(63 days)
The Arthrex Univers II Shoulder Prosthesis is indicated in replacements(s) when conditions include severe pain or significant disability resulting from degenerative, rheumatoid, traumatic disease, or injury of the glenohumeral joint; non-union humeral head fractures of long duration; irreducible 2- and 4- part proximal humeral fractures; avascular necrosis of the humeral head; or, other difficult clinical management problems where arthrodesis or resectional arthroplasty is not acceptable.
The glenoid components are designed for cemented fixation in the joint and must only be used with an appropriate bone cement.
The Arthrex Univers II XL Glenoids are manufactured from UHMWPE. The glenoid articular (lateral) surface is concave and is designed to articulate with the humeral head of the Univers II humeral stems. The fixation (medial) surface is convex and is designed either with a keel or with three pegs for cement interdigitation fixation.
The provided document describes a 510(k) Summary of Safety and Effectiveness for the Arthrex Univers II XL Glenoids. This submission is for a medical device (shoulder prosthesis components) and does not involve an AI/ML powered device. Therefore, many of the requested criteria, which are specific to the evaluation of AI/ML devices, are not applicable.
However, I can extract the information relevant to the device's acceptance criteria and the study that proves it meets them, based on the provided document.
Acceptance Criteria and Study Proving Device Meets Acceptance Criteria
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Equivalency Metric/Standard) | Reported Device Performance (Method/Result) |
|---|---|
| Substantial Equivalence to Predicate Devices | Product labeling, intended use, technology, engineering, and performance are the same as previously cleared glenoid devices. |
| Mechanical Performance Standard | ASTM F 2028 mechanical testing data. |
2. Sample Size Used for the Test Set and Data Provenance
Not applicable. This is a medical device clearance based on substantial equivalence and mechanical testing, not a clinical study involving human data in the context of an AI/ML algorithm. The "test set" and "data provenance" as described in the prompt are relevant to AI/ML model evaluation, not mechanical device testing.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. Ground truth, in the context of expert consensus, is not relevant for mechanical testing of a shoulder prosthesis component.
4. Adjudication Method for the Test Set
Not applicable. No adjudication method is mentioned as this is not a study requiring human readers or interpretation.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
No. This is not an AI/ML device that assists human readers, so an MRMC study is not relevant.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done
Not applicable. This is not an AI/ML algorithm. The "standalone performance" here refers to the device's mechanical performance in accordance with industry standards.
7. The Type of Ground Truth Used
The "ground truth" for demonstrating the safety and effectiveness of the Arthrex Univers II XL Glenoids relies on:
- Predicate Device Equivalence: The primary "ground truth" is the established safety and effectiveness of the predicate devices (Arthrex Univers II Shoulder System – Pegged Glenoid, K083435; Arthrex Univers Shoulder Prosthesis, K010124). The submission aims to prove the new device is substantially equivalent to these already cleared devices.
- Mechanical Testing Standards: Compliance with industry-recognized mechanical testing standards, specifically ASTM F 2028. This standard serves as the "ground truth" for evaluating the mechanical properties and performance of glenoid components.
8. The Sample Size for the Training Set
Not applicable. This is not an AI/ML algorithm that requires a training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable. As above, this is not an AI/ML algorithm.
Summary of the Study Proving Acceptance Criteria are Met:
The study proving the device meets the acceptance criteria is based on:
- Comparison to Predicate Devices: The submission states that "The product labeling, intended use, and the technology, engineering and performance of Univers XL Glenoids are the same as previously cleared glenoid devices." This forms the primary basis for demonstrating substantial equivalence.
- Mechanical Testing: "The ASTM F 2028 mechanical testing data demonstrated equivalency of the proposed XL glenoids and the predicate device." This testing provides objective evidence that the mechanical properties of the new XL Glenoids are comparable to the previously cleared predicate devices, thus ensuring similar safety and effectiveness in terms of physical performance.
The FDA's decision to clear the device (K120044) is based on the determination that it is "substantially equivalent" to legally marketed predicate devices, taking into account the information provided regarding consistent fundamental features, intended uses, and comparable mechanical performance.
§ 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.”