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The SC Ceramic Ball Heads are indicated for use in the treatment of severely disabled hip joints resulting from painful osteo-,rheumatoid and post-traumatic arthritis, and the late stages of avascular necrosis, and for revision of previous hip surgeries. The SC Femoral Hip Stem is indicated for use with or without bone cement. The SC Acetabular Cup is for use with bone cement only.

We added 6 sizes, 28 S, 28 M, 28 L, 32 S, 32 M, and 32 L of ceramic ball heads to the SC Total Hip System, which was cleared for marketing by FDA on 10/15/03 (K031474). These ball heads allow the surgeon a further option to meet the patient's needs.

This document is a 510(k) summary for a medical device modification, specifically the addition of new sizes of SC Ceramic Ball Heads to an existing hip replacement system. It is a regulatory submission, not a study report, and therefore does not contain the detailed information typically found in clinical or performance studies.

Therefore, many of the requested sections (2-9) cannot be answered from the provided text as the information is not present.

1. Table of Acceptance Criteria and Reported Device Performance

Information Not Available in the Provided Text:

The following information is not present in the 510(k) summary, as it is a regulatory document focused on demonstrating substantial equivalence rather than a detailed report of a specific study's methodology:

• 2. Sample sizes for the test set and data provenance: No information on the actual number of ceramic ball heads tested, or where the data came from (e.g., country of origin, retrospective/prospective).
• 3. Number of experts used to establish ground truth and their qualifications: Not applicable, as this was a biomechanical test, not an AI or diagnostic study.
• 4. Adjudication method for the test set: Not applicable, as this was a biomechanical test, not an AI or diagnostic study.
• 5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and its effect size: Not applicable, as this was a biomechanical test, not an AI or diagnostic study.
• 6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable, as this was a biomechanical test, not an AI or diagnostic study.
• 7. The type of ground truth used: For biomechanical tests, the "ground truth" would be the measured physical properties. The document states "Biomechanical tests have been performed," but does not detail the specific measurements or reference standards used.
• 8. The sample size for the training set: Not applicable, as this was a biomechanical test, not an AI or machine learning study.
• 9. How the ground truth for the training set was established: Not applicable, as this was a biomechanical test, not an AI or machine learning study.

Summary of the Study (as described in the document):

The document refers to "Biomechanical tests" that were performed to demonstrate the equivalence of the new SC Ceramic Ball Heads to existing, similar implants. The study's conclusion, as stated, is that "The test results were equivalent to other similar implants and are sufficient for in vivo loading." This indicates the device met the implicit acceptance criteria of performing comparably to already cleared devices. However, the specifics of these tests (e.g., fatigue testing, static strength, wear resistance, the standards followed, the number of devices tested) are not detailed in this 510(k) summary. This type of information would typically be found in the full 510(k) submission, not in the publicly available summary.

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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 pain and disability due to rheumatoid arthritis, osteoarthritis, 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 to previous fusion
• Patients with acute femoral neck fractures

The Excia Hip System is available with two femoral stems. One is manufactured from CoCr and is intended for cemented fixation. The other femoral stem is for uncemented fixation and is manufactured from Ti with a Ti plasma spray.

The Excia Total Hip System is available with two femoral designs. One is manufactured from Ti with a Ti plasma spray coating (Plasmapore). This component is intended for uncemented use. The other femoral component design is manufactured from CoCrMo and is intended for cemented use. Distal centralizers maintain the stem's alignment in the femoral canal. The centralizers are manufactured from PMMA.

The acetabular cup (Plasmacup) is manufactured from Ti and is coated with Plasmapore as well. Acetabular cup screws can be used for further cup fixation. The acetabular inserts are UHMWPE and available in symmetrical and asymmetrical designs.

Two femoral heads are available. The CoCrMo heads may be used with either the cemented or cementless femoral stems. However, the ceramic heads are for use only with the Ti alloy cementless stems.

The provided text describes the "Excia Total Hip System" and its clearance through the 510(k) premarket notification process by the FDA. This specific document is a 510(k) summary, which focuses on demonstrating substantial equivalence to already legally marketed devices, rather than presenting de novo clinical study data to prove novel acceptance criteria.

Therefore, the document does not contain information about:

• A table of acceptance criteria and reported device performance directly.
• Sample sizes used for a test set or its data provenance.
• Number of experts or their qualifications for establishing ground truth.
• Adjudication methods.
• Multi-Reader Multi-Case (MRMC) comparative effectiveness studies or effect sizes.
• Standalone algorithm performance.
• Type of ground truth used (pathology, outcomes data, etc.) for this particular device's testing (as it relies on equivalence).
• Sample size for a training set or how its ground truth was established, because it is comparing to previously approved predicate devices, not training an AI algorithm.

Instead, the provided text indicates that the device met acceptance criteria by demonstrating substantial equivalence to existing predicate devices through comprehensive non-clinical testing.

Here's an overview of how the "acceptance criteria" are addressed in the context of this 510(k) submission:

Acceptance Criteria and Device Performance (Demonstrated by Substantial Equivalence):

The acceptance criteria for the Excia Total Hip System are implicitly that it performs as safely and effectively as its predicate devices, as demonstrated by meeting relevant industry standards and guidance documents for orthopedic implants.

Study Proving Acceptance Criteria:

The "study" proving the device meets the acceptance criteria is primarily a non-clinical performance evaluation and a demonstration of substantial equivalence to predicate devices, rather than a de novo clinical trial with human subjects.

• Sample Size Used for Test Set and Data Provenance: Not applicable in the context of this 510(k) summary, as it describes non-clinical testing against established standards and comparison to predicate devices, not a clinical test set from human data. The "test set" would consist of the device components themselves undergoing specified mechanical and material tests.
• Number of Experts Used to Establish Ground Truth & Qualifications: Not applicable. Ground truth is established by engineering standards, material science, and the documented performance of predicate devices.
• Adjudication Method: Not applicable. Performance is measured against predetermined physical properties and regulatory standards.
• Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study: Not applicable. This is a medical device (hip replacement system), not an AI algorithm requiring MRMC studies.
• Standalone Performance (Algorithm Only): Not applicable, as this is a physical implant, not an algorithm.
• Type of Ground Truth Used: The ground truth is rooted in established engineering standards, material specifications, and the historical performance and regulatory clearance of the predicate devices. This includes mechanical properties, material composition, wear rates, and fixation attributes, as defined by the various guidance documents listed.
• Sample Size for Training Set: Not applicable. This device is not an AI algorithm and therefore does not have a "training set."
• How Ground Truth for Training Set was Established: Not applicable.

Summary of the Substantial Equivalence Claim:

Aesculap believes the Excia Total Hip System is substantially equivalent in design and performance to the following predicate devices:

• BiCONTACT Hip System (K040191)
• 36mm V40 Femoral Head Components (K022077)
• Alloclassic Zweymueller (K030373)
• SC Total Hip System (K031474)
• Smith & Nephew Hip System (K022902)
• Pinnacle Duofix HA Acetabular Cup (K031495)
• Trident Porous Ti Acetabular Component with Coating (K013475)

The FDA's clearance (K042344) indicates their agreement that the Excia Total Hip System is substantially equivalent to these predicate devices for its intended use. This substantial equivalence determination is the primary "proof" that the device meets the necessary safety and effectiveness criteria for market entry under the 510(k) pathway.

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