(207 days)
The Cofield2 Total Shoulder System, the Neer II Total Shoulder System, and the Neer III Total Shoulder System are indicated for use as orthopaedic implants for the partial replacement of the human shoulder joint articulating either directly against the glenoid face or a compatible glenoid component, respectively.
The Cofield2 Total Shoulder System, the Neer II Total Shoulder System, and the Neer III Total Shoulder System are intended for the following:
Proximal Humeral Prosthesis - (1) complex, acute fractures or fracture-dislocations of the humeral head (e.g. trauma - three and four-part injuries in the Neer classification, or head splitting, or head impression fractures); (2) complex, chronic fractures or fracture-dislocations of the humeral head with malunion, nonunion of a small osteoporotic head fragment, or chronic dislocation with loss of humeral head cartilage, or large impression fractures; (3) avascular necrosis with intact glenoid cartilage; and (4) selected patients with arthritis who do not have adequate scapular bone to support a glenoid component or must engage in moderately heavy activities.
Total Shoulder Arthroplasty (when used in conjunction with a compatible glenoid component) - severe destruction of the glenohumeral articular surfaces with intractable chronic pain in rheumatoid arthritis, osteoarthritis, traumatic arthritis, cuff tear arthroplasty, ancient septic arthritis avascular necrosis with secondary glenoid changes, radiation necrosis, and other failed reconstructive procedures. The subject all poly glenoid components are intended for cemented fixation only and for single use only.
The Orthopaedic Division of Smith & Nephew, Inc. will utilize the VHP® sterilization process to terminally sterilize all polyethylene glenoid components manufactured from UHMWPE material in the following product systems:
- Cofield Total Shoulder System (all polyethylene glenoid components) .
- Neer II Total Shoulder System (all polyethylene glenoid components) .
- Neer III Total Shoulder System (all polyethylene glenoid components)
There have been no changes in indications for use, design, or material property changes to any Cofield2, Neer II, or Neer III Total Shoulder System UHMWPE all polyethylene glenoid components that will be sterilized using the VHP® process.
The VHP sterilization process uses hydrogen peroxide (H2O2) vapor for sterilization of Coffeld2, Neer II, and Neer III Total Shoulder System components (all polyethylene glenoids) manufactured from UHMWPE using the Century SL VHP® Sterilizer. Sterilization is achieved by a series of H2O2 gas injections at deep vacuum set points. Aeration of the medical devices after sterilization is conducted by a series of chamber evacuations.
The provided text describes the 510(k) summary for the UHMWPE Components of the Cofield2, Neer II, and Neer III Total Shoulder Systems sterilized with the VHP® Sterilization Process. The focus of the acceptance criteria and study here is on the sterilization process itself, not on the performance of the shoulder systems as medical devices. The document aims to demonstrate that the VHP® sterilization process achieves a required sterility assurance level (SAL) and does not negatively affect the material properties of the UHMWPE components.
Here's a breakdown of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (for VHP® Sterilization Process) | Reported Device Performance (VHP® Sterilization Process) |
|---|---|
| Microbicidal effectiveness of the vaporized hydrogen peroxide to achieve a Sterility Assurance Level (SAL) of 10⁻⁶. | Test results demonstrated that the VHP® sterilization process is capable of terminally sterilizing UHMWPE orthopaedic implants and verifies achievement of a SAL of 10⁻⁶. |
| No detrimental effects of the VHP® sterilization cycle on UHMWPE materials. | The effects of the VHP® sterilization cycle on UHMWPE materials in which the product is packaged were evaluated. (No specific adverse effects reported, implying acceptance criteria met). |
| Process validation to demonstrate that the VHP® sterilization process is effective and reproducible. | Process validation efforts demonstrated that the VHP® sterilization process is effective and reproducible. |
| Safety, reproducibility, predictability, and effectiveness in sterilizing UHMWPE orthopaedic implants packaged and sealed in Tyvek®/Mylar® pouches. | The VHP sterilization process was also demonstrated to be safe, reproducible, predictable, and effective in sterilizing UHMWPE orthopaedic implants packaged and sealed in Tyvek®/Mylar® pouches. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the specific sample sizes (e.g., number of UHMWPE components or test runs) used for the sterilization validation tests. It refers to "numerous tests."
- Sample Size for Test Set: Not explicitly stated (referred to as "numerous tests").
- Data Provenance: Not explicitly stated. The document is from Smith & Nephew, Inc., an orthopaedic division, implying the data would come from their internal testing or commissioned labs. Given the date (2002), it is likely retrospective or conducted specifically for this submission.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
The concept of "experts" and "ground truth" in the typical medical imaging or diagnostic sense is not applicable here. The "ground truth" for sterilization is established through scientific and industry standards (e.g., SAL of 10⁻⁶), which are validated through microbiological and material science testing methods. Experts in sterilization science and material compatibility would be involved in designing and interpreting these tests, but their number and specific qualifications are not detailed in this summary.
4. Adjudication Method for the Test Set
Not applicable. Adjudication methods (e.g., 2+1) are typically used for subjective assessments by multiple human readers, common in medical imaging studies. Sterilization validation involves objective laboratory testing against defined standards.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No. This type of study (MRMC) is relevant for evaluating the impact of AI on human reader performance for diagnostic tasks. This submission is about the validation of a sterilization process, which does not involve human readers interpreting cases.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Study Was Done
Yes, in essence, the sterilization validation studies are "standalone" in that they evaluate the performance of the process (VHP® sterilization) directly against established criteria, without human intervention in the outcome of the sterilization itself (though humans operate the sterilizer and conduct the tests). The tests assess the microbicidal effectiveness and material compatibility of the process independently.
7. The Type of Ground Truth Used
The ground truth used for this device (sterilization process) is primarily based on:
- Microbiological Standards: Achieving a Sterility Assurance Level (SAL) of 10⁻⁶, which is a widely accepted industry standard for terminal sterilization indicating a probability of one in a million contaminated units. This is objectively measured and verified through biological indicators and process challenge devices.
- Material Compatibility Standards: Demonstrating no adverse effects on the mechanical or chemical properties of the UHMWPE material due to the sterilization process. This is assessed through physical, chemical, and mechanical testing.
8. The Sample Size for the Training Set
Not applicable. This is not an AI/machine learning device that requires a training set. The "training" for a sterilization process involves developing and optimizing the process parameters through experiments, but this is not referred to as a "training set" in the context of this 510(k) summary.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no "training set" in the AI/machine learning sense. The "ground truth" during the development and optimization of the VHP® sterilization process would have been established through a rigorous scientific and engineering approach, using microbiological assays and material characterization techniques to determine effective and safe process 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.”