(100 days)
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;
- · Cuff tear arthropathy (CTA Heads 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 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.
The SMR 3-Pegs Glenoids are made from conventional UHMWPE. They are intended for cemented fixation only.
The SMR 3-Pegs Glenoids are available in four sizes: size Small and Standard have been previously cleared for market via premarket notification K130642. The only difference between the subject SMR 3-Pegs Glenoids and those cleared via K130642 is the size offering: the subject device is offered in size Extra-Small and Large.
The SMR 3-Pegs Glenoids are characterized by an articulating surface with a radius of curvature greater than the corresponding humeral head. This mismatch allows for translation of the head in the superior/inferior and anterior/posterior directions. The back surface of the component is spherical in geometry and has three pegs for fixation in the glenoid.
The SMR 3-Pegs Glenoids are designed to articulate with the Limacorporate SMR humeral heads indicated for use in total shoulder replacement.
This document describes a 510(k) premarket notification for the "SMR 3-Pegs Glenoids" orthopedic implant. A 510(k) is a premarket submission made to FDA to demonstrate that the device to be marketed is at least as safe and effective, that is, substantially equivalent, to a legally marketed predicate device. This process does not typically involve the rigorous clinical trials or AI performance evaluations characteristic of novel medical devices. Therefore, many of the requested details about acceptance criteria, study design, expert involvement, and ground truth establishment are not applicable to this type of submission.
Here's a breakdown based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance:
For a 510(k), the "acceptance criteria" are typically related to demonstrating substantial equivalence to a predicate device, primarily through non-clinical testing for mechanical properties and the device's intended use, design, and materials. Clinical performance, in the sense of patient outcomes, is generally not required if substantial equivalence can be shown through other means.
In this case, the acceptance criteria are met by demonstrating mechanical equivalence to previously cleared devices.
| Acceptance Criteria (Demonstration of Substantial Equivalence) | Reported Device Performance (Non-clinical Testing) |
|---|---|
| Intended Use: Comparable to predicate devices | Confirmed |
| Design: Comparable to predicate devices | Confirmed |
| Materials: Comparable to predicate devices | Confirmed (UHMWPE, Ti6Al4V, CoCrMo, PoroTi) |
| Mechanical Performance: | Demonstrated ability to perform substantially equivalent to predicate devices in: |
| - Static Evaluation of Glenoid Locking Mechanism in Shear (ASTM F1829) | Met |
| - Dynamic Evaluation of Glenoid Loosening or Disassociation (ASTM F2028) | Met |
| - Range of Motion (ASTM F1378) | Met |
2. Sample Size Used for the Test Set and Data Provenance:
- Test Set Sample Size: Not applicable in the context of clinical patient data. The "test set" here refers to the mechanical tests performed on the physical devices. The document does not specify the number of devices tested for each mechanical evaluation (ASTM F1829, F2028, F1378).
- Data Provenance: The mechanical testing was conducted by the manufacturer, Limacorporate S.p.A. in Italy. It's non-clinical bench testing, not retrospective or prospective patient data.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
- Number of Experts: Not applicable. For mechanical testing, the "ground truth" is established by adherence to recognized international standards (e.g., ASTM standards) and validated testing methodologies. It does not involve human expert consensus on clinical outcomes or image interpretations.
- Qualifications of Experts: N/A. The "experts" would be engineering and quality control professionals overseeing the mechanical testing, ensuring compliance with standards.
4. Adjudication Method for the Test Set:
- Adjudication Method: Not applicable. This concept (e.g., 2+1, 3+1) is relevant for studies involving human interpretation of data, particularly medical imaging, where discrepancies need resolution. For mechanical testing, the results are quantitative measurements against predefined thresholds specified in the ASTM standards.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
- MRMC Study: No. This study type is highly relevant for AI-powered diagnostic devices to assess how AI assists human readers. This submission is for a physical orthopedic implant and does not involve AI assistance for interpretation.
- Effect Size of Human Readers Improvement: Not applicable.
