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The Actinia® hip stems are intended to be used in total hip arthroplasty for the following indications:

• 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 Actinia® hip stems cementless are intended for uncemented, press-fit fixation.

The Actinia® hip stems are intended to be used in partial (hemi) hip arthroplasty in conjunction with the ic-Bipolar Head 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 Actinia® hip stems are femoral stems for total or hemi hip arthroplasty. The Actinia® hip stems include collared and collarless variants in standard and lateralized offset configurations. Additionally, the scope includes the coxa vara hip stem variant in a standard offset configuration.

The Actinia® hip stems are monoblock, tapered straight stems made from titanium alloy with a coating of hydroxyapatite (HA). They are fixed by press-fitting.

The Actinia® hip stems are to be used alongside other previously cleared components to make a complete prosthesis. Specifically, Actinia® hip stems are compatible with legally marketed heads used with the implantcast EcoFit® Hip System (K163577, K180263 and K191569) and the implantcast ic-Bipolar Head System (K191569).

This is a 510(k) premarket notification for a medical device called "Actinia® hip stems". The document doesn't pertain to an AI/ML device, but rather a traditional implant. Therefore, the questions related to AI/ML device performance and ground truth establishment are not applicable.

Here's the relevant information provided about the device and its testing:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document states that "All testing was performed on test units representative of or worst-case compared to the finished device." However, specific sample sizes for each test are not provided. Data provenance (e.g., country of origin of data, retrospective or prospective) is not applicable or specified for this type of mechanical device testing.

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

Not applicable. This is a mechanical safety and performance test of an implant, not an AI/ML diagnostic or measurement device requiring expert interpretation for ground truth.

4. Adjudication Method for the Test Set

Not applicable. This is a mechanical safety and performance test, not a diagnostic study requiring adjudication.

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

Not applicable. This is not an AI/ML device, and an MRMC study is not relevant for its evaluation.

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

Not applicable. This is not an AI/ML device.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

For the mechanical tests, the "ground truth" or reference is established by the specified international and national standards (ISO, ASTM). The device's performance is measured against the criteria established within these standards to ensure safety and efficacy.

8. The Sample Size for the Training Set

Not applicable. This device does not involve machine learning and therefore has no "training set."

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

Not applicable. As there is no training set for an AI/ML algorithm.

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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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The MUTARS® Proximal Femur Replacement System is 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 MUTARS® Proximal Femur System is intended to for uncemented use in total hip arthroplasty 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 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 MUTARS® Proximal Femur Replacement System is a modular hip replacement system, which combines the 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 MUTARS® Proximal Femur Replacement System includes the MUTARS® Proximal Femur System. The MUTARS® Proximal Femur System is manufactured of TiAls V4 and includes the proximal femur, femoral stem, stem extension piece, connecting part, and screws. The MUTARS® Proximal Femur Replacement System can be used as a total hip system with previously cleared (K163577) modular cobalt chrome femoral head, Ecofit® uncemented titanium alloy acetabular cup and polyethylene liner.

The provided text describes a 510(k) premarket notification for a medical device, the "MUTARS® Proximal Femur Replacement System." This document is primarily focused on demonstrating substantial equivalence to previously marketed predicate devices rather than proving the device meets specific performance criteria through a clinical or algorithmic study with defined acceptance criteria for classification accuracy or similar measures.

Therefore, the information regarding acceptance criteria, study design for proving performance, and details about training/test sets, ground truth establishment, or expert adjudication as typically seen for AI/ML-based medical devices or diagnostic tools, is not present in this document.

The performance testing mentioned (Construct fatigue, Corrosion, Range of Motion, Modular Disassembly) relates to mechanical and physical properties of the implant, not to a study proving diagnostic or prognostic capabilities and therefore does not include the elements requested in the prompt (e.g., sample size for test sets, data provenance, number of experts for ground truth, MRMC studies, standalone performance of an algorithm, etc.).

No information for the requested points (1-9) can be extracted from the provided text as it is not relevant to the type of device and submission described.

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