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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 HipXpert 3D Display and Anchoring application with the HoloLens2 is indicated for visual alignment of an acetabular cup impactor during hip arthroplasty when pin-based fixation of the HipXpert tool is utilized.

The HipXpert system provides a patient-specific hip arthroplasty surgical plan allowing for accurate acetabular positioning using CT mapping of a patient's pelvis using a software application and a reusable, manual, mechanical navigation instrument.

The HipXpert software planning application uses 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 mechanical instrument has three legs which are secured to the pelvis. The legs form three points which define the sextant plane. The HipXpert mechanical instrument has two protractors that are adjusted to orientate an indicator pin in the direction of the desired orientation of the acetabular component.

The subject HipXpert 3D Display and Anchoring Application utilizes the previously cleared (K093491) HipXpert planning application and HipXpert tools in addition to a mixed reality headset (Microsoft HoloLens2) and QR target. The HoloLens2 is an off-the-shelf component developed and manufactured by Microsoft which is used to view superimposed 3D images from the HipXpert planning application on the real HipXpert tool. In order to properly orient the 3D images displayed by the HoloLens2, a QR target is used to anchor these 3D images in space as they are overlaid on the real HipXpert tool.

The HipXpert System, specifically the 3D Display and Anchoring application with the HoloLens2, was evaluated to ensure accurate alignment of an acetabular cup impactor during hip arthroplasty when pin-based fixation of the HipXpert tool is utilized.

Here's a breakdown of the acceptance criteria and the study proving the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance

The provided text details various validation and verification activities rather than specific quantitative acceptance criteria in a table format. However, the performance reported for the HipXpert System focused on aspects like software validation, system orientation and position accuracy, image registration and tracking accuracy, and headset display performance.

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

The non-clinical testing included a cadaveric model for verifying overall system orientation and position accuracy. The specific number of cadaveric models used is not specified.

Regarding data provenance for the accuracy testing, it was conducted internally as part of the device's verification and validation. The text does not specify the country of origin of the data or whether it was retrospective or prospective, but given it's a device validation, it would be considered prospective for the purpose of the study.

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 or qualifications of experts used to establish ground truth for the test set.

4. Adjudication Method for the Test Set

The document does not describe any specific adjudication method for establishing ground truth for the test set. The validation methods mentioned (cadaveric model using screws placed into the acetabulum and methods analogous to ASTM F2554-10) imply objective measurement rather than expert consensus on subjective evaluations.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, If So, What Was the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance

No MRMC comparative effectiveness study was mentioned. The HipXpert system is a surgical planning and alignment tool, and the focus of this submission is on the accuracy of the augmented reality display for guiding tool placement, not on interpreting images or improving human reader performance in a diagnostic context.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

The HipXpert system, including the 3D Display and Anchoring application, is inherently a human-in-the-loop system. It provides visual guidance to a human surgeon. Therefore, a standalone (algorithm only) performance evaluation without human interaction would not be applicable or relevant to its intended use and was not described. The validation focused on the system's accuracy while being used by a human, even if a cadaver was the "patient."

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

The ground truth for the accuracy evaluations appears to be based on objective physical measurements and established engineering standards. For instance, in the cadaveric model, the ground truth for "overall system orientation and position accuracy" would likely be the known, precise placement of screws in the acetabulum, validated by direct measurement or pre-defined landmarks. For system accuracy, image registration accuracy, and tracking accuracy, the ground truth would be precise measurements and positional data defined by the test setup, as per methods analogous to ASTM F2554-10, which are standards for evaluating the accuracy of medical image processing software and surgical navigation systems using precise physical fiducials and defined spatial relationships.

8. The Sample Size for the Training Set

The document does not provide information on the sample size used for the training set of any machine learning algorithms within the HipXpert System. The text primarily focuses on the validation of the system's functionality and accuracy, specifically the 3D display and anchoring application, rather than the development of the underlying planning algorithms (which existed in the predicate device K093491).

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

Since no specific information about a training set for machine learning was provided, the method for establishing its ground truth is also not mentioned. The HipXpert software planning application itself, which creates the 3D model and instrument settings, was part of a previously cleared device (K093491). The current submission focuses on the augmented reality display portion.

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