(198 days)
The TITAN Reverse Shoulder System is indicated for use in a grossly deficient rotator cuff joint with severe arthropathy or a previous failed joint replacement with a grossly deficient rotator cuff joint. The patient's joint must be anatomically and structurally suited to receive the selected implants and a functional deltoid muscle is necessary to use the device. The TITAN Reverse Shoulder System is indicated for primary, fractures - including proximal humeral, or revision total shoulder replacement for the relief of pain and significant disability due to gross rotator cuff deficiency. The glenoid base plate is intended for cementless application with the addition of screws for fixation. The humeral stem is indicated for cemented or uncemented use and the humeral body component is intended for cementless use.
The TITAN Reverse Total Shoulder System is a semi-constrained total shoulder construct. The humeral components consist of humeral stems, reverse bodies of varying heights, and humeral poly liners. The poly liners are available in varying thicknesses and constraints to achieve stability and offset of the glenohumeral joint. The variable length reverse bodies and proximally-filling shape are designed to accommodate the natural humeral geometry, providing stable fixation as well as proximal bone loading. The glenoid components are composed of a baseplate secured by a central compression screw and four peripheral screws, two of which can be locked. A glenosphere is attached to the baseplate via taper lock. Glenospheres are available in varying offsets and lateralizations. The stems are intended for
The provided text describes a 510(k) premarket notification for a medical device, the Integra TITAN Reverse Shoulder System, with a specific focus on a coating change. It outlines the regulatory process and provides a summary of nonclinical performance data used to demonstrate substantial equivalence to a predicate device.
Here's an analysis of the acceptance criteria and study information:
1. Table of Acceptance Criteria and Reported Device Performance
| Test | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Dynamic Evaluation of RSS Glenoid Component Loosening or Disassociation | The glenoid component must be as resistant to loosening, disassociation of modular components, and dislocation as the predicate device. | The glenoid component is as resistant to loosening, disassociation of modular components, and dislocation as the predicate. |
| Reverse Shoulder System Fatigue Test | The coating change must have no effect on the implant fatigue strength. | The coating change has no effect on the implant fatigue strength. |
| Evaluation of RSS Implant Titanium Plasma Spray Coating | The coating must meet all acceptance criteria presented in the FDA documents: "Class II Special Controls Guidance: Shoulder Joint Metal/Polymer/Metal Nonconstrained or Semi-Constrained Porous-Coated Uncemented Prosthesis" and "Guidance for Industry on the Testing of Metallic Plasma Sprayed Coatings on Orthopedic Implants to Support Reconsideration of Postmarket Surveillance Requirements". | The coating meets all acceptance criteria presented in the FDA documents. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the specific sample sizes for the test sets in the performance tests (Dynamic Evaluation, Fatigue Test, Coating Evaluation). It mentions that "The TITAN Reverse Shoulder System has undergone the following performance testing," implying that these were conducted on samples of the device components.
The data provenance is from nonclinical performance data (laboratory testing) conducted by the manufacturer, Integra Lifesciences Corp. No information on country of origin for the data is provided beyond being internal testing for the US market. The studies are prospective in nature, as they are specifically conducted to support the 510(k) submission for the modified device.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
This information is not provided in the document. For nonclinical performance tests of a medical device like this, ground truth is typically established by the results of standardized engineering and materials tests (e.g., measuring force, displacement, fatigue cycles) rather than by expert consensus in the way a clinical study would use radiologists or pathologists. The acceptance criteria themselves, referencing FDA guidance documents, serve as a form of "ground truth" for what constitutes acceptable performance for these types of tests.
4. Adjudication Method for the Test Set
This is not applicable as the tests are nonclinical (laboratory-based) and do not involve human interpretation or subjective assessment that would require an adjudication method. The results are quantitative measurements against predefined criteria.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No, an MRMC comparative effectiveness study was not done. The document explicitly states: "Clinical performance data are not required to demonstrate substantial equivalence to the predicate device, as there have been no changes to fit, form, or function of the device." This indicates that the 510(k) submission relies solely on nonclinical (bench) testing to show that the coating change does not alter the fundamental safety or effectiveness compared to the predicate device. Therefore, there's no discussion of human reader improvement with or without AI assistance.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
No, a standalone study (or any study related to an algorithm or AI) was not done. This device is a mechanical implant (Titanium Reverse Shoulder System) and does not involve AI or algorithms.
7. Type of Ground Truth Used
The ground truth used for the performance tests (Dynamic Evaluation, Fatigue Test, Coating Evaluation) is based on pre-defined acceptance criteria derived from FDA guidance documents and industry standards for mechanical and material properties of orthopedic implants. These criteria specify acceptable limits for mechanical performance (resistance to loosening, fatigue strength) and material characteristics (coating properties).
8. Sample Size for the Training Set
This information is not applicable. Since the device is a mechanical implant and not an AI/ML algorithm, there is no "training set." The engineering tests are performed on physical samples of the device components.
9. How the Ground Truth for the Training Set Was Established
This is not applicable for the same reason as above; there is no training set for a mechanical device. The "ground truth" for evaluating the performance of the device is established by the specified acceptance criteria for the nonclinical tests.
§ 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.”