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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 coff deficient joint with severe arthropathy (disabled shoulder). The patients 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 are intended for cemented and uncemented 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 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 140° Reverse Humeral Bodies (SMR 140° Reverse Humeral Body, SMR 140° Short Reverse Humeral Body, SMR 140° Finned Reverse Humeral Body) are manufactured from Ti6Al4V alloy (ASTM F1472 - ISO 5832-3); they are for tapercoupling with previously cleared Humeral extension (K113523), SMR CTA Head Adaptor for Reverse Humeral Body (K131112), Reverse Liners (K110598, K142139) and Humeral stems (K100858, K101263, K111212, K191963).

This document is a 510(k) premarket notification for the SMR 140° Reverse Humeral Body, a component of a shoulder replacement system. As such, it does not contain information about acceptance criteria or a study proving that an AI device meets acceptance criteria.

The document describes a medical device (SMR 140° Reverse Humeral Body for shoulder replacement) and its substantial equivalence to predicate devices, supported by non-clinical mechanical testing. It explicitly states that clinical testing was not necessary to demonstrate substantial equivalence.

Therefore, the requested information points regarding AI acceptance criteria and studies (sample size, data provenance, expert ground truth, adjudication, MRMC studies, standalone performance, ground truth type for training/test sets, and training sample size) are not applicable to this document.

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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.

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 SMR Reverse Shoulder System humeral bodies, cemented non-finned humeral stems and cemented revision stems are intended for cemented use. The SMR Reverse Shoulder System humeral bodies, finned humeral stems and uncemented revision stems are intended for cementless use. The SMR Reverse Shoulder System metal-backed glenoids and glenospheres are intended for uncemented press-fit use only with the addition of screws for fixation.

The SMR Reverse Shoulder System (cleared via 510(k): K110598) consists of a humeral stem, a reverse humeral body, a reverse liner, a metal-back glenosphere and a connector with screw. Bone screws are used for the fixation of the metal-back glenoid to the scapula. Humeral stems and reverse humeral bodies are provided for both cementless fixation. The SMR Reverse Shoulder System metal back glenoids and glenospheres are intended for uncemented press-fit use only with the addition of screws for fixation.

This submission is to add the SMR Revision Stems, cleared in K111212, as compatible humeral stem components of the SMR Reverse Shoulder System.

This document is a 510(k) premarket notification for a medical device called the SMR Reverse Shoulder System. It is concerned with demonstrating substantial equivalence to a predicate device, rather than presenting a study of device performance against specific acceptance criteria. Therefore, most of the information requested in your prompt is not available in this document.

Here's what can be extracted and what cannot:

1. Table of acceptance criteria and reported device performance:
Not applicable. This document is not a clinical study or a performance validation report against specific acceptance criteria. Its purpose is to demonstrate "substantial equivalence" of a modified device to a previously cleared predicate device.

2. Sample size used for the test set and the data provenance:
Not applicable. No "test set" in the context of device performance testing is mentioned. The submission relies on a "print review" and comparison of taper dimensions.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
Not applicable. No ground truth establishment by experts is described for performance testing.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
Not applicable. No adjudication method is described.

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 device is a shoulder implant, not an AI-assisted diagnostic tool.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. This is a physical medical device, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
Not applicable. For the purpose of this 510(k) submission, the "ground truth" equivalent would be the existing characteristics and performance of the predicate device, against which the modified device is compared to establish equivalence.

8. The sample size for the training set:
Not applicable. No training set is mentioned as this device is not an AI/ML algorithm.

9. How the ground truth for the training set was established:
Not applicable. No training set is mentioned.

Summary of available information related to "acceptance criteria" and "study":

The "acceptance criteria" for this 510(k) submission are based on demonstrating substantial equivalence to a predicate device.

• Predicate Device: Limacorporate SMR Reverse Shoulder System (K110598)
• "Study" conducted: A non-clinical "print review" was performed.
  • This review compared the taper dimensions and tolerances of the SMR Revision Stems (the modification) to the taper dimensions and tolerances of the SMR humeral stems cleared for use with the predicate device.
  • Conclusion: The comparison indicated that the SMR Revision Stem tapers were substantially equivalent to the SMR Humeral Stem tapers.
• Clinical Testing: The document explicitly states: "Clinical testing was not necessary to demonstrate substantial equivalence of the SMR Reverse Shoulder System with modified labeling to the predicate device."

In essence, for this specific 510(k) submission, the "acceptance criteria" were met by a successful non-clinical engineering comparison demonstrating that the modification (addition of SMR Revision Stems) maintained the equivalence in design and dimensions to previously cleared components within the existing system.

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