(153 days)
The INTEGRA® TITAN™ Modular Total Shoulder System Fin-Lock™ Glenoid is intended for use in Total Shoulder Arthroplasty which is indicated for:
- Severely painful and/or disabled joint resulting from osteoarthritis, traumatic arthritis 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)
The humeral component is intended for cemented or uncemented use.
The glenoid component is intended for cemented use only.
The Integra TITAN™ Modular Total Shoulder System Fin-Lock™ Glenoid is a fully cemented all highly cross-linked polyethylene glenoid used in total shoulder arthroplasty for resurfacing the glenoid fossa. The glenoid component has one central peg with barbs and three peripheral pegs. The articulating surface of the glenoid device will be the same dimensions and sizes as existing Titan Modular Total Shoulder System three peg inline glenoids for consistent mismatching. The Fin-Lock™ Glenoid is intended to be a part of the TITAN™ Modular Shoulder System, 2.5 (K142413) and be used with the humeral component.
Based on the provided text, the acceptance criteria and the study results for the INTEGRA® TITAN™ Modular Total Shoulder System Fin-Lock™ Glenoid are described in the "807.92(b)(1-2) – Nonclinical Tests Submitted" section.
Here's a breakdown of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance
The document states that "The results of these performance tests met their respective acceptance criteria." However, it does not explicitly list the quantitative acceptance criteria for each test. It only mentions that the device met them.
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not explicitly stated in the document | Met the respective acceptance criteria for each test. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify the sample sizes used for the test sets in the performance tests. It also does not mention the data provenance (e.g., country of origin, retrospective or prospective nature). The tests are described as "nonclinical," implying they were conducted in a laboratory setting rather than using patient data.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
This information is not applicable and not provided. The tests described are "nonclinical" performance tests (e.g., mechanical testing, material characterization), which typically do not involve human experts establishing ground truth in the way clinical studies or diagnostic AI algorithms do.
4. Adjudication Method for the Test Set
This information is not applicable and not provided. As mentioned above, these are nonclinical performance tests, not clinical studies requiring adjudication of outcomes by experts.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
No, an MRMC comparative effectiveness study was not done. The document describes nonclinical performance tests, not studies involving human readers or AI assistance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
This is not applicable. The device is a physical medical implant (shoulder prosthesis), not an algorithm or AI. The tests performed are for the physical properties and performance of the implant itself.
7. The Type of Ground Truth Used
The ground truth for these nonclinical tests would be based on engineering specifications, material science standards, and mechanical testing protocols. For example, for a "Glenoid Pull-out Fixation Test," the ground truth would be a defined force threshold or displacement limit that the device must withstand according to established engineering principles for such implants. The document implies these standards were used by stating "met their respective acceptance criteria."
8. The Sample Size for the Training Set
This is not applicable. The device is a physical medical device. There is no "training set" in the context of an AI/algorithm. The development and testing of a physical implant involve design iterations, material selection, and extensive pre-clinical testing, but not an AI-style training set.
9. How the Ground Truth for the Training Set was Established
This is not applicable as there is no training set for a physical medical device. The "ground truth" for the device's design and manufacturing would be based on biomaterial science, biomechanical engineering principles, clinical needs, existing standards for orthopedic implants, and the performance characteristics of predicate devices.
§ 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.”