(30 days)
All Exactech Hip Systems are indicated for use in skeletally mature individuals undergoing primary surgery for hip replacement due to osteoarthritis, rheumatoid arthritis, osteonecrosis, post-traumatic degenerative problems of the hip, and for treatment of proximal fractures where prosthetic replacement is determined by the surgeon as the preferred treatment. Components of Exactech Hip Systems are also potentially indicated for ankylosing spondylitis, congenital hip dysplasia. revision of failed previous reconstructions where sufficient bone stock is present, and to restore mobility resulting from previous fusion.
- . Cemented femoral stems and cemented acetabular cups are intended for cemented fixation only.
- Press-fit femoral stems and acetabular cups are intended for press-fit fixation. . Press-fit components without hydroxyapatite (HA) coating may also be used with bone cement at the discretion of the surgeon
- . Femoral heads and endoprostheses are intended for use in cemented and press-fit applications.
The proposed Novation Crown Cup with InteGrip acetabular shells are modifications to the Novation Crown Cup Acetabular Shell, Cluster Hole, Plasma Coated devices cleared through premarket notification #K070479, Novation Crown Cup and Liners.
The predicate and proposed devices have the same intended use and basic fundamental scientific technology.
The modified devices share the following similarities with the predicate devices:
- Indications for use
- . Design features (e.g., outer and inner geometries, constrained liner feature, apical locking feature , anti-rotational feature, and product scope)
- . Material (titanium alloy)
- Shelf life (5 years) ●
- . Packaging and sterilization materials and processes (gamma radiation sterilization to a sterility assurance level of 10°).
This submission proposes the following design change:
The proposed device will have a porous surface and will be manufactured from titanium alloy per ISO 5832-3 using an additive manufacturing process. The same material surface/coating was previously cleared for porous uncemented use in the hip in 510(k) K101761 - Exactech Novation Empire Acetabular Augments with InteGrip.
This 510(k) summary describes a modification to an existing device, the Exactech® Novation® Crown Cup® with InteGrip™ Acetabular Shell. The submission focuses on demonstrating substantial equivalence to a predicate device by evaluating a design change (porous surface manufacturing process) through engineering analyses and an animal study.
Here's an analysis of the provided information against your requested criteria:
Acceptance Criteria and Device Performance
| Acceptance Criteria / Test Performed | Reported Device Performance / Evaluation Method |
|---|---|
| Abrasion resistance (ASTM F1978-07) | Conducted to evaluate the integrity of the porous surface/coating. (Specific results not detailed in the summary, but stated to demonstrate substantial equivalence). |
| Shear fatigue strength (ASTM F1160-50) | Conducted to evaluate the integrity of the porous surface/coating. (Specific results not detailed in the summary, but stated to demonstrate substantial equivalence). |
| Static shear strength (ASTM F1044-08) | Conducted to evaluate the integrity of the porous surface/coating. (Specific results not detailed in the summary, but stated to demonstrate substantial equivalence). |
| Static tensile strength (ASTM F1147-05) | Conducted to evaluate the integrity of the porous surface/coating. (Specific results not detailed in the summary, but stated to demonstrate substantial equivalence). |
| Compressive deformation testing | Conducted to evaluate the integrity of the porous surface/coating. (Specific results not detailed in the summary, but stated to demonstrate substantial equivalence). |
| Volume % porosity (ASTM F1854-01) | Testing performed to demonstrate the porous surface/coating met the specifications of 21 CFR 888.3358 for a porous-coated uncemented hip prosthesis. (Specific results not detailed in the summary, but stated to meet specifications). |
| Pore size (ASTM F1854-01) | Testing performed to demonstrate the porous surface/coating met the specifications of 21 CFR 888.3358 for a porous-coated uncemented hip prosthesis. (Specific results not detailed in the summary, but stated to meet specifications). |
| Thickness (ASTM F1854-01) | Testing performed to demonstrate the porous surface/coating met the specifications of 21 CFR 888.3358 for a porous-coated uncemented hip prosthesis. (Specific results not detailed in the summary, but stated to meet specifications). |
| Interconnected porosity | Testing performed to demonstrate the porous surface/coating met the specifications of 21 CFR 888.3358 for a porous-coated uncemented hip prosthesis. (Specific results not detailed in the summary, but stated to meet specifications). |
| Biological fixation | 12-week ovine animal study conducted to indicate that stable fixation occurs via biological fixation and is comparable to predicate devices. (No specific quantitative results are provided in this summary, but the study conclusion is that it is "comparable"). These engineering analyses were originally provided and reviewed in premarket notification K101761 - Exactech Novation Empire Acetabular Augments with InteGrip. The results of engineering analyses demonstrate the proposed device is substantially equivalent to the predicate device. |
Study Details for Demonstrating Substantial Equivalence:
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Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Test Set (for physical/material testing): Not explicitly stated as a "test set" in the traditional sense of clinical data. The tests are engineering analyses performed on samples of the device or its components. The number of samples for each specific test (e.g., how many cups were tested for abrasion resistance) is not provided.
- Test Set (for animal study): The study was a "12-week ovine animal study." The number of animals used is not specified.
- Data Provenance: Not specified for the engineering tests or animal study. It is likely that these tests were conducted by or for Exactech, Inc. in Gainesville, Florida, USA, given the sponsor information. The data appears to be prospective in the context of generating data for this 510(k) submission, although the summary notes that these analyses were "originally provided and reviewed in premarket notification K101761."
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):
- This submission does not involve human expert review of clinical data for establishing ground truth. The "ground truth" for the material properties is defined by industry standards (ASTM) and FDA regulations (21 CFR 888.3358). For the animal study, the assessment of biological fixation would be performed by veterinary researchers/pathologists, but their number and specific qualifications are not detailed in this summary.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable. This is not a study requiring adjudication of expert opinions on clinical cases. The "adjudication" of the engineering tests comes from meeting predetermined pass/fail criteria based on ASTM standards and regulatory specifications. For the animal study, the determination of biological fixation would be based on scientific observation and analysis protocols.
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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:
- No MRMC comparative effectiveness study was done. This 510(k) pertains to a medical device (hip prosthesis), not an AI-powered diagnostic or assistive tool.
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If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Not applicable. This is not an algorithm or AI device.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- For Material Properties: The ground truth is defined by industry standards (ASTM) and regulatory specifications (21 CFR 888.3358) regarding porosity, pore size, thickness, and mechanical strength properties of porous-coated uncemented hip prostheses.
- For Biological Fixation: The ground truth is established through histological and potentially radiographic evaluation in the ovine animal model, aiming to demonstrate biological ingrowth and stable fixation, consistent with the accepted understanding of biological fixation for uncemented implants.
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The sample size for the training set:
- Not applicable. There is no "training set" as this is not an AI/machine learning device.
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How the ground truth for the training set was established:
- Not applicable. There is no training set for this device submission.
§ 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.