(250 days)
Yes
The summary mentions "segmentation algorithms of organs, hepatic veins, and lesions" and "instrument detection algorithms" which are validated against ground truth data and compared to "state-of-the-art algorithms". While not explicitly stating "AI" or "ML", these types of image analysis and detection algorithms are commonly implemented using machine learning techniques in modern medical devices. The validation metrics (DICE coefficient) are also standard for evaluating segmentation algorithms, often developed using ML.
No
The device is described as a stereotactic accessory intended to assist in planning, navigation, and verification of instrument position during CT-guided procedures. It does not exert a therapeutic effect on the patient.
No
The device is an accessory intended to assist in planning, navigation, and verification of instrument position during CT-guided procedures. It does not diagnose conditions.
No
The device description explicitly lists hardware components such as a mobile navigation platform with touch screens, a camera, a computer, and physical instruments (guide arm, aiming device, navigational pointer). While software is a key component, it is part of a larger system that includes hardware.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The description of CAS-One IR clearly states its purpose is to assist in planning, navigation, and verification during CT-guided interventional procedures. It is a stereotactic accessory used to guide instruments (needles, probes) within the patient's body based on imaging data.
- Lack of Sample Analysis: There is no mention of the device analyzing biological samples or performing any tests on materials taken from the body. Its function is entirely focused on guiding instruments within the body.
Therefore, CAS-One IR falls under the category of a surgical or interventional guidance system, not an In Vitro Diagnostic device.
No
The provided input states "Control Plan Authorized (PCCP) and relevant text: Not Found," indicating no mention of PCCP authorization.
Intended Use / Indications for Use
CAS-One IR is a user controlled, stereotactic accessory intended to assist in planning, navigation and manual advancement of one or more instruments, as well as in verification of instrument position and performance during Computed Tomography (CT) guided procedures.
In planning, the desired needle configuration and performance is defined relative to the target anatomy.
In navigation, the instrument position is displayed relative to the patient and guidance for needle alignment is provided while respiratory levels are monitored.
In verification, the achieved instrument configuration and performance are displayed relative to the previously defined plan through an overlay of the pre- and post- treatment image data.
CAS-One IR is indicated for use with rigid straight instruments such as needles and probes used in CT guided interventional procedures performed by physicians trained for CT procedures.
CAS-One IR is intended to be used for patients older than 18 years and eligible for CT-guided percutaneous interventions.
Product codes
JAK
Device Description
The system consists of the following main components:
- A mobile navigation platform: this platform can be moved in and out of radiology rooms and is positioned next to the patient in front of the CT scanner. The platform includes two touch screens, a camera, and a computer.
- Instruments: The instrument set comprises a guide arm, aiming device and a navigational pointer that are connected to each other and assist the user in aligning and positioning a needle trajectory relative to the patient. After positioning the aiming device using the guide arm, the aiming device is aligned with respect to the desired entry point (translational alignment) and rotationally oriented to the desired insertion angle.
- CAS-One IR software: The software provides the step-by-step workflow assistance for needle navigation. It provides a means for users to precisely plan a single or multiple needle trajectories, navigate a needle to this exact position and validate the inserted needle's position to the planned position.
Mentions image processing
Function to view, pan, zoom, adjust brightness and insensitivity, and carry out measurements in image data and to overlay image data.
Mentions AI, DNN, or ML
Not Found.
Input Imaging Modality
DICOM file format: CT or MRI image modality
Anatomical Site
Not Found.
Indicated Patient Age Range
patients older than 18 years
Intended User / Care Setting
Physicians trained for CT procedures.
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
Algorithm validation: Test protocols were systematically executed to assess the performance of the algorithmic validation procedures involved comparisons with ground truth data annotated by personnel considered expert in the domain.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Software Verification and Validation Testing:
- Software validation and documentation was prepared according to the "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices" (May 11, 2005).
- This includes a hazard analysis, and the potential hazards have been classified as a moderate level of concern similar to the predicate device.
Algorithm Validation:
- The segmentation algorithms of organs, hepatic veins, and lesions were validated by comparing the mean DICE coefficient with state-of-the-art algorithms.
- Defined acceptance criteria for mean DICE (Liver: 0.9, Tumor: 0.8, Effective Treatment Volume: 0.8, Kidney: 0.85, Lung: 0.9) and mean centerline DICE (Liver-Vessels: 0.6) were passed.
