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The Reverse® Shoulder Prosthesis Monoblock is indicated for patients with a functional deltoid muscle with a grossly deficient rotator cuff shoulder joint with severe arthropathy or a previously failed joint replacement with a grossly deficient rotator cuff shoulder joint:

• In cases of fracture of glenohumeral joint from trauma or pathologic conditions of the shoulder, . including humeral head fracture or displaced 3- or 4-part fractures of proximal humerus. (For cemented implantation only)
• In cases of bone defect in proximal humerus.
  The patient's joint must be anatomically and structurally suited to receive the selected implant(s).
  The glenoid baseplate is intended for cementless application with the addition of screws for fixation. The humeral stem is intended for cemented or cementless use.

The RSP system is designed so that the "ball" of the articulation fits into the glenoid baseplate, and the "cup" of the articulation fits into a metal cup that is joined to the humeral stem. The RSP Monoblock stem includes a humeral stem with socket attached, and humeral socket insert. This change is to replace the current titanium plasma spray coating with porous coating on the size 6 stem only. There are no changes to the fundamental scientific technology of the RSP Monoblock with the modifications in this 510(k) submission.

This document is a 510(k) premarket notification for a medical device (Reverse® Shoulder Prosthesis Monoblock). It does not describe a study conducted to demonstrate that a device meets specific acceptance criteria based on its performance in assessing or diagnosing conditions. Instead, this document is focused on demonstrating that a physical implant is substantially equivalent to previously marketed devices.

Therefore, most of the requested information (related to device performance in a diagnostic or assessment context, such as sample sizes, expert ground truth, adjudication methods, MRMC studies, standalone performance, training sets, etc.) is not applicable to this type of submission.

However, I can extract information regarding non-clinical testing which serves as the "study" demonstrating the device meets performance criteria for a physical implant.

Here's a breakdown of the relevant information provided in the document:

1. Table of Acceptance Criteria and Reported Device Performance:

The document describes non-clinical testing performed to ensure the updated device (specifically, the change from titanium plasma spray coating to porous coating on the size 6 stem) remains substantially equivalent to its predicates. The acceptance criteria are implicitly met if the test results are comparable to the predicate devices and demonstrate satisfactory performance for the intended use of the implant.

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

• Sample Size: Not specified in terms of number of physical devices or tests conducted for each parameter. The document generally states "All testing."
• Data Provenance: The testing was non-clinical (laboratory-based) and conducted by the manufacturer, DJO Surgical, in preparation for the 510(k) submission. Therefore, it is prospective in the context of the submission. The country of origin of the data would be the location where DJO Surgical conducted its testing (implicitly, the United States, given the address included).

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

• Not applicable. This device is a physical implant, and the "ground truth" for its performance is established through engineering and biomechanical testing standards, not expert medical opinion on a dataset.

4. Adjudication Method for the Test Set:

• Not applicable. This testing involves objective measurements against engineering specifications and comparison to predicate device performance, not subjective review requiring adjudication.

5. Multi Reader Multi Case (MRMC) Comparative Effectiveness Study:

• No. This is a 510(k) submission for a physical implant, not an AI/diagnostic device.

6. Standalone (i.e., algorithm only without human-in-the-loop performance) Study:

• No. This is a physical implant, not an algorithm.

7. Type of Ground Truth Used:

• The "ground truth" for this device's performance is established by engineering specifications, industry standards, and the performance characteristics of predicate devices that have been previously deemed safe and effective. The non-clinical tests verify that the modified device meets these established performance benchmarks.

8. Sample Size for the Training Set:

• Not applicable. This is not a machine learning or AI device.

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

• Not applicable. This is not a machine learning or AI device.

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