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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 implaFit® hip stems are indicated for use 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 implaFit® hip stems, when used in conjunction with the ic-Bipolar Heads, are intended 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 implaFit® hip stems cementless are intented, press-fit fixation. The implaFit® hip stems cemented are intended for cemented fixation.

The implaFit® hip stems are femoral stems for total or hemi hip arthroplasty. The implaFit® hip stems include cementless and cemented configurations (i.e., the implaFit® hip stems cementless and the implaFit® hip stems cemented).

The implaFit® hip stems cementless are monoblock, collarless tapered straight stems made from titanium alloy with a partial coating of commercially pure titanium (cpTi). They are fixed by press-fitting.

The implaFit® hip stems cemented are monoblock, collared, tapered straight stems made from cobalt chromium (CoCrMo). They are fixed using cement.

The provided text describes a 510(k) premarket notification for a medical device, the implaFit® hip stems, and primarily focuses on demonstrating its substantial equivalence to legally marketed predicate devices. This type of submission relies heavily on non-clinical performance testing rather than clinical study data involving AI.

Therefore, the information required to answer the prompt regarding "acceptance criteria and the study that proves the device meets the acceptance criteria" in the context of an AI/algorithm study (which would involve concepts like sample size for test sets, ground truth establishment, expert adjudication, MRMC studies, standalone performance, and training sets) is not present in the provided document.

The document describes performance testing for the physical device components (e.g., fatigue testing, impingement testing, coating testing). These tests have "predetermined acceptance criteria" related to the physical properties and performance of the hip stems, and the document states that "All performance testing conducted for the implaFit® hip systems met the predetermined acceptance criteria or were otherwise considered acceptable." However, this is not an AI-driven study.

In summary, this document does not contain the information needed to fill out the table or answer the questions related to an AI/algorithm study as requested.

If the request were about the acceptance criteria and study for a physical medical device, a different table and set of questions would be appropriate.

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