(266 days)
No reference devices were used in this submission.
Yes
The "Summary of Performance Studies" explicitly states "Standalone performance testing on an object detection AI/ML model." and the "Key Metrics" section lists performance metrics for this AI/ML model.
No.
Explanation: The HipCheck and HipMap devices provide quantitative measurements, visualizations, and analyses to support clinical decision-making by surgeons and radiologists, but they do not directly treat or diagnose a disease. They are tools for information and surgical planning, not therapeutic devices.
Yes
This device, through both HipCheck and HipMap FAI Analysis, provides measurements, visualizations, and morphological analyses of the hip to support surgeons and radiologists in pre-operative and intra-operative clinical decision-making regarding femoroacetabular impingement (FAI). This information aids in diagnosing or assessing a patient's condition.
No
The device description explicitly states the software is provided pre-installed on a mobile touchscreen tablet, indicating a hardware component is included as part of the device.
Based on the provided information, no, 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. They are used outside of the body (in vitro).
-
Device Function: The description clearly states that HipCheck and HipMap FAI Analysis are used for:
- Intraoperative measurements: HipCheck uses fluoroscopic images taken during surgery.
- Pre-operative analysis: HipMap uses CT scans to analyze hip morphology before surgery.
- Providing measurements and visualizations: The devices process medical images to provide quantitative data and visual aids to surgeons and radiologists.
-
Lack of Biological Sample Testing: There is no mention of the device analyzing any biological samples from the patient. Its function is solely based on processing medical imaging data.
Therefore, since the device operates on medical images and not on biological samples, it does not fit the definition of an In Vitro Diagnostic device. It falls under the category of medical imaging software or surgical planning/guidance software.
No
The provided text does not contain any explicit statement that the FDA has reviewed and approved or cleared a Predetermined Change Control Plan (PCCP) for this specific device. The 'Control Plan Authorized (PCCP) and relevant text' section explicitly states 'Not Found'.
Intended Use / Indications for Use
HipCheck assists the surgeon to determine quantitative measurements for femoroacetabular impingement (FAI) procedures. HipCheck provides static localization information derived from image processing of intra-operatively acquired static fluoroscopic images, by superposition of virtual measurement tools onto those X-ray images for skeletally mature patients.
HipMap FAI Analysis is a patient-specific report used to support surgeon or radiologist pre-operative clinical decision making. HipMap femoroacetabular impingement (FAI) Analysis provides a morphological analysis of a skeletally mature hip with potential FAI, including measurements and visualizations that describe hip impingement and stability.
Product codes (comma separated list FDA assigned to the subject device)
QIH
Device Description
HipCheck enables the surgeon to intraoperatively measure alpha angle during hip arthroscopy procedures for femoroacetabular impingement. The software is provided to the user pre-installed on a mobile touchscreen tablet for which it has been tested for compatibility.
Alpha angle is a value used to indicate cam deformity of the femoral head, seen in patients presenting with femoroacetabular impingement. HipCheck provides a visualization tool for surgeons to determine the alpha angle intraoperatively, using virtual measurement tools superimposed on X-ray images collected during the procedure, which informs clinical decision making.
HipCheck is not patient contacting. The user is instructed to appropriately drape the tablet when used in the sterile field.
Stryker HipMap FAI Analysis is a patient-specific report intended for use by surgeons or radiologists to support pre-operative clinical decision making by providing a morphological analysis of a skeletally mature hip with potential femoroacetabular impingement (FAI), including measurements and visualizations that describe hip impingement and stability. HipMap provides three-dimensional analyses, 3D surface reconstructions, and annotated images to support surgeons with pre-operative clinical decision-making.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Yes
Input Imaging Modality
HipCheck: intra-operatively acquired static fluoroscopic images, X-ray images
HipMap FAI Analysis: CT scan
Anatomical Site
Hip (femoroacetabular)
Indicated Patient Age Range
skeletally mature patients
Intended User / Care Setting
Intended Users: Surgeons and clinical staff.
Operational Environment: Surgical suite.
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 test dataset consists of 745 fluoroscopic images. 184 images did not contain images of hips and were used to test false positive detection. 561 images were taken of 81 hips. Geographically, the images come from 6 clinical sites in the United States, Netherlands, and Germany representative of the intended use population. Numerous subgroups were evaluated to demonstrate the generalizability of the device across the dataset. Images were collected during product development cadaver labs or from anonymized log files from patients undergoing surgery with the use of HipCheck. The images were labeled using software for labeling the femur with the precise location of femoral head and neck. All images were tagged by two people trained to use the software. Testing was done against the average value of the two taggers. The test dataset was independent of the data used during model training and stored in a different access-controlled location.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Design verification testing was performed on HipCheck due to the risk analysis and product requirements. Testing included software and bench verification testing, as well as design validation. Design validation testing was conducted in a simulated-use environment by surgeon and sales representative users. Users were successfully able to use the HipCheck as intended to determine the alpha angle and utilize the virtual measurement and visualization tools.