- For instrument detection algorithms, the reliability was gauged by analysing the pround truth positions and the positions identified by the algorithm.
- These validation efforts provide a robust foundation for asserting the accuracy and effectiveness of the algorithms in the context of their application in medical settings.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Mean DICE (Liver: 0.9, Tumor: 0.8, Effective Treatment Volume: 0.8, Kidney: 0.85, Lung: 0.9) and mean centerline DICE (Liver-Vessels: 0.6).
Predicate Device(s)
Reference Device(s)
Not Found.
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found.
§ 892.1750 Computed tomography x-ray system.
(a)
Identification. A computed tomography x-ray system is a diagnostic x-ray system intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from the same axial plane taken at different angles. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II.
0
March 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.
Cascination AG % Andreas Meschberger Senior Regulatory & Clinical Affairs Manager Steigerhubelstrasse 3 BERN. 3008 SWITZERLAND
Re: K232022
Trade/Device Name: CAS-One IR Regulation Number: 21 CFR 892.1750 Regulation Name: Computed Tomography X-Ray System Regulatory Class: Class II Product Code: JAK Dated: February 14, 2024 Received: February 14, 2024
Dear Andreas Meschberger:
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" (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).
1
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 (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 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,
Smita Kakar
for
Lu Jiang Assistant Director DHT8B: Division of Radiologic Imaging Devices and Electronic Products OHT8: Office of Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K232022
Device Name CAS-One IR
Indications for Use (Describe)
CAS-One IR is a user controlled, stereotactic accessory intended to assist in planning, navigation and manual advancement of one or more instruments, as well as in verification of instrument position and performance during Computed Tomography (CT) guided procedures.
In planning, the desired needle configuration and performance is defined relative to the target anatomy.
In navigation, the instrument position is displayed relative to the patient and guidance for needle alignment is provided while respiratory levels are monitored.
In verification, the achieved instrument configuration and performance are displayed relative to the previously defined plan through an overlay of the pre- and post- treatment image data.
CAS-One IR is indicated for use with rigid straight instruments such as needles and probes used in CT guided interventional procedures performed by physicians trained for CT procedures.
CAS-One IR is intended to be used for patients older than 18 years and eligible for CT-guided percutaneous interventions.
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
Image /page/3/Picture/0 description: The image shows the word "CASCINATION" in green font. To the right of the word is a red square with a white cross in the center. The cross is a symbol of Switzerland.
Steigerhubelstrasse 3 CH-3008 Bern Switzerland
510(K) SUMMARY
K232022
This summary of 510(k) safety and effectiveness information is submitted in accordance with the requirements of 21 CFR §807.92.
I. SUBMITTER
| Manufacturer: | CASCINATION AG |
|---|---|
| Steigerhubelstrasse 3 | |
| CH-3008 Bern | |
| Switzerland | |
| Tel: +41 31 306 26 26 | |
| Contact Person: | Andreas Meschberger |
| Senior Regulatory & Clinical Affairs Manager | |
| Date Prepared: | March 08, 2024 |
II. SUBJECT DEVICE
| Device Name: | CAS-One IR |
|---|---|
| Classification Name: | Computed tomography x-ray system |
| Regulation: | 892.1750 |
| Common Name: | System, X-Ray, Tomography, Computed |
| Regulatory Class: | Class II |
| Product Code: | JAK |
The Subject Device is an updated version of the Predicate Device.
4
III. PREDICATE DEVICE
| Primary Predicate Device | |
|---|---|
| Company: | CASCINATION AG, Steigerhubelstrasse 3, CH-3008 Bern, Switzerland |
| Device name: | CAS-One IR |
| 510(k) number: | K152473 |
| Classification Name: | Computed tomography x-ray system |
| Regulation: | 892.1750 |
| Common Name: | System, X-Ray, Tomography, Computed |
| Regulatory Class: | Class II |
| Product Code: | JAK |
IV. INDICATIONS FOR USE
CAS-One IR is a user controlled, stereotactic accessory intended to assist in planning, navigation and manual advancement of one or more instruments, as well as in verification of instrument position and performance during Computed Tomography (CT) guided procedures.
In planning, the desired needle configuration and performance is defined relative to the target anatomy.
In navigation, the instrument position is displayed relative to the patient and guidance for needle alignment is provided while respiratory levels are monitored.
