from the following equipment:
- GE Discovery CT590 RT ●
- GE Discovery STE
- GE Discovery ST
- SIEMENS SOMATOM PLUS 4
- SIEMENS Sensation 64
- PHILIPS Brilliance Big Bore
- TOSHIBA Aquilion ONE
- TOSHIBA Aquilion/LB
Segmentation Performance Test
The standalone performance of the subject device has been validated in a retrospective performance study on CT data previously acquired for RT treatment planning.
Data collection included 110 head and neck CT images and 110 pelvis CT images, with each anatomical site contributing 50 cases from Taiwan and 60 cases from the United States public dataset, TCIA. These 220 cases are independent of the data used in nonclinical tests and have not been reused. The demographic distribution of this data is as follows:
- Gender: 97 Female (55 Head and Neck; 42 Pelvis), 123 Male (55 Head and Neck; 68 Pelvis).
- Age: Adult (above 22 years old).
- Ethnicity: Data collected from the United States and Taiwan.
- Equipment:
- GE Discovery ST .
12
- GE MEDICAL SYSTEMS LightSpeed Plus .
- SIEMENS Sensation Open .
- PHILIPS Brilliance Big Bore .
- . PHILIPS GEMINI TF Big Bore
- . TOSHIBA Aquilion ONE
Ground truth annotations were established following CT-based delineation of organs at risk in the head and neck region: DAHANCA, EORTC, GORTEC, HKNPCSG, NCIC CTG, NCRI, NRG Oncology and TROG consensus guidelines and Pelvic Normal Tissue Contouring Guidelines for Radiation Therapy: A Radiation Therapy Oncology Group Consensus Panel Atlas.
| Body Part | OARs | Acceptance Criteria
(DSC) | | Model Performance | |
|------------------|----------------------------------|------------------------------|--|--------------------|---------------------|
| Head and
Neck | Brain stem | 0.87 | | 0.942
(±0.0215) | 4.173
(±20.9737) |
| | Esophagus | 0.76 | | 0.875
(±0.0859) | 4.694
(±5.5237) |
| | Mandible | 0.93 | | 0.956
(±0.0167) | 1.413
(±0.9036) |
| | Pharyngeal
constrictor muscle | 0.70 | | 0.820
(±0.0692) | 2.232
(±1.3013) |
| | Spinal cord | 0.87 | | 0.931
(±0.0282) | 2.330
(±3.3562) |
| | Thyroid | 0.83 | | 0.873
(±0.1756) | 3.249
(±5.7852) |
| | Right eye | 0.91 | | 0.956
(±0.0149) | 2.038
(±0.9599) |
| | Left lens | 0.80 | | 0.876
(±0.1150) | 1.526
(±1.0436) |
| | Left optic nerve | 0.66 | | 0.805
(±0.0849) | 3.548
(±3.0927) |
| | Right parotid | 0.86 | | 0.924
(±0.0303) | 3.825
(±2.7730) |
The results for standalone performance testing are as follows:
13
| Body Part | OARs | Acceptance Criteria
(DSC) | Model Performance | |
|-----------|-------------------------------|------------------------------|--------------------|----------------------|
| | | | DSC | HD95 |
| Pelvis | Anorectum | 0.70 | 0.929
(±0.0755) | 7.929
(±14.2608) |
| | Bladder | 0.82 | 0.959
(±0.0912) | 4.402
(±9.7696) |
| | Bowel bag | 0.70 | 0.944
(±0.0338) | 11.237
(±8.5063) |
| | Lumbar spine L5 | 0.90 | 0.960
(±0.0648) | 5.985
(±31.2018) |
| | Bilateral seminal
vesicles | 0.64 | 0.818
(±0.3178) | 3.638
(±6.6927) |
| | Right iliac | 0.90 | 0.985
(±0.0111) | 10.108
(±51.8553) |
| | Right proximal
femur | 0.90 | 0.980
(±0.0195) | 13.193
(±68.4094) |
The subject device achieved a median DSC > 0.80. Furthermore, organs not meeting predefined acceptance criteria were excluded from the product's intended use to ensure reliability and accuracy. In the performance results, it was found that regardless of whether contrast was injected or not, the system achieved the expected performance outcomes.
5.10.Clinical Tests
No clinical test was conducted as part of submission to prove substantial equivalence.
5.11.Conclusion
The subject device has a similar intended use to the predicate device, and the slight difference does not affect the substantial equivalence. In addition, there are no differences in technological characteristics that affect the safety and effectiveness of the subject device relative to the predicate. Moreover, the performance testing results are similar to the predicate device. Therefore, the subject device, QOCA® image Smart RT Contouring System, is substantially equivalent to the predicate device.