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The Comprehensive® Reverse Shoulder is indicated for use in patients whose shoulder joint has a grossly deficient rotator cuff with severe arthropathy and/or previously failed shoulder joint replacement with a grossly deficient rotator cuff. The patient must be anatomically and structurally suited to receive the implants and a functional deltoid muscle is necessary.

The Comprehensive® Reverse Shoulder is indicated for primary, fracture, or revision total shoulder replacement for the relief of pain and significant disability due to gross rotator cuff deficiency.

Glenoid components with Hydroxyapatite (HA) coating applied over the porous coating are indicated only for uncemented biological fixation applications. The Glenoid Baseplate components are intended for cementless application with the addition of screw fixation.

Interlok® finish humeral stems are intended for cemented use and the MacroBond® coated humeral stems are intended for press-fit or cemented applications. Humeral components with porous coated surface coating are indicated for either cemented or uncemented biological fixation applications.

The Comprehensive® Reverse Shoulder is intended for total shoulder replacement in a reverse shoulder configuration. Unlike traditional total shoulder replacement, a reverse shoulder employs a ball for articulation on the glenoid side of the joint and a polyethylene bearing surface on the humeral side of the joint. This device configuration increases the lever arm of the deltoid muscle bundle to provide stability and the ability to raise the arm. This is especially useful in cases where a patient has a non-functioning rotator cuff which severely limits traditional joint replacement options.

This document describes a 510(k) premarket notification for the "Comprehensive® Reverse Shoulder - Mini Baseplate" device. The submission focuses on demonstrating substantial equivalence to a legally marketed predicate device (Comprehensive® Reverse Shoulder, 510(k) K080642), rather than establishing new acceptance criteria for a novel device. Therefore, the information typically associated with acceptance criteria and a study proving a device meets these criteria in the context of an AI/ML or diagnostic device is not directly applicable here.

However, I can extract the relevant information regarding the performance data section and how substantial equivalence was demonstrated for this medical device, which serves a similar purpose of proving the device's safety and effectiveness compared to an existing standard.

Here's a breakdown of the available information structured to best fit your request:

1. Table of Acceptance Criteria and Reported Device Performance

In the context of this 510(k) submission for a medical implant, "acceptance criteria" refers to demonstrating that the new device (Mini Baseplate) performs equivalently to the predicate device in terms of mechanical properties and materials, ensuring it is safe and effective for its intended use. The table below summarizes the comparison to the predicate device. Specific numerical acceptance criteria are not explicitly stated as pass/fail thresholds in this summary but are implied by the statement "performed within the intended use" and "did not raise any new safety and efficacy issues."

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

• Sample Size: Not explicitly stated. For mechanical testing of medical devices, sample sizes are typically determined by relevant ISO or ASTM standards (e.g., n=5 or n=6 per group for certain tests), but the exact numbers are not provided in this summary.
• Data Provenance: The tests are non-clinical (mechanical bench testing). Therefore, there is no "country of origin of the data" in the human data sense, nor is it retrospective or prospective. The data is generated in a laboratory setting.

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

This information is not applicable to this type of submission. "Ground truth" in this context would refer to the physical and mechanical properties of the materials and device components. The "truth" is established by standard engineering principles and validated testing methods according to recognized standards.

4. Adjudication Method for the Test Set

Not applicable. Adjudication methods like 2+1 or 3+1 typically refer to human expert judgment in clinical or diagnostic studies. This submission relies on objective mechanical testing.

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

No, an MRMC study was not done. This type of study is relevant for diagnostic devices where human readers interpret medical images or data, and AI assistance can potentially improve their performance. This submission is for a surgical implant, not a diagnostic tool.

6. Standalone (Algorithm Only) Performance Study

No, a standalone algorithm performance study was not done. This point is relevant for AI/ML diagnostic tools.

7. Type of Ground Truth Used

The "ground truth" for non-clinical performance data for an orthopedic implant like this is based on:

• Material specifications: Compliance of the Ti-6Al-4V material to established standards (e.g., ASTM F136).
• Design specifications: The dimensions and geometric features of the components.
• Mechanical properties: The measured strength, stiffness, fixation integrity, and separation resistance against established performance benchmarks or comparisons to the predicate device, as determined by standardized mechanical testing methods.

8. Sample Size for the Training Set

Not applicable. This device is not an AI/ML product and does not have a "training set."

9. How the Ground Truth for the Training Set was Established

Not applicable. As this is not an AI/ML device, there is no training set or ground truth established in this manner.

In summary: The submission demonstrates substantial equivalence of the "Comprehensive® Reverse Shoulder - Mini Baseplate" to its predicate device through non-clinical performance testing (e.g., compressed shear load, baseplate fixation, axial separation, torsional separation). The results of these tests confirmed that the modified device "performed within the intended use, did not raise any new safety and efficacy issues and were found to be substantially equivalent to the predicate devices." This is the primary "proof" for regulatory acceptance for this type of medical device.

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