(42 days)
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 ioint with severe arthropathy (disabled shoulder). The patient's ion t must be anatomically suited to receive the selected implants and a functional deltoid muscle is neces sary 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 SMR Shoulder System is a complete system intended to be used in primary or revision total shoulder joint replacement in either anatomic or reverse configurations. The SMR Shoulder System was cleared via several 510(k) submission, up to the latest approval under K220792.
The new compatibilities introduced with this 510(k) are related to the system when used in reverse shoulder configuration 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 SMR Shoulder System in reverse configuration consists of humeral stems, reverse humeral bodies, reverse liners, glenospheres, metal back glenoid components and pegs. The metal back glenoid component, when used as part of a reverse shoulder replacement, is intended for cementless fixation with bone screws.
Glenoid components of the SMR Shoulder System are cleared for use also with the humeral components of the PRIMA Humeral System (K212800). When used in combination with the PRIMA Humeral System, the device consists of a humeral stem, tray, reverse insert, glenospheres, metal back glenoid components and pegs.
With this Traditional 510(k) submission, new compatibilities between already cleared devices of the SMR Shoulder System are introduced:
- Bone Screws dia. 5.0 mm (K210717) compatible with SMR Metal Back Glenoid -(K113254) and SMR TT Baseplate (K133349);
- -SMR TT Hybrid Glenoid Reverse Baseplate (K163397) compatible with SMR Glenosphere dia. 42 mm (K212800).
No changes in indications for use, materials, manufacturing processes, packaging and sterilization are introduced with this 510(k) on already cleared devices.
The provided document is a 510(k) summary for the SMR Shoulder System, a medical device. It focuses on demonstrating substantial equivalence to a predicate device based on non-clinical testing and comparison of technological characteristics. 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 device.
This document specifically states: "Clinical testing was not necessary to demonstrate substantial equivalence of the SMR Shoulder System to the predicate device." This indicates that the device's performance was evaluated through non-clinical means (mechanical tests), not through studies involving clinical data or AI performance metrics.
Therefore, I cannot provide the requested information for acceptance criteria and a study proving those criteria, as the document does not describe such a study for an AI/ML device.
However, I can extract the information related to the device and its testing as presented:
Device: SMR Shoulder System
1. A table of acceptance criteria and the reported device performance:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Fulfilled intended use | Mechanical tests demonstrated that device performance fulfilled the intended use. |
| Substantially equivalent to predicate devices | Mechanical tests demonstrated that the device is substantially equivalent to the predicate devices. |
| Dynamic Evaluation of Glenoid Loosening or Disassociation (ASTM F2028) | Performed on worst-case components. (Specific results or acceptance thresholds not provided in this summary.) |
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):
- Sample Size: Not specified for mechanical testing. The phrase "worst case components" suggests a targeted selection rather than a large statistical sample.
- Data Provenance: Not applicable. The testing was non-clinical (mechanical).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. This was a non-clinical mechanical test, not an evaluation requiring expert-established ground truth for an AI/ML device.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable. This was a non-clinical mechanical test, not an evaluation requiring adjudication for an AI/ML device.
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:
- 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." This type of study is relevant for AI/ML devices involving human readers interpreting clinical data, which is not the case here.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This device is a shoulder implant system, not a software algorithm or AI. The testing was on the physical components.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Not applicable in the context of clinical or AI/ML ground truth. The "ground truth" for non-clinical mechanical testing would be the engineering specifications and performance standards (e.g., ASTM F2028).
8. The sample size for the training set:
- Not applicable. This is not an AI/ML device; therefore, 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; therefore, there is no training set or associated ground truth establishment.
§ 888.3670 Shoulder joint metal/polymer/metal nonconstrained or semi-constrained porous-coated uncemented prosthesis.
(a)
Identification. A shoulder joint metal/polymer/metal nonconstrained or semi-constrained porous-coated uncemented prosthesis is a device intended to be implanted to replace a shoulder joint. The device limits movement in one or more planes. It has no linkage across-the-joint. This generic type of device includes prostheses that have a humeral component made of alloys such as cobalt-chromium-molybdenum (Co-Cr-Mo) and titanium-aluminum-vanadium (Ti-6Al-4V) alloys, and a glenoid resurfacing component made of ultra-high molecular weight polyethylene, or a combination of an articulating ultra-high molecular weight bearing surface fixed in a metal shell made of alloys such as Co-Cr-Mo and Ti-6Al-4V. The humeral component and glenoid backing have a porous coating made of, in the case of Co-Cr-Mo components, beads of the same alloy or commercially pure titanium powder, and in the case of Ti-6Al-4V components, beads or fibers of commercially pure titanium or Ti-6Al-4V alloy, or commercially pure titanium powder. The porous coating has a volume porosity between 30 and 70 percent, an average pore size between 100 and 1,000 microns, interconnecting porosity, and a porous coating thickness between 500 and 1,500 microns. This generic type of device is designed to achieve biological fixation to bone without the use of bone cement.(b)
Classification. Class II (special controls). The special control for this device is FDA's “Class II Special Controls Guidance: Shoulder Joint Metal/Polymer/Metal Nonconstrained or Semi-Constrained Porous-Coated Uncemented Prosthesis.”