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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; 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 Hybrid Glenoid System (K223876) is a modular system intended to be used in combination with previously cleared devices of the SMR Shoulder System. The system consists of a SMR Hybrid Glenoid component to be used in anatomical shoulder configuration and a reverse baseplate with screws and glenosphere that are used in reverse shoulders.

The SMR Hybrid Glenoid is a cemented glenoid component composed of a polyethylene baseplate connected to a central peg made of Trabecular Titanium. The baseplate has two peripheral pegs intended to be cemented into the native glenoid with the central peg being uncemented. The SMR Hybrid Glenoid is available in different sizes of baseplate and peg.

If a SMR Hybrid Glenoid is in place and revision to a reverse prosthesis is required, the patient can be revised by removing the anatomic polyethylene baseplate and leaving the metal peg in place. A metal SMR Hybrid Glenoid Reverse Baseplate is then connected to the central peg and a SMR Glenosphere coupled to the metal SMR Hybrid Glenoid Reverse Baseplate to articulate with a SMR Reverse Shoulder humeral liner, body and stem assembly on the humeral side. The metal SMR Hybrid Glenoid Reverse Baseplate and central porous peg assembly is intended for uncemented use with the addition of screws for fixation in reverse shoulder reconstructions.

This 510(k) is to introduce Selective Laser Melting (SLM) as a manufacturing option for central peg comprised of Trabecular Titanium. The subject device peg, made by SLM, has the same design of the predicate SMR Hybrid Glenoid System (K223876) and features the same net on the external surface.

This document is a 510(k) Premarket Notification from the FDA regarding the "SMR Hybrid Glenoid System." It primarily concerns the substantial equivalence of a new manufacturing method (Selective Laser Melting - SLM) for a component (central TT peg) of an already cleared medical device, rather than the initial clearance of an AI/ML medical device.

Therefore, many of the typical acceptance criteria and study elements associated with AI/ML device clearances (like those relating to diagnostic accuracy, human-in-the-loop performance, ground truth establishment by experts, etc.) are not applicable to this specific submission. This submission focuses on demonstrating that the new manufacturing process for a physical implant component does not change the core safety and effectiveness of the device as previously cleared.

Here's an analysis based on the provided text, addressing the points where information is available and explaining why other points are not relevant to this type of submission:

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

The acceptance criteria for this 510(k) are based on demonstrating that the SLM manufactured central TT peg performs equivalently to the peg made by the previous manufacturing method of the predicate device (K223876). This is primarily established through non-clinical testing.

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

• Sample Size: Not specified in the text. For non-clinical (mechanical) testing, sample sizes are typically determined by relevant ASTM/ISO standards to achieve statistical significance for the properties being measured.
• Data Provenance: The testing was "conducted according to the following test standards," implying laboratory testing. The specific country of origin for the lab data is not stated, but the manufacturer is based in Italy. This is retrospective in the sense that the testing was performed, and the results were subsequently submitted to the FDA. It is not human subject data (clinical data).

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

Not applicable. This submission is not for an AI/ML device requiring human expert annotation or ground truth for diagnostic accuracy. The "ground truth" here is the performance of the predicate device's component and the established engineering standards for orthopedic implants.

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

Not applicable. No expert adjudication process similar to those used for clinical image review or diagnostic ground truth was performed or required.

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 implant, not an AI/ML diagnostic or assistive device. No MRMC study was conducted.

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

Not applicable. This is a physical implant, not a software algorithm.

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

The "ground truth" for this engineering submission is based on:

• Established Material and Mechanical Standards: Such as ISO 5832-3 for Ti6Al4V, and various ASTM standards for tensile strength, shear, fatigue, and abrasion (e.g., ASTM E8, F1044, F1147, F1160, F1978). These standards define the expected performance benchmarks for the material and component.
• Performance of the Predicate Device Component: The existing SMR Hybrid Glenoid System (K223876) serves as the benchmark, demonstrating that the new manufacturing process yields an equivalent product.

8. The sample size for the training set:

Not applicable. This is not an AI/ML device requiring a training set. If referring to the manufacturing process, the "training" involves optimizing the SLM parameters, though "sample size" in a machine learning context is irrelevant here.

