(79 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 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 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 use as specified in the following table.
In the Anatomic shoulder the humeral construct consists of the humeral stem, the humeral body, the adaptor taper and the humeral head. In the Reverse shoulder the humeral construct 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, 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, the polyethylene glenoid with metal peg or the metal back determines if the construct is cemented or uncemented.
The provided text is a 510(k) Premarket Notification from the FDA regarding LimaCorporate S.p.A.'s SMR Finned Short Stems. It details the device's intended use, description, and comparison to predicate devices, focusing on demonstrating substantial equivalence for a medical device that is a physical orthopedic implant.
Crucially, this document does not describe an AI/software as a medical device (SaMD) or any device that relies on algorithms for diagnostic or therapeutic decisions. Therefore, the concepts of acceptance criteria for algorithm performance, sample sizes for test sets, establishment of ground truth by experts, MRMC studies, or standalone algorithm performance are not applicable to this submission.
The "study that proves the device meets the acceptance criteria" in this context refers to non-clinical (mechanical) testing for the physical implant, not a clinical trial involving patient data and algorithm performance.
Here's a breakdown based on the provided document, addressing the prompt's categories where applicable, and explicitly stating when information is R/NA (Refers to Not Applicable) due to the nature of the device:
Acceptance Criteria and Device Performance (for a physical orthopedic implant)
There isn't a direct "acceptance criteria table" for algorithm performance as would be seen in an AI/SaMD submission. Instead, the acceptance criteria are met through mechanical testing that demonstrates the new device performs similarly to or better than predicate devices in terms of structural integrity and function.
| Acceptance Criteria (Implied for Physical Device) | Reported Device Performance |
|---|---|
| Fatigue-fretting behavior: Must be comparable to or better than predicate devices and suitable for intended use. | Fulfilled: Mechanical tests demonstrated that device performance fulfilled the intended use. Specifically, "fatigue-fretting behaviour of the new SMR Finned Short Stems" was evaluated. |
| Residual torque of safety screw and push-out force of coupling between stem and humeral body: Must meet established thresholds for secure coupling. | Fulfilled: Mechanical tests demonstrated that device performance fulfilled the intended use. "Evaluation of residual torque of the safety screw and push-out force of the coupling between stem and humeral body" was performed. |
| Substantial Equivalence: Must be substantially equivalent to predicate devices in intended use, design, and materials. | Claimed: "The intended use, design, and materials of the SMR Finned Short Stems are substantially equivalent to the ones of the predicate devices." "Mechanical tests demonstrated that device performance fulfilled the intended use and that the devices is substantially equivalent to the predicate devices." |
Detailed breakdown of the study (non-clinical testing for a physical implant):
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A table of acceptance criteria and the reported device performance:
- See the table above. These are implicit criteria for mechanical performance of an orthopedic implant for substantial equivalence.
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Sample sizes used for the test set and the data provenance:
- Sample Size: Not explicitly stated in the document in terms of number of physical stems tested. It refers to "worst case components or constructs."
- Data Provenance: This refers to the testing of physical samples of the manufactured SMR Finned Short Stems. "Worst case components or constructs identified through FE analysis" were tested. This is a form of prospective, in-vitro testing. (R/NA for geographic provenance as it's mechanical testing of manufactured parts).
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- R/NA: This is not an AI/SaMD submission requiring expert consensus for ground truth on medical images or diagnoses. The "ground truth" for a physical implant's performance is derived from standardized mechanical testing protocols and engineering principles.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- R/NA: This concept applies to human assessment of data, often in AI/SaMD studies to resolve discrepancies. It is not relevant for mechanical testing of a physical implant.
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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:
- R/NA: This is specifically for AI/SaMD devices. No such study was performed or required as this is a physical medical device. The document explicitly states: "Clinical testing was not necessary to demonstrate substantial equivalence of the new SMR Finned Short Stems to the predicate devices."
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- R/NA: This is for AI/SaMD devices. The device is a physical shoulder implant.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Ground Truth Type: For a physical implant, the "ground truth" is established by engineering standards and mechanical properties. This includes successful completion of "fatigue-fretting behaviour" and "evaluation of residual torque of the safety screw and push-out force of the coupling between stem and humeral body" based on established engineering test methods and design specifications.
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The sample size for the training set:
- R/NA: This is for AI/SaMD devices. This device does not have a "training set." The design and "worst case components" for mechanical testing might be identified through engineering analysis (e.g., Finite Element Analysis as mentioned "FE analysis"), but this is not an AI training process.
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How the ground truth for the training set was established:
- R/NA: As there is no training set for this physical device, this question is not applicable.
§ 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.”