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The EcoFit® Hip System is indicated for use as a total hip replacement in cases of:

• Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis;
• · Rheumatoid arthritis;

· Treatment of non-union, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement that are unmanageable by other techniques; and

• Revision of previously failed total hip arthroplasty.
  The EcoFit® Hip Stem and EcoFit® Acetabular Cup is intended for uncemented, press-fit fixation.

The EcoFit® Vit E Acetabular System is a line extension of EcoFit® Hip System, a modular hip replacement system offering various components that can be combined to replace the hip joint and address major bone defects with various options depending upon the size and location of the defects of each patient. The EcoFit® Vit E Acetabular System adds additional liners, CoCr femoral heads, and Biolox® delta heads to the currently cleared system. Additionally, Vit E liners are added as compatible components in the system.

This FDA 510(k) summary for the EcoFit® Vit E Acetabular System does not describe an AI medical device or a clinical study in the typical sense that would involve acceptance criteria and performance against a ground truth as commonly found in AI/ML reviews. Instead, it concerns a medical device (a hip replacement system) and its substantial equivalence to previously cleared predicate devices. Therefore, the questions about acceptance criteria, ground truth, sample sizes for test and training sets, expert adjudication, and MRMC studies are not applicable in this context.

The document primarily focuses on:

• Indications for Use: The conditions for which the hip replacement system is intended.
• Device Description: What the system is and how it extends a previously cleared system.
• Performance Testing: A list of engineering and materials tests performed to ensure the device meets mechanical and material specifications, rather than clinical performance against a diagnostic or predictive outcome.
• Substantial Equivalence: The primary basis for clearance, demonstrating that the new device is as safe and effective as existing legally marketed predicate devices.

Summary of Device Acceptance:

The device is accepted based on its substantial equivalence to predicate devices in terms of materials, indications, function, and/or performance. This is demonstrated through a series of non-clinical performance tests that evaluate the physical properties and mechanical behavior of the components.

Table of "Acceptance Criteria" (interpreted as engineering performance tests) and "Reported Device Performance":

Note: The document states "All necessary testing has been performed for the worst-case configuration... to assure substantial equivalence... and to demonstrate the subject devices perform as intended." It does not provide specific numerical outcomes or thresholds for these tests, only that they were completed and demonstrated performance as intended for substantial equivalence.

Regarding the other questions:

• Sample sized used for the test set and the data provenance: Not applicable. The "test set" here refers to physical test units of the device, not a dataset for an AI model.
• Number of experts used to establish the ground truth... and qualifications: Not applicable, as there's no diagnostic or predictive "ground truth" being established by experts in this context.
• Adjudication method: Not applicable.
• If a multi reader multi case (MRMC) comparative effectiveness study was done: Not applicable. This is not an AI-assisted diagnostic device.
• If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is a physical medical implant.
• The type of ground truth used: Not applicable. Performance is assessed against mechanical and material standards, not a diagnostic ground truth.
• The sample size for the training set: Not applicable, as there is no training set for an AI model.
• How the ground truth for the training set was established: Not applicable.

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