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510(k) Data Aggregation
(314 days)
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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(137 days)
OptiVu™ ROSA® MxR is indicated for displaying surgical workflow images from the ROSA® RECON platform in Mixed Reality. It includes functions for viewing the same surgical workflow steps and 2D visualizations as presented on the existing ROSA RECON platform user interface. When accessing ROSA® MxR from a stereoscopic head mounted display (HMD), images viewed are for informational purposes only and are not intended for diagnostic use.
OptiVu™ ROSA® Mixed Reality (ROSA® MxR) is indicated for displaying surgical workflow images from the ROSA® RECON Platform and the corresponding ROSA® clinical applications intra-operatively during orthopedic surgeries. It is intended to provide an additional means of display where the ROSA® RECON Platform user interface is duplicated into a Mixed Reality see-through environment. OptiVu™ ROSA® MxR allows the ROSA® RECON Platform user interface and corresponding ROSA® clinical applications (e.g. ROSA® Knee, ROSA® Partial, or ROSA® Hip) to be streamed through a compatible head-mounted display (HMD) (e.g. HoloLens 2).
The subject device's main purpose is to place the duplicated virtual ROSA® user interface at a convenient location to provide the following functionalities:
- Mixed Reality visualization solution
- Register hand gestures as inputs such as to touch, move and resize views
- Wireless connectivity between a HMD (e.g. HoloLens 2) and the ROSA® RECON Platform
The OptiVu™ ROSA® MxR device is designed to display surgical workflow images from the ROSA® RECON platform in Mixed Reality. It includes functions for viewing the same surgical workflow steps and 2D visualizations as presented on the existing ROSA RECON platform user interface via a head-mounted display (HMD) like the HoloLens 2. It's important to note that images viewed through the HMD are for informational purposes only and are not intended for diagnostic use.
Here's an analysis of the acceptance criteria and the study proving the device meets them:
1. Table of Acceptance Criteria and Reported Device Performance
The provided document does not explicitly list quantitative acceptance criteria in a typical tabular format. Instead, it describes general performance goals and verification activities. The overall acceptance criterion is demonstrating substantial equivalence to predicate devices without raising new questions of safety and effectiveness.
| Acceptance Criterion (Inferred from Document) | Reported Device Performance (Summary) |
|---|---|
| Display surgical workflow images from ROSA® RECON platform in Mixed Reality | Successfully streams a duplicate of the ROSA® RECON Platform user interface in Mixed Reality in real-time. |
| View same surgical workflow steps as existing ROSA RECON platform UI | Includes functions for viewing the same surgical workflow steps. |
| View same 2D visualizations as existing ROSA RECON platform UI | Includes functions for viewing the same 2D visualizations. |
| Register hand gestures as inputs (touch, move, resize views) | Device is designed to register hand gestures as inputs. |
| Wireless connectivity between HMD and ROSA® RECON Platform | Provides wireless connectivity between the HMD (e.g., HoloLens 2) and the ROSA® RECON Platform. |
| Performance of implemented features | Physical/Performance Tests were conducted to ensure performance of implemented features and verify related design inputs. |
| Software safety and effectiveness | Software Verification and Validation Testing was conducted, meeting FDA Guidance and IEC 62304 standards for a "major" level of concern. Testing demonstrates no new issues of safety and effectiveness. |
| No new questions of safety and effectiveness compared to predicates | Differences between the device and predicates do not raise new questions of safety and effectiveness; device is at least as safe and effective. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify a separate "test set" in the context of a clinical study with patient data. The performance evaluations described are primarily non-clinical device performance testing, engineering analysis, software verification and validation, and usability engineering. Therefore, the concept of sample size for patient data or data provenance (country of origin, retrospective/prospective) is not directly applicable in the information provided.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
As there is no mention of a clinical test set requiring expert-established ground truth related to patient data or diagnostic interpretations, this information is not provided. The device explicitly states that images viewed through the HMD are "for informational purposes only and are not intended for diagnostic use."
4. Adjudication Method for the Test Set
Given the absence of a clinical test set requiring expert interpretation of patient data, there is no mention of an adjudication method (e.g., 2+1, 3+1). The performance testing described focuses on the device's technical functionality and software integrity.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC comparative effectiveness study involving human readers with and without AI assistance was not mentioned in the provided document. The device's indications for use emphasize displaying surgical workflow information rather than diagnostic interpretation or AI-driven decision support for human readers.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
The document describes "Software Verification and Validation Testing" and "Device Performance Testing." While these are standalone tests of the algorithm's functional performance, they are not presented as a standalone clinical performance study in the sense of an algorithm making diagnostic or treatment decisions without human oversight. The device is an accessory for surgical workflow information display, not an autonomous diagnostic or therapeutic algorithm.
7. The Type of Ground Truth Used
For the software and device performance testing:
- Engineering specifications and design inputs served as the "ground truth" or reference for verification and validation activities. The tests aimed to ensure the device met these predefined requirements.
- Regulatory standards and guidance documents (e.g., FDA Guidance for Content Premarket Submissions for Software, IEC 62304) provided the "ground truth" for software quality and safety.
No "ground truth" in terms of expert consensus, pathology, or outcomes data for clinical decision-making is mentioned, consistent with its informational purpose.
8. The Sample Size for the Training Set
The document does not provide information on a "training set" in the context of machine learning. The device appears to be primarily an interface and display tool, integrating with existing ROSA® RECON Platform software, rather than a system that learns from a large dataset.
9. How the Ground Truth for the Training Set Was Established
As no training set (for machine learning) is discussed, the method for establishing its ground truth is not applicable or provided.
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