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The TITAN Reverse Shoulder System is indicated for use in a grossly deficient rotator cuff joint with severe arthropathy or a previous failed joint replacement with a grossly deficient rotator cuff joint. The patient's joint must be anatomically and structurally suited to receive the selected implants and a functional deltoid muscle is necessary to use the device. The TITAN Reverse Shoulder System is indicated for primary, fractures - including proximal humeral, or revision total shoulder replacement for the relief of pain and significant disability due to gross rotator cuff deficiency. The glenoid base plate is intended for cementless application with the addition of screws for fixation. The humeral stem is indicated for cemented or uncemented use and the humeral body component is intended for cementless use.

The TITAN Reverse Total Shoulder System is a semi-constrained total shoulder construct. The humeral components consist of humeral stems, reverse bodies of varying heights, and humeral poly liners. The poly liners are available in varying thicknesses and constraints to achieve stability and offset of the glenohumeral joint. The variable length reverse bodies and proximally-filling shape are designed to accommodate the natural humeral geometry, providing stable fixation as well as proximal bone loading. The glenoid components are composed of a baseplate secured by a central compression screw and four peripheral screws, two of which can be locked. A glenosphere is attached to the baseplate via taper lock. Glenospheres are available in varying offsets and lateralizations. The stems are intended for

The provided text describes a 510(k) premarket notification for a medical device, the Integra TITAN Reverse Shoulder System, with a specific focus on a coating change. It outlines the regulatory process and provides a summary of nonclinical performance data used to demonstrate substantial equivalence to a predicate device.

Here's an analysis of the acceptance criteria and study information:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not explicitly state the specific sample sizes for the test sets in the performance tests (Dynamic Evaluation, Fatigue Test, Coating Evaluation). It mentions that "The TITAN Reverse Shoulder System has undergone the following performance testing," implying that these were conducted on samples of the device components.

The data provenance is from nonclinical performance data (laboratory testing) conducted by the manufacturer, Integra Lifesciences Corp. No information on country of origin for the data is provided beyond being internal testing for the US market. The studies are prospective in nature, as they are specifically conducted to support the 510(k) submission for the modified device.

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

This information is not provided in the document. For nonclinical performance tests of a medical device like this, ground truth is typically established by the results of standardized engineering and materials tests (e.g., measuring force, displacement, fatigue cycles) rather than by expert consensus in the way a clinical study would use radiologists or pathologists. The acceptance criteria themselves, referencing FDA guidance documents, serve as a form of "ground truth" for what constitutes acceptable performance for these types of tests.

4. Adjudication Method for the Test Set

This is not applicable as the tests are nonclinical (laboratory-based) and do not involve human interpretation or subjective assessment that would require an adjudication method. The results are quantitative measurements against predefined criteria.

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

No, an MRMC comparative effectiveness study was not done. The document explicitly states: "Clinical performance data are not required to demonstrate substantial equivalence to the predicate device, as there have been no changes to fit, form, or function of the device." This indicates that the 510(k) submission relies solely on nonclinical (bench) testing to show that the coating change does not alter the fundamental safety or effectiveness compared to the predicate device. Therefore, there's no discussion of human reader improvement with or without AI assistance.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

No, a standalone study (or any study related to an algorithm or AI) was not done. This device is a mechanical implant (Titanium Reverse Shoulder System) and does not involve AI or algorithms.

7. Type of Ground Truth Used

The ground truth used for the performance tests (Dynamic Evaluation, Fatigue Test, Coating Evaluation) is based on pre-defined acceptance criteria derived from FDA guidance documents and industry standards for mechanical and material properties of orthopedic implants. These criteria specify acceptable limits for mechanical performance (resistance to loosening, fatigue strength) and material characteristics (coating properties).

8. Sample Size for the Training Set

This information is not applicable. Since the device is a mechanical implant and not an AI/ML algorithm, there is no "training set." The engineering tests are performed on physical samples of the device components.

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

This is not applicable for the same reason as above; there is no training set for a mechanical device. The "ground truth" for evaluating the performance of the device is established by the specified acceptance criteria for the nonclinical tests.

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