(72 days)
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
| Test Type | Standard(s) | Acceptance Criteria | Reported Device Performance |
|---|---|---|---|
| Fatigue Testing | ISO 7206-4, ISO 7206-6 | Not explicitly stated in the provided text, but implied to demonstrate the device's ability to withstand repeated loading cycles without failure, complying with the respective ISO standards. | Met predetermined acceptance criteria. |
| Impingement Testing | ASTM F2582-14 | Not explicitly stated in the provided text, but implied to demonstrate the device's ability to resist impingement or excessive contact between components during physiological range of motion as per ASTM F2582-14. | Met predetermined acceptance criteria. |
| Taper Disassembly Testing | ASTM F2009 | Not explicitly stated in the provided text, but implied to assess the strength of the taper lock mechanism, ensuring components remain securely attached during use, according to ASTM F2009. | Met predetermined acceptance criteria. |
| Range of Motion (ROM) Evaluation | ISO 21535 | Not explicitly stated in the provided text, but implied to conform to typical physiological range of motion for hip joints as defined by ISO 21535, ensuring appropriate mobility and preventing dislocation. | Met predetermined acceptance criteria. |
| Coating Characterization | ASTM F1609, ASTM F1926, ASTM F2024, ISO 13779 | Not explicitly stated in the provided text, but implied to ensure the hydroxyapatite (HA) coating properties (e.g., adhesion, thickness, composition) meet specified requirements as per the listed ASTM and ISO standards for biocompatibility and mechanical durability. | Met predetermined acceptance criteria. |
| Corrosion and Fretting Performance Rationale | Not specified | Not explicitly stated in the provided text, but implied to demonstrate resistance to degradation due to corrosion and fretting, which could lead to material loss and adverse biological responses. | Considered acceptable (implying criteria were met). |
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.
§ 888.3353 Hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis.
(a)
Identification. A hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis is a device intended to be implanted to replace a hip joint. This device limits translation and rotation in one or more planes via the geometry of its articulating surfaces. It has no linkage across-the-joint. The two-part femoral component consists of a femoral stem made of alloys to be fixed in the intramedullary canal of the femur by impaction with or without use of bone cement. The proximal end of the femoral stem is tapered with a surface that ensures positive locking with the spherical ceramic (aluminium oxide, A12 03 ) head of the femoral component. The acetabular component is made of ultra-high molecular weight polyethylene or ultra-high molecular weight polyethylene reinforced with nonporous metal alloys, and used with or without bone cement.(b)
Classification. Class II.