(99 days)
NovoHip Vitamin E liners are intended for use with the NovoSource NovoHip Total Hip System. NovoSource hip implant components are indicated for use in cementless reconstruction of the articulating surface of femoral and/or acetabular portions of the hip that are severely disabled and/or very painful as a result of:
- Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis
- Rheumatoid arthritis or traumatic arthritis
- Correction of functional deformity
- Non-union femoral neck fracture
- Trochanteric fractures of the proximal femur with head involvement which is unmanageable using other techniques.
The components can be used for primary hip arthroplasty or for revision of a failed total hip arthroplasty.
The NovoHip Total Hip System is a non-cemented hip prosthesis that consists of a 4-part total hip replacement system including femoral head, acetabular liner, and acetabular shell components. The femoral head component articulates within the poly acetabular component. The acetabular liner snaps into the acetabular shell component. The design and sizing of the components correspond to natural hip anatomy to restore normal rotation, extension, and flexion.
The NovoHip Vitamin E liners are components to be used with the NovoHip Total Hip System, previously cleared via K132158. The Vitamin E poly acetabular component snaps into the metal acetabular components that were previously cleared with the NovoHip Total Hip System.
The provided document is a 510(k) summary for a medical device called the "NovoHip Vitamin E liner." It describes the device, its intended use, technological characteristics, and importantly, the non-clinical performance data used for its clearance.
Here's an analysis of the acceptance criteria and study information:
Acceptance Criteria and Reported Device Performance
The document does not explicitly state quantitative acceptance criteria in a table format alongside reported device performance. Instead, it lists numerous non-clinical tests performed on the device and concludes that, "Based on testing results and the comparisons provided, the NovoHip Vitamin E liner is considered substantially equivalent to the Zimmer Vivacit-E Vitamin E Highly Crosslinked Polyethylene Liners, DePuy Pinnacle Acetabular System, and Wright Medical Lineage Acetabular System in material, construction, and performance characteristics."
This indicates that the acceptance criterion for each test was likely that the NovoHip Vitamin E liner performed commensurately with, or acceptably against, the predicate devices based on the established standards/methods for those tests. The "reported device performance" is summarized by the overall statement of substantial equivalence rather than specific numerical results for each criterion.
Here's a conceptual representation of what such a table might look like, based on the provided information, if specific numerical criteria were explicitly listed:
| Acceptance Criterion (Test Name) | Standard/Method | Expected Performance (Based on Predicate) | Reported Device Performance (NovoHip Vitamin E Liner) | Meets Criteria? |
|---|---|---|---|---|
| Thermal Properties (DSC) Test | Implied standard | Commensurate with predicates | Performance demonstrated substantial equivalence | Yes |
| Small Punch Testing | Implied standard | Commensurate with predicates | Performance demonstrated substantial equivalence | Yes |
| Oxidation Index Analysis | Implied standard | Commensurate with predicates | Performance demonstrated substantial equivalence | Yes |
| Density Testing | Implied standard | Commensurate with predicates | Performance demonstrated substantial equivalence | Yes |
| Trans-Vinylene Yield Index Analysis | Implied standard | Commensurate with predicates | Performance demonstrated substantial equivalence | Yes |
| In Situ Determination of Network Parameters | Implied standard | Commensurate with predicates | Performance demonstrated substantial equivalence | Yes |
| Tensile Property Test | Implied standard | Commensurate with predicates | Performance demonstrated substantial equivalence | Yes |
| Izod Impact Test | Implied standard | Commensurate with predicates | Performance demonstrated substantial equivalence | Yes |
| Residual Free Radical Content | Implied standard | Commensurate with predicates | Performance demonstrated substantial equivalence | Yes |
| Compressive Modulus | Implied standard | Commensurate with predicates | Performance demonstrated substantial equivalence | Yes |
| Fatigue Crack Propagation | Implied standard | Commensurate with predicates | Performance demonstrated substantial equivalence | Yes |
| Poisson's Ratio | Implied standard | Commensurate with predicates | Performance demonstrated substantial equivalence | Yes |
| Exhaustive Extraction | Implied standard | Commensurate with predicates | Performance demonstrated substantial equivalence | Yes |
| Consolidation Assessment | Implied standard | Commensurate with predicates | Performance demonstrated substantial equivalence | Yes |
| Post-Wear Analysis | Implied standard | Commensurate with predicates | Performance demonstrated substantial equivalence | Yes |
| Orbital Hip Wear | Implied standard | Commensurate with predicates | Performance demonstrated substantial equivalence | Yes |
| Wear Particle Analysis at 1,000,000 Cycles | Implied standard | Commensurate with predicates | Performance demonstrated substantial equivalence | Yes |
| Locking Mechanism Strength Evaluation | Implied standard | Commensurate with predicates | Performance demonstrated substantial equivalence | Yes |
| Lever-Out Test | Implied standard | Commensurate with predicates | Performance demonstrated substantial equivalence | Yes |
| Torque-Out Test | Implied standard | Commensurate with predicates | Performance demonstrated substantial equivalence | Yes |
| Push-In Test | Implied standard | Commensurate with predicates | Performance demonstrated substantial equivalence | Yes |
| Push-Out Test | Implied standard | Commensurate with predicates | Performance demonstrated substantial equivalence | Yes |
| Rotational Stability Test | Implied standard | Commensurate with predicates | Performance demonstrated substantial equivalence | Yes |
| Torsional Strength of Metallic Bone Screws | Implied standard | Commensurate with predicates | Performance demonstrated substantial equivalence | Yes |
| Driving Torque of Metallic Bone Screws | Implied standard | Commensurate with predicates | Performance demonstrated substantial equivalence | Yes |
| Axial Pullout Strength of Metallic Bone Screws | Implied standard | Commensurate with predicates | Performance demonstrated substantial equivalence | Yes |
Study Details:
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Sample size used for the test set and the data provenance:
The document lists 28 non-clinical performance tests. For each of these tests, a sample size of the device (NovoHip Vitamin E liners) would have been used. However, the specific sample sizes for each test are not detailed in this 510(k) summary. These would typically be found in the full test reports, which are not included here.
The data provenance is non-clinical bench testing, meaning the data was generated in a lab setting, not from human or animal subjects. Details like country of origin are not specified, but it's implied the testing was conducted by or for NovoSource Inc. to support regulatory submission in the U.S. -
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This question is not applicable as the studies were non-clinical (bench testing) rather than clinical studies requiring expert interpretation of medical images or patient outcomes. The "ground truth" for these tests would be the established scientific methods and engineering standards used to measure device properties. -
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
This question is not applicable for non-clinical bench testing as there is no human interpretation of data requiring adjudication. The results are typically quantitative measurements against defined specifications. -
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:
This question is not applicable. The device is an orthopedic implant (hip liner), not an AI-powered diagnostic or assistive tool. No MRMC study was performed. -
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
This question is not applicable. The device is a physical implant; there is no AI algorithm involved in its function or assessment. -
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
For these non-clinical tests, the "ground truth" refers to the established scientific and engineering principles, measurement standards (e.g., ISO, ASTM), and the physical properties of the material and device components themselves. Performance was measured against these objective standards and compared to the performance of predicate devices. -
The sample size for the training set:
This question is not applicable. This is not a machine learning or AI device that requires a training set. The device is a physical medical implant. -
How the ground truth for the training set was established:
This question is not applicable as there is no training set for this device.
§ 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.