Standalone Performance Testing:
Stryker conducted standalone performance testing on an object detection AI/ML model that is a part of the image processing pipeline. The test dataset consists of 745 fluoroscopic images. 184 images did not contain images of hips and were used to test false positive detection. 561 images were taken of 81 hips. Geographically, the images come from 6 clinical sites in the United States, Netherlands, and Germany representative of the intended use population. Numerous subgroups were evaluated to demonstrate the generalizability of the device across the dataset. Images were collected during product development cadaver labs or from anonymized log files from patients undergoing surgery with the use of HipCheck. The images were labeled using software for labeling the femur with the precise location of femoral head and neck. All images were tagged by two people trained to use the software. Testing was done against the average value of the two taggers. The test dataset was independent of the data used during model training and stored in a different accesscontrolled location.
The results of the standalone performance testing demonstrate the AI/ML model:
- Automatically detects the presence or absence of a hip (90% Lower Bound of -97.5%)
- Finds the region of the image that contains the femur with high accuracy:
- Head center X coordinate is within +3.3%/-3.5 o
- Head center Y coordinate is within +3.8%/-4.8% o
- Neck Angle relative to vertical is within +13.63°/-15.35° O
Additionally, the performance was also validated for the following subgroups:
- Image Quality
- Average
- Good
- Alpha Angle
- Low (65.5°)
- Neck Width (as a ratio to Head Diameter)
- Low (0.73) O
- Neck Length (as a ratio to Head Diameter)
- Low (0.465)
- Hip Position
- 30° Internal Rotation, 0° Flexion o
- 0° Rotation, 0° Flexion O
- 30° External Rotation, 0° Flexion O
- 0° Rotation, 50° Flexion O
- 40° External Rotation, 50° Flexion O
- 60° External Rotation, 50° Flexion O
- Femoral Head Size (as a ratio to Image Size)
- O Low (0.343)
HipMap Performance Testing:
Stryker conducted a segmentation accuracy and reliability study using HipMap workflow software. It reviews the performance of Stryker personnel segmenting pelvic CT scans using HipMap workflow software against trained third-party personnel performing image segmentation of the same scans using 510(k) cleared software. It also reviews the reliability of segmentation between Stryker personnel, and the reliability of the HipMap FAI Analysis by comparing clinical measurement outputs generated from the third-party segmentation (external rater vs internal rater), Stryker employee segmentations (inter-rater reliability), and iterations of segmentations performed by the same Stryker employee (intra-rater reliability).
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Automatically detects the presence or absence of a hip (90% Lower Bound of -97.5%)
Head center X coordinate is within +3.3%/-3.5 o
Head center Y coordinate is within +3.8%/-4.8% o
Neck Angle relative to vertical is within +13.63°/-15.35° O
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.
No reference devices were used in this submission.
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
§ 892.2050 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
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food & Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
Stryker Corp. % Lucas Dan Staff Regulatory Affairs Specialist 5900 Optical Ct SAN JOSE CA 95138
Re: K230045
September 29, 2023
Trade/Device Name: HipCheck Regulation Number: 21 CFR 892.2050 Regulation Name: Medical image management and processing system Regulatory Class: Class II Product Code: QIH Dated: August 21, 2023 Received: August 21, 2023
Dear Lucas Dan:
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 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,
Jessica Lamb
Jessica Lamb, Ph.D. Assistant Director Imaging Software Team DHT8B: Division of Radiological Imaging Devices and Electronic Products OHT8: Office of Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health
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Indications for Use
510(k) Number (if known) K230045
Device Name HipCheck
Indications for Use (Describe)
HipCheck assists the surgeon to determine quantitative measurements for femoroacetabular impingement (FAI) procedures. HipCheck provides static localization information derived from image processing of intra-operatively acquired static fluoroscopic images, by superposition of virtual measurement tools onto those X-ray images for skeletally mature patients.