In verification, the achieved instrument configuration and performance are displayed relative to the previously defined plan through an overlay of the pre- and post- treatment image data.
CAS-One IR is indicated for use with rigid straight instruments such as needles and probes used in CT guided interventional procedures performed by physicians trained for CT procedures.
CAS-One IR is intended to be used for patients older than 18 years and eligible for CT-guided percutaneous interventions.
V. DEVICE DESCRIPTION
The system consists of the following main components:
- . A mobile navigation platform: this platform can be moved in and out of radiology rooms and is positioned next to the patient in front of the CT scanner. The platform includes two touch screens, a camera, and a computer.
- . Instruments: The instrument set comprises a guide arm, aiming device and a navigational pointer that are connected to each other and assist the user in aligning and positioning a needle trajectory relative to the patient. After positioning the aiming device using the guide arm, the
5
aiming device is aligned with respect to the desired entry point (translational alignment) and rotationally oriented to the desired insertion angle.
- CAS-One IR software: The software provides the step-by-step workflow assistance for needle ● navigation. It provides a means for users to precisely plan a single or multiple needle trajectories, navigate a needle to this exact position and validate the inserted needle's position to the planned position.
VI. SUBSTANTIAL EQUIVALENCE
The following characteristics were compared between the subject device and the predicate device in order to demonstrate substantial equivalence:
| Item | Subject Device
(CAS-One IR) | Predicate Device
(CAS-One IR) K152473 | Conclusion |
|----------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Regulation
Number | Regulation Number: 21 CFR
892.1750
Product Code: JAK | Regulation Number: 21 CFR
892.1750
Product Code: JAK | ⇒ Same
Both the subject and
predicate devices have
the same product code
and regulation number |
| Item | Subject Device
(CAS-One IR) | Predicate Device
(CAS-One IR) K152473 | Conclusion |
| Indications For
Use Statement | CAS-One IR is a user controlled,
stereotactic accessory intended
to assist in planning, navigation
and manual advancement of
one or more instruments, as well
as in verification of instrument
position and performance during
Computed Tomography (CT)
guided procedures.
In planning, the desired needle
configuration and performance
is defined relative to the target
anatomy.
In navigation, the instrument
position is displayed relative to
the patient and guidance for
needle alignment is provided
while respiratory levels are
monitored.
In verification, the achieved
instrument configuration and
performance are displayed
relative to the previously defined
plan through an overlay of the
pre- and post- treatment image
data.
CAS-One IR is indicated for use
with rigid straight instruments
such as needles and probes
used in CT guided interventional
procedures performed by
physicians trained for CT
procedures.
CAS-One IR is intended to be
used for patients older than 18
years and eligible for CT-guided
percutaneous interventions. | CAS-One IR is a user controlled,
stereotactic accessory intended
to assist in planning, navigation
and manual advancement of
one or more instruments, as well
as in verification of instrument
position and performance during
Computed Tomography (CT)
guided procedures.
In planning, the desired needle
configuration and performance
is defined relative to the target
anatomy.
In navigation, the instrument
position is displayed relative to
the patient and guidance for
needle alignment is provided
while respiratory levels are
monitored.
In verification, the achieved
instrument configuration and
performance are displayed
relative to the previously defined
plan through an overlay of the
pre- and post- treatment image
data.
