(28 days)
hipEOS is indicated for assisting healthcare professionals in preoperative planning of hip replacement surgery. The software allows for overlaying of 3D/2D implant models on radiological images and 3D reconstruction of bone, and includes tools for performing measurements on the image and for selecting and positioning the implant model. Clinical judgments and experience are required to properly use the software.
hipEOS allows surgeons to perform pre-operative surgical planning for hip replacement. The program features an extensive regularly updated library of digital 3D models of implants form leading implant manufacturers. It allows the overlay of the 3D/2D implant models on the radiological images and on the 3D reconstruction and permits the selection of appropriate size and position of implant. hipEOS is accessible on any computer via ONEFIT Management System that provides secure internet interface through authentication mechanisms, web accessible authentication servers and access for authorized users through secure protocols to web server.
The provided text does not contain detailed information about specific acceptance criteria or an in-depth study that proves the device meets those criteria, as typically found in a robust clinical validation report. The document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device rather than a comprehensive performance study that meets strict statistical criteria for a new device.
However, based on the information available in the text, here's what can be inferred and presented:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state numerical acceptance criteria for performance metrics (e.g., accuracy, precision of measurements, etc.) nor does it provide specific quantitative results of the device's performance against such criteria. The "Performance Data" section broadly states that "Software verification and validation testing were conducted and documentation was provided as recommended by FDA's Guidance..."
2. Sample Size Used for the Test Set and Data Provenance
This information is not provided in the document.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
This information is not provided in the document.
4. Adjudication Method for the Test Set
This information is not provided in the document.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
A MRMC comparative effectiveness study is not mentioned or described in the provided text. The document focuses on demonstrating substantial equivalence to a predicate device, which typically relies on comparisons of technological characteristics and intended use rather than a full clinical effectiveness study with human readers.
6. Standalone Performance Study
The document states that "Software verification and validation testing were conducted." This implies that some form of internal testing was performed on the algorithm itself, which could be considered a standalone performance assessment. However, specific details about the methodology, metrics, and results of this standalone performance are not provided. The acceptance of the device is based on "Performance data demonstrate that hipEOS is as safe and effective as the company's cleared ONEFIT Hip Planner device," suggesting a comparison against the predicate rather than a specific standalone performance against defined clinical metrics.
7. Type of Ground Truth Used
The document does not specify the type of ground truth used for any testing. Medical device software for surgical planning often relies on expert consensus (e.g., orthopedic surgeons), anatomical measurements from high-resolution imaging, or potentially intraoperative findings as ground truth, but this is not confirmed here.
8. Sample Size for the Training Set
This information is not provided in the document.
9. How the Ground Truth for the Training Set Was Established
This information is not provided in the document.
Summary of what is present:
- Acceptance Criteria & Performance: Not explicitly stated with quantitative metrics. The overall acceptance is based on demonstrating "substantially equivalent" safety and effectiveness to the predicate device through verification and validation testing.
- Study Details: The document mentions "Software verification and validation testing were conducted" as per FDA guidance for "moderate" level of concern devices. This implies internal testing was performed.
- Focus: The submission focuses on showing the modified hipEOS is substantially equivalent to its predicate device (ONEFIT Hip Planner K142671) by highlighting minor modifications (integration of prosthesis with modular neck and online validation by the surgeon) that "raise no new issues of safety or effectiveness."
To summarize, the provided text, being a 510(k) summary, offers a high-level overview and a declaration of substantial equivalence rather than a detailed technical report of the studies, acceptance criteria, and specific performance metrics typically found in a comprehensive validation study.
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
June 28, 2016
ONEFIT Medical % Mr. Julien Simon OA / RA Manager 18 rue Alain Savary BESANCON 25000 FRANCE
Re: K161479 Trade/Device Name: hipEOS Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: May 27, 2016 Received: May 31, 2016
Dear Mr. Simon:
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. 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 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. 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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours.
Michael D'Hara
For
Robert 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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known)
Device Name hipEOS
Indications for Use (Describe)
hipEOS is indicated for assisting healthcare professionals in preoperative planning of hip replacement surgery. The software allows for overlaying of 3D/2D implant models on radiological images and 3D reconstruction of bone, and includes tools for performing measurements on the image and for selecting and positioning the implant model. Clinical judgments and experience are required to properly use the software.
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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510(k) SUMMARY ONEFIT's hipEOS
Submitter
ONEFIT medical, Inc.
18, rue Alain Savary 25000 Besançon France
Phone: +33(0) 3 81 25 24 27 Fax: +33(0) 3 81 25 53 51
Contact Person: Mr. Julien SIMON, QA/RA Manager Date Prepared: May 27th, 2016
Device
Trade name: hipEOS Common or Usual Name: ONEFIT Hip Planner Classification Name: Picture Archiving and Communication System (21 CFR 892.2050) Requlatory Class: II Product Code: LLZ
Predicate Device
ONEFIT Hip Planner (K142671) by ONEFIT medical.
Intended Use/Indications for Use
hipEOS is indicated for assisting healthcare professionals in preoperative planning of hip replacement surgery. The software allows for overlaying of 3D/2D implant models on radiological images and 3D reconstruction of bone, and includes tools for performing measurements on the image and 3D model of bones and for selecting and positioning the implant model. Clinical judgments and experience are required to properly use the software.
Device Description
hipEOS allows surgeons to perform pre-operative surgical planning for hip replacement. The program features an extensive regularly updated library of digital 3D models of implants form leading implant manufacturers. It allows the overlay of the 3D/2D implant models on the radiological images and on the 3D reconstruction and permits the selection of appropriate size and position of implant. hipEOS is accessible on any computer via ONEFIT Management System that provides secure internet interface through authentication mechanisms, web accessible authentication servers and access for authorized users through secure protocols to web server.
Comparison of Technological Characteristics with the predicate device
The technological characteristics of the modified hipEOS are essentially identical to the cleared ONEFIT Hip Planner (K142671).The main differences with the cleared ONEFIT Hip Planner consist of the following minor modifications:
- Integration of prosthesis with modular neck. .
- Online validation of the 3D modeling and landmarks positioning by the surgeon. .
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Performance Data
Software verification and validation testing were 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 was considered as a "moderate" level of concern, since a failure or latent design flaw could directly result in minor injury to the patient or operator, or could indirectly result in minor injury to the patient or operator through incorrect or delayed information or through the action of a care provider.
Conclusions
The device has similar intended uses and indications, technological characteristics, and principles of operation as its predicate device. The minor differences between the device and its predicate devices raise no new issues of safety or effectiveness. Performance data demonstrate that hipEOS is as safe and effective as the company's cleared ONEFIT Hip Planner device and, thus, is substantially equivalent.
§ 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).