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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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The indications for use of the total hip replacement prosthesis include: noninflammatory degenerative joint disease including osteoarthritis and avascular necrosis; rheumatoid arthritis; correction of functional deformity; revision procedures where other treatments or devices have failed; and treatment of nonunion, femoral neck and trochanteric fractures of the proximal femur with head involvement, which is unmanageable using other techniques. This stem is to be press-fit.

The Linear stems without HA coating were cleared for commercial distribution on K974294 and K991325; the Foundation stem on K973302 and K991226; and the The only difference between the devices cleared in the Revelation on K973685. aforementioned submissions and this is the addition of hydroxyapatite to the porous The porous coating is plasma sprayed with coated regions of the proximal bodies. hydroxyapatite (HA).

I am sorry, but the provided text does not contain information about acceptance criteria or a study proving the device meets acceptance criteria for HA Coated Hip Stems. The document is a 510(k) summary and FDA letter, which primarily focuses on establishing substantial equivalence to predicate devices for regulatory clearance, rather than detailing performance studies and specific acceptance criteria.

The information provided only discusses:

• The submitter's name and address
• Device name, common name, and classification name
• Legally marketed predicate devices
• Subject device description and intended use
• Technological characteristics and basis for substantial equivalence to predicate devices.
• The FDA's decision to clear the device for market based on substantial equivalence.

Therefore, I cannot extract the requested information regarding acceptance criteria or a study proving the device meets those criteria from the provided text.

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