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1. The TITAN Modular Total Shoulder System is indicated for use as a hemi or total shoulder replacement for:
   Severely painful and/or disabled joint resulting from osteoarthritis, traumatic arthritis or rheumatoid
   arthritis.Fracture-dislocations of the proximal humerus where the articular surface is severely comminuted,
   separated from its blood supply or where the surgeon's experience indicates that alternative methods
   of treatment are unsatisfactory.Other difficult clinical problems where shoulder arthrodesis or resection arthroplasty are not
   acceptable (e.g., revision of a failed primary component).Shoulder Hemiarthroplasty is also indicated for:
   Ununited humeral head fractures.Avascular necrosis of the humeral head.Rotator cuff arthropathy.Deformity and/or limited motion.The humeral component is intended for cemented or uncemented use. The glenoid component is intended for
   cemented use only.
2. 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 baseplate 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.
3. The Ascension HRA System is intended for resurfacing of the humeral head due to:
   Patients disabled by either non-inflammatory or inflammatory arthritis (i.e., rheumatoid arthritis,
   osteoarthritis and avascular necrosis)Mild or moderate humeral head deformity and/or limited motionPost-traumatic arthritisMalunions of the humeral headAcute fractures of the humeral headPatients with an intact or reparable rotator cuffContraindications:
   Infection, sepsis, and osteomyelitisOsteoporosisMetabolic disorders which may impair bone formationOsteomalaciaRapid joint destruction, marked bone loss or bone resorption apparent on roentgenogramRevision procedures where other devices or treatments have failed4. The Ascension Modular Radial Head is intended for:
   Replacement of the radial head for degenerative or post-traumatic disabilities presenting pain,
   crepitation, and decreased motion at the radio-humeral and/or proximal radio-ulnar joint with:

• joint destruction or subluxation visible on x-ray
• resistance to conservative treatmentPrimary replacement after fracture of the radial headSymptomatic sequelae after radial head resectionRevision following failed radial head arthroplasty5. The Katalyst Radial Head system is generally indicated for use in radial head replacement arthroplasty.
  Use of the implant is contraindicated in those cases where complete avascular necrosis has rendered bone
  stock inadequate.

The purpose of this submission is the addition of MR Conditional information to the labeling of the predicate devices.
There are no other changes proposed in this submission. The following aspects of the devices are not impacted by
the additional labeling and remain identical to the predicate devices as cleared in their respective 510(k)s.
• Intended Use/Indications for Use
• Contraindications
• Design and Dimensions
• Performance Specifications
• Materials
• Biocompatibility

The provided document is a 510(k) summary for the Smith & Nephew TITAN Total Shoulder System (TSS), TITAN Reverse Shoulder System (RSS), TITAN Humeral Resurfacing Arthroplasty System (HRA), Modular Radial Head System (MRH), and Katalyst Bipolar Radial Head System (Katalyst).

However, the document does not contain information about an AI/ML-based medical device or any study demonstrating its performance against acceptance criteria. Instead, it focuses on the addition of MR Conditional information to the labeling of existing predicate devices. The "Non-Clinical Performance Data" section describes the testing performed to ensure MR compatibility, which is a different type of performance testing than what would be expected for an AI/ML device.

Therefore, I cannot extract the requested information regarding acceptance criteria and a study proving the device meets those criteria for an AI/ML-based medical device from this document. The document describes a traditional medical device submission for orthopedic implants.

To answer your request, if this were a document about an AI/ML device, I would look for sections describing:

• Clinical Performance Study: Details about how the AI/ML model's output was evaluated, often involving a comparison to a ground truth or human expert readings.
• Performance Metrics: Specific metrics like sensitivity, specificity, AUC, F1-score, accuracy.
• Acceptance Criteria: Predetermined thresholds for these metrics that the device must meet to be considered effective.
• Test Set Description: Information on the size, source, and characteristics of the data used for testing.
• Ground Truth Establishment: How the definitive diagnosis or finding for the test data was determined (e.g., expert consensus, pathology, long-term follow-up).
• Reader Study Information: If applicable, details about human reader performance with and without AI assistance.

Since the provided document does not contain this type of information, I must state that it is not possible to fulfill the request based on the given input.

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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.

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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 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.

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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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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.

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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 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 modular shoulder prosthesis system. 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.

The provided document describes the Integra TITAN Reverse Shoulder System, a medical device. The information details nonclinical testing performed to establish substantial equivalence to predicate devices, rather than a study proving the device meets specific acceptance criteria in a clinical or AI-assisted diagnostic context.

Therefore, the following information, as requested in the prompt, is not available in the provided text:

• A table of acceptance criteria and reported device performance (in a diagnostic context)
• Sample size used for the test set and data provenance (for diagnostic performance)
• Number of experts used to establish ground truth for the test set
• Qualifications of those experts
• Adjudication method
• If a multi reader multi case (MRMC) comparative effectiveness study was done
• Effect size of human readers improving with AI vs without AI assistance
• If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
• The type of ground truth used (expert consensus, pathology, outcomes data, etc.) for a diagnostic algorithm
• The sample size for the training set (for a diagnostic algorithm)
• How the ground truth for the training set was established (for a diagnostic algorithm)

However, I can extract information regarding the nonclinical performance testing that was conducted for the device. The document explicitly states: "Clinical performance data were not necessary to support substantial equivalence." This means no human clinical trials (as one might expect a diagnostic AI to undergo) were presented for this 510(k) submission.

Here's what can be extracted about the device's nonclinical performance:

Nonclinical Testing and Acceptance Criteria:

The Integra TITAN Reverse Shoulder System underwent several nonclinical performance tests to confirm its ability to perform under expected clinical conditions. The acceptance criteria for each test are implicitly met as the summary states the "System met all acceptance criteria" or "is acceptable" for each respective test.

Additional Notes:

• Sample Size (for nonclinical tests): The document does not specify the exact sample sizes (number of units tested) for each nonclinical test, but refers to "worst-case components or constructs" being tested.
• Data Provenance (for nonclinical tests): These are laboratory-based engineering tests, not clinical data from patients or a specific country.
• Ground Truth (for nonclinical tests): The ground truth for these tests is based on established engineering principles, biomechanical justification, industry standards (e.g., ASTM F2009-00(2011)), and FDA guidance documents.
• Training Set (for nonclinical tests): This concept does not apply to the nonclinical testing described. These are physical performance assessments against predefined engineering parameters.

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