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The SMR Anatomic Shoulder System is indicated for partial or total, primary or revision shoulder joint replacement in patients suffering from disability due to:

• · Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis;
• · Inflammatory degenerative joint disease such as rheumatoid arthritis;
• · Treatment of acute fractures of the humeral head that cannot be treated with other fracture fixation methods;
• · Revision of a failed primary implant;
• · Cuff tear arthropathy (CTA Heads only).

The SMR Reverse Shoulder System is indicated for primary, fracture or revision total shoulder replacement in a grossly rotator cuff deficient joint with severe arthropathy (disabled shoulder). 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 Modular SMR Shoulder System allows the assembly of components in various humeral and glenoid constructs. The constructs are intended for cemented and uncemented use as specified in the following table.

The SMR 3-Pegs Glenoids are made from conventional UHMWPE. They are intended for cemented fixation only.

The SMR 3-Pegs Glenoids are available in four sizes: size Small and Standard have been previously cleared for market via premarket notification K130642. The only difference between the subject SMR 3-Pegs Glenoids and those cleared via K130642 is the size offering: the subject device is offered in size Extra-Small and Large.

The SMR 3-Pegs Glenoids are characterized by an articulating surface with a radius of curvature greater than the corresponding humeral head. This mismatch allows for translation of the head in the superior/inferior and anterior/posterior directions. The back surface of the component is spherical in geometry and has three pegs for fixation in the glenoid.

The SMR 3-Pegs Glenoids are designed to articulate with the Limacorporate SMR humeral heads indicated for use in total shoulder replacement.

This document describes a 510(k) premarket notification for the "SMR 3-Pegs Glenoids" orthopedic implant. A 510(k) is a premarket submission made to FDA to demonstrate that the device to be marketed is at least as safe and effective, that is, substantially equivalent, to a legally marketed predicate device. This process does not typically involve the rigorous clinical trials or AI performance evaluations characteristic of novel medical devices. Therefore, many of the requested details about acceptance criteria, study design, expert involvement, and ground truth establishment are not applicable to this type of submission.

Here's a breakdown based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance:

For a 510(k), the "acceptance criteria" are typically related to demonstrating substantial equivalence to a predicate device, primarily through non-clinical testing for mechanical properties and the device's intended use, design, and materials. Clinical performance, in the sense of patient outcomes, is generally not required if substantial equivalence can be shown through other means.

In this case, the acceptance criteria are met by demonstrating mechanical equivalence to previously cleared devices.

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

• Test Set Sample Size: Not applicable in the context of clinical patient data. The "test set" here refers to the mechanical tests performed on the physical devices. The document does not specify the number of devices tested for each mechanical evaluation (ASTM F1829, F2028, F1378).
• Data Provenance: The mechanical testing was conducted by the manufacturer, Limacorporate S.p.A. in Italy. It's non-clinical bench testing, not retrospective or prospective patient data.

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

• Number of Experts: Not applicable. For mechanical testing, the "ground truth" is established by adherence to recognized international standards (e.g., ASTM standards) and validated testing methodologies. It does not involve human expert consensus on clinical outcomes or image interpretations.
• Qualifications of Experts: N/A. The "experts" would be engineering and quality control professionals overseeing the mechanical testing, ensuring compliance with standards.

4. Adjudication Method for the Test Set:

• Adjudication Method: Not applicable. This concept (e.g., 2+1, 3+1) is relevant for studies involving human interpretation of data, particularly medical imaging, where discrepancies need resolution. For mechanical testing, the results are quantitative measurements against predefined thresholds specified in the ASTM standards.

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

• MRMC Study: No. This study type is highly relevant for AI-powered diagnostic devices to assess how AI assists human readers. This submission is for a physical orthopedic implant and does not involve AI assistance for interpretation.
• Effect Size of Human Readers Improvement: Not applicable.

6. Standalone (Algorithm Only Without Human-in-the-Loop) Performance:

• Standalone Performance: Not applicable. This device is a physical implant; there is no algorithm or AI component to assess.

7. Type of Ground Truth Used:

• Ground Truth Type: For this submission, the "ground truth" is defined by the acceptance criteria established by recognized industry standards (ASTM) for the mechanical performance of the glenoid components. It is not clinical expert consensus, pathology, or outcomes data, as such data was deemed "not necessary to demonstrate substantial equivalence."

8. Sample Size for the Training Set:

• Training Set Sample Size: Not applicable. There is no AI model being trained for this device.

