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The ic-Bipolar Heads is for uncemented use in conjunction with the MUTARS® Proximal Femoral Replacement System for the following indications:

• Proximal femur replacement in oncology cases where radical resection and replacement of bone is required.

• Limb salvage procedures including surgical intervention for severe trauma, failed previous prosthesis, and/or oncology indications, where radical resection and replacement of the bone is required.

Use of this prosthesis is generally only indicated in skeletally mature patients.

The ic-Bipolar Heads is for uncemented use in conjunction with the EcoFit® Hip System for the following indications:

• Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis

• Rheumatoid arthritis

• Correction of functional deformity

• Treatment of non-union, femoral neck fracture and trochanteric fractures of the proximal femur with head involvement, unmanageable using other techniques.

The ic-Bipolar Head System consists of a bipolar liner, retaining ring, and femoral head. The system is used for hip replacements in which the femur requires replacement but the acetabulum does not (i.e. hemi-arthroplasty) The ic-Bipolar Head System articulates directly with the natural (non-replaced) acetabulum on the outer side and with a femoral head on the inner side. The ic-Bipolar Head System is manufactured of CoCrMo and UHMWPE. The ic-Bipolar Head System is used in conjunction with the EcoFit® Hip System (K163577) and MUTARS® Proximal Femur Replacement System (K181778).

The provided FDA 510(k) summary (K191569 for the implantcast ic-Bipolar Head System) outlines performance testing but does not specify numerical acceptance criteria or provide detailed study results for those criteria. Instead, it generally states that testing was performed to assure substantial equivalence and demonstrate performance as intended.

Based on the available information, here's what can be extracted and what is missing:

1. Table of Acceptance Criteria and Reported Device Performance

Missing Information: The document states that "All necessary testing has been performed... to assure substantial equivalence to its predicates and to demonstrate the subject devices perform as intended." However, it does not explicitly list quantitative acceptance criteria for each test (e.g., "Taper Disassembly Force > X N" or "Range of Motion > Y degrees") nor does it provide the specific results obtained during these tests.

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

• Sample Size for Test Set: Not specified. The document mentions "test units representative of finished devices" were used for performance testing, but the number of units tested per performance test is not provided.
• Data Provenance: Not specified. Performance testing is generally conducted in a laboratory setting by the manufacturer (Implantcast GmbH) or a contracted testing facility. The document doesn't specify if any data used for testing was derived from clinical sources (e.g., country of origin, retrospective/prospective). Given the nature of mechanical and material tests, it's highly likely to be prospective laboratory testing.

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

• Not applicable / Not specified. This type of information (expert review for ground truth) is typically relevant for AI/ML device submissions where clinical images or data require expert interpretation. For a physical medical device like a hip implant, ground truth is established through standardized engineering and material testing methods, often against international standards (e.g., ISO, ASTM, which are not explicitly cited here but are implied by "Performance Testing").

4. Adjudication Method for the Test Set

• Not applicable. See point 3. Mechanical and material tests do not involve expert adjudication in the way clinical diagnostic studies do. The "adjudication" is determined by whether the test results meet pre-defined performance specifications derived from standards or predicate device performance.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

• No, not done. An MRMC study is not relevant for this type of device (bipolar head system). This is a physical implant, not a diagnostic AI device requiring human reader interaction.

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

• No, not applicable. This device is a physical implant, not an algorithm or AI product. "Standalone performance" in this context would refer to the device's mechanical and material performance, which is what the "Performance Testing" section generally describes.

7. The Type of Ground Truth Used

• Engineering and Material Specifications / Predicate Device Performance: The "ground truth" for the performance measures described would be established by:
  • Industry standards: Conformance to relevant ISO or ASTM standards for implant materials and mechanical properties (e.g., fatigue strength, wear resistance, dimensional accuracy).
  • Predicate device characteristics: Demonstrating that the device performs "substantially equivalently" to the predicate device (Aesculap Bipolar Acetabular Cup K060707) in terms of mechanical and material properties. This usually involves showing that test results fall within an acceptable range or meet specific thresholds generally accepted for such devices.

8. The Sample Size for the Training Set

• Not applicable. This device does not involve a "training set" in the context of machine learning or AI.

9. How the Ground Truth for the Training Set was Established

• Not applicable. See point 8.

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