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The Stemless Shoulder System is comprised of modular humeral heads to be used in total shoulder arthroplasty.

The Stemless Shoulder System is indicated for a severely painful and/or disabled joint resulting from osteoarthritis or traumatic arthritis.

The Stemless humeral components are intended for press-fit fixation without the use of bone cements are intended only for use with bone cement.

The GLOBAL ICON Stemless Shoulder System includes cobalt-chromium alloy humeral heads that mate with titanium alloy anchor plates. The anchor plates include four grooved peripheral legs which are seated in the proximal humerus, and hydroxyapatite coating on all bone- contacting surfaces.

The document describes the GLOBAL ICON Stemless Shoulder System, a medical device for total shoulder arthroplasty. It details the device's indications for use, technological characteristics, and a summary of non-clinical and clinical tests conducted to demonstrate substantial equivalence to predicate devices.

1. Acceptance Criteria and Reported Device Performance

The acceptance criteria for the GLOBAL ICON Stemless Shoulder System were based on a composite success endpoint at 24 months post-operative in a clinical study. The criteria and reported performance are summarized in the table below:

2. Sample Size for the Test Set and Data Provenance

• Sample Size: The clinical study included 128 subjects for the 24-month interim data analysis.
• Data Provenance: The document does not explicitly state the country of origin for the data. However, it is a submission to the U.S. Food & Drug Administration (FDA), indicating the device is intended for the U.S. market. The study is described as having "interim 24-month data," which suggests it is a prospective study (following subjects forward in time).

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

The document does not provide details on the number or qualifications of experts used to establish ground truth for the test set. It mentions "Radiographs indicate" and "adjusted Constant-Murley score," suggesting these assessments were made by healthcare professionals, but specific qualifications (e.g., radiologist with X years of experience) or the number of such experts are not specified.

4. Adjudication Method for the Test Set

The document does not describe any specific adjudication method (e.g., 2+1, 3+1, none) for the clinical outcomes or radiological assessments in the test set.

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

No. The document presents a clinical study evaluating the device's performance directly, not a comparative effectiveness study involving human readers with and without AI assistance for interpretation. The device itself is a physical medical implant, not an AI diagnostic tool.

6. Standalone Performance Study (Algorithm Only)

No. The device is a surgical implant (GLOBAL ICON Stemless Shoulder System), not an algorithm or AI software. Therefore, a standalone (algorithm only) performance study is not applicable. The clinical study evaluates the performance of the implanted device in human subjects.

7. Type of Ground Truth Used

The ground truth for the clinical study was established using a combination of:

• Radiological assessment: To determine the presence or absence of continuous radiolucent lines around the humeral component.
• Clinical outcome scores: Specifically, the adjusted Constant-Murley score, which is a functional assessment used in shoulder arthroplasty.
• Device integrity/removal data: Tracking whether the humeral component was removed for any reason.
• Adverse event reporting: Documentation of device-related serious adverse events.

8. Sample Size for the Training Set

The document describes a clinical study for device approval, not an algorithm's development. Therefore, there is no mention of a "training set" in the context of machine learning. The 128 subjects are part of the clinical evaluation for the device's performance.

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

As this is not a study involving an AI algorithm that requires training data, the concept of establishing ground truth for a "training set" is not applicable to this document. The clinical study evaluated the device's performance in patients.

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The DePuy Global C.A.P.™ CTA Resurfacing Shoulder prosthesis is intended for use in hemi-shoulder arthroplasty.

The DePuy Global C.A.P.™ CTA Resurfacing Shoulder is indicated for hemi-shoulder replacement in patients with rotator cuff tears and arthritis. Specific indications include:

1. Rotator cuff tear arthropathy.
2. Difficult clinical management problems where other methods of treatment may not be suitable or may be inadequate.

CAUTION: The DePuy Global C.A.P.™ CTA Resurfacing Shoulder is intended for cementless use only.

The DePuy Global C.A.P.™ CTA Resurfacing Shoulder is a conservative Cuff Tear Arthropathy (CTA) device designed for resurfacing of the humeral head (hemi-shoulder). Resurfacing requires less bone and cartilage removal than is required in total shoulder replacement. Because bone stock is preserved, future revision or arthrodesis can be more easily performed. The prosthesis is intended for uncemented (i.e., press-fit) fixation, and is designed to mimic the normal humeral head geometry.

Composed of a cobalt-chrome-molybdenum alloy (ASTM F-75), the DePuy Global C.A.P.™ CTA Resurfacing Shoulder is available in a variety of diameters. The proposed implant will be available in curvatures of 40, 44, 48, 52 and 56mm, with head heights of 15mm (40 and 44mm curvatures), 18mm (all curvatures) or 21mm (48, 52 and 56mm curvatures).

The proposed humeral head is a one-piece shell, manufactured from cobalt-chrome-molybdenum alloy (ASTM F-75). The inner surface of the dome, or humeral head, has a cobalt-chrome-molybdenum porous coating. The stem has a cobalt-chrome-molybdenum porous coating proximally and is glass bead blasted distally. The distal stem has a cruciate design with a tapered distal tip. A thin layer of plasma-sprayed hydroxyapatite (Duofix™) has been applied to the inner surface of the dome and proximal stem.

