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General Indications:
The LINK Embrace Shoulder System - Reverse Configuration is intended for reverse total shoulder arthroplasty.
Indications:
Primary, fracture, or revision total shoulder arthroplasty in a grossly rotator cuff deficient joint with severe arthropathy. A functional deltoid muscle is necessary, and the patient's joint must be anatomically and structurally suited to receive the implants.
The Reverse Glenoid Baseplate component is intended for cementless fixation with the addition of bone screws.
The Humeral Stems Standard with CaP (HX) and Short with CaP (HX) are intended for cementless fixation.
The Humeral Stems Standard without CaP (HX) are intended for cemented or cementless fixation.
The Humeral Fracture Stems and Proximal Bodies are intended for cemented or cementless fixation.
The Modular Stems 75mm are intended for cemented or cementless fixation.
The Modular Stems, fully corundum blasted, are intended for cementless fixation.
The Modular Stems, fully polished, are intended for cemented fixation.

This Line Extension portfolio includes:

• Smaller 25 mm Ø Reverse Glenoid Baseplates (RGBs) in neutral designs and in wedged (10°, 15° and 20°) and lateralized variants (+3mm and +6mm). The new 25mm Ø RGB components include new peripheral 4.5mm Ø cortical screws in lengths of 20-60mm with a reduced head diameter as compared with the predicate 4.5mm Ø cortical screws cleared in K200368. The screws are available in standard and angle-stable/locking versions.
• Glenospheres in sizes 36mm, 39mm and 42mm diameter with +3mm and +6mm lateralization.
• Humeral Reverse Tray in a neutral (concentric) version with extended +5mm height.

The provided document is a 510(k) summary for a medical device called the "LINK Embrace Shoulder System - Reverse Configuration." It is a premarket notification to the FDA for a new component (25mm diameter reverse glenoid baseplates, glenospheres, and a humeral reverse tray) to an existing shoulder replacement system.

Based on the information provided in the document, here's a breakdown of the requested points:

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

The document does not present quantitative acceptance criteria or specific numerical performance results in a table format for this specific device modification. The performance testing section states:

The tests performed were:

• Range of Motion analysis (ASTM F1378)
• Bone screw testing
• Wear testing rationale for no new worst case
• Glenoid fretting fatigue rationale for no new worst case
• Humeral fatigue test rationale for no new worst case
• Micromotion test (ASTM F2028)
• Biocompatibility Evaluation

It's important to note that this 510(k) is for an addition/modification to an already cleared device, and the evaluation relies heavily on demonstrating "substantial equivalence" to existing predicate devices through non-clinical testing and rationales, rather than establishing entirely new performance benchmarks.

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

The document explicitly states: "Clinical performance testing was not required to demonstrate the substantial equivalence of this device." Therefore, there was no clinical "test set" in the sense of human patient data. The "test set" consisted of components tested in laboratory/benchtop settings. The document does not specify the sample sizes (e.g., number of screws tested, number of components for micromotion) for each of the non-clinical tests.

Data Provenance: The testing was non-clinical (laboratory/benchtop). The manufacturer, Waldemar Link GmbH & Co. KG, is based in Germany.

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

Not applicable. Since no clinical testing was performed, there was no human "ground truth" to establish for a clinical test set. The "truth" for the non-clinical tests is derived from engineering and materials science principles, and standards (e.g., ASTM).

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

Not applicable. No clinical test set requiring expert adjudication was used.

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 a physical implantable medical device (shoulder replacement components), not an AI/software device that assists human readers.

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

Not applicable. This is a physical implantable medical device.

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

For the non-clinical testing, the "ground truth" is based on:

• Engineering design specifications
• Performance requirements outlined in relevant ASTM standards (e.g., ASTM F1378 for Range of Motion, ASTM F2028 for Micromotion)
• Material properties and biocompatibility standards.
• Comparisons to the performance characteristics of predicate devices.

8. The sample size for the training set

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

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

Not applicable. As above, this device does not utilize a training set or machine learning.

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The LINK Embrace Shoulder System - Reverse Configuration is intended for reverse total shoulder arthroplasty.

