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Indicated for use in patients with a grossly rotator cuff deficient shoulder joint with severe arthropathy or a previously failed joint replacement with a grossly rotator cuff deficient shoulder joint. The patient's joint must be anatomically and structurally suited to receive the selected implant(s), and a functional deltoid muscle is necessary to use the device. The glenoid baseplate is intended for cementless application with the addition of screws for fixation. The humeral stem is intended for cemented use only.

The RSP Modular Glenoid Baseplate is a multiple piece construct as opposed to a single piece construct as the predicate Reverse Shoulder Prosthesis Baseplate (K041066). The RSP Modular Glenoid Baseplate is fabricated from wrought/forged Ti-6A 1-4V that conforms to ASTM F136. The bottom surface of the baseplate is porous coated with commercially pure titanium (ASTM F67 grade 2) beads. This is the same coating previously cleared under K974294. The baseplate is Hydroxyapatite coated that conforms to ASTM F1185. The distal surface of the glenoid baseplate is porous coated with an incorporated 6.5mm cancellous screw and is intended to be used with four peripheral screws (3.5mm non-locking and/or 5mm locking and non-locking) for additional fixation. The RSP Modular Glenoid Baseplate female taper of the adapter have geometry identical to those used in the predicate Turon Shoulder (K080402).

Here's an analysis of the provided text regarding the acceptance criteria and study for the RSP Modular Glenoid Baseplate, organized to address your specific points:

Acceptance Criteria and Device Performance

Study Information:

Based on the provided text, the device clearance was based on non-clinical testing only. There were no clinical studies performed. The "study" mentioned below refers to the non-clinical testing described.

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

   • Sample Size: Not explicitly stated. The text only mentions "Mechanical fatigue testing, Dynamic testing." The specific number of devices tested for fatigue and dynamic performance is not provided.
   • Data Provenance: Not applicable as this was non-clinical (laboratory) testing, not human data.

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

   • Not applicable. As this was non-clinical mechanical testing, "experts" in the sense of clinical reviewers establishing ground truth for patient data are not relevant. The ground truth would be established by engineering standards and measurements.

3. Adjudication Method for the Test Set:

   • Not applicable. This was non-clinical mechanical testing, not a clinical study requiring adjudication of expert opinions.

4. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:

   • No, an MRMC comparative effectiveness study was not done. The document explicitly states "Clinical Testing: None provided." This type of study is for comparing human reader performance with and without AI assistance, which is not relevant for a mechanical device clearance based on non-clinical testing.

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

   • No, a standalone algorithm performance study was not done. This device is a physical implant, not an AI algorithm.

6. The Type of Ground Truth Used:

   • For the non-clinical testing, the "ground truth" would be established by engineering standards and measurements. This includes material specifications (ASTM F136, F67 grade 2, F1185), as well as the measured fatigue life and dynamic performance data compared against the performance of predicate devices.

7. The Sample Size for the Training Set:

   • Not applicable. There was no "training set" in the context of an AI/machine learning model, as this device uses non-clinical mechanical testing for clearance.

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

   • Not applicable. There was no training set.

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