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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, osteoarthritis, . traumatic arthritis, polyarthritis, collagen disorders, avascular necosis 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 to previous fusion .
• Patients with acute femoral neck fractures ●

The Excia Hip System is available with two femoral stems. One is manufactured from CoCriMo and is intended for cemented fixation. The other femoral stem is for uncemented fixation and manufactured from Ti with Plasmapore with or without y CaP®.

The Excia lateral offset femoral stem is available in two designs and standard lengths. The stem is designed to provide an increased offset during total joint replacement. One is manufactured from Ti with a plasma spray coating (Plasmapore) with or with out u-CaP®. This component is intended for uncemented use. The other femoral component is manufactured from CoCrMo and is intended for cemented use.

The provided text describes a 510(k) premarket notification for the Excia Total Hip System Lateral Offset. This is for a medical device (a hip implant), not a software or AI device. Therefore, the concept of "acceptance criteria" and a "study that proves the device meets the acceptance criteria" in the context of AI performance metrics (like accuracy, F1-score, sensitivity, specificity, etc.) and associated studies (like MRMC, standalone performance) does not directly apply here.

Instead, for a device like this, acceptance criteria are generally related to biocompatibility, mechanical performance, design specifications, and manufacturing quality, and the "study" demonstrating this involves various types of engineering and materials testing.

Based on the provided text, here's a breakdown of the relevant information:

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not provide explicit "acceptance criteria" with numerical targets like a software evaluation would. Instead, it references adherence to established guidance documents and material properties. The "performance data" section indicates that the device met the requirements outlined in these guidance documents.

• "Draft Guidance for the Preparation of Premarket Notifications (510(k)s) Applications for Orthopedic Devices-The Basic Elements"
• "Guidance Document for Testing Orthopedic Implants with Modified Metallic Surfaces Apposing Bone or Bone Cement"
• "Guidance for Industry on the Testing of Metallic Plasma Sprayed Coatings on Orthopedic Implants to Support Reconsideration of Postmarket Surveillance Requirements"
• "Guidance Document for Testing Non-articulating, "Mechanically Locked" Modular Implant Components"
• "Draft Guidance Document for Testing Acetabular Cup Prostheses"
• "Points to Consider for Femoral Stem Prostheses"
• "Guidance Document for the Preparation of Premarket Notifications for Ceramic Ball Hip Systems"
• "Data Requirements for Ultrahigh Molecular Weight Poletheylene (UHMWPE) Used in Orthopedic Devices" | "All required testing... were done where applicable."
  The device met the requirements of the referenced guidance documents for the specified tests. This implies that the device's mechanical, material, and design performance was found to be satisfactory according to these established standards. |
  | Material equivalence to predicate devices (Ti with plasma spray coating / u-CaP, CoCrMo) | "The material used for the Aseculap device is the same as that used to manufacture the predicate devices." |
  | Design and size similarity to predicate devices | "The new lateral offset femoral stems of the Excia Total Hip System are offered in similar shapes and sizes as the predicate devices." |

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

• Sample Size: Not applicable in the context of this device. The testing described is primarily mechanical and materials-based, not involving patient data or test sets in the AI sense.
• Data Provenance: Not applicable. The "data" here refers to test results from laboratory experiments on the physical device and its materials, not collected patient information.

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

• Number of Experts: Not applicable. The "ground truth" for a hip implant's mechanical and material performance is established by scientific and engineering principles, standardized testing protocols, and regulatory guidance, not by expert consensus on data interpretation.
• Qualifications of Experts: Not applicable in the conventional sense of clinical experts interpreting data. The "experts" involved would be biomedical engineers, materials scientists, and regulatory specialists within the company and at the FDA, who define and evaluate the compliance with the testing guidance.

4. Adjudication Method:

• Not applicable. This is a concept related to resolving discrepancies in human interpretation of data, which is not relevant for the described device testing.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:

• No. An MRMC study is relevant for evaluating the impact of AI on human readers' diagnostic performance. This device is a physical implant, not an AI software.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done:

• No. This refers to AI algorithm performance. The device is a physical product.

7. The Type of Ground Truth Used:

• Engineering and Material Standards/Specifications: The "ground truth" here is defined by industry standards, FDA guidance documents, and scientific principles governing the mechanical, chemical, and biological properties required for a safe and effective orthopedic implant. For example, a fatigue test will have a specified load and number of cycles that the implant must withstand without failure, based on established biomechanical understanding and regulatory requirements.

8. The Sample Size for the Training Set:

• Not applicable. There is no AI training set for this physical device.

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

• Not applicable. There is no AI training set for this physical device.

In summary, the provided document describes a 510(k) for a physical medical device (a hip implant). The "acceptance criteria" and "study" are focused on demonstrating substantial equivalence to predicate devices through adherence to established mechanical and material testing standards and regulatory guidance, rather than the performance metrics and study designs typically associated with AI/software devices.

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