HipCheck by Stryker Corp. | FDA 510(k) Summary

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.

HipCheck assists the surgeon to determine quantitative measurements during femoroacetabular impingement procedures.

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.

The femoral head detection algorithm on which the alpha angle algorithm is built, is based on the Femoral Head Detector algorithm used in the FluoroMap 1.0 software, which belongs to the secondary predicate device, the FluoroMap Computer Assisted Surgery System (K103400).

AI/ML Overview

The provided text does not contain specific acceptance criteria, reported device performance metrics, or detailed study results for HipCheck. While it mentions various types of testing conducted (software, alpha angle performance, mechanical, electrical safety, EMC, simulated-use), it only states that all testing had "overall passing results" and "demonstrates that HipCheck performs as intended."

Therefore, I cannot fulfill all parts of your request with the given information. Below is a summary of what can be extracted and indications of what is missing.

1. Table of Acceptance Criteria and Reported Device Performance

This information is not explicitly detailed in the provided document. The document states that testing was conducted for "overall passing results" but does not specify the numerical acceptance criteria or the measured performance values for HipCheck.

2. Sample Size Used for the Test Set and Data Provenance

The document does not specify the sample size for any test sets used. It only mentions "simulated-use environment by surgeon and nurse users" for design validation. There is no information about the country of origin of the data or whether it was retrospective or prospective.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

The document does not specify the number of experts used or their qualifications for establishing ground truth for any test sets. It mentions "surgeon and nurse users" for simulated-use testing but not in the context of ground truth establishment.

4. Adjudication Method for the Test Set

The document does not describe any adjudication method used for the test set.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

The document does not mention a multi-reader multi-case (MRMC) comparative effectiveness study, nor does it provide an effect size for human readers with and without AI assistance.

6. Standalone (Algorithm Only Without Human-in-the-Loop) Performance Study

The document describes "Alpha Angle Performance Testing" including "verification testing based on the identified design requirements and software requirement specifications of the Alpha Angle Core Algorithm," which suggests standalone algorithm testing. However, no specific performance metrics (e.g., accuracy, precision, recall) are reported for this standalone performance.

7. Type of Ground Truth Used

The document does not explicitly state the type of ground truth used for any of the testing. For example, it doesn't mention whether pathology, expert consensus, or outcomes data were used.

8. Sample Size for the Training Set

The document does not mention any training set or its sample size.

9. How the Ground Truth for the Training Set Was Established

Since no training set is mentioned, there is no information on how its ground truth was established.

Summary of Device Features and Testing Mentioned:

Device Name: HipCheck
Purpose: 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. Assists the surgeon to determine quantitative measurements (specifically alpha angle) during femoroacetabular impingement procedures.
Core Technology: Alpha angle algorithm built on the Femoral Head Detector algorithm from the FluoroMap 1.0 software (secondary predicate K103400).
Testing Conducted:
- Software testing (considered "moderate" level of concern).
- Alpha Angle Performance Testing (verification and validation to meet design requirements and user needs).
- Mechanical testing (battery life, tablet weight, securement, UI temperature/functionality, RF ablation interference, mounting arm staying force, simulated-use testing).
- Electrical safety and Electromagnetic Compatibility (EMC) testing (compliant with IEC 60601-1 and IEC 60601-1-2 standards).
Results: All testing had "overall passing results" and "demonstrates that HipCheck performs as intended."
No Clinical Studies or Animal Studies: The device was supported by non-clinical testing only.

Summary

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December 13, 2018

Stryker Corp. Cara Mellits Sr. Regulatory Affairs Specialist 5900 Optical Ct SAN JOSE, CA 95138

Re: K182359

Trade/Device Name: HipCheck Regulation Number: 21 CFR 892.2050 Regulation Name: Picture Archiving And Communications System Regulatory Class: Class II Product Code: LLZ Dated: November 12, 2018 Received: November 14, 2018

Dear Cara Mellits:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part

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801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice

(https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Michael D. O'Hara For

Robert A. Ochs, Ph.D. Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known)

K182359

Device Name

HipCheck

Indications for Use (Describe)

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.

HipCheck assists the surgeon to determine quantitative measurements during femoroacetabular impingement procedures.

Type of Use (Select one or both, as applicable)

Prescription Use (Part 21 CFR 801 Subpart D)

| Over-The-Counter Use (21 CFR 801 Subpart C)

... ... ......................................................................................................................................................................