6. Standalone (Algorithm Only Without Human-in-the-Loop) Performance:
- Standalone Performance: Not applicable. This device is a physical implant; there is no algorithm or AI component to assess.
7. Type of Ground Truth Used:
- Ground Truth Type: For this submission, the "ground truth" is defined by the acceptance criteria established by recognized industry standards (ASTM) for the mechanical performance of the glenoid components. It is not clinical expert consensus, pathology, or outcomes data, as such data was deemed "not necessary to demonstrate substantial equivalence."
8. Sample Size for the Training Set:
- Training Set Sample Size: Not applicable. There is no AI model being trained for this device.
9. How the Ground Truth for the Training Set Was Established:
- Ground Truth for Training Set: Not applicable, as there is no training set or AI involved.
§ 888.3660 Shoulder joint metal/polymer semi-constrained cemented prosthesis.
(a)
Identification. A shoulder joint metal/polymer semi-constrained cemented prosthesis is a device intended to be implanted to replace a shoulder joint. The device limits translation and rotation in one or more planes via the geometry of its articulating surfaces. It has no linkage across-the-joint. This generic type of device includes prostheses that have a humeral resurfacing component made of alloys, such as cobalt-chromium-molybdenum, and a glenoid resurfacing component made of ultra-high molecular weight polyethylene, and is limited to those prostheses intended for use with bone cement (§ 888.3027).(b)
Classification. Class II. The special controls for this device are:(1) FDA's:
(i) “Use of International Standard ISO 10993 ‘Biological Evaluation of Medical Devices—Part I: Evaluation and Testing,’ ”
(ii) “510(k) Sterility Review Guidance of 2/12/90 (K90-1),”
(iii) “Guidance Document for Testing Orthopedic Implants with Modified Metallic Surfaces Apposing Bone or Bone Cement,”
(iv) “Guidance Document for the Preparation of Premarket Notification (510(k)) Application for Orthopedic Devices,” and
(v) “Guidance Document for Testing Non-articulating, ‘Mechanically Locked’ Modular Implant Components,”
(2) International Organization for Standardization's (ISO):
(i) ISO 5832-3:1996 “Implants for Surgery—Metallic Materials—Part 3: Wrought Titanium 6-aluminum 4-vandium Alloy,”
(ii) ISO 5832-4:1996 “Implants for Surgery—Metallic Materials—Part 4: Cobalt-chromium-molybdenum casting alloy,”
(iii) ISO 5832-12:1996 “Implants for Surgery—Metallic Materials—Part 12: Wrought Cobalt-chromium-molybdenum alloy,”
(iv) ISO 5833:1992 “Implants for Surgery—Acrylic Resin Cements,”
(v) ISO 5834-2:1998 “Implants for Surgery—Ultra-high Molecular Weight Polyethylene—Part 2: Moulded Forms,”
(vi) ISO 6018:1987 “Orthopaedic Implants—General Requirements for Marking, Packaging, and Labeling,” and
(vii) ISO 9001:1994 “Quality Systems—Model for Quality Assurance in Design/Development, Production, Installation, and Servicing,” and
(3) American Society for Testing and Materials':
(i) F 75-92 “Specification for Cast Cobalt-28 Chromium-6 Molybdenum Alloy for Surgical Implant Material,”
(ii) F 648-98 “Specification for Ultra-High-Molecular-Weight Polyethylene Powder and Fabricated Form for Surgical Implants,”
(iii) F 799-96 “Specification for Cobalt-28 Chromium-6 Molybdenum Alloy Forgings for Surgical Implants,”
(iv) F 1044-95 “Test Method for Shear Testing of Porous Metal Coatings,”
(v) F 1108-97 “Specification for Titanium-6 Aluminum-4 Vanadium Alloy Castings for Surgical Implants,”
(vi) F 1147-95 “Test Method for Tension Testing of Porous Metal,”
(vii) F 1378-97 “Standard Specification for Shoulder Prosthesis,” and
(viii) F 1537-94 “Specification for Wrought Cobalt-28 Chromium-6 Molybdenum Alloy for Surgical Implants.”