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The SMR Shoulder System is intended for partial or total, primary or revision shoulder joint replacement.

The SMR Anatomic Shoulder System is indicated for partial or total, primary or 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; in case of SMR Short Stems only if sufficient bone stock remains);
• . cuff tear arthropathy (CTA Heads only);
• . glenoid arthrosis without excessive glenoid bone loss: A1, A2 and B1 according to Walch classification (SMR TT Hybrid Glenoid 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 suited to receive the selected implants and a functional deltoid muscle is necessary to use the device.

The SMR TT Hybrid Glenoid Reverse Baseplate must not be used in cases of excessive glenoid bone loss and/or when bone graft is needed.

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 TT Augmented Glenoid System is a modular system intended to be used in combination with previously cleared components of the SMR Reverse Shoulder System. The system consists of a modular glenoid component to be used in total shoulder replacement in a reverse shoulder configuration. The glenoid component consists of a metal back glenoid (named SMR TT Augmented 360 Baseplate) made of Ti6Al4V, coupled to a peg made of Trabecular Titanium; the metal back glenoid is fixed to the glenoid bone by means of bone screws made of Ti6Al4V. The glenoid component is intended for uncemented use. With this 510(k) new sizes of the SMR TT Augmented 360 Baseplate (7°X, 10°X, 15°X, 19°X, 19°) and bone screws (dia. 4,5mm and length ranging between 16 to 24 mm) are introduced.

The provided document is a 510(k) premarket notification for a medical device, the SMR TT Augmented Glenoid System. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than providing detailed acceptance criteria and a comprehensive study demonstrating independent device performance against those criteria.

Therefore, the document does not contain the acceptance criteria and study details in the format requested. It clearly states:

• Clinical testing was not necessary to demonstrate substantial equivalence of the SMR TT Augmented Glenoid System to the predicate devices.

Instead, the document focuses on non-clinical (mechanical) testing to compare the device to its predicates.

However, I can extract the information that is present and note where the requested information is absent.

1. Table of Acceptance Criteria and Reported Device Performance

Note: The document states "Mechanical testing had demonstrated the device's ability to perform substantially equivalent to the predicate devices" for these aspects. Specific quantitative acceptance criteria (e.g., "pull-out strength > X N") and their numerical results are not provided in this summary.

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

• Sample Size for Test Set: Not specified in the document. Mechanical tests typically use a certain number of samples, but the exact count isn't detailed here.
• Data Provenance: Not explicitly stated. Non-clinical mechanical testing data would typically be generated in a lab setting. The manufacturer, Limacorporate S.p.A., is based in Italy.

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

• This information is not applicable and not provided in the document. The study described is a non-clinical, mechanical testing study, not one requiring expert human interpretation or ground truth establishment in a clinical context.

4. Adjudication Method for the Test Set

• This information is not applicable and not provided in the document. Adjudication methods (like 2+1) are typically used in clinical studies involving multiple expert readers to resolve discrepancies in diagnoses or assessments, which is not the nature of the mechanical testing described.

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

• No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. The document explicitly states: "Clinical testing was not necessary to demonstrate substantial equivalence of the SMR TT Augmented Glenoid System to the predicate devices." Therefore, there is no information on the effect size of human readers improving with or without AI assistance.

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

• No, a standalone performance study was not done. This device is a physical shoulder implant system, not a software algorithm that would have "standalone performance" in the way AI or diagnostic algorithms do. The "study" here refers to mechanical testing of the physical components.

7. Type of Ground Truth Used

• The concept of "ground truth" as typically used in studies involving diagnostic accuracy (e.g., pathology, outcomes data, expert consensus) is not applicable to the mechanical testing described. For mechanical tests, the "ground truth" would be the measured physical properties or failure points under specified conditions, typically compared against pre-defined engineering standards or predicate device performance.

8. Sample Size for the Training Set

• This information is not applicable and not provided. The device is a physical implant, not an AI/ML algorithm that requires a "training set."

9. How Ground Truth for the Training Set Was Established

• This information is not applicable and not provided, as there is no training set for a physical implant device.

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The SMR Shoulder System is intended for partial or total, primary or revision shoulder joint replacement.

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);
• glenoid arthrosis without excessive glenoid bone loss: A1, A2 and B1 according to Walch classification (SMR TT Hybrid Glenoid only).

The SMR Reverse Shoulder System is indicated for primary, fracture or revision total shoulder cuff deficient joint with severe arthropathy (disabled shoulder). The patient's joint must be anatomically suited to receive the selected implants and a functional deltoid muscle is necessary to use the device.

The SMR TT Hybrid Glenoid Reverse Baseplate must not be used in cases of excessive glenoid bone graft is needed.

The Modular SMR Shoulder System allows the assembly of components in various humeral and glenoid constructs are intended for cemented and uncemented use as specified in the following table.

The SMR TT Augmented Glenoid System is a modular system intended to be used in combination with previously cleared components of the SMR Reverse Shoulder System. The system consists of a modular glenoid component to be used in total shoulder replacement in a reverse shoulder configuration. The glenoid component consists of a metal back glenoid (named SMR TT Augmented 360 Baseplate), coupled to a peg made of Trabecular Titanium. The glenoid component is intended for uncemented use with the addition of bone screws for fixation to the bone.

The provided text is related to a 510(k) premarket notification for the "SMR TT Augmented Glenoid System," a medical device for shoulder joint replacement. This document primarily focuses on demonstrating substantial equivalence to predicate devices through design, materials, intended use, and non-clinical mechanical testing.

Crucially, the document explicitly states: "Clinical testing was not necessary to demonstrate substantial equivalence of the SMR TT Augmented Glenoid System to the predicate devices."

This means that the device's acceptance criteria were not proven through a clinical study involving human patients, nor through a performance study that would typically involve test sets, expert ground truth, or MRMC studies for an AI/CAD type of device. The acceptance criteria and proof of their fulfillment are based on equivalence to predicate devices and mechanical testing of the device components.

Therefore, for the specific questions you've asked, the information is largely not applicable or not present in the provided text, as this device's clearance was based on non-clinical data.

Here's a breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Since clinical testing for device performance in the context of AI/CAD (e.g., diagnostic accuracy) was not conducted or deemed necessary, the acceptance criteria and performance relate to mechanical integrity and material properties.

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

• Not Applicable. No clinical test set involving human data was used for performance evaluation as "Clinical testing was not necessary." The evaluation was based on mechanical testing of the device components. The specifics of the mechanical test samples are not detailed beyond referencing ASTM standards.

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. As no clinical "test set" in the context of diagnostic accuracy was used, no human experts were involved in establishing ground truth for such a purpose.

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

• Not Applicable. Since no test set requiring expert interpretation was used, no adjudication method was employed.

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. No MRMC study was conducted. This device is a surgically implanted prosthetic, not an AI/CAD system assisting human readers with interpreting medical images.

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

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

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

• The "ground truth" for this device, in terms of demonstrating safety and effectiveness, was established through adherence to material standards and performance against specified mechanical testing standards (e.g., ASTM F543, ASTM F2028, ASTM F1378). The comparative aspect was based on substantial equivalence to legally marketed predicate devices in terms of intended use, design, and materials.

8. The sample size for the training set

• Not Applicable. This is not an AI/ML device, so there is no "training set."

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

• Not Applicable. This is not an AI/ML device, so there is no "training set" or associated ground truth for a training set.

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