The hydroxyapatite (HA) coating applied to the DePuy Global C.A.P.™ CTA Resurfacing Shoulder is substantially equivalent to the HA coating process used in previously cleared products (e.g., DePuy Global C.A.P.™ Resurfacing Replacement Shoulder, K031971; DePuy Global C.A.P.™ HA Resurfacing Shoulder Humeral Heads, K033516). The composition of the coating is the same as that used for previously cleared products, (e.g., DePuy Global C.A.P.™ Resurfacing Replacement Shoulder, K031971; DePuy Global CAP™ HA Resurfacing Shoulder Humeral Heads, K033516).

The DePuy Global C.A.P.™ CTA Resurfacing Shoulder features an extended articulation surface to cover the superior-lateral aspect of the resurfacing head. This additional material keeps the implant surface in contact with the coracoacromial arch for a longer period of time during abduction.

This device also features a stem with a distal cruciate press fit to provide initial fixation. For long-term fixation and implant support, a surface-to-surface contact between the underside of the cup and the humeral head is created because of a flat located on the underside of the cup. Fixation is also provided by biological tissue in-growth into the porous coating.

I am sorry, but the provided text does not contain information about acceptance criteria, study details, sample sizes, expert qualifications, or ground truth establishment for a device. The document is a 510(k) summary for a medical device (DePuy Global C.A.P.™ CTA Resurfacing Shoulder) and focuses on describing the device, its intended use, indications for use, and establishing substantial equivalence to previously cleared predicate devices. It does not include a performance study with acceptance criteria.

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The Ascension® HRA® System TPS/HA 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 motion.
• Post-traumatic arthritis.
• Patients with an intact or reparable rotator cuff.

The Ascension® HRA® System TPS/HA includes an anatomically designed, semi-constrained, monolithic device designed for resurfacing of the humeral head (hemi-shoulder). The system is designed for noncemented (i.e. press-fit) fixation. Each device is boxed individually and delivered sterile for single use. The system incorporates eight anatomically designed head geometries with appropriately sized stems. Head sizes are identified using width and height (in millimeters). The Ascension® HRA® device incorporates design features for replacing the damaged humeral head bearing surface and restoring normal anatomy with minimal bone resection. The stem is tapered and fluted to provide rotational as well as axial stability of the seated implant. System instrumentation, including a range of implant trials, is designed to offer precise implant preparation. The HRA device is made from Cobalt Chrome (ASTM F-1537 wrought or ASTM F-75 cast) and features a highly polished bearing surface with a CP Titanium or HA plasma spray undersurface and stem coating for osseointegration. No new materials are introduced with this device. Ascension® HRA® System components will be manufactured by contract manufacturers per Ascension Orthopedics, Inc., specifications.

The provided document is a 510(k) summary for the Ascension® HRA® System TPS/HA, a medical device for humeral head resurfacing. This document focuses on demonstrating substantial equivalence to predicate devices rather than proving the device meets specific performance acceptance criteria through clinical studies in the way a diagnostic AI device might.

Therefore, many of the requested categories related to AI device evaluation (e.g., sample size for test set, number of experts for ground truth, MRMC study, standalone performance, training set details) are not applicable to this type of submission.

However, I can extract the information that is relevant to the "acceptance criteria" (which in this context refers to the characteristics that demonstrate substantial equivalence) and the "study" (which is the comparison to predicate devices) as presented in the 510(k) summary.

1. Table of Acceptance Criteria and Reported Device Performance

In the context of this 510(k) submission, "acceptance criteria" are the features and characteristics that the new device must meet to be considered substantially equivalent to the predicate devices. The "reported device performance" is how the new device measures up against these criteria, often shown by direct comparison to the predicate.

2. Sample size used for the test set and the data provenance

• Sample size used for the test set: Not applicable. This is a 510(k) submission based on substantial equivalence, not a clinical trial with a "test set" in the context of AI or diagnostic device evaluation. The "test set" here would refer to the characteristics and materials of the device itself and its comparison to legally marketed predicate devices.
• Data provenance: Not applicable in the traditional sense of patient data. The "data" here comes from a comparison of design specifications, materials, and intended use as documented for the submitted device and previously cleared predicate devices (Biomet Coneland Humeral Resurfacing Head K010664, K010827 and K051843; DePuy Global C.A.P. K031971 and K033516; Ascension® Humeral Resurfacing Arthroplasty (HRA) System K062861). The study is a retrospective comparison of existing device specifications and regulatory clearances. The origin is the specifications of the devices themselves.

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

• Not applicable. There is no "ground truth" established by experts for a test set in the context of this 510(k) submission. The ground truth, in a sense, is the regulatory acceptance of the predicate devices and the documented specifications of all devices.

4. Adjudication method for the test set

• Not applicable. No adjudication method was used, as there was no test set or expert assessment of outcomes.

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 or diagnostic imaging device, so MRMC studies are not relevant.

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

• Not applicable. This is not an algorithm-based device.

7. The type of ground truth used

• The "ground truth" for this 510(k) is the established regulatory acceptance and performance specifications of the predicate devices. The new device demonstrates "substantial equivalence" to these established benchmarks.

8. The sample size for the training set

• Not applicable. This is not an AI or machine learning device and therefore does not have a training set.

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

• Not applicable. As there is no training set, this question is not relevant.

In summary, this 510(k) submission demonstrates that the Ascension® HRA® System TPS/HA is substantially equivalent to legally marketed predicate devices by comparing its design, materials, and intended use. The "study" is a feature-by-feature comparison, and the "acceptance criteria" are derived from the characteristics of the predicate devices. It is crucial to understand that this type of submission follows a different regulatory pathway than, for instance, an AI-powered diagnostic device, and thus many of the questions are not applicable to the information provided.

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