(62 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 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 and uncemented use as specified in the following table.
SMR Reverse Liners are made from LimaVit (cross-linked ultra-high molecular weight polyethylene with Vitamin E) conforming to ISO 5834-2, ASTM F648 and ASTM F2695. SMR Reverse Liners are coupled to SMR Reverse Humeral Bodies (K110598, K201905), with or without the use of the SMR Humeral Extension (K113523), and articulates with the SMR Glenosphere (K110598, K142139, K163397). SMR Reverse Liners have an articulating surface diameter of 36 mm and 40mm to articulate with the same diameter glenospheres respectively.
This document is a 510(k) summary for a medical device called the "SMR Reverse Liner." It describes the device, its intended use, and argues for its substantial equivalence to previously cleared devices.
Here's an analysis of the provided text in relation to acceptance criteria and study information:
1. Table of Acceptance Criteria and Reported Device Performance:
The document does not explicitly state specific pass/fail acceptance criteria values for the device's performance. Instead, it broadly states that "Mechanical tests demonstrated that device performance fulfilled the intended use and that the devices is substantially equivalent to the predicate devices."
The reported device performance is qualitative, indicating that the device "fulfilled the intended use."
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not explicitly stated as quantitative thresholds. The implicit criterion is that the device's mechanical performance should be equivalent to or better than the predicate devices and suitable for its intended use. | Mechanical tests demonstrated that device performance fulfilled the intended use and that the devices is substantially equivalent to the predicate devices. |
2. Sample Size Used for the Test Set and Data Provenance:
The document mentions "Mechanical testing was performed on worst case components or constructs." However, it does not specify the sample size (N) for these mechanical tests. It also does not mention data provenance (e.g., country of origin, retrospective or prospective) as the testing is non-clinical/bench testing, not data derived from patients.
3. Number of Experts Used to Establish Ground Truth and Qualifications:
This information is not applicable as the study is a non-clinical/mechanical testing study, not a study involving human data or expert review for ground truth establishment.
4. Adjudication Method:
This information is not applicable as the study is a non-clinical/mechanical testing study, not a study requiring adjudication of expert opinions.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
This information is not applicable as the study is a non-clinical/mechanical testing study, not a study evaluating human reader performance with or without AI assistance.
6. Standalone Performance Study:
A standalone performance study was done in the form of non-clinical mechanical testing. The device (SMR Reverse Liner) was tested directly for its mechanical properties (fatigue, wear, pull-out, torque-out, lever-out). The performance was compared to predicate devices for substantial equivalence.
7. Type of Ground Truth Used:
The "ground truth" for this non-clinical study is based on:
- Engineering Requirements/Standards: The device's performance must meet established mechanical properties deemed safe and effective for orthopedic implants. These are often guided by relevant ISO and ASTM standards (e.g., ISO 5834-2, ASTM F648, ASTM F2695 mentioned for materials).
- Predicate Device Performance: The performance of the SMR Reverse Liner is compared to that of the predicate devices to establish substantial equivalence.
8. Sample Size for the Training Set:
This information is not applicable as the study is a non-clinical/mechanical testing study, not a machine learning or AI-based study that would involve a "training set."
9. How the Ground Truth for the Training Set Was Established:
This information is not applicable for the same reason as point 8.
§ 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.”