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The Cofield2 Total Shoulder System is indicated for the following:

Proximal Humeral Prosthesis

• 1. Complex, acute fractures or fracture-dislocations of the humeral head (e.g. frauma 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, non-union of a small osteoporotic head fragment, or chronic dislocation with loss of humeral head cartilage, or large impression fractures.
• Avascular necrosis with intact glenoid cartilage.
• 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

Severe destruction of the glenohumeral articular surfaces with intractable chronic pain in rheumatoid arthritis, juvenile 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 Cofield Total Shoulder System includes porous coated devices which are intended for use without bone cement, and are single use devices.

The overall design, components, and materials of the Cofield Total Shoulder System are substantially equivalent to the existing components of the Cofield Total Shoulder System cleared under previous cquirvation to the 'existing components of between the subject components of the Cofield Total Shoulder premanet notified on the currently is the intended use of the system without bone cement.

The provided text describes a 510(k) premarket notification for the Smith & Nephew Cofield2 Total Shoulder System. This document focuses on demonstrating substantial equivalence to previously cleared devices for the purpose of market clearance. It does not present a study designed to establish acceptance criteria or demonstrate device performance against those criteria in a clinical or analytical setting.

Therefore, I cannot populate the requested table and answer the study-related questions based on the provided text. The information typically associated with acceptance criteria and a detailed performance study (such as sample size, ground truth establishment, expert qualifications, adjudication methods, or MRMC studies) is not present in this type of regulatory submission summary.

This document is a declaration of intent to market, asserting similarity to existing devices, rather than a detailed report of a performance study with defined acceptance criteria.

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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

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.

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