Search Results

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.

Indications for RSP Humeral Stem Adapters:
The Reverse® Shoulder Prosthesis (RSP) is indicated for treatment of patients with a grossly rotator cuff deficient shoulder joint with severe arthropathy 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.
During primary surgery, after the humerus is prepared for the RSP humeral stem (modular and monoblock), if purchase to the glenoid bone is insufficient to bear the load of the glenoid baseplate and alternative glenoid bone reconstruction and/or repair is inadequate, the corresponding RSP humeral stem adapter can be used to convert the RSP humeral stem to hemiarthroplasty prosthesis as a salvage procedure. During revision surgery of an RSP (modular or monoblock), if the glenoid bone stock appears to be insufficient to bear the load of the glenoid baseplate and alternative glenoid bone reconstruction and/or repair is inadequate, the corresponding RSP humeral stem adapter can be used to convert the RSP device to hemiarthroplasty prosthesis as a salvage procedure. For modular RSP stems, the Foundation Shoulder hymeral head should be used. For the monoblock stem, the Turon humeral head should be used. This stem/adapter construct is not approved for use as a surrogate for traditional hemiarthroplasty or anatomic replacement indications.

The RSP Monoblock 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 components included in this system are a glenoid head, a humeral socket joined with humeral stem, a glenoid baseplate screws.
The modification outlined in this application consists of an addition to the Indications for Use for the humeral stem to allow for cementless implantation. There is no change to the fundamental scientific technology of the RSP Monoblock with the modifications in this 510(k) submission. This includes no changes to materials, design, sterilization, packaging, or method of manufacture.

The provided text is a 510(k) summary for a medical device called the "Reverse® Shoulder Prosthesis Monoblock." This document is a regulatory submission to the FDA for market clearance and does not describe an AI/ML device or a study involving acceptance criteria and device performance in the context of an AI model.

Instead, it details a modification to an existing shoulder prosthesis (allowing cementless implantation of the humeral stem) and asserts its substantial equivalence to predicate devices based on comparable features (material, indications, surgical technique, intended use).

Therefore, I cannot extract the requested information regarding acceptance criteria and a study proving device performance for an AI/ML device from this document. The sections you asked about pertain to AI/ML device evaluations, which are not present here.

Here's why each point cannot be fulfilled based on the provided text:

1. A table of acceptance criteria and the reported device performance: This document discusses a physical medical implant, not a software device with performance metrics like accuracy, sensitivity, or specificity against predefined criteria.
2. Sample sized used for the test set and the data provenance: Not an AI/ML device; no test set in this context.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not an AI/ML device; no ground truth establishment for a test set.
4. Adjudication method for the test set: Not an AI/ML device; no adjudication method described.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done: "Clinical Testing: None provided."
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not an AI/ML device.
7. The type of ground truth used: Not an AI/ML device; no ground truth in the AI/ML sense.
8. The sample size for the training set: Not an AI/ML device; no training set.
9. How the ground truth for the training set was established: Not an AI/ML device; no ground truth for a training set.

Ask a specific question about this device