(157 days)
The Arthrex UNIVERS II Shoulder Prosthesis is indicated in replacement(s) when conditions including severe pain or significant disability resulting from degenerative, theumatic disease, or injury of the glenohumeral joint; nonunion humeral head fractures of long duration: irreducible 2- and 4-part proximal humeral fractures; of the humeral head, or other difficult clinical management problems where arthrodesis or resectional arthroplasty is not acceptable.
The glenoid components are intended fixation in the joint and must only be used with appropriate bone cement.
The Arthrex Titanium Humeral Head is indicated for patients with suspected cobalt alloy sensitivity. The wear properties of Titanium and Titanium alloys are inferior to that of cobalt alloy. A Titanium humeral head is not recommended for patients who lack suspected material sensitivity to cobalt alloy.
The Titanium humeral heads are intended to be used in the Arthrex Univers II Shoulder Prosthesis System. The humeral heads were originally cleared under predicate K071032 as cobalt-chromium (CoCr) devices. The design of the titanium humeral heads is identical to the CoCr heads cleared under predicate K071032. The only difference between the proposed device and the predicate is the material. The titanium humeral heads will provide an alternative to CoCr for use on patients with nickel allergies.
The provided text is a 510(k) Premarket Notification from the FDA regarding a medical device, the Arthrex Univers II Shoulder Prosthesis System: Titanium Humeral Heads. This document describes the device, its intended use, and the basis for its substantial equivalence to a predicate device.
However, the provided text does not contain information about a study proving the device meets acceptance criteria in the context of an AI-powered diagnostic device, nor does it refer to acceptance criteria or performance metrics such as accuracy, sensitivity, specificity, or AUC, or details about test set size, expert adjudication, or MRMC studies.
The "Performance Data" section of the document mentions:
- "Fatigue testing, pull-off testing, and wear testing were conducted to evaluate the strength and fatigue properties of the proposed titanium humeral heads."
- "Additionally, an engineering analysis was performed to address the substantial equivalence of hardness, adhesion, surface roughness, scratch resistance, young's modulus, and articulating congruency compared to the predicate device."
- "Bacterial endotoxin per EP 2.6.14/USP was conducted to demonstrate that the device meets pyrogen limit specifications."
This indicates that the performance data gathered relates to the physical and material properties of the orthopedic implant (a shoulder prosthesis), and its biocompatibility, not the performance of an AI or diagnostic algorithm.
Therefore, I cannot fulfill your request for information regarding acceptance criteria and performance of an AI device based on this document. The information you've asked for (e.g., sample size for test/training sets, expert qualifications, MRMC studies, ground truth establishment) is specific to the validation of AI/ML-based diagnostic devices, which is not what this FDA notification is about.
§ 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.”