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I. SUBMITTER

Stryker Corp. 5900 Optical Court San Jose, CA 95138 Phone: 408-754-2367 Email: cara.mellits@stryker.com Contact Person: Cara Mellits Date Prepared: August 28, 2018

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: LLZ

III. PREDICATE DEVICES

Primary Predicate:

Dyonics Plan Hip Impingement Planning Software, K132636

Secondary Predicate:

FluoroMap Computer Assisted Surgery System, K103400

Neither predicate has been subject to a design-related recall.

IV. DEVICE DESCRIPTION

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HipCheck is not patient contacting. The user is instructed to appropriately drape the tablet when used in the sterile field.

V. INTENDED USE

HipCheck provides static localization information derived from image processing of intraoperatively acquired X-ray images, by superposition of virtual measurement tools onto those X-ray images.

VI. INDICATIONS FOR USE

HipCheck assists the surgeon to determine quantitative measurements during femoroacetabular impingement procedures.

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Characteristic	Subject Device	Primary Predicate DeviceDyonics Plan Hip ImpingementPlanning Software	Secondary Predicate DeviceFluoroMap Computer Assisted SurgerySystem
Intended Use	HipCheck provides staticlocalization information derivedfrom image processing of intra-operatively acquired X-ray images,by superposition of virtualmeasurement tools onto those X-ray images.	The DYONICS PLAN is intended aspre-operative or post-operativesoftware for simulating/evaluatinghip preservation surgical treatmentoptions and historical case review,respectively.	FluoroMap is a computer controlledstereotaxic image guided surgerysystem.It provides static localizationinformation derived from imageprocessing of intra-operativelyacquired X-ray images, bysuperposition of virtual implants andinstruments onto those X-ray images.
Indications for UseStatement	HipCheck assists the surgeon todetermine quantitativemeasurements duringfemoroacetabular impingementprocedures.	The DYONICS PLAN HipImpingement Planning Systemsoftware is intended for use as asoftware interface and imagesegmentation system for thetransfer of imaging informationfrom a medical scanner such as a CTscanner to an output file. It is alsointended as pre-operative or post-operative software forsimulating/evaluating hippreservation surgical treatmentoptions and historical case review,respectively.	FluoroMap assists the surgeon todetermine the needed size andposition of orthopedic implantsduring proximal femur fracturesurgery using the Stryker Gamma3Nail system.The system should be operated onlyby trained personnel such assurgeons and clinical staff.
Product Code(s)	Same as predicate.	LLZ	OLO, LLZ
Regulation Number	Same as predicate.	892.2050	882.4560
Intended PatientPopulation	Same as predicate.	Patients undergoing orthopedicsurgery.	Patients undergoing orthopedicsurgery.
Surgical Approach	Orthopedic surgery, specificallyfemoroacetabular impingement.	Orthopedic surgery, specifically hippreservation treatment options.	Orthopedic surgery, specifically at theproximal femur.
Intended Users	Same as predicate.	Orthopedic surgeons and otherhealthcare professionals.	Surgeons and clinical staff.
OperationalEnvironment	Surgical suite.Postoperative case review.	Preoperative planning.Postoperative case review.	Surgical suite.
Primary DeviceFunction	Locate the femoral head and neckto determine the alpha angle usingintra-operative X-ray images.	Visualization and assessment of hippreservation surgical treatmentoptions using CT images.	Assistance in planning andpositioning of orthopedic implantsusing intra-operative X-ray images.
Main SystemComponents	Same as predicate.	- Software	- Software- Reference device for C-arm- Reference device forinstrumentation
User Interface	Tablet.	Personal Computer (PC).	Computer and monitor.
Body Contact and Use	Same as predicate.	N/A – Device does not have anypatient contact.	Reference device for instrumentation(closed tube clip) has patient contact.
Sterile, Single-use	Same as predicate.	N/A – Device is not provided sterileor as a single use product.	Reference device for instrumentation(closed tube clip) is delivered sterileand as a single use product.
Design	- Workstation for viewing software- Dedicated software for imageprocessing and display of virtualmeasurement tools	- Installed and run locally on a PC- Software for image processing- Provides virtual measurementtools, surgical simulation andplanning tools	- Reference frames containing metalmarker spheres- Reference frames are attached to theimplant system and to the C-arm- Workstation for viewing software- Dedicated software for imageprocessing and display of positionalinformation
Principles of Operation	Acquire intra-operative X-rayimages, process the images and	Stand-alone software for computerassisted surgical planning, via	Acquire intra-operative X-ray images,register the images through metal
	display the virtual measurementtools onto images.	import of CT scans in DICOM format,provides image processing andmeasurement tools.	marker detection and display theactual position of instruments andimplants onto images.
Function	Display on a tablet screen virtualmeasurement tools in relationshipto X-ray images.	Display on a computer screenvirtual measurement and surgicalplanning tools in relationship to 2Dviews and 3D renderings generatedfrom CT scans.	Display on a computer screennavigated instruments and implantsin relationship to X-ray images.
Image Processing	- Transfer X-ray images from C-armto computer platform- Overlay virtual measurementtools onto images	- Import DICOM images from CTscans to computer platform.- Process images to display various2D views and 3D renderings.- Provide virtual measurementtools, surgical simulation andplanning tools.	- Transfer X-ray images from C-arm tocomputer platform- Remove image distortions- Register images to patient space- Overlay instruments and implantsonto images
Energy Source	Same as predicate.	No energy applied to the patient oroperating staff.	No energy applied to the patient oroperating staff.