CAS-One IR is indicated for use
with rigid straight instruments
such as needles and probes
used in CT guided interventional
procedures performed by
physicians trained for CT
procedures. | ⇒ Same, but more
specific
Both the subject and
predicate devices have
the same general
indications for use
statement and the
subject device has an
additional specificity
regarding the target
population |
| User | physicians trained for
interventional CT procedures | physicians trained for
interventional CT procedures | ⇒ Same
Both the subject and
predicate devices have
the same user |
| Item | Subject Device
(CAS-One IR) | Predicate Device
(CAS-One IR) K152473 | Conclusion |
| | | System | |
| System | Consists of:
• Platform
• Pointer, Aiming device, Guide Arm
• CAS-One IR software | Consists of:
• Platform
• Pointer, Aiming device, Guide Arm
• CAS-One IR software | ⇒ Same
There was no change
in the system concept |
| Compatibility | The system is compatible
with needle-shaped devices
used in percutaneous
interventional procedures
that have the following
physical properties:
• Cylindrical, straight shape
• Design that allows the
placement of instruments in
the Guide | The system is compatible
with needle-shaped devices
used in percutaneous
interventional procedures
that have the following
physical properties:
• Cylindrical, straight shape
• Design that allows the
placement of instruments in
the Guide | ⇒ Same
There was no change
in the system
compatibility |
| | | Hardware | |
| Navigation
Platform | Same: Camera, Rack,
Screen Arms, Camera Arms
Updated: Touch screens,
Graphic Cards, Mother board
and Power Supplier | Same: Camera, Rack,
Screen Arms, Camera Arms
Predicate: Touch screens,
Graphic Cards, Mother board
and Power Supplier | ⇒ Same
The updated
components have the
same technical
principles and just
represent an updated
technical state. The
parts are covered by
the Electrical Safety
and EMC Testing, and
System Validation |
| Pointer (Aiming
Insert and
Marker Shield),
Aiming Device,
Guide Arm. | Surgical Stainless Steel
1.4301 & 1.4305
Slight mechanical design
improvements. | Surgical Stainless Steel
1.4301 | ⇒ Same
Both devices use a
surgical stainless steel
of a slightly different
type. Minor mechanical
design improvements. |
| Patient
Fixation | Vacuum cushion on top of
carbon baseplate. | Vacuum cushion on top of
carbon baseplate. | ⇒ Same |
| Energy Source | 110-230V, 50-60Hz, single
phase | 110-230V, 50-60Hz, single
phase | ⇒ Same |
| Item | Subject Device
(CAS-One IR) | Predicate Device
(CAS-One IR) K152473 | Conclusion |
| Software | | | |
| Operating
System | Windows 10 | Windows 7 | ⇒ Same
Both devices run on
Microsoft Windows,
installed on the
platform. Programming
language and software
architecture remain the
same. Full Software
V&V has been
executed and passed |
| Image datasets | DICOM file format:
• CT or MRI image modality | DICOM file format:
• CT image modality | ⇒ Same
The subject device
allows to import MRI
images, but they must
also comply to the
DICOM standard |
| Data
Management | Function to import image
datasets. | Function to import image
datasets. | ⇒ Same |
| DICOM Viewer | Function to view, pan, zoom,
adjust brightness and
insensitivity, and carry out
measurements in image data
and to overlay image data | Function to view, pan, zoom,
adjust brightness and
insensitivity, and carry out
measurements in image data
and to overlay image data | |
| Module Plan | Trajectory Planning
Single / Multiple needles
Display of manufacturer
ablation parameters
Point-based image fusion CT
to CT or MR.
Segmentation of organs (liver
tissue, portal vein, hepatic
vein, liver lesions, kidney
tissue, lung tissue, and lung
airway) | Trajectory Planning
Single / Multiple needles
Display of manufacturer
ablation parameters
Point-based image fusion CT
to CT | ⇒ Different
Technological
characteristic
"Segmentation of
organs and lesions"
which does not raise
any concern about
safety and
effectiveness.
The Point-based
registration MRI to CT
images of the subject
device is similar to the
Point-based
registration CT to CT
images of the
predicate device and
does not represent a
technological
difference |
| Item | Subject Device
(CAS-One IR) | Predicate Device
(CAS-One IR) K152473 | Conclusion |
| Navigation | Module Name "Place" | Module Name "Navigation" | ⇒ Same |
| | Supports Instrument Guide | Supports Instrument Guide
and Freehand | The module was
renamed but the
functionality remains
the same |
| | | | The optional support of
freehand navigation
has been discontinued
in the subject device |
| Verify (Control
Scan) | Verify (Control Scan)
Instrument Detection | Verify (Control Scan) | ⇒ Different
Technological
characteristic
"Instrument Detection"
which does not raise
any concern about
safety and
effectiveness. |
| Verification | Module "Assess"
Manual review of planning
and validation images (toggle
visibility)
AblaSure® Ablation
Assessment (for liver lesions) | Module "Assess"
Manual review of planning
and validation images (toggle
visibility) | ⇒ Different
Technological
characteristic
"AblaSure® Ablation
Assessment" which
does not raise any
concern about safety
and effectiveness. |
| Performance Testing | | | |
| Performance
Testing | Software design verification
and validation and
documentation (the software
for this device was
considered a "moderate"
level of concern.) | Software design verification
and validation and
