(307 days)
The Univers Revers Shoulder Prosthesis System is indicated for use in a grossly rotator cuff deficient glenohumeral joint with severe arthropathy. 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 Univers Revers Shoulder Prosthesis System is indicated for primary total shoulder replacement for the relief of pain and significant disability due to rotator cuff deficiency.
(Humeral) Stems are intended for cementless applications for use with Arthrex Humeral Suture Cups. The glenoid baseplate is CaP coated and is intended for cementless use with the addition of screws for fixation.
The Arthrex Univers Revers Apex Humeral Stems are Titanium humeral stems with a Calcium Phosphate coating designed to articulate with the Arthrex Univers Revers Shoulder Prosthesis System. The stem will be offered sterile in 10 sizes (Size 6-15). The primary differences between the Arthrex Univers Revers Apex Humeral Stem and the predicate device are that the proposed device is shorter in superior to inferior length and contains two suture holes.
The provided document describes Arthrex Univers Revers Apex Humeral Stems, a medical device, and its 510(k) summary. This document focuses on the performance data provided to demonstrate substantial equivalence to a predicate device, rather than a study proving the device meets specific acceptance criteria in the context of diagnostic accuracy, as might be found for AI/ML devices. As such, the responses below are tailored to the type of information available for this specific product.
Here's an analysis based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Type of Test) | Reported Device Performance |
|---|---|
| Dynamic Fatigue Testing (Compression) | All constructs survived 10 million cycles |
| Dynamic Fatigue Testing (Torsion) | All constructs survived 10 million cycles |
| Bacterial Endotoxin Test (EP 2.6.14/USP ) | Meets pyrogen limit specifications |
| Stem Fixation (Engineering Analysis) | Was conducted and presumably demonstrated acceptable fixation (exact criteria not specified in this summary) |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify general "test sets" or "data provenance" in the way one would for diagnostic algorithms. Instead, it describes engineering and biological tests conducted on the device components.
- Sample Size: The document does not explicitly state the number of samples (e.g., number of stems) tested for dynamic fatigue or bacterial endotoxin. For dynamic fatigue, it refers to "all constructs," implying that multiple samples were tested, but the exact number isn't given.
- Data Provenance: Not applicable in the context of device performance testing of physical components (e.g., not patient data). The testing was conducted by Arthrex Inc. as part of their premarket notification.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
Not applicable. The ground truth for mechanical and biological performance is based on established engineering standards and test methods, not expert consensus on diagnostic interpretation.
4. Adjudication Method for the Test Set
Not applicable. This device underwent performance testing against engineering standards, not expert adjudication of diagnostic outcomes.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No. This document describes a mechanical orthopedic implant, not an AI/ML diagnostic tool. Therefore, an MRMC comparative effectiveness study is not relevant.
6. Standalone (Algorithm Only Without Human-in-the-Loop) Performance
No. This is a physical medical device (humeral stem), not a software algorithm.
7. Type of Ground Truth Used
- For dynamic fatigue testing: The ground truth is the established mechanical failure criteria (e.g., fracture, loosening) after a specified number of cycles. The criteria are likely derived from industry standards for orthopedic implants.
- For bacterial endotoxin testing: The ground truth is the established pyrogen limit as defined by pharmacopeia standards (EP 2.6.14/USP ).
- For stem fixation: The ground truth is likely based on biomechanical principles and potentially industry standards for implant stability.
8. Sample Size for the Training Set
Not applicable. This is not an AI/ML device that requires a training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable.
§ 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.”