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The Shoulder NextAR™ RSA Platform supports the surgeon during glenoid implantation in reverse shoulder replacement procedures providing information on bone preparation, instrument guidance, and implant positioning. The Shoulder NextAR™ RSA Platform works in conjunction with NextAR™ stereotaxic instruments and general surgical instruments to implant the Medacta Shoulder System Reverse Shoulder Arthroplasty). As an optional display, the smart glasses can be used auxiliary to the Shoulder NextAR™ Platform to view the same 2D stereotaxic information as presented by the Shoulder NextARTM Platform.

The Shoulder NextAR™ stereotaxic instruments are to support the surgeon during specific orthopedic surgical steps 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.

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

• PC based hardware platform; (K193559 and K202152)
• optical tracking system; (K193559 and K202152)
• Augmented Reality glasses; (K193559 and K202152)
• Platform (K193559 and K202152)
• navigation software which displays information to the surgeon in real-time;
• Reusable surgical instruments to perform the surgical steps of a shoulder reverse 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 view 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™ RSA Platform aids the surgeon in executing the surgical plan by visualizing all the information in real time on a screen monitor.

The NextAR™ RSA 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.

The provided text describes the 510(k) summary for the Medacta International SA NextAR™ RSA Platform, a CT-based computer-assisted surgical navigation platform for reverse shoulder arthroplasty. The performance data section is brief, stating that testing was conducted according to written protocols with acceptance criteria based on standards, and mentions a "cadaver study" and an "in vitro study." However, it does not provide specific details about the acceptance criteria themselves, the reported device performance against those criteria, the sample sizes, expert qualifications, ground truth methods, or any MRMC study results. The text indicates that some studies were accepted from previous submissions of related devices (NextAR™ TKA Platform K193559 and K202152), but these are general safety and performance tests (biocompatibility, sterilization, shelf-life, electrical safety, EMC, mechanical/optical properties) and not performance data explicitly proving the navigation system's accuracy or effectiveness in its specific use case for shoulder arthroplasty.

Therefore, based solely on the provided text, I cannot populate most of the requested information regarding the acceptance criteria and the study that proves the device meets them. The document states that the studies were performed "in support of a substantial equivalence determination," but it does not present the detailed results of these specific performance studies.

Here's a breakdown of what can be inferred or what is explicitly missing:

Acceptance Criteria and Device Performance (As much as can be extracted from the provided text)

The document broadly states that "Testing was conducted according to written protocols with acceptance criteria that were based on standards." However, it does not present a table of specific acceptance criteria or the reported device performance against them.

Study Details:

1. A table of acceptance criteria and the reported device performance:

   • Not provided in the document. The document mentions "acceptance criteria that were based on standards" but does not list them or the performance results.

2. Sample sized used for the test set and the data provenance:

   • The document mentions a "cadaver study" and an "in vitro study."
   • Sample Size: Not specified for either study.
   • Data Provenance: Not specified (e.g., country of origin). Both appear to be prospective experimental studies (cadaveric and in vitro).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

   • Not specified. The document does not describe how ground truth was established for the cadaver or in vitro studies, nor does it mention experts for this purpose.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

   • Not specified.

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:

   • Not specified. The document does not mention an MRMC study or any assessment of human reader improvement with AI assistance. The device is a surgical navigation platform, not an AI diagnostic tool that assists human readers.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

   • The document mentions "performance testing to evaluate mechanical and optical properties" and "software validation," which would likely involve standalone performance evaluations of system components and the algorithm. However, specific details of these tests as they relate to clinical accuracy or a defined "standalone" performance metric for the navigation itself are not elaborated. The cadaver and in vitro studies would assess the system's performance, but how "standalone" vs. "human-in-the-loop" was defined and measured is not clear.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):

   • Not specified. For a navigation system, ground truth would typically refer to highly accurate measurements of actual bone or instrument positions relative to an established plan. The method (e.g., CMM measurements, highly accurate image registration) is not detailed.

8. The sample size for the training set:

   • Not applicable/Not specified. The document describes a navigation system based on "established technologies of navigation" and "dedicated registration algorithm," rather than a machine learning model that requires a "training set" in the conventional sense for AI. If elements of the "software validation" involved training machine learning components, this is not disclosed.

9. How the ground truth for the training set was established:

   • Not applicable/Not specified, for the same reasons as #8.

Summary of Missing Information:

The provided 510(k) summary is very high-level regarding the specific performance studies. It confirms that a cadaver study and an in vitro study were performed to support substantial equivalence, but it omits the critical details of these studies, such as:

• Specific quantitative acceptance criteria.
• The numerical results obtained from the device (e.g., accuracy, precision values).
• The number of samples (cadavers, in vitro setups).
• The methodologies for establishing ground truth.
• Any details about expert involvement or adjudication.

This type of detailed information is typically found in the full testing reports or sections within the 510(k) submission that are not publicly available in this summary format.

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