documentation (the software
for this device was
considered a "moderate"
level of concern.) | ⇒ Same
The performance
testing for the subject
device are the same,
additional tests were
carried out for the
segmentation
algorithms, while
testing for
biocompatibility and
sterilization were not
required to the similar
design and materials
to the predicate device |
| | Formal Internal Testing
Standards | Formal Internal Testing
Standards | |
| | Electrical Safety according to
ANSI AAMI ES60601-1 | Electrical Safety according to
ANSI AAMI ES60601-1 | |
| | Electromagnetic
Compatibility according to
IEC 60601-1-2 | Electromagnetic
Compatibility according to
IEC 60601-1-2 | |
| | Testing of Segmentation
Algorithms according to
internal Testing Standards | Biocompatibility and
Sterilization | |
6
7
8
9
10
Substantial Equivalence Discussion
Both the Subject Device and the Predicate Device have the same Intended Use. The Subject Device is an updated version of the Predicate Device. The differences between the Subject and Predicate Device are: Incremental improvements to the hardware (updated mainboard, GPU, and touchscreens on the platform; mechanical improvements to the pointer, aiming device, and quide arm), and Software Changes (update Operating System, increments, addition of segmentation functions for tumor and ablation area)
The subject device introduces seven new software functions which are considered to have the same technological characteristics as the predicate device because similar software functions are included in the predicate device.
The subject device has three different technological characteristics compared to the predicate device: Segmentation of organs and liver lesions, Instrument Detection, AblaSure® Ablation Assessment (for liver lesions). All three different technological characteristics are related to Software Functions.
Software Validation has been carried out for all functions. Specific Non-Clinical Performance Testing has been carried out for the segmentation algorithms. The instructions for use include warnings for the limitations of the segmentation algorithms.
It has been demonstrated that the technological differences do not adversely affect the safety and effectiveness of the subject device. No questions for safety and effectiveness were raised. Therefore, we can conclude that no technological differences, that may adversely affect the safety and effectiveness, have been identified between the subject and predicate device.
Conclusion - Substantial Equivalence Discussion:
The subject device is substantially equivalent to the predicate device with regard to intended use, safety, and effectiveness. This conclusion is based upon a comparison of intended use, technological characteristics, and non-clinical performance testing.
VII. PERFORMANCE DATA
The following performance data were provided in support of the substantial equivalence determination.
Biocompatibility Testing
Not Applicable. The subject device has similar material properties, and it was evaluated there is no effect to the biocompatibility properties of the subject device.
Electrical safety and electromagnetic compatibility (EMC)
The subject device was tested for electrical safety (ANSI AAMI ES60601-1) and electromagnetic compatibility (ANSI AAMI IEC 60601-1-2).
11
Mechanical and Acoustic Testing
Not Applicable to the subject device.
Software Verification and Validation Testing
Software verification and validation testing were provided to demonstrate safety and effectiveness of the subject device. Software validation and documentation was prepared according to the "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices" (May 11, 2005).
This includes a hazard analysis, and the potential hazards have been classified as a moderate level of concern similar to the predicate device.
Algorithm validation
Test protocols were systematically executed to assess the performance of the algorithmic validation procedures involved comparisons with ground truth data annotated by personnel considered expert in the domain.
The segmentation algorithms of organs, hepatic veins, and lesions were validated by comparing the mean DICE coefficient with state-of-the-art algorithms. Defined acceptance criteria for mean DICE (Liver: 0.9, Tumor: 0.8, Effective Treatment Volume: 0.8, Kidney: 0.85, Lung: 0.9) and mean centerline DICE (Liver-Vessels: 0.6) were passed.
For instrument detection algorithms, the reliability was gauged by analysing the pround truth positions and the positions identified by the algorithm.
These validation efforts provide a robust foundation for asserting the accuracy and effectiveness of the algorithms in the context of their application in medical settings.
Animal Study
Animal performance testing was not required to demonstrate safety and effectiveness of the device.
Clinical Studies
Clinical testing was not required to demonstrate the safety and effectiveness of the device. This conclusion is based upon a comparison of intended use, technological characteristics, and non-clinical performance data (Software Verification and Validation Testing, and Internal Test Standards).
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VIII. CONCLUSIONS
The subject device is substantially equivalent to the predicate device with regard to device performance. This conclusion is based upon a comparison of the intended use, technological characteristics, and benchtop testing.