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The Accin™ Hip System components are for use in total hip arthroplasty as a result of: Hip arthritis caused by rheumatoid disease, non-inflammatory degenerative joint disease, osteoarthritis, and arthritis resulting from biologic or mechanical trauma to the hip Correction of functional deformity Avascular Necrosis Treatment of non-unions, femoral neck and trochanteric fractures of the proximal femur Difficult clinical management problems involving persistent pain and physical impairment where conventional arthodesis is not likely to achieve satisfactory results These components are single use only and are intended for implantation without bone cement.

The Accin™ Hip System consists of plasma spray coated titanium alloy femoral component, a cobalt chrome femoral head, a plasma spray coated titanium alloy acetabular shell, bone screws and a polyethylene acetabular insert.

The provided document, K073068, describes the Accin™ Hip System, a medical device. This document is a summary of safety and effectiveness, indicating the device's comparison to predicate devices and the testing performed. However, it does not contain detailed information regarding acceptance criteria and a study that proves the device meets those criteria in the format requested.

Specifically, the document states:

• "Testing has shown that the proposed device meets the requirements of the current FDA Guidance documents on total hip arthroplasty product and the proposed device is equivalent to the predicate device."
• "Tests were performed on the Hip System. The tests performed can be found in the guidance documents entitled 'Guidance for Industry on the Testing of Metallic Plasma Sprayed Coatings on Orthopedic Implants to Support Reconsideration of Postmarket Surveillance Requirements;' 'Class II Special Controls Guidance Document: Hip Joint Metal/Polymer Constrained Cermented or Uncom of the Prosthesis;' and 'Guidance for Industry and FDA Staff - Non-clinical Information for Femoral Stem Prostheses.'"

This indicates that testing was conducted to demonstrate equivalence to predicate devices and adherence to FDA guidance documents, which serve as the implicit acceptance criteria for this type of device. However, the document does not provide:

1. A specific table of acceptance criteria and reported device performance. It only generally states that the device meets requirements and is equivalent.
2. Sample size used for the test set or data provenance. The document only states "Tests were performed on the Hip System."
3. Number of experts, their qualifications, or adjudication methods. These are not applicable as the tests described are mechanical/material performance tests, not clinical studies involving expert interpretation or ground truth establishment in a diagnostic context.
4. Information on any Multi Reader Multi Case (MRMC) comparative effectiveness study. This type of study is not relevant for a hip implant's mechanical and material safety/effectiveness demonstration.
5. Standalone algorithm performance. This is not applicable as the device is a physical hip implant, not an AI algorithm.
6. Type of ground truth used. The document refers to FDA guidance documents and predicate device equivalence as the basis for evaluation, implying engineering and material standards rather than expert consensus, pathology, or outcomes data in a clinical trial sense.
7. Sample size for the training set or how ground truth was established for it. These concepts are not relevant for the type of device and testing described.

Therefore, based only on the provided text, I cannot complete the requested tables and information. The document focuses on regulatory approval through substantial equivalence to predicate devices and adherence to existing guidance for materials and mechanical testing, rather than a detailed clinical study report with the specified metrics.

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