(160 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 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 Integra TITAN Reverse Shoulder System is a modular shoulder prosthesis system. The humeral components consist of humeral stems, varying heights of reverse bodies, 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 4 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 provided document describes the Integra TITAN Reverse Shoulder System, a medical device. The information details nonclinical testing performed to establish substantial equivalence to predicate devices, rather than a study proving the device meets specific acceptance criteria in a clinical or AI-assisted diagnostic context.
Therefore, the following information, as requested in the prompt, is not available in the provided text:
- A table of acceptance criteria and reported device performance (in a diagnostic context)
- Sample size used for the test set and data provenance (for diagnostic performance)
- Number of experts used to establish ground truth for the test set
- Qualifications of those experts
- Adjudication method
- If a multi reader multi case (MRMC) comparative effectiveness study was done
- Effect size of human readers improving with AI vs without AI assistance
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.) for a diagnostic algorithm
- The sample size for the training set (for a diagnostic algorithm)
- How the ground truth for the training set was established (for a diagnostic algorithm)
However, I can extract information regarding the nonclinical performance testing that was conducted for the device. The document explicitly states: "Clinical performance data were not necessary to support substantial equivalence." This means no human clinical trials (as one might expect a diagnostic AI to undergo) were presented for this 510(k) submission.
Here's what can be extracted about the device's nonclinical performance:
Nonclinical Testing and Acceptance Criteria:
The Integra TITAN Reverse Shoulder System underwent several nonclinical performance tests to confirm its ability to perform under expected clinical conditions. The acceptance criteria for each test are implicitly met as the summary states the "System met all acceptance criteria" or "is acceptable" for each respective test.
| Test ID / Description | Reported Device Performance (Conclusion) |
|---|---|
| 1. TP/TR -04-0172 rev A TSS Taper Axial Disassembly Force | The taper in the TITAN Total Shoulder System is identical to the taper in the Reverse Shoulder system; therefore, additional testing was not required. The test report concludes that the locking efficiency of the AOI taper is acceptable. (Previously submitted in K100448). |
| 2. TP/TR-04-0245 Rev B TITAN Reverse Shoulder Body/Spacer to Liner Axial Disassembly Test | The objective of this test was to verify that the force required to disassemble the TITAN Reverse Shoulder System (RSS) humeral liner from the modular body or the humeral spacer exceeds a biomechanically justified worst-case load. The Spacer and Liner assemblies of the TITAN Reverse Shoulder System met all acceptance criteria. |
| 3. TP/TR-04-0248 Dynamic Evaluation of Glenoid Baseplate Disassociation | The objective of this test was to verify that the TITAN Reverse Shoulder System (RSS) glenoid assembly does not loosen during cyclic loading representing one year of post-arthroplasty daily living. The TITAN Reverse Shoulder System Glenoid construct met all acceptance criteria. |
| 4. TP/TR-04-0283 rev A RSS Fatigue Evaluation Test | The objective of this test was to verify that the modular TITAN Reverse Shoulder System (RSS) maintains functional integrity after enduring a challenging fatigue regimen representing 10 years of daily worst-case post-arthroplasty cyclic loading in a simulated biological corrosive environment. The TITAN Reverse Shoulder System met all acceptance criteria. |
| 5. TP/TR-04-0254-01 TITAN Reverse Shoulder System Glenosphere-Baseplate Taper Axial Disassembly Force | The purpose of this test was to determine the force required to disassemble the Glenosphere/Baseplate taper junction of the Integra TITAN Reverse Shoulder System. Heuristic models of the Reverse glenosphere male taper and baseplate female taper were tested as per ASTM F2009-00(2011). The taper design for the Glenosphere-Baseplate junction of the TITAN Reverse Shoulder System met all acceptance criteria. |
| 6. TP/TR-04-0281 Rev A Reverse Shoulder System Liner Rotational Resistance Test Protocol | The objective of this test was to verify that the TITAN Reverse Shoulder System (RSS) humeral liner could withstand worst-case torques created by rotation about the glenosphere without disassociating from the body implant or spacer implant. The rotational resistance at the interface of the Spacer and Liner of the TITAN Reverse Shoulder System met all acceptance criteria. |
| 7. TP/TR-09-0082 Reverse Shoulder 4.5mm Screw Properties | The purpose of this test was to verify that the TITAN Reverse Shoulder System (RSS) 4.5mm screw meets all criteria for its intended use. These criteria include driving properties, torsional properties and axial pullout strength. The RSS 4.5mm screws met all acceptance criteria. |
| 8. TP/TR-09-0083 Reverse Shoulder 5.5mm Screw Properties | The purpose of this test was to verify that the TITAN Reverse Shoulder System (RSS) 5.5mm screw meets all criteria for its intended use. These criteria include driving properties, torsional properties and axial pullout strength. The RSS 5.5mm screws met all acceptance criteria. |
| 9. TR-09-0088 rev C Asymmatrix Coating Characteristics | The Asymmatrix coating (sintered asymmetrical titanium bead coating) used on the Humeral Bodies and Glenoid Baseplates meets the requirements of the appropriate FDA guidance documents for use in the Integra Reverse Shoulder System. |
| 10. TR-09-0249 rev B RSS Range of Motion | This document verifies the range of motion of the TITAN Reverse Shoulder System in flexion, abduction, internal rotation, external rotation and extension. The range of motion of the TITAN Reverse Shoulder System meets the performance requirements. The testing was conducted on worst-case components or constructs according to standard test methods, where possible. (Details about the "performance requirements" for range of motion are not provided in this summary, but are stated as met). |
Additional Notes:
- Sample Size (for nonclinical tests): The document does not specify the exact sample sizes (number of units tested) for each nonclinical test, but refers to "worst-case components or constructs" being tested.
- Data Provenance (for nonclinical tests): These are laboratory-based engineering tests, not clinical data from patients or a specific country.
- Ground Truth (for nonclinical tests): The ground truth for these tests is based on established engineering principles, biomechanical justification, industry standards (e.g., ASTM F2009-00(2011)), and FDA guidance documents.
- Training Set (for nonclinical tests): This concept does not apply to the nonclinical testing described. These are physical performance assessments against predefined engineering parameters.
§ 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.”