HipMap FAI Analysis is a patient-specific report used to support surgeon or radiologist pre-operative clinical decision making. HipMap femoroacetabular impingement (FAI) Analysis provides a morphological analysis of a skeletally mature hip with potential FAI, including measurements and visualizations that describe hip impingement and stability.
| 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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Image /page/3/Picture/1 description: The image shows the word "stryker" in a bold, sans-serif font. The word is all lowercase and black. The letters are closely spaced together, giving the word a solid, block-like appearance.
I. SUBMITTER
Stryker Endoscopy 5900 Optical Court San Jose, CA 95138
Phone: 303-931-2353 Email: lucas.dan@stryker.com
Contact Person: Lucas Dan Date Prepared: January 5th, 2023
II. DEVICE
Name of Device: HipCheck Common or Usual Name: HipCheck Classification Name: Picture Archiving and Communications System (21 CFR 892.2050) Regulatory Class: II Product Code: QIH
III. PREDICATE DEVICE
HipCheck, K182359 This predicate has not been subject to a design-related recall.
No reference devices were used in this submission.
IV. DEVICE DESCRIPTION
HipCheck enables the surgeon to intraoperatively measure alpha angle during hip arthroscopy procedures for femoroacetabular impingement. The software is provided to the user pre-installed on a mobile touchscreen tablet for which it has been tested for compatibility.
Alpha angle is a value used to indicate cam deformity of the femoral head, seen in patients presenting with femoroacetabular impingement. HipCheck provides a visualization tool for surgeons to determine the alpha angle intraoperatively, using virtual measurement tools superimposed on X-ray images collected during the procedure, which informs clinical decision making.
HipCheck is not patient contacting. The user is instructed to appropriately drape the tablet when used in the sterile field.
4
Stryker HipMap FAI Analysis is a patient-specific report intended for use by surgeons or radiologists to support pre-operative clinical decision making by providing a morphological analysis of a skeletally mature hip with potential femoroacetabular impingement (FAI), including measurements and visualizations that describe hip impingement and stability. HipMap provides three-dimensional analyses, 3D surface reconstructions, and annotated images to support surgeons with pre-operative clinical decision-making.
V. INTENDED USE/INDICATIONS FOR USE STATEMENT
HipCheck assists the surgeon to determine quantitative measurements for femoroacetabular impingement (FAI) procedures. HipCheck provides static localization information derived from image processing of intra-operatively acquired static fluoroscopic images, by superposition of virtual measurement tools onto those X-ray images for skeletally mature patients.
HipMap FAI Analysis is a patient-specific report used to support surgeon or radiologist preoperative clinical decision making. HipMap femoroacetabular impingement (FAI) Analysis provides a morphological analysis of a skeletally mature hip with potential FAI, including measurements and visualizations that describe hip impingement and stability.
| Characteristic | Subject Device
HipCheck
[K230045] | Predicate Device
HipCheck
[K182359] |
|--------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended
Use/Indications for Use
Statement | HipCheck assists the surgeon to
determine quantitative measurements
for femoroacetabular impingement
(FAI) procedures. HipCheck provides
static localization information derived
from image processing of intra-
operatively acquired static fluoroscopic
images, by superposition of virtual
measurement tools onto those X-ray
images for skeletally mature patients.
HipMap FAI Analysis is a patient-
specific report used to support surgeon
or radiologist pre-operative clinical
decision making. HipMap
femoroacetabular impingement (FAI)
Analysis provides a morphological
analysis of a skeletally mature hip with | HipCheck assists the surgeon to
determine quantitative measurements
during femoroacetabular impingement
procedures.
HipCheck provides static localization
information derived from image
processing of intra-operatively acquired
X-ray images, by superposition of virtual
measurement tools onto those X-ray
images. |
| | | |
| | potential FAI, including measurements and visualizations that describe hip impingement and stability. | |
| Product Code(s) | QIH | LLZ |
| Intended Patient
Population | Same as predicate. | Patients undergoing arthroscopic surgery. |
| Surgical Approach | Same as predicate. | Arthroscopic surgery, specifically
femoroacetabular impingement. |
| Intended Users | Same as predicate. | Surgeons and clinical staff. |
| Operational
Environment | Same as predicate. | Surgical suite. |
| Primary Device Function | HipCheck:
Locate the femoral head and neck to determine the alpha angle using intra-operative X-ray images.
