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The Exactech All Polyethylene Acetabular Cup is indicated for use in skeletally mature individuals undergoing primary surgery for total hip replacement due to osteoarthritis, osteonecrosis, congenital hip dysplasia, rheumatoid arthritis, ankylosing spondylitis and/or posttraumatic degenerative problems. It is also potentially indicated for revision of failed previous reconstructions where sufficient bone stock is present.

The Exactech All Poly Acetabular Cup consists of various sizes and is made from Medical Grade Ultra High Molecular Weight polyethylene (UHMWPE) with a Cobalt Chrome F 90-87 radiographic marker wire. The component is produced in various inside and outside diameters and accommodates numerous femoral head sizes. The device is designed for use with all Exactech femoral components and femoral heads. A complete trial set and instrumentation is available to assist in accurate implantation of the prosthetic components. Design drawings are typical for such components that have been used in the industry since their introduction by Charnley in the late '60's.

This 510(k) summary (K9633313) for the Exactech All Poly Acetabular Cup is a premarket notification for a medical device and therefore describes substantial equivalence to existing devices rather than presenting a study demonstrating the device meets a set of acceptance criteria in the manner of a novel medical device. The document focuses on establishing equivalence based on design, materials, and historical use, rather than presenting new performance data from a dedicated study with acceptance criteria.

The information requested in the prompt is generally associated with performance studies for novel devices or significant modifications, which are not typically found in a 510(k) for a device claiming substantial equivalence to older, well-established technologies.

Below is an attempt to structure the available information relevant to your request, but it's important to note the limitations inherent in this type of submission.

Analysis of the Provided Text (K9633313 - Exactech All Poly Acetabular Cup):

The document primarily establishes substantial equivalence to predicate devices marketed before May 28, 1976, and other legally marketed devices. It does not present a new study with explicit acceptance criteria and corresponding device performance metrics in the typical sense of a clinical trial or performance study for a novel device. Instead, the "performance" is implicitly deemed acceptable due to its similarity to historically successful, legally marketed devices.

However, we can infer some "acceptance criteria" through the design considerations and material specifications, and the "study" is the cumulative historical clinical evidence of the predicate devices and the material itself.

1. Table of Implicit Acceptance Criteria and Reported Device "Performance"

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size for Test Set: Not applicable in the context of this submission. There is no new "test set" of patients or devices specifically studied for this 510(k). The "evidence" is based on the performance of predicate devices and the established properties of the materials.
• Data Provenance: The data provenance for the biocompatibility comes from published clinical and laboratory studies cited for UHMWPE and from the historical performance of predicate devices which would have been used globally (Charnley in the UK, etc.). This is primarily retrospective evidence from existing literature and market history.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

• Number of Experts: Not applicable. No "ground truth" for a new test set was established by a panel of experts for this 510(k) in the way one would for a diagnostic AI device. The "ground truth" is the historical clinical acceptance and performance of the predicate devices and the established biocompatibility of the materials.
• Qualifications of Experts: The experts involved are the authors of the cited scientific literature and the developers/manufacturers of the predicate devices whose designs and materials inform the Exactech All Poly Acetabular Cup.

4. Adjudication Method for the Test Set

• Adjudication Method: Not applicable. No specific test set requiring adjudication was used.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

• MRMC Study: No, an MRMC comparative effectiveness study was not done. This device is a passive implantable medical device, not a diagnostic tool where human readers assess cases.

6. Standalone Performance Study

• Standalone Study: Yes, in an indirect sense, the properties of the materials (UHMWPE, Cobalt Chrome) and the design principles of the acetabular cup have undergone extensive standalone evaluation through decades of research, clinical use, and regulatory scrutiny by various bodies and researchers. The biocompatibility studies cited (Charnley, Halley, Mirra, Turner, etc.) represent a form of "standalone performance" evaluation of the material itself. However, there isn't a single prospective standalone study for this specific device mentioned in the 510(k).

7. Type of Ground Truth Used

• Type of Ground Truth: The ground truth used is primarily historical clinical outcomes data and expert consensus from the long-term use of UHMWPE in hip arthroplasty, as documented in published clinical literature and the established safety and effectiveness of predicate devices. Pathology data from these historical studies also contributes to the understanding of material biocompatibility and performance.

8. Sample Size for the Training Set

• Sample Size for Training Set: Not applicable. This is not an AI/ML device that requires a "training set" in the computational sense. The "training" for the design of this device comes from decades of cumulative engineering knowledge, clinical experience, and material science research in total hip arthroplasty.

9. How the Ground Truth for the Training Set Was Established

• How Ground Truth for Training Set Was Established: Not applicable. The "ground truth" for the cumulative knowledge base that informed this device's design was established through a combination of:
  • Clinical observation and follow-up of millions of patients who received total hip replacements using similar designs and materials over several decades (e.g., Charnley's extensive work).
  • Mechanical testing and material science research on UHMWPE and other orthopedic biomaterials.
  • Pathological examination of explanted prostheses and surrounding tissues.
  • Regulatory review and approval processes for predicate devices, which established their safety and effectiveness.

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