(127 days)
Avenir Complete Hip System is intended for total or hemi hip arthroplasty and is indicated for the following conditions:
· Advanced wear of the joint due to degenerative, post-traumatic or rheumatic diseases.
- · Failed previous hip surgery including joint reconstruction (osteotomy), arthroplasty or total hip replacement (THR).
- · Acute traumatic fracture of the femoral head or neck.
- · Avascular necrosis of the femoral head.
Avenir Complete Hip System is for cementless use only.
The purpose of this 510(k) premarket notification is to introduce two Size 0 Coxa Vara Avenir Complete™ Hip System femoral stems; one with a collar and one without a collar. The stems are manufactured from a forged titanium alloy Ti-6Al-4V and feature a wedge-shaped design with a proximal-to-distal taper and reduced distal geometry. The Coxa Vara offset provides a 126.5° neck angle. Below the highly polished femoral neck region, the surface is gritblasted and plasma sprayed with commercially pure titanium (CP-Ti) and hydroxyapatite (HA) coating. The stems are designed for cementless implantation into the proximal femur and mates with compatible femoral heads and adapters for use in total or hemi hip arthroplasty through a 12/14 male taper connection. The stems are provided sterile and are for single-use only.
This document is a 510(k) premarket notification for a medical device and thus the provided text does not contain acceptance criteria or a study that proves the device meets specific acceptance criteria in the way a clinical trial report or a post-market surveillance study would.
Instead, this document focuses on demonstrating substantial equivalence to a previously cleared predicate device, rather than proving the device meets acceptance criteria in the context of a clinical performance study with specific endpoints and statistical measures. Substantial equivalence is established through comparison of intended use, indications for use, technological characteristics, and performance data (primarily non-clinical in this case).
However, I can extract the information relevant to what you've asked, focusing on the performance data presented to support substantial equivalence:
1. Table of Acceptance Criteria and Reported Device Performance
As specific "acceptance criteria" are not explicitly defined in terms of sensitivity, specificity, or other clinical performance metrics in this document, the table below will summarize the comparative performance claims made regarding the proposed device in relation to its predicate and reference devices, and how these claims support "substantial equivalence." The "acceptance criteria" for a 510(k) typically align with demonstrating that the new device is "at least as safe and effective" as the predicate.
| Acceptance Criteria (Implied for Substantial Equivalence) | Reported Device Performance |
|---|---|
| Mechanical Performance: |
- Distal Stem Fatigue Strength equivalent to predicate/reference device | Proposed device determined to have distal stem fatigue strength equivalent to the legally marketed reference device (K120030). |
| Mechanical Performance: - Proximal Stem Fatigue Performance not a "new worst-case" compared to predicate device | Proposed device not a new worst-case for proximal stem fatigue testing compared to the previously evaluated predicate Avenir Complete™ Hip System (K182048). |
| Material Properties: - Ti/HA Coating Characteristics similar to predicate | Ti/HA Coating Characterization Evaluation was performed (details not provided, but implies similarity as part of overall SE reasoning). |
| Biocompatibility/Safety: - Corrosion Fatigue performance acceptable | Corrosion Fatigue Evaluation was performed (details not provided, but implies acceptable performance for SE). |
| Functionality: - Range of Motion compatible with intended use | Range of Motion Analysis was performed (details not provided, but implies compatibility for SE). |
| Assembly/Fixation: - Pull-Off Strength adequate for intended use | Pull-Off Strength Evaluation was performed (details not provided, but implies adequacy for SE). |
| Imaging Compatibility: - MRI Compatibility for diagnostic purposes | Magnetic Resonance Imaging Compatibility (MRI) testing was performed (details not provided, but implies compatibility for SE). |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: The document indicates that non-clinical performance testing and engineering evaluations were conducted. While specific sample sizes for each test (e.g., number of stems tested for fatigue) are not explicitly stated in this summary, it refers to "fatigue testing," "pull-off strength evaluation," etc. These are typically performed on a statistically relevant number of samples for mechanical testing, but the exact numbers are not in this public summary.
- Data Provenance: The data is generated from non-clinical laboratory testing and engineering evaluations. There is no mention of country of origin for this testing, which is typical for such submissions. This is retrospective in the sense that the testing was performed before the submission for clearance.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
- This question is not applicable as the ground truth here is based on engineering and physical measurements from non-clinical testing, not expert interpretation of clinical data or images.
4. Adjudication Method for the Test Set
- This question is not applicable for the same reasons as above. No human adjudication is involved in determining the results of mechanical fatigue tests or material characterization.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
- No, an MRMC comparative effectiveness study was not done. This submission explicitly states: "Clinical data and conclusions were not needed for this device."
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- This question is not applicable as the device is a physical hip implant system, not an algorithm or AI-driven software device.
7. The Type of Ground Truth Used
- The "ground truth" for the performance data presented is based on laboratory measurements and engineering analyses derived from physical testing (e.g., force, cycles to failure, material composition analyses). It is not based on expert consensus, pathology, or outcomes data.
8. The Sample Size for the Training Set
- This question is not applicable. There is no "training set" as this is a physical medical device, not a machine learning algorithm.
9. How the Ground Truth for the Training Set Was Established
- This question is not applicable for the same reason as above.
§ 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.