HipMap FAI Analysis:
Provide three-dimensional analyses, 3D surface reconstructions, and annotated images to support surgeons with pre-operative clinical decision-making. | Locate the femoral head and neck to determine the alpha angle using intra-operative X-ray images. |
| Main System
Components | Same as predicate. | Software |
| User Interface | HipCheck:
Tablet
HipMap FAI Analysis:
General purpose computing platform and/or HipCheck tablet. | Tablet. |
| Body Contact and Use | Same as predicate. | N/A – Device does not have any patient contact. |
| Sterile, Single-use | Same as predicate. | N/A – Device is not provided sterile or as a single use product. |
| Design | HipCheck:
- Workstation for viewing software
- Dedicated software for image processing and display of virtual measurement tools
HipMap FAI Analysis:
Interactive HTML report for viewing on general purpose computing platform and/or HipCheck tablet. | - Workstation for viewing software
- Dedicated software for image processing and display of virtual measurement tools |
| | | |
| Principles of Operation | HipCheck:
Acquire intra-operative X-ray images,
process the images and display the
virtual measurement tools onto images. | Acquire intra-operative X-ray images,
process the images and display the
virtual measurement tools onto images. |
| | HipMap FAI Analysis:
Process CT scan to create patient
specific report with three-dimensional
analyses, 3D surface reconstructions,
and annotated images. | |
| Function | HipCheck:
Display on a tablet screen virtual
measurement tools in relationship to X-ray images. | Display on a tablet screen virtual
measurement tools in relationship to X-ray images. |
| | HipMap FAI Analysis:
Display a patient-specific report on a
general purpose computing platform
and/or HipCheck tablet. | |
| Input Methods | HipCheck: - USB
- Stryker eRequest Platform (also
referred to as the HipMap Portal) | - USB |
| | HipMap FAI Analysis: - Stryker eRequest Platform (also
referred to as the HipMap Portal) | |
| Export Methods | HipCheck: - USB
- Stryker Health Cloud | - USB |
| | HipMap FAI Analysis: - Stryker eRequest Platform (also
referred to as the HipMap Portal) | |
| Image Processing | HipCheck: - Transfer X-ray images from C-arm to
computer platform - Overlay virtual measurement tools
onto images | - Transfer X-ray images from C-arm to
computer platform - Overlay virtual measurement tools
onto images |
| | HipMap FAI Analysis: - Generate three-dimensional analyses
and 3D surface reconstructions from
CT scan | |
| Femoral Head Detection
Workflow | Same as predicate. | - Extraction of the region of interest - Extended Gabor filtering
- Binary edge detection and
classification - Circular Hough transformation
- Feature point tracing
- RANSAC circle matching
- Target circle selection |
| Energy Source | Same as predicate. | No energy applied to the patient or
operating staff. |
| Software Level of
Concern | Same as predicate. | Moderate |
| Software Operating
Environment | HipCheck:
Programming language used is C/C++.
The operating system is Windows 10.
The hardware platform consists of a
microprocessor-controlled system,
based on a PC. | Programming language used is C/C++.
The operating system is Windows 8.1.
The hardware platform consists of a
microprocessor-controlled system,
based on a PC. |
| Compatible Hospital
Equipment | Same as predicate. | Compatible to 2D C-arms. |
VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE
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stryker
510(k) Summary
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Discussion of Similarities and Differences
HipCheck version 1.5.6 contains three primary changes which are the subject of this 510(k). The first is a connectivity feature (Wireless and Ethernet) on the HipCheck tablet which allows for the secure importation and exportation of case data. The second is the change in operating system the HipCheck software runs on; HipCheck 1.5.6 utilizes the Windows 10 operating system whereas the predicate utilizes Windows 8. The third change is the inclusion of HipMap FAI Analysis.
Both the subject device and the predicate device share the core functionality to achieve visualization of the placement of virtual measurement tools for the determination of alpha angle. Updating to HipCheck version 1.5.6's Alpha Angle algorithm has been done to enhance capabilities of the algorithm on uncommon image types (i.e., corner cases) while maintaining consistent capabilities on other image types.
In addition to these changes, bug fixes, administrator tool updates, new troubleshooting features, and graphical user interface updates were implemented with the upgrade to HipCheck version 1.5.6. Differences between the subject device and predicate device's intended use, indications for use, and technological characteristics were evaluated through performance testing.
VII. PERFORMANCE DATA/NON-CLINICAL TESTING
Design yerification testing was performed on HipCheck due to the risk analysis and product requirements. Testing included software and bench verification testing, as well as design validation. Design validation testing was conducted in a simulated-use environment by surgeon and sales representative users. Users were successfully able to use the HipCheck as intended to determine the alpha angle and utilize the virtual measurement and visualization tools.
