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510(k) Data Aggregation
(314 days)
HipXpert and HipInsight System
The HipXpert system is a manual surgical instrument and associated software application designed for use in planning surgery and aligning the acetabular components during hip arthroplasty procedures.
The Hiplnsight system with the HoloLens2 is indicated for visualization of the HipXpert surgical plan and alignment of acetabular implants and instrumentation during hip arthroplasty when pin-based fixation of the HipXpert tools is utilized.
The Hiplnsight System was cleared in K200384 and utilizes the Microsoft HoloLens2 mixed reality headset to display 3D images from the HipXpert planning application. The 3D images are superimposed on the actual patient using known anchoring landmarks relative to the anterior pelvic plane.
The HipXpert software planning application uses CT patient image data to create a detailed 3D model of the pelvis as well as the instrument settings necessary for proper acetabular cup orientation. The HipXpert planning application has the ability to show implant and instrument templates that are either generic or manufacturer specific. The templates can be positioned in relation to the patient's pelvis and femur bones in the surgical plan.
The surgical plan, including all tool settings and usage instructions, is posted to the surgeon's secure folder on the HipXpert website.
The operating surgeon can then download the plan to a desktop or laptop computer and use the HipXpert viewer application to view and adjust the plan according to his/her best surgical judgment.
The purpose of this submission is to introduce additional options for the Hiplnsight system.
Additional surgeon needs include being able to:
- Use mixed-reality guidance with additional 3D objects
- Use mixed-reality quidance without using the HipXpert mechanical docking tools
- Use mixed-reality guidance that provides position accuracy in addition to orientation accuracy
- Use mixed-reality guidance for limb length measurements
The provided text describes the HipXpert and HipInsight Systems, focusing on updates to the HipInsight system. While it mentions performance evaluation, it lacks specific numerical acceptance criteria and detailed study results. The information provided heavily emphasizes comparison to a previously cleared predicate device (K200384) and states that no clinical testing was conducted for this submission.
Therefore, the following response is based on the limited information available in the provided text. Many sections will indicate "Not specified" or "Not applicable" due to the nature of the submission (a 510(k) for device modifications rather than de novo clearance, relying heavily on prior clearance).
Acceptance Criteria and Device Performance Study
The information provided is for a 510(k) submission (K233315) for modifications to the HipXpert and HipInsight Systems, with a strong emphasis on demonstrating substantial equivalence to a previously cleared predicate device (K200384). The performance testing described is primarily comparison testing against the predicate's performance.
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state numerical acceptance criteria in the typical sense (e.g., "accuracy must be within X mm or Y degrees"). Instead, the performance evaluation aims to show "equivalence" to the predicate device.
| Performance Metric | Acceptance Criteria (as implied) | Reported Device Performance |
|---|---|---|
| Orientation Accuracy | Equivalent to the predicate device (HipXpert System cleared under K200384). | "All results in terms of orientation accuracy of the subject device were equivalent to those of the predicate." |
| Positional Accuracy | Equivalent to the predicate device (HipXpert System cleared under K200384). | "All results in terms of position accuracy of the subject device were equivalent to those of the predicate." |
| Functionality (3D object display) | Ability to display additional 3D objects, including instruments, aligned with the HoloLens2. | Device allows for "additional 3D objects to be aligned using the HoloLens2, including instruments." |
| Functionality (without mechanical tools) | Ability to provide mixed-reality guidance without requiring HipXpert mechanical docking tools. | Allows for "orientation alignment and positional placement of additional 3D objects... without the requirement to use the physical HipXpert mechanical tool." |
| Functionality (limb length measurements) | Ability to use mixed-reality guidance for limb length measurements. | Not explicitly stated as "met" but listed as an added capability in "Additional surgeon needs." |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: "Simulated cadaveric specimens were used." The exact number of specimens is not specified.
- Data Provenance: The study was likely conducted in the United States, given the applicant and correspondent addresses. The study uses "simulated cadaveric specimens," indicating a pre-clinical, prospective evaluation.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
Not specified. The document does not describe the involvement of human experts for establishing ground truth in this particular performance study, as it focused on direct comparative measurements with the predicate using simulated scenarios rather than expert interpretations of clinical images.
4. Adjudication Method for the Test Set
Not applicable. This type of adjudication (e.g., 2+1, 3+1) is typically used in studies involving human interpretation (e.g., radiologists reviewing images) where disagreements need to be resolved. The described testing involved physical and technical measurements on simulated cadaveric specimens.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No. The document explicitly states: "No clinical testing was conducted to support the determination of substantial equivalence." Therefore, an MRMC study to compare human readers with and without AI assistance was not done for this submission.
6. Standalone Performance Study (Algorithm Only Without Human-in-the-Loop)
While the HipInsight system involves human interaction via the HoloLens2, the performance evaluation described ("orientation and position accuracy") is for the system's ability to accurately place 3D objects. This is essentially a standalone (system performance) evaluation, as it quantifies the accuracy of the device's output independently of a surgeon's final clinical outcome. The study aimed to demonstrate the technical accuracy of the augmented features.
7. Type of Ground Truth Used
The ground truth was established through technical measurement and comparison on simulated cadaveric specimens. The "ground truth" for evaluating improvements to the HipInsight system would be the known or measured accurate orientation and position of implants/instruments in the simulated environment, against which the device's output (superimposed 3D objects) was compared. The primary benchmark for the "ground truth" in this 510(k) was the performance of the previously cleared predicate device.
8. Sample Size for the Training Set
Not applicable/Not specified. The document describes a 510(k) submission for modifications to an existing device, and the performance testing mentioned is for verification/validation of these changes (test set), not for training an underlying AI model. The HipXpert planning application uses CT patient image data to create 3D models, which implies some form of data processing, but the document does not discuss a "training set" for a machine learning model. It's possible the original HipXpert development involved training data, but that information is not part of this specific submission summary.
9. How the Ground Truth for the Training Set Was Established
Not applicable/Not specified. See point 8. No training set is explicitly discussed in the context of this 510(k) summary.
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