(55 days)
The Univers Revers Shoulder Prosthesis 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 Shoulder Prosthesis 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.
(Humeral) Stems are intended for cemented or cementless applications. The glenoid baseplate is CaP coated and is intended for cementless use with the addition of screws for fixation.
The Arthrex Univers Revers Shoulder Prosthesis System has an articular design that is inverted compared to traditional total shoulder prosthesis. The system is comprised of two main components; the Arthrex Univers Revers Shoulder Prosthesis and the Universal Glenoid Shoulder Prosthesis. The Arthrex Univers Revers Shoulder Prosthesis is a titanium humeral stem and epiphysis or humeral cup, a titanium spacer, and an UHMWPE humeral cup liner. The humeral stem and epiphysis are available uncoated or with CaP coating. The Universal Glenoid Shoulder Prosthesis consists of a TPS/CaP coated titanium glenoid baseplate, a cobalt chrome glenosphere, and titanium screws.
This document, K142863, is a 510(k) premarket notification for a medical device called the "Universe Revers Shoulder Prosthesis System." It's a submission to include a fracture indication for an existing system. Therefore, the "study" referenced in the document is a comparison to a predicate device that already has the fracture indication, rather than a de novo clinical trial or AI model validation.
Here's an analysis based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Mechanical Performance (Implied Equivalence) | Mechanical testing of the Univers Revers Shoulder Prosthesis System was conducted and the results were compared to the Zimmer Anatomical Revers Shoulder System (K053274) and the Tornier Aequalis (referenced in K130129). |
| Predicate Device Equivalence - Fracture Indication | The Zimmer Anatomical Revers Shoulder System (K053274) "is cleared with the fracture indication; therefore no further performance testing is necessary to add the fracture indication to the Univers Revers Shoulder Prosthesis System." |
| Material Equivalence | The proposed shoulder devices are substantially equivalent to the predicate devices in regards to its intended use, design, size ranges, and materials. |
| Design Equivalence | The proposed shoulder devices are substantially equivalent to the predicate devices in regards to its intended use, design, size ranges, and materials. |
| Intended Use Equivalence | The Univers Revers Shoulder Prosthesis System is substantially equivalent to the predicate devices in which the basic features and intended uses are the same. |
2. Sample Size Used for the Test Set and Data Provenance
- Test Set: Not applicable in the context of a de novo AI model validation. The "testing" here refers to mechanical testing for the device itself and a comparison to predicate devices, not a test set for an AI algorithm.
- Data Provenance: The document does not specify the provenance of the data used for the comparative mechanical testing. It does not mention retrospective or prospective studies in relation to the fracture indication.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
- Not applicable. This is not an AI algorithm requiring expert ground truth for a test set. The determination of substantial equivalence relies on regulatory review and comparison to already cleared devices and their data.
4. Adjudication Method for the Test Set
- Not applicable. This is not an AI algorithm with a test set requiring adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- No. This is not an AI device. This is a shoulder prosthesis system.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
- No. This is not an AI algorithm.
7. The Type of Ground Truth Used
- The "ground truth" in this context is the established safety and effectiveness of the predicate device (Zimmer Anatomical Revers Shoulder System K053274), which already has the fracture indication. The rationale is that if the proposed device is substantially equivalent to a device already cleared for a fracture indication, then it also meets the criteria. Mechanical testing also serves as evidence of performance for the physical device.
8. The Sample Size for the Training Set
- Not applicable. This is not an AI algorithm.
9. How the Ground Truth for the Training Set was Established
- Not applicable. This is not an AI algorithm.
Summary of the Study for K142863:
The "study" that proves the device meets the acceptance criteria for the fracture indication is primarily based on a demonstration of substantial equivalence to a legally marketed predicate device (K053274: Zimmer Anatomical Shoulder System) that already holds the fracture indication, coupled with mechanical testing of the Univers Revers Shoulder Prosthesis System itself to confirm its performance compared to predicate devices.
The key statement is: "The Zimmer Anatomical Revers Shoulder System (K053274) is cleared with the fracture indication; therefore no further performance testing is necessary to add the fracture indication to the Univers Revers Shoulder Prosthesis System." This indicates a reliance on the previous FDA clearance of a similar device for the targeted indication.
§ 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.”