(132 days)
The Univers Revers Modular Glenoid System is indicated for use in a grossly rotator cuff deficient glenohumeral joint with severe arthropathy or a previously failed joint replacement with a gross rotator cuff deficiency. The patient's joint must be anatomically and structurally suited to receive the selected implant(s), and a functional deltoid muscle is necessary to use the device.
The Univers Revers Modular Glenoid System is indicated for primary, fracture, or revision total shoulder replacement for the relief of pain and significant disability due to gross rotator cuff deficiency.
The Univers Revers Modular Glenoid System is porous coated and is intended for cementless use with the addition of screws for fixation.
The proposed devices are augmented modular glenoid baseplates made of titanium with BioSync coating. The proposed devices are half-wedge augmented modular glenoid baseplates available in two sizes (24 and 28). The baseplates are designed to be used cementless with peripheral screws and glenospheres (cleared under K193372 and K173900).
The provided document is a 510(k) summary for a medical device (Univers Revers Modular Glenoid System, Half Augment Baseplate). It focuses on demonstrating substantial equivalence to a predicate device through material, design, and performance testing, rather than presenting clinical study results for diagnostic accuracy or efficacy with human participants. Therefore, many of the requested criteria (like sample size for test/training sets, expert qualifications, adjudication methods, MRMC studies, effect sizes, and specific ground truth types like pathology or outcomes data) are not applicable or cannot be extracted from this type of regulatory submission.
However, I can extract the acceptance criteria related to mechanical performance and the study that was performed to demonstrate that the device met these criteria.
Acceptance Criteria and Study for Univers Revers Modular Glenoid System, Half Augment Baseplate
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criterion | Reported Device Performance | Study Performed |
|---|---|---|
| Mechanical Stability (specifically Rocking Horse Testing) | Achieved standard requirements. | Mechanical testing per ASTM F2028. |
| MRI Safety | Met requirements of FDA guidance and ASTM F2182. | MRI testing per FDA guidance and ASTM F2182. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify a "test set" in the context of human participant data, as this is a non-clinical submission for a Class II medical device. The studies mentioned are primarily benchtop or in-vitro tests:
- Mechanical Testing (ASTM F2028): The sample size for this testing is not explicitly mentioned but would typically involve multiple units of the device to ensure statistical robustness. The provenance is from laboratory testing.
- MRI Testing (FDA guidance and ASTM F2182): The sample size for this testing is not explicitly mentioned but involves the device itself. The provenance is from laboratory testing.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
Not applicable. The studies performed are mechanical and MRI safety tests, not studies requiring expert clinical interpretation for ground truth establishment.
4. Adjudication Method for the Test Set
Not applicable. This is not a study requiring adjudication of clinical findings.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No. An MRMC comparative effectiveness study was not done. This device is a shoulder prosthesis and the submission focuses on its physical and material properties, not diagnostic performance or human-AI interaction.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
Not applicable. This device is a physical medical implant, not an algorithm or AI-based software.
7. Type of Ground Truth Used
The "ground truth" for the performance studies is based on established engineering standards and regulatory guidelines:
- Mechanical Performance: The "ground truth" is defined by the requirements of ASTM F2028, a recognized standard for testing glenoid component stability.
- MRI Safety: The "ground truth" is defined by FDA guidance "Testing and Labeling Medical Devices for Safety in the Magnetic Resonance (MR) Environment" and ASTM F2182, a standard for measuring RF-induced heating in MRI.
8. Sample Size for the Training Set
Not applicable. There is no training set in the context of this device and the presented performance data. This is not a machine learning or AI-based device.
9. How the Ground Truth for the Training Set Was Established
Not applicable. There is no training set.
§ 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.”