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

• Ground Truth for Training Set: Not applicable, as there is no training set or AI involved.

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The SMR Anatomic Shoulder System is indicated for partial or total, primary or revision shoulder joint replacement in patients suffering from disability due to:

• Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis: .
• Inflammatory degenerative joint disease such as rheumatoid arthritis: .
• Treatment of acure fractures of the humeral head that cannot be treated with other fracture fixation . methods:
• Revision of a failed primary implant; .
• . " Cuff tear arthropathy (CTA Heads only).

The Large Resection Stems (not available in the US) are indicated for oncology applications.

The SMR Reverse Shoulder System is indicated for primary, fracture or revision total shoulder replacement in a grossly rotator cuff deficient joint with severe arthropathy (disabled shoulder). 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 Modular SMR Shoulder System allows the assembly of components in various humeral and glenoid constructs. The constructs are intended for cemented use as specified in the following table.

In the Anatomic shoulder the humeral consists of the humeral stem. the humeral body, the adaptor taper and the humeral head. In the Reverse shoulder the humeral consists of the humeral stem, the reverse humeral body and the reverse liner. On the humeral side the fixation of the humeral stem determines if the construct is cemented or uncemented.

The Anatomic glenoid construct consists of an all polyethylene glenoid or a metal back assembled with a liner while the Reverse glenoid consists of the metal back, the connector and the glenosphere. On the glenoid side, the fixation of the all polyethylene glenoid or the metal-back-determines if the construct is cemented or uncemented.

The SMR 3-Pegs Glenoids are made from standard UHMWPE ). They are intended for cemented fixation only.

The SMR 3-Pegs Glenoids are available in two sizes (Small and Standard). They are characterized by an articulating surface with a radius of curvature greater than the corresponding humeral head. This mismatch allows for translation of the head in the superior/inferior and anterior/posterior directions. The back surface of the component is spherical in geometry and has three pegs for fixation in the glenoid.

The SMR 3-Pegs Glenoids are designed to articulate with the Limacorporate SMR humeral heads indicated for use in total shoulder replacement.

This document describes the premarket notification (510(k)) for the Limacorporate SMR 3-Pegs Glenoids, a component for shoulder joint replacement. The submission aims to demonstrate substantial equivalence to previously cleared predicate devices.

1. Table of Acceptance Criteria and Reported Device Performance

The device is a medical implant, and its performance is evaluated based on mechanical and material properties, rather than diagnostic accuracy as would be common for AI devices. Therefore, the "acceptance criteria" here refer to meeting established mechanical testing standards and material specifications, and "reported device performance" refers to the results of those tests confirming compliance.

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

This is a medical device approval based on non-clinical testing (mechanical and materials), not an AI/software device. Therefore, the concepts of "test set sample size" and "data provenance" (country of origin, retrospective/prospective) are not directly applicable in the same way they would be for an AI study.

• Test Set Sample Size: "All mechanical testing was done on worst case components or constructs." The specific number of physical units tested is not provided in this summary.
• Data Provenance: Not applicable as it's mechanical testing of physical components, not patient data.

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

Not applicable. Ground truth for mechanical testing is established by conforming to predefined engineering standards (ASTM standards) and manufacturing specifications, not by expert consensus on clinical cases.

4. Adjudication Method for the Test Set

Not applicable, as this refers to expert review of clinical data, which was not performed.

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

Not applicable. This is not an AI device or an imaging device requiring human reader interpretation. No MRMC study was performed.

6. Standalone (Algorithm Only) Performance Study

Not applicable. This is a physical medical device. There is no algorithm, and therefore no standalone algorithm performance to evaluate.

7. Type of Ground Truth Used

The "ground truth" for this medical device submission is established through:

• Engineering Standards: Compliance with established ASTM (American Society for Testing and Materials) standards (F1829 and F2028) for mechanical properties relevant to glenoid components.
• Material Specifications: Adherence to specifications for UHMWPE and UHMWPE X-Lima.
• Design Specifications: Ensuring the dimensions and design features (e.g., radius of curvature, peg design) match those of legally marketed predicate devices and achieve their intended purpose (e.g., range of motion).

8. Sample Size for the Training Set

Not applicable. There is no "training set" in the context of an AI/machine learning model for this physical medical device approval. Performance is demonstrated through direct mechanical testing and comparison to predicate device characteristics.

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

Not applicable, as there is no training set.

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