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The NextAR Shoulder™ Platform supports the surgeon during glenoid implantation in anatomic shoulder replacement procedures providing information on bone preparation, instrument guidance, and implant positioning.

The NextAR Shoulder™ Platform works in conjunction with NextAR™ stereotaxic instruments and general surgical instruments to implant the Medacta Shoulder System Anatomic (TSA - Total Shoulder Arthroplasty). As an optional display, the smart glasses can be used auxiliary to the NextAR Shoulder™ Platform to view the same 2D stereotaxic information as presented by the NextAR Shoulder™ Platform.

The NextAR Shoulder™ stereotaxic instruments are to support the surgeon during specific orthopedic surgical procedures by providing information on bone preparation, instrument guidance, and implant positioning. Once registered, the NextAR™ stereotaxic instruments provide reference to a patient's rigid anatomical structures on the surface of the glenoid that are identified relative to preoperative C.T. based planning.

The smart glasses should not be relied upon solely and should always be used in conjunction with the primary computer display.

Device Description

The Shoulder NextAR™ TSA Platform is a CT based computer-assisted surgical navigation platform used to perform a total shoulder arthroplasty on the glenoid and includes the following components:

PC based hardware platform; (K210153)
. optical tracking system: (K210153)
. Augmented Reality glasses: (K210153)
Platform (K210153) ●
navigation software which displays information to the surgeon in real-time; ●
Reusable surgical instruments to perform the surgical steps of a shoulder anatomic . arthroplasty on the glenoid.

The system operates on the common principle of stereotaxic technology in which markers are mounted on the bones and an infrared camera is used to monitor the spatial location of the markers. Tracking sensors attached to the scapula and surgical instruments enable the surgeon to register the position and orientation of scapula and instrumentation relative to preoperative data in real-time while performing the surgical procedure. The tracking sensors are provided sterile.

Shoulder NextAR™ TSA Platform aid the surgeon in executing the surgical plan by visualizing all the information in real time in a screen monitor.

The NextARTM TSA system is intended to assist the surgeon in executing a preoperative surgical planning. The navigation platform tracks the surgical instruments in real-time and displays intraoperative and planned surgical parameters on a screen, thus allowing the surgeon to match the intraoperative parameters with the planned ones.

Specifically, the navigation system utilizes established technologies of navigation and via an active infrared camera rigidly coupled with the scapula and an active infrared tracker that can be rigidly coupled to the surgical instruments. The registration of the patient's scapula on the preoperative scapula model is performed through the use of dedicated surgical instruments (pointers) and a dedicated registration algorithm.

AI/ML Overview

Here's an analysis of the acceptance criteria and study information for the NextAR™ TSA Platform, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Acceptance Criteria	Reported Device Performance
Cadaver Study	(Specific criteria not detailed in the provided text, but implied as meeting a standard for accuracy and functionality in glenoid implantation.)	Successfully performed in cadaveric testing.
Software Validation	(Specific criteria for software accuracy, reliability, and functionality not detailed in the provided text.)	Validated.
Biocompatibility	Compliance with ISO 10993-1:2009.	Complies.
Sterilization Validation	(Specific criteria for sterility assurance not detailed in the provided text.)	Validated.
Shelf-Life Testing	(Specific criteria for maintaining device integrity and functionality over time not detailed in the provided text.)	Tested.
Electrical Safety	Compliance with IEC 60601-1:2005, COR1:2006, COR2:2007, Amd1:2012.	Complies.
Electromagnetic Compatibility (EMC)	Compliance with IEC 60601-1-2:2014.	Complies.
Mechanical & Optical Properties	(Specific performance metrics not detailed, but implies meeting design specifications.)	Tested.
Glasses Communication	(Criteria for reliable and accurate data transmission to smart glasses not detailed.)	Tested.
Glenoid Registration	Implied as comparable to the predicate (NextAR™ RSA) despite a change in point acquisition method (6+20 points vs. 4+30 points). The rational addressing this change was accepted.	Rational accepted.

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

The document mentions "cadaver study", but does not provide a specific sample size (i.e., number of cadavers) used for this test. The provenance of this data is not explicitly stated beyond "cadaveric testing," so the country of origin and whether it was retrospective or prospective is unknown.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

The document does not provide information on the number of experts used, nor their specific qualifications, for establishing ground truth in the cadaver study.

4. Adjudication Method for the Test Set

The document does not mention any specific adjudication method (e.g., 2+1, 3+1, none) used for the test set.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size

The document does not indicate that an MRMC comparative effectiveness study was conducted. Therefore, no effect size of human readers improving with AI vs. without AI assistance is provided. The device focuses on assisting the surgeon, not necessarily comparing human performance with and without AI in an MRMC setting.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

The document describes the device as a "computer-assisted surgical navigation platform" that "supports the surgeon" and "aids the surgeon." It functions with human-in-the-loop, displaying information "in real-time" to the surgeon. While software validation ensures the algorithm's correctness, the regulatory submission does not explicitly detail a standalone performance study without human input for the primary clinical function. The smart glasses are specifically mentioned as an "optional display" that "should not be relied upon solely and should always be used in conjunction with the primary computer display," reinforcing the human-in-the-loop nature.

7. The Type of Ground Truth Used

The ground truth for the cadaver study is implied to be based on the surgical plan and desired anatomical positioning/accuracy, as the device aims to "aid the surgeon in executing a preoperative surgical planning" and "match the intraoperative parameters with the planned ones." It implicitly relies on the accuracy of the CT-based planning and the ability of the system to guide instruments to achieve that plan in a cadaveric setting. There is no mention of pathology or outcomes data as ground truth for this initial regulatory clearance.

8. The Sample Size for the Training Set

The document does not provide information on the sample size used for the training set of the navigation software or any machine learning components within the device.

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

The document does not provide information on how the ground truth for the training set was established. Given the nature of a navigation system, it would likely involve highly accurate anatomical models, surgical planning data, and potentially expert annotations, but these details are not present in the provided text.

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