Search Results

The Integra 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 Integra TITAN Reverse Shoulder System (RSS) is a semi-constrained total shoulder construct. The humeral components consist of humeral stems, reverse bodies of varying heights, and humeral liners. The humeral 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 implant scope of the RSS is being expanded to include additional options for humeral liners manufactured from highly crosslinked Ultra High Molecular Weight Polyethylene (XLPE) per ASTM F2565. The existing humeral liners are manufactured from conventional UHMWPE per ASTM F648. The change in material allows for improved wear characteristics of the humeral liners.

I am sorry, but the provided text describes a medical device called the "Integra TITAN Reverse Shoulder System" which is a shoulder joint prosthesis. The document is a 510(k) premarket notification from the FDA. This type of document pertains to the mechanical and material characteristics of an implantable device, rather than the performance of a software algorithm or AI-powered diagnostic tool.

Therefore, the requested information regarding acceptance criteria and studies related to AI/software performance is not present in the provided text. The document focuses on bench testing (nonclinical performance data) for the physical properties of the implant, such as fatigue, disassembly, rotational resistance, and wear.

Here's a breakdown of why I cannot fulfill your request based on this document:

• No AI/Algorithm: The Integra TITAN Reverse Shoulder System is a physical medical implant, not a software or AI-driven device.
• No Diagnostic Claims: It does not make diagnostic claims that would require evaluation of metrics like sensitivity, specificity, or reader performance.
• No Test Set/Training Set: Concepts like test sets, training sets, ground truth, expert adjudication, or MRMC studies are irrelevant to this type of device and its regulatory review.

The document states: "Clinical performance data is not required to demonstrate substantial equivalence to the predicate RSS device." This indicates that the evaluation for this device relies on non-clinical (bench) testing, rather than clinical trials or studies involving human readers or algorithm performance.

Ask a specific question about this device

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 Integra TITAN Reverse Shoulder System (RSS) is a semi-constrained total shoulder construct. The humeral components consist of humeral stems, reverse bodies of varying heights, and humeral liners. The humeral 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 cemented and cementless use. The scope of the RSS is being expanded via a line extension to include additional options for baseplates, glenospheres, and screws. The baseplate option features a smaller post in comparison to the currently commercialized baseplate options, along with glenospheres that work in conjunction with the baseplate. The baseplate under this line extension is referred to as the Small Post Baseplate (SPB). Additional Star screw options have also been incorporated as part of the line extension.

The provided text is related to a 510(k) premarket notification for a medical device: the Integra TITAN Reverse Shoulder System. It describes the device, its intended use, and the nonclinical performance data used to demonstrate substantial equivalence to a predicate device.

However, the text does not contain any information about:

• Acceptance criteria in the context of device performance metrics (e.g., accuracy, sensitivity, specificity) for an AI/algorithm-based device.
• A study comparing algorithm performance against a ground truth or human readers.
• Sample sizes for test or training sets for an AI device.
• Ground truth establishment methods (expert consensus, pathology, etc.).
• Multi-reader multi-case (MRMC) comparative effectiveness studies.
• Standalone algorithm performance.

The document is a regulatory submission for a physical medical implant (shoulder prosthesis) and focuses on engineering testing (e.g., fatigue, taper disassembly, torsional properties) to demonstrate mechanical equivalence, not the performance of a diagnostic or AI-driven device. The "Clinical Performance Data" section explicitly states: "Clinical performance data is not required to demonstrate substantial equivalence to the predicate RSS device."

Therefore, I cannot provide the requested information based on the provided text, as it describes a different type of medical device and regulatory submission where AI performance metrics are not applicable.

Ask a specific question about this device

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.

Ask a specific question about this device

The Titan Reverse Shoulder System is indicated for use in a grossly deficient rotator cuff joint with severe arthropathy or a previously 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 Integra TITAN Reverse Shoulder System is a semi-constrained modular total shoulder construct. The humeral components consist of humeral stems, varying heights of reverse bodies, 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 4 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.

This document is a 510(k) premarket notification for the Integra® TITAN™ Reverse Shoulder System, specifically for an expanded indication to include fractures. It does not contain acceptance criteria or a study proving the device meets said criteria for an AI/CADe device.

The document states: "No additional verification and validation test data were required as part of this submission. This 510(k) was submitted to expand the current INTEGRA® TITAN™ Reverse Shoulder System to include fracture indications."

Therefore, I cannot provide the requested information for an AI/CADe device performance study from this document. The information focuses on demonstrating substantial equivalence to a predicate device for a change in labeling (adding a fracture indication) for a conventional medical implant.

Ask a specific question about this device