(206 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 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:
- Device Description: The SMR Hybrid Glenoid System is a modular shoulder replacement system.
- 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).
- Predicate Devices: It lists existing, legally marketed devices to which the SMR Hybrid Glenoid System is compared for substantial equivalence.
- 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.
- 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.
§ 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.”