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The Excia Hip System is intended to replace a hip joint. The device is intended for: Patients suffering from severe hip and disability due to rheumatoid arthritis, traumatic arthritis, polyarthritis, collagen disorders, avascular necrosis of the femoral head and nonunion of previous fractures of the femur. Patients with congenital hip dysplasia, protrusion acetabuli, or slipped capital femoral epiphysis Patients suffering from disability due previous fusion Patients with acute femoral neck fractures The Excia Hip System is available with two femoral stems. One is manufactured from CoCrMo and is intended for cemented fixation. The other femoral stem is for uncemented fixation and re numeratured from Ti with Plasmapore with or without u-CaP®. The Metha® Hip System (uncemented, press-fit fixation) is intended to replace a hip joint. The device is intended for: skeletally mature individuals undergoing primary surgery for total hip replacement . patients suffering from severe hip pain and disability due to rheumatoid arthritis, traumatic arthritis, polyarthritis, collagen disorders, avascular necrosis of the femoral head and nonunion of provious fractures of the femur. patients with congenital hip dysplasia, protrusion acetabuli, or slipped capital femoral epiphysis . patients suffering from disability due to previous fusion ◆ ◆ patients with acute femoral neck fractures

The Aesculap Implant Systems BIOLOX® OPTION Ceramic Femoral Head System consist of a ceramic head manufactured from an alumina matrix composite available in diameters of 28, 32, and 36 mm and a titanium adapter for the femoral stem cone with a range of neck lengths. The BIOLOX® OPTION Ceramic head provides the surgeon another option to both the metal and alumina ceramic femoral heads for use in total hip arthroplasty. Two Metha® XL Heads are available. The CoCrMo head is offered in two diameters (28mm and 32mm). The BIOLOX® delta ceramic head is composed of an alumina matrix composite and is available in two diameters (32mm and 36mm).

The provided text describes a medical device submission (K090299) for the BIOLOX® OPTION Ceramic Femoral Head System and Metha® XL Heads. It outlines the device, its intended use, and claims substantial equivalence to predicate devices. However, the document does not contain information regarding acceptance criteria or a study proving the device meets those criteria in the context of performance metrics like sensitivity, specificity, accuracy, or other statistical measures typically found in clinical studies or performance evaluations for AI/ML devices.

Instead, the "Performance Data" section lists various guidance documents from the FDA that were followed for testing. This suggests that the "acceptance criteria" for this device are related to compliance with these established standards and guidelines for orthopedic implants, rather than statistical performance thresholds from a specific study.

Therefore, most of the requested information regarding acceptance criteria, device performance, sample sizes, experts, adjudication, MRMC studies, standalone performance, and ground truth for a clinical or AI/ML study cannot be extracted from this document.

Here's an attempt to answer based on the available information:

1. Table of acceptance criteria and the reported device performance:

2. Sample size used for the test set and the data provenance:

• Not applicable/Not provided. The document refers to engineering and material testing standards, not a clinical "test set" with patient data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• Not applicable/Not provided. Ground truth in this context would refer to material science and mechanical engineering standards, not expert consensus on medical images or patient outcomes.

4. Adjudication method for the test set:

• Not applicable/Not provided. This concept is for clinical studies with human review of data.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done:

• No, an MRMC comparative effectiveness study was not done. The document focuses on regulatory compliance for mechanical and material properties of an implant, not clinical effectiveness studies comparing human readers with and without AI assistance.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:

• Not applicable/Not provided. This device is a physical orthopedic implant, not an algorithm or software.

7. The type of ground truth used:

• The "ground truth" for this device's performance would be established through material property testing, mechanical performance testing, and biocompatibility assessments based on the referenced FDA guidance documents and recognized international standards (e.g., ISO standards for implants, not specified in detail here but implied by "where applicable"). This is not "expert consensus, pathology, or outcomes data" in the typical sense of AI/ML evaluation.

8. The sample size for the training set:

• Not applicable/Not provided. There is no "training set" in the context of an AI/ML algorithm for this physical device.

9. How the ground truth for the training set was established:

• Not applicable/Not provided. There is no "training set" or corresponding ground truth for an AI/ML algorithm for this physical device.

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