(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.
§ 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).