(119 days)
The Arthrex UNIVERS REVERS MODULAR GLENOID 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 suited to receive the selected implant(s), and a functional deltoid muscle is necessary to use the device.
The Arthrex UNIVERS REVERS MODULAR GLENOID 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. The Arthrex UNIVERS REVERS MODULAR GLENOID SYSTEM is porous coated and is intended for cementless use with the addition of screws for fixation.
The Arthrex UNIVERS REVERS MODULAR GLENOID SYSTEM consists of a monoblock baseplate or a modular baseplate; both baseplates are available with either a central screw or central post. The baseplate is designed to be used cementless with peripheral screws and a glenosphere. A humeral insert has been included in this system, to be used with the humeral side of the predicate Univers Revers Shoulder Prosthesis System (K142863).
The UNIVERS REVERS MODULAR GLENOID SYSTEM is comprised of known materials. The baseplates, central screws and posts are comprised of titanium with a BioSync coating, the peripheral screws are titanium and the glenospheres are available in either titanium or cobalt chrome. The humeral inserts are comprised of UHMWPE.
The provided text details a 510(k) premarket notification for a medical device, the Arthrex UNIVERS REVERS MODULAR GLENOID SYSTEM. This type of submission aims to demonstrate substantial equivalence to a legally marketed predicate device rather than proving safety and effectiveness de novo. Therefore, the information provided focuses on comparative performance, particularly mechanical and material testing, rather than clinical study data from human subjects or AI algorithm performance as might be seen for devices utilizing AI.
Based on the provided text, there is no information regarding acceptance criteria or a study proving an AI device meets acceptance criteria. The document describes a shoulder prosthesis, not an AI device.
However, if we interpret "acceptance criteria" and "study" in the context of this non-AI medical device (shoulder prosthesis), we can extract the following:
1. Table of Acceptance Criteria and Reported Device Performance (as inferred from the 510(k) submission):
| Acceptance Criteria Category | Specific Test/Standard | Reported Device Performance/Conclusion |
|---|---|---|
| Mechanical Performance | Rocking horse testing per ASTM F2028 | Demonstrated equivalence to the predicate device. |
| Disassembly testing per ASTM F2009 | Demonstrated equivalence to the predicate device. | |
| Torsional testing per ASTM F543 | Demonstrated equivalence to the predicate device. | |
| Material Safety/Compatibility | MR testing per ASTM F2182, F2052, and F2119 (Magnetic Resonance compatibility) | Demonstrated equivalence to the predicate device. |
| Baseplate coating compliance with FDA Guidance for Industry on Testing of Metallic Plasma Sprayed Coatings on Orthopedic Implants | The baseplate coating is in compliance with the guidance to support reconsideration of postmarket surveillance requirements. | |
| Bacterial endotoxin per EP 2.6.14/USP (Pyrogen limit specifications) | Demonstrated that the Arthrex UNIVERS REVERS POROUS COATED BASEPLATE AND UNIVERSAL GLENOID INLAY meets pyrogen limit specifications. | |
| Substantial Equivalence | Comparison of indications for use, technological characteristics, and performance data to predicate devices (K142863, K133349, K162455) | The proposed device is substantially equivalent to the predicate devices in which the basic design features and intended uses are the same. Differences are considered minor and do not raise questions concerning safety or effectiveness. |
2. Sample size used for the test set and the data provenance:
- Sample Size: The document does not specify the precise number of physical samples used for each mechanical and material test (e.g., how many glenoid components were subjected to rocking horse testing). It refers to tests being "conducted" but not the exact quantity of items.
- Data Provenance: The data comes from non-clinical testing (mechanical and material laboratory tests) performed by the manufacturer, Arthrex Inc. The location of the testing facility is not specified, but the company is based in Naples, Florida, USA. The data is prospective in the sense that these tests were conducted specifically for this 510(k) submission to demonstrate equivalence.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This question is not applicable to this type of device. The "ground truth" for a mechanical orthopedic implant is established by engineering standards (e.g., ASTM standards) and validated test methodologies, not by expert human interpretation of results like in an AI imaging study. The tests evaluate physical properties against established benchmarks for similar devices.
4. Adjudication method for the test set:
- This question is not applicable. Adjudication methods like 2+1 or 3+1 are used in clinical studies, particularly for subjective assessments or expert consensus in AI model validation. For mechanical and material testing, the acceptance is based on quantitative measurements meeting predefined criteria from industry standards.
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:
- This question is not applicable. This is a physical medical implant, not an AI-assisted diagnostic tool. Therefore, no MRMC study involving human readers and AI assistance was conducted or would be relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- This question is not applicable. This device is a mechanical prosthesis, not an algorithm or software. "Standalone performance" in this context would refer to the purely mechanical performance of the device itself, which is what the mechanical and material tests evaluated.
7. The type of ground truth used:
- The ground truth for this device is based on engineering standards and established performance benchmarks for similar predicate orthopedic implants. Specifically:
- Mechanical Integrity: Compliance with ASTM standards (F2028, F2009, F543) ensures the device's physical strength, stability, and resistance to wear meet accepted anatomical and functional requirements for shoulder prostheses.
- Biocompatibility/Material Safety: Compliance with pyrogen limits (EP 2.6.14/USP ) and FDA guidance on plasma sprayed coatings ensures the materials are safe for implantation and do not elicit adverse biological responses.
- Magnetic Resonance Compatibility: Compliance with ASTM standards (F2182, F2052, F2119) ensures the device is safe for patients undergoing MRI procedures.
8. The sample size for the training set:
- This question is not applicable. There is no "training set" in the context of demonstrating substantial equivalence for a mechanical prosthetic device. The design and manufacturing processes are informed by existing biomechanical knowledge, material science, and the performance of predicate devices, not by a data-driven training process for an algorithm.
9. How the ground truth for the training set was established:
- This question is not applicable as there is no "training set." The engineering principles and material science knowledge applied in the design and testing of such devices are established through decades of research, manufacturing experience, and regulatory guidance, rather than a specific "ground truth" for a training set.
§ 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.”