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The Encore Reverse Shoulder Prosthesis (RSP) is intended 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.

During primary surgery, after the humerus is prepared for the RSP humeral stem, if the glenoid bone stock appears "insufficient" to bear the load of the glenoid baseplate, a RSP humeral stem adapter can be used to convert the RSP humeral stem to a hemiarthroplasty prosthesis. During revision surgery of an RSP, if the glenoid bone stock appears to be "insufficient" to bear the load of the glenoid baseplate device; a RSP Humeral Stem Adapter is used to convert the RSP device to a hemiarthroplasty prosthesis.

The Encore Reverse Shoulder Prosthesis (RSP) is indicated for salvage procedures for irreparable rotator cuff, failed hemi or total shoulder arthroplasty with irreparable rotator cuff, and for fracture in which the tuberosity and rotator cuff are irreparable. Unlike traditional total shoulders, the RSP 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 attached to the humeral stem. The RSP Humeral Stem Adapter is used to convert the RSP to a hemiarthroplasty when the glenoid bone stock appears to be "insufficient" to bear the load of the glenoid baseplate device. There is no change to the intended use or fundamental scientific technology of the RSP with the modifications in this Special 510(k) submission.

The provided text describes a medical device, the Encore Reverse Shoulder Prosthesis (RSP), and its approval via a 510(k) submission. However, it does not contain information about acceptance criteria or a study proving the device meets specific performance metrics.

The 510(k) process is primarily a demonstration of substantial equivalence to a legally marketed predicate device, rather than a clinical trial proving specific performance acceptance criteria. The document states: "We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices..." and "The modified Encore RSP is similar in design, materials, and intended use to the previously cleared Encore RSP devices, K041066 and K051075."

Therefore, I cannot provide the requested information as it is not present in the given text.

To answer your specific questions, based on the provided text:

1. A table of acceptance criteria and the reported device performance: Not available. The document does not describe specific performance criteria or a study that measures the device against them.
2. Sample sized used for the test set and the data provenance: Not available. No "test set" in the context of performance evaluation is mentioned.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not available.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not available.
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 applicable. This device is a shoulder prosthesis, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is a physical implant.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc): Not available. The approval is based on substantial equivalence to predicate devices, not on direct performance against a "ground truth" as might be seen for diagnostic devices.
8. The sample size for the training set: Not applicable. This is not an AI/ML device that requires a training set.
9. How the ground truth for the training set was established: Not applicable.

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The Encore Reverse Shoulder Prosthesis® (RSP) is 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 Encore Reverse Shoulder Prosthesis (RSP) is indicated for salvage procedures for irreparable rotator cuff, failed hemi or total shoulder arthroplasty with irreparable rotator cuff, in operation our, half, half hand rotator cuff are irreparable. Unlike traditional total shoulders, the RSP 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 attached to the humeral stem. buooplate, and this system are a glenoid head, a humeral socket, a humeral stem, a glenoid baseplate, and baseplate screws. The glenoid baseplate is intended for cementless a glondia baouplate, and bon of screws for fixation. The humeral stem is intended for cemented use only. There is no change to the intended use or fundamental scientific technology of the RSP with the modifications in this Special 510(k) submission.

The provided text does not contain information about acceptance criteria, device performance, or any studies conducted to prove the device meets specific criteria. The document is primarily a 510(k) summary and an FDA clearance letter for the Encore Reverse Shoulder Prosthesis (RSP), stating its indications for use and substantial equivalence to a previously cleared device.

Therefore, I cannot populate the table or answer the specific questions regarding acceptance criteria and study details. The information about the device's technical specifications and the regulatory clearance process is present, but not the performance evaluation data you're asking for.

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The Reverse Shoulder is indicated for use in patients with a grossly rotator cuff deficient shoulder joint and one of the following:

1. Pseudoparalysis of the shoulder.
2. Severely painful and functionally impaired shoulder joint.
3. 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 Reverse Shoulder Prosthesis is a total shoulder prosthesis designed specifically for use in patients with non-functional rotator cuffs. The articulation of this design is "inverted" compared to traditional total shoulder prosthesis'. Unlike traditional total shoulders, the Reverse Shoulder is designed so that the "ball" of the articulation fits into the glenoid baseplate, and the "cup" of the articulation fits into the humeral stem. The distal surface of the glenoid baseplate is porous coated with an incorporated 6.5 cancellous screw and is intended to be used with 4 peripheral screws (3.5 non-locking and/or 5.0mm locking and non-locking) for additional fixation.

The provided text is a 510(k) premarket notification for the Encore Reverse Shoulder Prosthesis. This type of regulatory document is for medical devices and focuses on demonstrating substantial equivalence to a predicate device, rather than conducting new clinical studies to prove effectiveness or meet specific performance criteria beyond those of the predicate.

Therefore, the document does not contain the acceptance criteria or a study proving the device meets said criteria in the way you've outlined for a typical diagnostic algorithm or AI study. Instead, it relies on demonstrating that the new Encore Reverse Shoulder is substantially equivalent to the DePuy Delta Shoulder (K0231478).

Here's why the information you're asking for isn't present in this type of document:

• Medical Device Equivalence: 510(k) clearances are for demonstrating that a new device is as safe and effective as a legally marketed predicate device. This is often done through comparison of technological characteristics, indications for use, and possibly bench testing or non-clinical data, but not typically through new clinical trials with acceptance criteria for performance metrics like sensitivity, specificity, accuracy, etc.
• Physical Prosthesis vs. AI/Diagnostic Device: The Encore Reverse Shoulder Prosthesis is a physical implant, not a diagnostic algorithm or an AI-powered device. Therefore, the concepts of a "test set," "ground truth," "expert adjudication," "MRMC study," or "standalone algorithm performance" are not applicable in this context. Performance for such devices usually relates to biocompatibility, mechanical strength, surgical outcomes (which would be tracked post-market), and safety, rather than classification metrics.

In summary, the information requested in your prompt (Table of acceptance criteria, sample sizes for test/training, number/qualifications of experts, adjudication, MRMC, standalone performance, ground truth types, etc.) is not present in the provided 510(k) document because it pertains to a different type of device and regulatory approval pathway.

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