(60 days)
The Arthrex UNIVERS REVERS POROUS COATED BASEPLATE is designed to be used as the glenoid component of the existing Univers Revers Shoulder Prosthesis System or Univers II Shoulder Arthroplasty System.
The Arthrex UNIVERS REVERS POROUS COATED BASEPLATE is indicated for use in a grossly rotator cuff deficient glenohumeral joint with severe arthropathy failed joint replacement with a gross rotator cuff deficiency. The patient's joint must be anatomically suited to receive the selected implant(s), and a functional deltoid muscle is necessary to use the device.
The Arthrex UNIVERS REVERS POROUS COATED BASEPLATE 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 Arthrex UNIVERS REVERS POROUS COATED BASEPLATE is porous coated and is intended for cementless use with the addition of screws for fixation.
The Arthrex UNIVERS REVERS POROUS COATED BASEPLATE AND UNIVERSAL GLENOID INLAY are indicated for use in anatomic joint replacement(s) when conditions including severe pain or significant disability resulting from degenerative, rheumatic disease, fracture or injury of the glenohumeral joint; non-union humeral head fractures of long duration; avascular necrosis of the humeral head; neoplastic diseases; or other difficult clinical management problems where arthrodesis or resectional arthroplasty is not acceptable.
For anatomic joint replacement, the Arthrex UNIVERS REVERS POROUS COATED BASEPLATE AND UNIVERSAL GLENOID INLAY are indicated to be used with the humeral components of the Arthrex II Shoulder Prosthesis System for total shoulder arthroplasty. The UNIVERSAL GLENOID INLAY is intended for use with the UNIVERS REVERS POROUS COATED BASEPLATE.
The Arthrex UNIVERS REVERS POROUS COATED BASEPLATE AND UNIVERSAL GLENOID INLAY consists of a porous coated titanium glenoid baseplate and a UHMWPE inlay bearing. The baseplate is designed to be used as the glenoid component of the existing Univers Revers Shoulder Prosthesis System or Univers II Shoulder Arthroplasty System. The baseplate is centrally anchored by a barbed post with superior and inferior multi-directional screws to ensure optimal fixation. The baseplate and inlay bearing come in three sizes to match anatomical size variations.
For a reversed shoulder application, the baseplate can be paired with the Univers Revers glenosphere.
For an anatomic shoulder application, the baseplate should be paired with the inlay bearing. The inlay bearing is available in two thicknesses (standards and +2mm) and in sizes corresponding to the glenoid baseplate. Pegs on the underside of the inlay bearing snap into corresponding recesses in the baseplate, ensuring a secure attachment to the bearing inlay, while at the same time minimizing angular rotation.
The provided text describes a 510(k) premarket notification for a medical device, the "Arthrex UNIVERS REVERS POROUS COATED BASEPLATE and UNIVERSAL GLENOID INLAY." This document focuses on demonstrating substantial equivalence to existing predicate devices, primarily through comparison of design features, intended uses, and performance testing, rather than an AI-driven system.
Therefore, the information required to populate the fields related to acceptance criteria and ground truth for an AI/ML-based device (e.g., sample size for test/training sets, adjudication methods, expert qualifications, MRMC studies) is not present in this document. This document pertains to a physical orthopedic implant.
Here's what can be extracted regarding performance criteria for this specific device:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Stated) | Reported Device Performance (Stated) |
|---|---|
| Equivalence to predicate device demonstrated through: | "Performance testing (shear force, comparative, glenoid dynamic loosening testing and locking mechanism disassembly testing) demonstrated that the Arthrex UNIVERS REVERS POROUS COATED BASEPLATE AND UNIVERSAL GLENOID INLAY performs equivalently to the predicate device." |
| Compliance with FDA Guidance for Metallic Plasma Sprayed | "Non-clinical testing demonstrates that the baseplate coating is in compliance with the FDA Guidance for Industry on Testing of Metallic Plasma Sprayed Coatings on Orthopedic Implants to Support Reconsideration of Postmarket Surveillance Requirements." |
| Meet pyrogen limit specifications | "The Arthrex UNIVERS REVERS POROUS COATED BASEPLATE AND UNIVERSAL GLENOID INLAY meets pyrogen limit specifications." |
| Design features and intended uses same as predicate device | "The proposed device is substantially equivalent to the predicate devices in which the basic design features and intended uses are the same. Any differences between the proposed device and the predicate device are considered minor and do not raise questions concerning safety or effectiveness." (Conclusion based on data submitted) |
| Substantial Equivalence to currently marketed predicate | "Based on the indications for use, technological characteristics, and the summary of data submitted, Arthrex Inc. has determined that the proposed device is substantially equivalent to the currently marketed predicate device." (Overall conclusion) |
Missing Information (as pertains to AI/ML device evaluation):
The following points are Not Applicable (N/A) to this document, as it is a 510(k) submission for a physical implant, not an AI/ML diagnostic or therapeutic device:
- Sample sizes used for the test set and the data provenance.
- Number of experts used to establish the ground truth for the test set and their qualifications.
- Adjudication method for the test set.
- If a multi reader multi case (MRMC) comparative effectiveness study was done.
- If a standalone (i.e., algorithm only without human-in-the loop performance) was done.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.).
- The sample size for the training set.
- How the ground truth for the training set was established.
§ 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.”