(224 days)
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 stem, femoral head, acetabular poly liner, and acetabular metal (or shell) components. The femoral head component articulates within the poly acetabular component. The poly acetabular component snaps into the metal acetabular component. The design and sizing of the components correspond to natural hip anatomy to restore normal rotation, extension, and flexion.
The femoral stem component is made from forged Ti 6AL 4V, with a Ti plasma spray coating. The unipolar femoral head component is made from CoCr, or BIOLOX® delta ceramic, in 28, 32, and 36 mm sizes.
The acetabular poly liner component is made of standard UHMWPE polyethylene in both hooded and non-hooded options. The acetabular poly liner component is offered with different inner and outer diameter combinations to accept various size uni-polar femoral heads and acetabular metal components.
The acetabular metal (or shell) component is made from forged Ti 6AL 4V with a Ti porous coating. It is available in no-hole, cluster-hole, and revision multi-hole styles.
Here's an analysis of the provided text regarding the acceptance criteria and study for the NovoHip Total Hip System:
Summary of Acceptance Criteria and Study Findings
The NovoHip Total Hip System's acceptance criteria are based on its ability to perform comparably to predicate devices through a series of non-clinical mechanical tests. The study demonstrates that all tested components met their required performance specifications, thereby establishing substantial equivalence to existing marketed hip prostheses.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Test | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|---|
| Mechanical Strength & Durability | Fatigue Performance Test for NovoHip Stem | Meet required performance specifications for fatigue | Met required performance specifications |
| Fatigue Performance Test for the Neck Portion of the NovoHip Stem | Meet required performance specifications for fatigue | Met required performance specifications | |
| Burst Strength Test for NovoHip Ceramic Femoral Heads (Static Compression) | Meet required performance specifications for static burst strength | Met required performance specifications | |
| Cyclic Fatigue Test for NovoHip Ceramic Femoral Heads (Cyclic Compression) | Meet required performance specifications for cyclic fatigue | Met required performance specifications | |
| Post-Cyclic Fatigue Burst Test for NovoHip Ceramic Femoral Heads (Static Compression) | Meet required performance specifications for post-cyclic burst strength | Met required performance specifications | |
| Interface Stability & Integrity | Disassembly Force Test for the NovoHip Neck Taper/Femoral Head Interface | Meet required performance specifications for interface disassembly force | Met required performance specifications |
| Pull-Off Test for NovoHip Ceramic Femoral Heads | Meet required performance specifications for pull-off strength | Met required performance specifications | |
| Rotational Stability Test for NovoHip Ceramic Femoral Heads | Meet required performance specifications for rotational stability | Met required performance specifications | |
| Lever-Out Test for NovoHip Acetabular Shell/Liner Assembly | Meet required performance specifications for lever-out resistance | Met required performance specifications | |
| Torque-Out Test for NovoHip Acetabular Shell/Liner Assembly | Meet required performance specifications for torque-out resistance | Met required performance specifications | |
| Push-In Test for NovoHip Acetabular Shell/Liner Assembly | Meet required performance specifications for push-in force | Met required performance specifications | |
| Push-Out Test for NovoHip Acetabular Shell/Liner Assembly | Meet required performance specifications for push-out force | Met required performance specifications | |
| Anatomical & Functional | Range of Motion Test for the NovoHip Total Hip System | Meet required performance specifications for range of motion | Met required performance specifications |
| Bone Screw Performance (if applicable) | Torsional Properties Test for NovoHip Bone Screws | Meet required performance specifications for torsional strength | Met required performance specifications |
| Driving Torque Test for NovoHip Bone Screws | Meet required performance specifications for driving torque | Met required performance specifications | |
| Axial Pull-Out Strength Test for NovoHip Bone Screws | Meet required performance specifications for axial pull-out strength | Met required performance specifications |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the sample sizes used for each of the non-clinical tests. The data provenance is non-clinical laboratory testing, likely conducted by or for the manufacturer (NovoSource, Inc.), and is retrospective in the sense that it evaluates the device's characteristics against predefined specifications rather than observing its performance over time in a living system. The country of origin for the data is implied to be within the US, given the submission to the FDA.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
This information is not applicable to this type of submission. The ground truth for mechanical testing is established by engineering standards and predefined performance specifications derived from regulatory guidelines and predicate device performance, not by expert interpretation of data.
4. Adjudication Method for the Test Set
This information is not applicable. Since the tests are objective mechanical performance evaluations against defined specifications, there is no need for expert adjudication. The result is either "meets specification" or "does not meet specification."
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC comparative effectiveness study was not done. This type of study is typically used for diagnostic or screening devices where human readers interpret medical images or data. The NovoHip Total Hip System is a mechanical implant, and its performance is evaluated through objective physical and mechanical testing.
6. If a Standalone Study (Algorithm Only Without Human-in-the-Loop Performance) Was Done
This question is not applicable as the device is a physical hip implant, not an algorithm or software. The "standalone" performance here refers to the device's mechanical integrity as tested in a laboratory setting. All listed tests are "standalone" in this physical sense, meaning the device's performance was evaluated independently without human surgical interaction during the test itself (though humans designed and conducted the tests).
7. The Type of Ground Truth Used
The ground truth for the non-clinical tests used in this submission is based on:
- Engineering Standards and Specifications: Performance requirements derived from nationally and internationally recognized standards (e.g., ISO, ASTM for medical devices) for hip implants and their components.
- Predicate Device Performance: The performance characteristics of the legally marketed predicate devices (Stelkast Provident Hip System, Smith & Nephew Biolox Delta Ceramic Femoral Head, Wright Medical Lineage Acetabular System) serve as a benchmark for substantial equivalence.
8. The Sample Size for the Training Set
This information is not applicable. There is no "training set" in the context of this device because it is a physical medical implant, not an AI or machine learning model that requires training data.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable for the same reason as point 8.
§ 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.