(247 days)
- Noninflammatory 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.
- Revision of previously failed total hip arthroplasty.
- Dislocation risks.
The E1™ Avantage™ Head is a single-use implant, intended for uncemented applications.
The E1 Active Articulation™ belongs to the family of dual mobility acetabular implants; the presence of two articulating surfaces in the same joint device. The E1 Active Articulation™ Head fits over a femoral modular head, which articulates within the E1™ Head. The resultant assembly then articulates within the acetabular metal shell. The E1™ Head is designed to be used with several styles of acetabular shells that have been cleared in previous submissions: Ma Magnum™ (K042037), Magnum™ Tri-Spike (K062995), and Mra 38™ Flared Cups and Non-Flared Cups (K01110). The E1 Active Articulation™ Heads are available in sizes 44-66mm and are manufactured from 100 kGy E1™, which is the same 100 kGy E-Poly™ material cleared in K070364, The claims based on small punch testing for the K070364 E-Poly™ (E1™) material were cleared previously in K100048 and are applicable to the identical E-Poly™ (E1™) subject material. The E1™ Active Articulation is designed for both primary and total revision surgeries, where all device components associated with the wear couple are removed and replaced. The system is intended for uncemented applications.
The provided text describes a 510(k) premarket notification for a medical device, the E1™ Avantage™ Head (a.k.a. E1™ Active Articulation), which is an artificial hip replacement component. The submission focuses on demonstrating substantial equivalence to predicate devices and detailing the characteristics of the E1™ Antioxidant Infused Technology material used in the device.
However, the document does not describe an acceptance criteria table for device performance against specific metrics in the way that would typically apply to software or AI-based devices. Instead, it details a series of claims for the material's performance based on non-clinical (bench) testing, comparing the E1™ material to control materials.
Therefore, the following information will be structured to address the spirit of the request based on the available data, acknowledging that it's a materials-based product and not a diagnostic AI device.
Acceptance Criteria and Study for the E1™ Avantage™ Head Device Material
The acceptance criteria are derived from the performance claims and test results for the E1™ Antioxidant Infused Technology material, which is a key component of the E1™ Avantage™ Head. The studies conducted are non-clinical (bench) tests comparing the E1™ material to various control or predicate materials.
1. Table of Acceptance Criteria and Reported Device Performance (Material Performance)
| Acceptance Criteria Claim | Acceptance Metric / Comparison | Reported E1™ Material Performance |
|---|---|---|
| Claim 1: Prevent oxidative degradation of polyethylene. | No evidence of environmental stress cracking and no detectable oxidation (oxidation indices 0.05) in ultimate load, ultimate tensile strength, or yield strength after accelerated aging (per ASTM F2003: 70°C and 5 atm of oxygen for 14 days). | E1™ Knee Material: |
- Ultimate load: 97.2 ± 6.4 N (before) vs. 100.0 ± 5.0 N (after aging, P>0.05).
- Ultimate tensile strength: 45.8 ± 1.6 MPa (before) vs. 46.1 ± 2.9 MPa (after aging, P>0.05).
- Yield strength: 22.6 ± 0.2 MPa (before) vs. 22.8 ± 0.3 MPa (after aging, P>0.05).
E1™ Hip Material: - Ultimate load: 105.0 ± 5.5 N (before) vs. 115.0 ± 3.2 N (after aging, P>0.05).
- Ultimate tensile strength: 43.1 ± 1.3 MPa (before) vs. 43.1 ± 1.2 MPa (after aging, P>0.05).
- Yield strength: 24.2 ± 0.2 MPa (before) vs. 24.4 ± 0.2 MPa (after aging, P>0.05).
No significant decrease in these mechanical properties after accelerated aging for both hip and knee E1™ materials (P>0.05). |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state numerical sample sizes (e.g., number of specimens tested) for each specific test. However, it indicates multiple test specimens were used for each comparison (e.g., "E1™ specimens showed no evidence...", "GUR1050 E1™ specimens ran head to head...", "multiple samples for statistical analysis implicitly through the use of "±" notation for standard deviations).
- Provenance: All data appears to be from bench testing conducted in a laboratory setting, not from human or animal studies. The studies reference a literature source (Nabar, Sean, et al. Transactions of the 54th Annual Meeting of the ORS, Poster No. 1684) and ASTM standards (F2183, D638, F2003). The location of the testing laboratories is not specified, but the applicant is based in Warsaw, Indiana, USA.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
This request is not applicable to this submission. The device is a physical orthopaedic implant component, and the "ground truth" for its material properties is established through standardized laboratory testing methods and measurements, not through expert human interpretation or consensus of observational data.
4. Adjudication Method for the Test Set
This request is not applicable. As above, the "test set" consists of material specimens undergoing physical and chemical characterization, not subjective assessments requiring adjudication. The results are quantitative measurements against established standards.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
This request is not applicable. An MRMC study is relevant for diagnostic devices that involve multiple human readers interpreting medical images or data. The E1™ Avantage™ Head is a physical implant, and its performance is evaluated through bench testing of its material properties and mechanical characteristics, not through human interpretation of cases.
6. Standalone (Algorithm Only) Performance Study
This request is not applicable. This is not an algorithm or AI-based device. The "performance" described is the material performance of the polyethylene, not an algorithm's output.
7. Type of Ground Truth Used
The "ground truth" for the material performance claims is established through standardized physical and chemical measurements obtained from controlled bench tests. This includes:
- Observations of environmental stress cracking (absence/presence).
- Infrared spectroscopy for oxidation indices.
- Small punch testing (ASTM F2183) for ultimate load.
- Tensile testing (ASTM D638) for ultimate tensile strength and yield strength.
- Accelerated aging protocols (ASTM F2003).
These methods provide objective, quantitative data about the material's properties.
8. Sample Size for the Training Set
This request is not applicable. There is no "training set" in the context of this device. The described studies are non-clinical performance evaluation tests of a manufactured material, not a machine learning model. The material itself is a result of a manufacturing process using specific raw materials and treatments (e.g., GUR1020/GUR1050 UHMWPE, 100 kGy gamma irradiation, vitamin E infusion, gamma sterilization).
9. How the Ground Truth for the Training Set Was Established
This request is not applicable. As there is no training set, there is no ground truth established for it in this context.
§ 888.3358 Hip joint metal/polymer/metal semi-constrained porous-coated uncemented prosthesis.
(a)
Identification. A hip joint metal/polymer/metal semi-constrained porous-coated uncemented prosthesis is a device intended to be implanted to replace a hip joint. The device limits translation and rotation in one or more planes via the geometry of its articulating surfaces. It has no linkage across the joint. This generic type of device has a femoral component made of a cobalt-chromium-molybdenum (Co-Cr-Mo) alloy or a titanium-aluminum-vanadium (Ti-6Al-4V) alloy and an acetabular component composed of an ultra-high molecular weight polyethylene articulating bearing surface fixed in a metal shell made of Co-Cr-Mo or Ti-6Al-4V. The femoral stem and acetabular shell have a porous coating made of, in the case of Co-Cr-Mo substrates, beads of the same alloy, and in the case of Ti-6Al-4V substrates, fibers of commercially pure titanium or Ti-6Al-4V alloy. The porous coating has a volume porosity between 30 and 70 percent, an average pore size between 100 and 1,000 microns, interconnecting porosity, and a porous coating thickness between 500 and 1,500 microns. The generic type of device has a design to achieve biological fixation to bone without the use of bone cement.(b)
Classification. Class II.