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The Aesculap BiPolar Cup is for uncemented use in conjunction with a standard cemented or uncemented femoral replacement implant for the following:

• 1. Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis
• 2. Rheumatoid arthritis
• 3. Correction of functional deformity
• 4. Treatment of non-union, femoral neck fracture and trochanteric fractures of the proximal femur with head involvement, unmanageable using other techniques

The BiPolar cup is a sub-component of an endoprosthetic replacement for the human hip where it assumes the function of the natural femoral head and is combined with a prosthesis head and a hip stem. It consists of a highly polished CoCr shell and a polyethylene insert. In vivo, the shell articulates directly with the well-preserved acetabulum while the insert articulates with a modular head component of a femoral hip. The head is held in place by a retaining ring that is pre-assembled into the insert of the cup. The BiPolar components are available in a variety of sizes to allow the surgeon to rebuild the natural anatomy of the hip joint as accurately as possible while implanting the hemi-arthroplasty.

The provided document is a 510(k) Premarket Notification for the Aesculap BiPolar Acetabular Cup, which is a medical device. This type of notification focuses on demonstrating substantial equivalence to a predicate device, rather than proving the device meets specific acceptance criteria through clinical studies. Therefore, the information requested in your prompt (e.g., acceptance criteria, detailed study design, sample sizes for test/training sets, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types) is not typically found in a 510(k) summary for a device like this.

510(k) submissions for orthopedic implants often rely on bench testing (biomechanical, material characterization) and comparison to predicate devices, rather than extensive human clinical trials to establish safety and effectiveness.

Here's a breakdown of what can be extracted from the document, and why other requested information is not present:

1. Table of Acceptance Criteria and Reported Device Performance

Study that Proves the Device Meets the Acceptance Criteria:

The document mentions "Biomechanical testing was performed to evaluate the effects of destructive forces on the ball/cup assembly for both head diameters at the extreme size ranges." The primary "proof" for regulatory clearance is the demonstration of substantial equivalence to existing, legally marketed predicate devices through comparison of technological characteristics and performance data (which includes the described biomechanical testing).

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

• Sample Size for Test Set: Not specified. The biomechanical testing likely used a sample of physical devices for mechanical evaluation, not a human "test set" in the clinical trial sense.
• Data Provenance: Not specified, but given it's biomechanical testing, it would have been conducted in a laboratory setting, likely at the manufacturer's facility or a contract lab. It is not clinical data (retrospective or prospective).

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

• This information is not applicable to this type of submission. There was no "ground truth" derived from expert consensus on imaging or clinical outcomes for a "test set" as would be seen in, for example, an AI/radiology study. The "ground truth" for biomechanical testing is typically defined by engineering standards and measurement accuracy.

4. Adjudication method for the test set

• Not applicable. There was no human interpretation or adjudication required for this type of biomechanical testing.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

• No. This is not an AI/imaging device. MRMC studies are not relevant here.

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

• Not applicable. This is a physical orthopedic implant, not an algorithm.

7. The type of ground truth used

• For the biomechanical testing: The "ground truth" would be established by engineering specifications and validated testing methodologies to measure and quantify "destructive forces" and the integrity of the "ball/cup assembly."

8. The sample size for the training set

• Not applicable. There is no "training set" as this is not an AI/machine learning model.

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

• Not applicable. See point 8.

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