Software testing
Software testing was conducted, and documentation provided, as recommended by FDA Guidance for Industry and Staff - Content of Premarket Submissions for Device Software Functions (June 2023). The software for this device was considered to be of Basic Documentation Level of concern since a failure or flaw of any device software function could not present a hazardous situation with a probable risk of death or serious injury either to a patient, user of the device, or others in the environment of use prior to the implementation of risk control measures.
9
Mechanical testing
Mechanical functionality testing was leveraged from the predicate device, HipCheck (K182359), including the following to ensure the device design meets user needs in the environment of use:
- Battery life -
- Tablet weight -
- -Tablet securement and attachment force to evaluate the connection between the tablet and its docking interface on the compatible operating table mounting arm
- -User interface temperature and functionality at operating temperatures
- RF ablation interference -
- Mounting arm staying force -
- -Simulated-use testing
Electrical safety and electromagnetic compatibility (EMC)
Electrical safety and EMC testing was conducted on the compatible touchscreen tablet that the HipCheck software is provided pre-installed on. The tablet complies with the IEC 60601-1 standard for safety and the IEC 60601-1-2 standard for EMC.
Animal Study
No animal testing was conducted to determine the safety and effectiveness of HipCheck.
Clinical Studies
No human clinical testing was conducted to determine the safety and effectiveness of HipCheck.
HipCheck Design Testing
Design verification testing was performed on HipCheck due to the risk analysis and product requirements. Testing included bench verification and design validation testing. Design validation testing was conducted in a simulated-use environment by surgeon and sales representative users. Testing from the previously cleared HipCheck (K182359) was leveraged as appropriate. Users were successfully able to use the HipCheck as intended to determine the alpha angle and utilize the virtual measurement and visualization tools.
Standalone Performance Testing
Stryker conducted standalone performance testing on an object detection AI/ML model that is a part of the image processing pipeline. The test dataset consists of 745 fluoroscopic images. 184 images did not contain images of hips and were used to test false positive
10
detection. 561 images were taken of 81 hips. Geographically, the images come from 6 clinical sites in the United States, Netherlands, and Germany representative of the intended use population. Numerous subgroups were evaluated to demonstrate the generalizability of the device across the dataset. Images were collected during product development cadaver labs or from anonymized log files from patients undergoing surgery with the use of HipCheck. The images were labeled using software for labeling the femur with the precise location of femoral head and neck. All images were tagged by two people trained to use the software. Testing was done against the average value of the two taggers. The test dataset was independent of the data used during model training and stored in a different accesscontrolled location.
The results of the standalone performance testing demonstrate the AI/ML model:
- Automatically detects the presence or absence of a hip (90% Lower Bound of -97.5%)
- -Finds the region of the image that contains the femur with high accuracy:
- Head center X coordinate is within +3.3%/-3.5 o
- Head center Y coordinate is within +3.8%/-4.8% o
- Neck Angle relative to vertical is within +13.63°/-15.35° O
Additionally, the performance was also validated for the following subgroups:
- Image Quality
- o Average
- o Good
- Alpha Angle
- o Low (65.5°)
- Neck Width (as a ratio to Head Diameter) -
- Low (0.73) O
- Neck Length (as a ratio to Head Diameter)
- o Low (0.465)
- Hip Position
- 30° Internal Rotation, 0° Flexion o
- 0° Rotation, 0° Flexion O
- 30° External Rotation, 0° Flexion O
- 0° Rotation, 50° Flexion O
- 40° External Rotation, 50° Flexion O
- 60° External Rotation, 50° Flexion O
- Femoral Head Size (as a ratio to Image Size)
- O Low (0.343)
HipMap Performance Testing
Stryker conducted a segmentation accuracy and reliability study using HipMap workflow software. It reviews the performance of Stryker personnel segmenting pelvic CT scans using HipMap workflow software against trained third-party personnel performing image segmentation of the same scans using 510(k) cleared software. It also reviews the reliability of segmentation between Stryker personnel, and the reliability of the HipMap FAI Analysis by comparing clinical measurement outputs generated from the third-party segmentation (external rater vs internal rater), Stryker employee segmentations (inter-rater reliability), and iterations of segmentations performed by the same Stryker employee (intra-rater reliability).
VIII. CONCLUSIONS
Based on the shared technological characteristics and intended use, HipCheck version 1.5.6 is substantially equivalent to the predicate, HipCheck (K182359). Differences between the subject and predicate devices' technological characteristics do not raise different questions of safety and effectiveness of HipCheck. The results of the non-clinical testing conducted supports the safety of the device and demonstrates that HipCheck performs as intended in the specified use conditions.