(27 days)
The Reverse® Shoulder Prosthesis Monoblock is indicated for patients with a functional deltoid muscle with a grossly deficient rotator cuff shoulder joint with severe arthropathy or a previously failed joint replacement with a grossly deficient rotator cuff shoulder joint:
- In cases of fracture of glenohumeral joint from trauma or pathologic conditions of the shoulder, . including humeral head fracture or displaced 3- or 4-part fractures of proximal humerus. (For cemented implantation only)
- In cases of bone defect in proximal humerus.
The patient's joint must be anatomically and structurally suited to receive the selected implant(s).
The glenoid baseplate is intended for cementless application with the addition of screws for fixation. The humeral stem is intended for cemented or cementless use.
The RSP system is designed so that the "ball" of the articulation fits into the glenoid baseplate, and the "cup" of the articulation fits into a metal cup that is joined to the humeral stem. The RSP Monoblock stem includes a humeral stem with socket attached, and humeral socket insert. This change is to replace the current titanium plasma spray coating with porous coating on the size 6 stem only. There are no changes to the fundamental scientific technology of the RSP Monoblock with the modifications in this 510(k) submission.
This document is a 510(k) premarket notification for a medical device (Reverse® Shoulder Prosthesis Monoblock). It does not describe a study conducted to demonstrate that a device meets specific acceptance criteria based on its performance in assessing or diagnosing conditions. Instead, this document is focused on demonstrating that a physical implant is substantially equivalent to previously marketed devices.
Therefore, most of the requested information (related to device performance in a diagnostic or assessment context, such as sample sizes, expert ground truth, adjudication methods, MRMC studies, standalone performance, training sets, etc.) is not applicable to this type of submission.
However, I can extract information regarding non-clinical testing which serves as the "study" demonstrating the device meets performance criteria for a physical implant.
Here's a breakdown of the relevant information provided in the document:
1. Table of Acceptance Criteria and Reported Device Performance:
The document describes non-clinical testing performed to ensure the updated device (specifically, the change from titanium plasma spray coating to porous coating on the size 6 stem) remains substantially equivalent to its predicates. The acceptance criteria are implicitly met if the test results are comparable to the predicate devices and demonstrate satisfactory performance for the intended use of the implant.
| Acceptance Criteria (Implied by testing) | Reported Device Performance |
|---|---|
| Sufficient fatigue resistance | Testing determined device is substantially equivalent to predicates. |
| Adequate coating shear strength | Testing determined device is substantially equivalent to predicates. |
| Adequate coating tensile strength | Testing determined device is substantially equivalent to predicates. |
| Appropriate bead size | Testing determined device is substantially equivalent to predicates. |
| Appropriate pore size | Testing determined device is substantially equivalent to predicates. |
| Satisfactory porosity | Testing determined device is substantially equivalent to predicates. |
| Adequate bead layer | Testing determined device is substantially equivalent to predicates. |
| Sufficient coating thickness | Testing determined device is substantially equivalent to predicates. |
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size: Not specified in terms of number of physical devices or tests conducted for each parameter. The document generally states "All testing."
- Data Provenance: The testing was non-clinical (laboratory-based) and conducted by the manufacturer, DJO Surgical, in preparation for the 510(k) submission. Therefore, it is prospective in the context of the submission. The country of origin of the data would be the location where DJO Surgical conducted its testing (implicitly, the United States, given the address included).
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
- Not applicable. This device is a physical implant, and the "ground truth" for its performance is established through engineering and biomechanical testing standards, not expert medical opinion on a dataset.
4. Adjudication Method for the Test Set:
- Not applicable. This testing involves objective measurements against engineering specifications and comparison to predicate device performance, not subjective review requiring adjudication.
5. Multi Reader Multi Case (MRMC) Comparative Effectiveness Study:
- No. This is a 510(k) submission for a physical implant, not an AI/diagnostic device.
6. Standalone (i.e., algorithm only without human-in-the-loop performance) Study:
- No. This is a physical implant, not an algorithm.
7. Type of Ground Truth Used:
- The "ground truth" for this device's performance is established by engineering specifications, industry standards, and the performance characteristics of predicate devices that have been previously deemed safe and effective. The non-clinical tests verify that the modified device meets these established performance benchmarks.
8. Sample Size for the Training Set:
- Not applicable. This is not a machine learning or AI device.
9. How the Ground Truth for the Training Set Was Established:
- Not applicable. This is not a machine learning or AI device.
§ 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.”