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The INTEGRA® TITAN™ Modular Total Shoulder System Fin-Lock™ Glenoid is intended for use in Total Shoulder Arthroplasty which is indicated for:

1. Severely painful and/or disabled joint resulting from osteoarthritis, traumatic arthritis or rheumatoid arthritis.
2. Fracture dislocations of the proximal humerus where the articular surface is severely comminuted, separated from its blood supply or where the surgeon's experience indicated that alternative methods of treatment are unsatisfactory.
3. Other difficult clinical problems where shoulder arthrodesis or resection arthroplasty are not acceptable (e.g. – revision of a failed primary component)
   The humeral component is intended for cemented or uncemented use.
   The glenoid component is intended for cemented use only.

The Integra TITAN™ Modular Total Shoulder System Fin-Lock™ Glenoid is a fully cemented all highly cross-linked polyethylene glenoid used in total shoulder arthroplasty for resurfacing the glenoid fossa. The glenoid component has one central peg with barbs and three peripheral pegs. The articulating surface of the glenoid device will be the same dimensions and sizes as existing Titan Modular Total Shoulder System three peg inline glenoids for consistent mismatching. The Fin-Lock™ Glenoid is intended to be a part of the TITAN™ Modular Shoulder System, 2.5 (K142413) and be used with the humeral component.

Based on the provided text, the acceptance criteria and the study results for the INTEGRA® TITAN™ Modular Total Shoulder System Fin-Lock™ Glenoid are described in the "807.92(b)(1-2) – Nonclinical Tests Submitted" section.

Here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

The document states that "The results of these performance tests met their respective acceptance criteria." However, it does not explicitly list the quantitative acceptance criteria for each test. It only mentions that the device met them.

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

The document does not specify the sample sizes used for the test sets in the performance tests. It also does not mention the data provenance (e.g., country of origin, retrospective or prospective nature). The tests are described as "nonclinical," implying they were conducted in a laboratory setting rather than using patient data.

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

This information is not applicable and not provided. The tests described are "nonclinical" performance tests (e.g., mechanical testing, material characterization), which typically do not involve human experts establishing ground truth in the way clinical studies or diagnostic AI algorithms do.

4. Adjudication Method for the Test Set

This information is not applicable and not provided. As mentioned above, these are nonclinical performance tests, not clinical studies requiring adjudication of outcomes by experts.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No, an MRMC comparative effectiveness study was not done. The document describes nonclinical performance tests, not studies involving human readers or AI assistance.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done

This is not applicable. The device is a physical medical implant (shoulder prosthesis), not an algorithm or AI. The tests performed are for the physical properties and performance of the implant itself.

7. The Type of Ground Truth Used

The ground truth for these nonclinical tests would be based on engineering specifications, material science standards, and mechanical testing protocols. For example, for a "Glenoid Pull-out Fixation Test," the ground truth would be a defined force threshold or displacement limit that the device must withstand according to established engineering principles for such implants. The document implies these standards were used by stating "met their respective acceptance criteria."

8. The Sample Size for the Training Set

This is not applicable. The device is a physical medical device. There is no "training set" in the context of an AI/algorithm. The development and testing of a physical implant involve design iterations, material selection, and extensive pre-clinical testing, but not an AI-style training set.

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

This is not applicable as there is no training set for a physical medical device. The "ground truth" for the device's design and manufacturing would be based on biomaterial science, biomechanical engineering principles, clinical needs, existing standards for orthopedic implants, and the performance characteristics of predicate devices.

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The INTEGRA® TITAN™ Modular Total Shoulder System is a Total Shoulder Arthroplasty which is indicated for: Severely painful and/or disabled joint resulting from osteoarthritis 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 indicated 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 Hemiathroplasty is also indicated for: Ununited humeral head factures, 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.

The TITAN™ Modular Total Shoulder System consists of a line of metaphyseal bodies, humeral stems, humeral heads and all polyethylene glenoid components. The body, stem and humeral head may be used by themselves, as a hemiarthroplasty, if the natural glenoid provides a sufficient bearing surface, or in conjunction with the glenoid, as a total replacement. The metaphyseal bodies and humeral stems are shaped to provide proximal fixation and optimal fixation area. Their variable length and proximally-filling shape are designed to accommodate the natural humeral geometry and provide stable fixation. proximal bone loading and proper head placement. The humeral heads are offered with both concentric and eccentric articulating surfaces. The humeral head may articulate against the natural glenoid bone, if it is of sufficient quality, or against the all polyethylene cemented glenoid. The glenoid has multiple options: keeled or standard pegged (3 pegs). All glenoid options are designed to function with both the concentric and eccentric heads. The humeral components are intended for cemented or uncemented use, while the glenoid component is for use with cement only.

The provided document is a 510(k) Premarket Notification summary for the INTEGRA® TITAN™ Modular Total Shoulder System. This document outlines the device description, intended use, and a comparison to a predicate device, focusing on demonstrating substantial equivalence rather than a detailed study proving the device meets specific acceptance criteria in the manner of an AI/ML device or a clinical trial.

The "acceptance criteria" and "device performance" described are related to non-clinical mechanical testing of the orthopedic implant, not to diagnostic accuracy or clinical outcomes in the way one would assess an AI/ML device. Therefore, many of the requested categories in your prompt are not applicable or cannot be extracted from this type of regulatory submission.