VII. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICES

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Discussion of Similarities and Differences

Primary Predicate (Dyonics Plan, K132636): Dyonics Plan is a surgical planning tool, in that its operational environment is primarily pre-operative, thereby outside the surgical suite. However, the software allows for the export of the plan in PDF or HTML format, which can be referenced intraoperatively. As such, the Dyonics Plan utilizes CT preoperative imaging for displaying 2D views and 3D renderings and provides virtual measurement tools for visualization and analysis of hip preservation treatment options. HipCheck's operational environment is primarily intraoperative, within the surgical suite. Since HipCheck is primarily used intraoperatively, it displays intraoperatively collected X-ray images, likewise providing virtual measurement tools for visualization purposes during femoroacetabular impingement procedures.

While the operational environment may differ, the intended use is the same. Dyonics Plan utilizes image processing of preoperative CT images and virtual measurement tools to visualize hip anatomy and plan preservation procedures. HipCheck utilizes image processing of intraoperatively collected X-ray images and virtual measurement tools to visualize hip anatomy during femoroacetabular impingement procedures. The Dyonics Plan and HipCheck have the same intended use, as defined in their shared regulation 21 CFR 892.2050. Though their indications for use statements differ, both are used in the treatment of femoroacetabular impingement.

Secondary Predicate (FluoroMap, K103400): In addition to its clearance as an orthopedic stereotaxic instrument (OLO; 21 CFR 882.4560), FluoroMap is also cleared as a picture archiving and communications system (LLZ; 21 CFR 892.2050). This is due to the core functionality of FluoroMap's software that supports the acceptance, display, and digital processing of X-ray images in order for FluoroMap to function as intended. FluoroMap software facilitates image manipulation and quantification in order to achieve visualization of the placement of virtual implants and instruments.

Similarly, HipCheck shares this core functionality to achieve visualization of the placement of virtual measurement tools for the determination of alpha angle. HipCheck's Alpha Angle algorithm is built directly on the Femoral Head Detector algorithm within the FluoroMap software (K103400). HipCheck leverages the Femoral Head Detector algorithm from FluoroMap for its same intended purpose, simply in a different application.

While the primary function of FluoroMap is as a navigated surgical system for placing orthopedic implants, the how behind the device's ability to achieve its intended purpose is important in the substantial equivalence discussion for HipCheck.

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VIII. PERFRMANCE DATA/NON-CLINICAL TESTING

Design verification testing was performed on HipCheck as a result of 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 nurse 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 was provided as recommended by FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices." The software for this device was considered to be of "moderate" level of concern since a failure or latent flaw in the software could indirectly result in minor injury to the patient or operator.

Alpha Angle Performance Testing

Alpha angle performance was evaluated in both verification and validation testing performed for HipCheck. Verification testing was conducted based on the identified design requirements and software requirement specifications of the Alpha Angle Core Algorithm. Additionally, validation testing was conducted to ensure applicable user needs were met for generating, manipulating, and using the overlay to determine the alpha angle. All testing had overall passing results.

Mechanical testing

Mechanical functionality testing included 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.

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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.

IX. CONCLUSIONS

Based on the shared technological characteristics and intended use, HipCheck is substantially equivalent to the primary predicate, Dyonics Plan Hip Impingement Planning Software (K132636), and the secondary predicate, FluoroMap Computer Assisted Surgery System (K103400). 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.

Regulation Number and Section

§ 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).