(78 days)
The INTEGRA® TITAN™ Modular Total Shoulder System is a Total Shoulder Arthroplasty which is indicated for: Severely painful and/or disabled joint resulting from osteoarthritis or rheumatoid arthritis. Fracture-dislocations of the proximal humerus where the articular surface is severely comminuted, separated from its blood supply or where the surgeon's experience indicated that alternative methods of treatment are unsatisfactory. Other difficult clinical problems where shoulder arthrodesis or resection arthroplasty are not acceptable (e.g. - revision of a failed primary component) Shoulder Hemiathroplasty is also indicated for: Ununited humeral head factures, Avascular necrosis of the humeral head, Rotator cuff arthropathy, Deformity and/or limited motion. The humeral component is intended for cemented or uncemented use. The glenoid component is intended for cemented use only.
The TITAN™ Modular Total Shoulder System consists of a line of metaphyseal bodies, humeral stems, humeral heads and all polyethylene glenoid components. The body, stem and humeral head may be used by themselves, as a hemiarthroplasty, if the natural glenoid provides a sufficient bearing surface, or in conjunction with the glenoid, as a total replacement. The metaphyseal bodies and humeral stems are shaped to provide proximal fixation and optimal fixation area. Their variable length and proximally-filling shape are designed to accommodate the natural humeral geometry and provide stable fixation. proximal bone loading and proper head placement. The humeral heads are offered with both concentric and eccentric articulating surfaces. The humeral head may articulate against the natural glenoid bone, if it is of sufficient quality, or against the all polyethylene cemented glenoid. The glenoid has multiple options: keeled or standard pegged (3 pegs). All glenoid options are designed to function with both the concentric and eccentric heads. The humeral components are intended for cemented or uncemented use, while the glenoid component is for use with cement only.
The provided document is a 510(k) Premarket Notification summary for the INTEGRA® TITAN™ Modular Total Shoulder System. This document outlines the device description, intended use, and a comparison to a predicate device, focusing on demonstrating substantial equivalence rather than a detailed study proving the device meets specific acceptance criteria in the manner of an AI/ML device or a clinical trial.
The "acceptance criteria" and "device performance" described are related to non-clinical mechanical testing of the orthopedic implant, not to diagnostic accuracy or clinical outcomes in the way one would assess an AI/ML device. Therefore, many of the requested categories in your prompt are not applicable or cannot be extracted from this type of regulatory submission.
Here's a breakdown of the available information:
1. Table of acceptance criteria and reported device performance:
| Test | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Taper Axial Disassembly Test | Not explicitly stated in the document, but can be inferred as meeting a predefined standard or benchmark for safe and effective performance of the taper connection. | "The results of these performance tests met their respective acceptance criteria and demonstrate that the INTEGRA® TITAN™ Modular Total Shoulder System is safe for the intended use..." |
| Fatigue Test | Not explicitly stated, but inferred as meeting a predefined standard or benchmark for the cyclic loading capability of the implant components, ensuring durability over time. | "The results of these performance tests met their respective acceptance criteria and demonstrate that the INTEGRA® TITAN™ Modular Total Shoulder System is safe for the intended use..." |
| Maximum Static Load Test | Not explicitly stated, but inferred as meeting a predefined standard or benchmark for the maximum force the device can withstand without failure. | "The results of these performance tests met their respective acceptance criteria and demonstrate that the INTEGRA® TITAN™ Modular Total Shoulder System is safe for the intended use..." |
| Impact Assembly Test | Not explicitly stated, but inferred as meeting a predefined standard or benchmark for the robust assembly of the modular components, likely involving resistance to impact forces during implantation or use. | "The results of these performance tests met their respective acceptance criteria and demonstrate that the INTEGRA® TITAN™ Modular Total Shoulder System is safe for the intended use..." |
| Suture Verification Report | Not explicitly stated, but inferred as ensuring that sutures, if any are part of the device or its intended use, function as designed and maintain structural integrity. This might be more related to surgical technique or a component of the implant. | "The results of these performance tests met their respective acceptance criteria and demonstrate that the INTEGRA® TITAN™ Modular Total Shoulder System is safe for the intended use..." |
Study Proving Acceptance Criteria:
The study that proves the device meets the acceptance criteria consists of the non-clinical tests listed above. The document states: "Testing to verify the performance of the INTEGRA® TITAN™ Modular Total Shoulder System included the following: Taper Axial Disassembly Test, Fatigue Test, Maximum Static Load Test, Impact Assembly Test, Suture Verification Report. The results of these performance tests met their respective acceptance criteria and demonstrate that the INTEGRA® TITAN™ Modular Total Shoulder System is safe for the intended use, and is substantially equivalent to the predicate device identified."
2. Sample sized used for the test set and the data provenance:
- Sample Size: Not specified for these non-clinical mechanical tests. Typically, mechanical testing involves a certain number of test articles (e.g., usually 3, 5, or more per test condition as per ISO or ASTM standards) rather than "patients" or "data sets." Specific quantities are not disclosed in this summary document.
- Data Provenance: N/A. These are laboratory-based mechanical tests performed on device components, not based on human data from a geographic origin.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- N/A. For mechanical testing, the "ground truth" is typically defined by engineering specifications, material properties, and established test standards (e.g., ASTM, ISO standards for orthopedic implants). It does not involve human expert interpretation in the way clinical diagnostic data would.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- N/A. This concept is for clinical data adjudication, not mechanical engineering tests.
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:
- N/A. This is a non-clinical 510(k) submission for a physical orthopedic implant, not an AI/ML diagnostic device.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- N/A. Not an AI/ML device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For these mechanical tests, the "ground truth" is based on engineering specifications, material science principles, and established international or national standards for orthopedic implant mechanical performance (e.g., ASTM F2028-14 for humeral prostheses, or similar standards for fatigue, static loading, and taper connections). The "acceptance criteria" are derived from these standards and the predicate device's performance.
8. The sample size for the training set:
- N/A. There is no concept of a "training set" for physical mechanical device testing as there would be for an AI/ML algorithm. The design of the device is based on engineering principles and comparison to the predicate.
9. How the ground truth for the training set was established:
- N/A. Not applicable to this type of device and testing.
§ 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.”