Here's a breakdown of the available information:

1. Table of acceptance criteria and reported device performance:

Study Proving Acceptance Criteria:

The study that proves the device meets the acceptance criteria consists of the non-clinical tests listed above. The document states: "Testing to verify the performance of the INTEGRA® TITAN™ Modular Total Shoulder System included the following: Taper Axial Disassembly Test, Fatigue Test, Maximum Static Load Test, Impact Assembly Test, Suture Verification Report. The results of these performance tests met their respective acceptance criteria and demonstrate that the INTEGRA® TITAN™ Modular Total Shoulder System is safe for the intended use, and is substantially equivalent to the predicate device identified."

2. Sample sized used for the test set and the data provenance:

• Sample Size: Not specified for these non-clinical mechanical tests. Typically, mechanical testing involves a certain number of test articles (e.g., usually 3, 5, or more per test condition as per ISO or ASTM standards) rather than "patients" or "data sets." Specific quantities are not disclosed in this summary document.
• Data Provenance: N/A. These are laboratory-based mechanical tests performed on device components, not based on human data from a geographic origin.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• N/A. For mechanical testing, the "ground truth" is typically defined by engineering specifications, material properties, and established test standards (e.g., ASTM, ISO standards for orthopedic implants). It does not involve human expert interpretation in the way clinical diagnostic data would.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

• N/A. This concept is for clinical data adjudication, not mechanical engineering tests.

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:

• N/A. This is a non-clinical 510(k) submission for a physical orthopedic implant, not an AI/ML diagnostic device.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:

• N/A. Not an AI/ML device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

• For these mechanical tests, the "ground truth" is based on engineering specifications, material science principles, and established international or national standards for orthopedic implant mechanical performance (e.g., ASTM F2028-14 for humeral prostheses, or similar standards for fatigue, static loading, and taper connections). The "acceptance criteria" are derived from these standards and the predicate device's performance.

8. The sample size for the training set:

• N/A. There is no concept of a "training set" for physical mechanical device testing as there would be for an AI/ML algorithm. The design of the device is based on engineering principles and comparison to the predicate.

9. How the ground truth for the training set was established:

• N/A. Not applicable to this type of device and testing.

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The Ascension TITAN 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 indicated 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.

The TITAN Modular Total Shoulder System consists of a line of metaphyseal bodies, humeral stems, humeral heads and all polyethylene glenoid components. The body, stem and humeral head may be used by themselves, as a hemiarthroplasty, if the natural glenoid provides a sufficient bearing surface, or in conjunction with the glenoid, as a total replacement. The metaphyseal bodies and humeral stems are shaped to provide proximal fixation and optimal fixation area. Their variable length and proximally-filling shape are designed to accommodate the natural humeral geometry and provide stable fixation, proximal bone loading and proper head placement. The humeral heads are offered with both concentric and eccentric articulating surfaces. The humeral head may articulate against the natural glenoid bone, if it is of sufficient quality, or against the all polyethylene cemented glenoid. The glenoid has two options: keeled or standard pegged (3 pegs). All glenoid options are designed to function with both the concentric and eccentric heads.
The humeral components are intended for cemented or uncemented use, while the glenoid component is for use with cement only.

The provided text is a 510(k) Summary for the Ascension® TITAN™ Total Shoulder System. This document is a premarket notification for a medical device and, as such, primarily focuses on demonstrating substantial equivalence to a predicate device rather than presenting a performance study with detailed acceptance criteria for a new device's efficacy or diagnostic accuracy.

Therefore, the information required to answer most of your questions (acceptance criteria, device performance, sample sizes, ground truth, experts, adjudication methods, MRMC studies, standalone performance, training set details) is not present in the provided text.

Here is what can be extracted based on the document:

1. A table of acceptance criteria and the reported device performance

The document does not specify quantitative acceptance criteria or report device performance in terms of clinical outcomes or diagnostic accuracy. Its primary claim is substantial equivalence to a predicate device (K100448).

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Sample size for test set: Not applicable. No clinical test set data is presented.
• Data provenance: Not applicable. No clinical data is presented.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

• Not applicable. No clinical test set or ground truth establishment is described.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

• Not applicable. No clinical test set or adjudication is described.

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 is not an AI-powered device, and no MRMC studies are mentioned.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

• Not applicable. This device is a physical shoulder implant, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

• Not applicable. No clinical ground truth is described.

8. The sample size for the training set

• Not applicable. This is not an AI/machine learning device, so there is no "training set."

9. How the ground truth for the training set was established

• Not applicable.

What the document does state regarding testing:

• Non-clinical Performance Data: "Testing to support the material change and additional lengths for the humeral stems has been completed. The testing conforms to ASTM F1378." (This is a standard for testing metallic implant materials, specifically for implantable materials for surgical implants). This non-clinical data is the basis for proving substantial equivalence for these specific changes.
• Clinical Performance Data: "Clinical performance data are not required for the minor changes that are the subject of this Special 510(k)." This explicitly states that clinical data (which would involve patients, outcomes, and likely the other questions you posed) was not deemed necessary for this particular submission, implying previous clinical data for the predicate device might have satisfied regulatory requirements, or the changes were minor enough not to warrant new clinical trials.

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