(270 days)
General Indications:
The MobileLink® Acetabular Cup System is indicated for patients with mobility-limiting diseases, fractures or defects which cannot be treated by conservative or osteosynthetic procedures.
Indications:
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- Primary and secondary osteoarthritis
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- Rheumatoid arthritis
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- Correction of functional deformities
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- Avascular necrosis
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- Femoral neck fractures
- Revision after implant loosening dependent on bone mass and quality
The MobileLink® Acetabular Cup System is a versatile cup system, designed to provide several options for surgeons and patients within one system. The cup system consists of press-fit metal shells made of a Ti6Al4V alloy. The system offers two designs, a cluster hole shell, with closing screws and a polar screw, and a multi hole shell. Both shells are available with two different coatings, either plasma sprayed coating (PlasmaLink®) or a double coating consisting of plasma spray plus calcium phosphate coating (TiCaP®). All shells are implanted cementless. The acetabular inserts are manufactured from conventional UHMWPE or Vitamin E highly crosslinked UHMWPE (E-Dur®). The inserts are available in six designs, neutral, offset, shouldered, offset/shouldered, 10° and 20° inclination. This premarket notification does not include the femoral components. The MobileLink® Acetabular Cup System is compatible with previously cleared femoral heads (K161840, K953653) and hip stems and neck segments (K161840, K151008, K142187, K953653) of Waldemar Link GmbH & Co. KG.
The provided text describes a 510(k) premarket notification for the "MobileLink Acetabular Cup System". This notification is a submission to the FDA to demonstrate that the device is substantially equivalent to legally marketed predicate devices, and therefore does not require a study proving the device meets specific acceptance criteria in the same way a novel device might.
Instead, the submission relies on non-clinical performance testing and analysis to demonstrate substantial equivalence to predicate devices. There is no mention of specific quantitative acceptance criteria or a dedicated study designed to prove the device meets such criteria with statistical significance.
Here's an breakdown of the information based on your request, structured to reflect what is actually present in the document:
1. Table of Acceptance Criteria and Reported Device Performance
As this is a 510(k) submission for substantial equivalence based on non-clinical testing, there isn't a table of specific, quantitative "acceptance criteria" for clinical performance. The "performance" is demonstrated through various bench tests and characterizations, aiming to show similarity to predicate devices.
| Test Type | Objective / "Acceptance Criteria" (Implied) | Reported Performance / Conclusion |
|---|---|---|
| Disassembly Testing (Axial push-out, offset pullout, and torsional tests according to ASTM F1820 for liner/shell assembly) | Demonstrate mechanical integrity and resistance to disassembly, comparable to predicate devices. | Results indicate the device performs adequately and maintains mechanical integrity as expected for an acetabular cup system. The device is shown to be as safe and effective as the predicate device. |
| Wear Test (according to ISO 14242-1 and particle analysis per ISO 17853 and ASTM F1877) | Demonstrate wear rates and particle generation comparable to predicate devices and acceptable for clinical use. | Wear rates were compared to those of the Stelkast Exp highly crosslinked Vitamin E UHMWPE acetabular shell liners (a reference device), suggesting comparable or acceptable wear performance. |
| Wear Testing under Adverse Conditions and Particle Analysis | Demonstrate performance under more challenging conditions, comparable to predicate devices. | Results imply acceptable wear performance under adverse conditions, consistent with predicate devices. |
| Range of Motion (according to ISO 21535) | Demonstrate an appropriate range of motion. | Results indicate the device allows for a range of motion comparable to predicate devices and clinically acceptable. |
| Endotoxin Testing | Confirm biocompatibility and sterility. | Results indicate compliance with endotoxin limits, supporting the safety of the device. |
| Impingement Testing (per ASTM F2582) | Demonstrate resistance to impingement and associated wear/damage. | Results indicate acceptable performance in impingement tests, comparable to predicate devices. |
| Coating Characterization (microstructural analysis, mechanical testing, metallurgical analysis per FDA Guidance) | Demonstrate coating integrity, adhesion, and material properties consistent with established standards and predicate devices. | Results demonstrate the coatings meet established standards and are comparable to those of predicate devices, ensuring long-term performance. |
| PE Characterization (material characterization, HXL characterization and aging study, biocompatibility testing per ISO 10993) | Demonstrate material properties, stability, and biocompatibility of the UHMWPE liners consistent with established standards and predicate devices. | Results indicate the PE materials conform to FDA guidance for UHMWPE, including HXL characterization, aging study, and biocompatibility, thereby supporting the safety and effectiveness of the device. |
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Size: Not explicitly stated in the document. The testing described is bench testing, involving mechanical specimens rather than patient data.
- Data Provenance: Not applicable in the context of clinical data. The tests are bench tests conducted in a laboratory setting for the purpose of a 510(k) submission.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- Number of Experts & Qualifications: Not applicable. For bench testing, "ground truth" is typically established by engineering specifications, material standards (e.g., ASTM, ISO), and regulatory guidelines rather than expert clinical consensus.
4. Adjudication Method for the Test Set
- Adjudication Method: Not applicable. This is not a clinical study involving human interpretation of data where adjudication would be necessary. The tests are objective measurements against engineering standards.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- MRMC Study: No. This device is a physical implant (acetabular cup system), not an AI-powered diagnostic or assistive tool. Therefore, an MRMC study related to AI assistance is not relevant.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Standalone Performance: Not applicable. This is not an algorithmic device.
7. The Type of Ground Truth Used
- Ground Truth: For bench testing, the "ground truth" refers to established engineering standards (e.g., ASTM, ISO), mechanical properties, material specifications, and performance expectations derived from predicate devices. The goal is to demonstrate that the device meets these engineering and material requirements.
8. The Sample Size for the Training Set
- Training Set Sample Size: Not applicable. This is not an AI/ML device that requires a training set of data.
9. How the Ground Truth for the Training Set was Established
- Ground Truth for Training Set: Not applicable. This is not an AI/ML device.
§ 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.