Indications:

Primary, fracture, or revision total shoulder arthroplasty in a grossly rotator cuff deficient joint with severe arthropathy. A functional deltoid muscle is necessary, and the patient's joint must be anatomically and structurally suited to receive the implants.

The Reverse Baseplate is intended for cementless fixation with the addition of bone screws.

The Humeral Stems, Standard with CaP (HX) and Short with CaP (HX), are intended for cementless fixation.

The Humeral Stems, Standard without CaP (HX) and Short without CaP (HX), are intended or cementless fixation.

The Humeral Fracture Stems are intended for cementless fixation.

Humeral Stems (Ti6Al4V) are available in monoblock designs, and feature a proximal modular taper connection for assembly to reverse tray components for rTSA configurations. The monoblock Humeral Stems are available in Standard Stems and Short Stems with a broad size spectrum, and in non-coated and Calcium Phospate coated versions. Humeral fracture stems are also available.

The Reverse Glenoid Baseplate (Ti6Al4V) hosts a central Bone Screw and up to 4 peripheral Bone Screws. The system includes anglestable (locking screws), polyaxial anglestable and standard screw fixation with cortical and cancellous thread designs. The baseplate's backside and central peg feature a porous titanium surface for biologic fixation. The Reverse Glenoid Baseplate is assembled with a CoCrMo Glenosphere for rTSA.

The LINK Embrace Shoulder System - Reverse Configuration offers Glenospheres in several diameters. And neutral and eccentric designs. The Embrace Glenospheres are connected to the Reverse Baseplate by means of a taper and locking screw.

Reverse Trays (CoCrMo) are available in neutral, inclined and offset versions, which are combined with Reverse Inserts (polyethylene) in neutral and 10° & 20° inclined versions, enabling the surgeon to adjust the mechanical parameters in different spatial planes (e.g. retroversion and inclination) independently from each other. In addition, different Insert heights are available.

The reverse inserts are available in conventional polyethylene and in highly crosslinked polyethylene with Vitamin E (E-Dur®).

The LINK Embrace Shoulder System – Reverse Configuration is supported by a streamlined, lightweight and ergonomic instrument set.

The provided text is an FDA 510(k) summary for a medical device called the "LINK Embrace Shoulder System - Reverse Configuration." This document focuses on demonstrating substantial equivalence to already legally marketed devices, rather than proving the device meets specific performance criteria through clinical studies, AI algorithm validation, or human-in-the-loop performance evaluation.

Therefore, I cannot provide a table of acceptance criteria and reported device performance using the information given, nor can I answer questions related to AI performance, sample sizes for test/training sets, expert consensus, or MRMC studies. The document explicitly states:

"Clinical Testing: Clinical performance testing was not required to demonstrate the substantial equivalence of this device."

Instead, the submission relies on non-clinical performance testing and analysis to demonstrate that the device is suitable for its intended purpose and substantially equivalent to predicate devices. These tests are primarily mechanical and material characterization tests, not studies assessing clinical outcomes or AI algorithm performance.

Here's what I can extract from the provided text regarding the non-clinical testing:

Summary of Non-Clinical Performance Testing (as provided in the document):

Study Details from the provided document (where applicable):

• Sample sizes: Not specified for any of the non-clinical tests. These would typically be determined by the specific ASTM standards or internal validation protocols.
• Data provenance: Not explicitly stated, but these are laboratory-based, non-clinical tests likely conducted by the manufacturer or a contracted testing facility.
• Experts and Ground Truth: Not applicable in the context of this 510(k) summary, as it describes non-clinical mechanical testing, not clinical studies or AI algorithm validation requiring human expert consensus.
• Adjudication method: Not applicable.
• MRMC Comparative Effectiveness Study: Not performed (as per "Clinical performance testing was not required").
• Standalone Performance (algorithm only): Not applicable, as this is a physical medical device, not an AI algorithm.
• Type of Ground Truth Used: Not applicable for non-clinical, mechanical testing. The "ground truth" would be the measured physical properties and performance against specified engineering criteria.
• Training Set Sample Size & Ground Truth Establishment: Not applicable, as this document does not describe the development or validation of an AI algorithm.

Conclusion stated in the document: The results of the non-clinical performance testing demonstrate that the device is suitable for its intended purpose and Substantially Equivalent to the predicate devices.

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