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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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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 components are intended for use in cemented and uncemented applications, as specified in the following table:

The SMR Reverse Shoulder System consists of a humeral stem, a reverse humeral body, a reverse liner, a metal-back glenoid, a glenosphere and a connector with screw. Bone screws are used for the fixation of the metal-back glenoid to the scapula. Humeral stems are provided for both cemented (cleared via 510(k): K100858) and cementless (cleared via 510(k): K101263) fixation as well as reverse humeral bodies (object of this submission). 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. Two designs of humeral stems are available: the first one (cleared via 510(k): K100858) is intended for cemented use only while the second one (cleared via 510(k): K101263) is intended for uncemented use. The stems are provided with a male Morse taper to allow coupling with the reverse humeral bodies. All reverse humeral bodies for SMR Reverse Shoulder Systems are made from Ti6Al4V (ASTM F1472 - ISO 5832-3). They are intended to be coupled by means of a Morse taper with the humeral stem; further stabilization is achieved with a screw that joins the humeral body to the stem. SMR reverse humeral bodies have a fixed cervico-diaphyseal angle of 150° to provide the correct varus-valgus alignment of the joint. The humeral body has a female taper for coupling with the reverse liner. Two versions of the SMR reverse liners are available: standard (available in Standard and Short sizes) and finned for trauma applications (fins with holes for tuberosities reconstruction provided). Reverse liners are made from standard ultra-high molecular weight polycthylene (ASTM F648 - ISO 5834-2); they are coupled via the internal tapcr of the reverse humeral bodies. Two designs of reverse liners are available: standard and retentive (characterized by deeper spherical concavity, higher lateral rim to provide a larger articulating surface and greater congruency between the liner and the glenosphere than the standard liners). Three thicknesses are available: STD, +3mm and +6mm. As reported for standard liners, the choice of the thickness is made by the surgeon to ensure the appropriate tension and prevent laxity in the joint. Metal-backed glenoids are made from Ti6Al4V (ASTM F1472 - ISO 5832-3). The surface of the metal-backed glenoid which comes in contact with bone is coated with Ti plasma spray coating. These devices are intended to be press-fitted into a hole drilled into the glenoid cavity during surgery; the peg surface has several wings to aid in fixation. Metal backed glenoids are available in four sizes (small-R, Small, Standard and Large). The plate has curved surfaces to adapt to the spherical shape of the glenoid cavity. The plate is provided with holes to allow the insertion of screws to fix the device in the glenoid cavity: Small-R, Small and Standard glenoids have two holes while the Large size has four holes. Glenospheres are made from CoCrMo alloy that conforms to ASTM F1537 - ISO 5832-12. Two different designs are available: a standard glenosphere that can be centered with respect to the glenoid component or eccentrical glenosphere to provide offset. Both designs have a spherical shape of 36mm diameter and articulate with the standard UHMWPE liners of the humeral body. Glenospheres are intended to be coupled to the metal-back glenoid through the use of a connector manufactured of Ti6Al4V (ASTM F1472 - ISO 5832-3). It incorporates a double male taper: one side is connected to the glenosphere while the other is coupled with the glenoid component. To increase the solidity of the system, a screw is used to link the glenosphere to the glenoid component. The screw is inserted through a hole on the surface of the glenosphere, passing through the internal cavity of the connector and then screwed to the metal-backed liner. Two types of connectors are used depending on the metal backed glenoid component: Small-STD and Small-R.

This document describes the SMR Reverse Shoulder System, a medical device for shoulder replacement. However, it does not contain information about acceptance criteria or a study that proves the device meets those criteria in the context of an AI/ML-based medical device.

The provided text is a 510(k) premarket notification summary for a physical medical device (a shoulder implant system). It focuses on:

• Device Description: The components and materials of the SMR Reverse Shoulder System.
• Intended Use: The medical conditions and patient types for which the device is indicated.
• Predicate Devices: Other similar devices already on the market that establish substantial equivalence.
• Non-Clinical Testing: Mechanical and wear testing performed on the physical components (e.g., fatigue strength, wear of liners and glenospheres). This testing is to ensure the physical components meet performance requirements, not an AI algorithm.
• Clinical Testing: Explicitly states, "Clinical testing was not necessary to demonstrate substantial equivalence of the SMR Reverse Shoulder System to the predicate device(s)."

Therefore, I cannot extract the requested information regarding acceptance criteria and study details for an AI/ML device from this document. The document pertains to a traditional orthopedic implant, not an AI-powered diagnostic or assistive tool.

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