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

Not applicable. As above, no training set in the AI/ML sense was used. For the manufacturing process, "ground truth" would relate to achieving desired material properties and geometric accuracy, established through quality control, material characterization, and metrology.

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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 replace ment 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: A J , A2 and B1 according to Walch classification (SMR 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 and structurally suited to receive the selected implants and a functional deltoid muscle is neces-sary to use the device. The 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 hummeral and glenoid constructs. The constructs are intended for cemented and uncemented use as specified in the following table.

In the Anatomic shoulder the humeral consists of 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 consists of an all polyethylene glenoid, a polyethylene glenoid with metal peg or a metal back assembled with a liner; the Reverse glenoid consists of a metal back/connector/glenosphere construct or of a peg/ baseplate/glenosphere construct.

On the glenoid side, the fixation of the all polyethylene glenoid with metal peg or the metal back determines if the construct is cemented or uncemented.

The SMR Hybrid Glenoid System is a modular shoulder system intended to be used in combination with previously cleared devices of the SMR Shoulder System. The system consists of a glenoid component (SMR Hybrid Glenoid) to be used in anatomical shoulder configuration and a reverse baseplate with screws and glenosphere that are used in reverse shoulders.

The SMR Hybrid Glenoid is a cemented glenoid component composed of a polyethylene baseplate connected to a central peg made of Trabecular Titanium. The baseplate has two peripheral pegs intended to be cemented into the native glenoid with the central peg being uncemented. The SMR Hybrid Glenoid is available in different sizes of baseplate and peg.

If a SMR Hybrid Glenoid is in place and revision to a reverse prosthesis is required, the patient can be revised by removing the anatomic polyethylene baseplate and leaving the metal peg in place. A metal SMR Hybrid Glenoid Reverse Baseplate is then connected to the central peg and a SMR Glenosphere coupled to the metal SMR Hybrid Glenoid Reverse Baseplate to articulate with a SMR Reverse Shoulder humeral liner, body and stem assembly on the humeral side. The metal SMR Hybrid Glenoid Reverse Baseplate and central porous peg assembly is intended for uncemented use with the addition of screws for fixation in reverse shoulder reconstructions.

The provided document is a 510(k) premarket notification for a medical device (SMR Hybrid Glenoid System). It does not describe acceptance criteria and a study proving the device meets those criteria in the context of an AI/ML-driven device or diagnostic. Instead, it describes:

1. Device Description: The SMR Hybrid Glenoid System is a modular shoulder replacement system.
2. Intended Use/Indications for Use: It specifies the conditions for which the device is intended (e.g., osteoarthritis, fractures of the humeral head, revision of failed implants).
3. Predicate Devices: It lists existing, legally marketed devices to which the SMR Hybrid Glenoid System is compared for substantial equivalence.
4. Non-clinical testing: This section details mechanical testing performed to demonstrate substantial equivalence to predicate devices (e.g., static and dynamic evaluation, fatigue fretting tests, range of motion tests). It also mentions LAL testing for pyrogen limits.
5. Clinical testing: Crucially, the document states: "Clinical testing was not necessary to demonstrate substantial equivalence of the new sizes of SMR Hybrid Glenoid System to the predicate devices."

Therefore, based on the provided text, I cannot extract the information required to answer your prompt because:

• No AI/ML component: The device is a physical shoulder implant, not an AI/ML-driven diagnostic or treatment tool.
• No "acceptance criteria" for AI performance: Since there's no AI, there are no AI-specific performance acceptance criteria (like sensitivity, specificity, AUC). The "acceptance criteria" mentioned implicitly refer to meeting established mechanical and material standards for orthopedic implants.
• No "study that proves the device meets the acceptance criteria" in an AI/ML sense: The studies mentioned are non-clinical (mechanical tests) and aim to prove substantial equivalence to predicate devices rather than meeting a specific performance threshold for an AI algorithm. Clinical testing was explicitly stated as not necessary.
• No "ground truth" or "expert consensus" related to diagnostic accuracy: These concepts are typically associated with validating AI/ML diagnostic tools.

In summary, the provided document does not contain the information requested in your prompt regarding acceptance criteria and study data for an AI/ML device.

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