(70 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 femoral 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 Exactech Novation Tapered 12/14 Press-Fit Femoral Stems are a modification of the Exactech Novation 12/14 Press-Fit Femoral Stems cleared through premarket notification #K042842.
The predicate and proposed devices have the same intended use and the same basic fundamental scientific technology.
The modified devices share the following similarities with predicate devices:
- The same indications for use
- The same design features (e.g. neck and stem geometry, femoral head taper . design, stem insertion feature, offsets - standard and extended)
- The same materials (titanium alloy, commercially pure titanium plasma spray) .
- The same shelf life (5 years), and .
- Are packaged and sterilized using the same materials and processes (gamma ● radiation sterilization to a sterility assurance level (SAL) of 100).
This submission proposed the following design changes: - A change to the sizing range and increments between additional femoral stem . sizes
- A heat treatment change for the additional femoral stem sizes only .
The provided document describes a Special 510(k) submission for the Exactech® Novation® Tapered 12/14 Press-Fit Femoral Stems. This type of submission is used for modifications to a manufacturer's own legally marketed device (predicate device) where the proposed changes do not "affect the fundamental scientific technology of the device" and "do not raise different questions of safety and effectiveness."
Therefore, the submission does not involve a study to meet new acceptance criteria in the traditional sense of a clinical trial or algorithm performance validation. Instead, the "acceptance criteria" are demonstrating substantial equivalence to the predicate device through engineering analyses.
Here's an analysis of the provided text based on your request, highlighting why many sections are not applicable to this type of submission:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Demonstrated Equivalence) | Reported Device Performance |
|---|---|
| Geometric features of the proposed device correspond to the anatomical features of the femur. | An engineering evaluation was conducted that determined "the geometric features of the proposed device correspond to the anatomical features of the femur." This suggests the modifications (sizing range and increments) maintain appropriate anatomical fit. |
| The proposed device has fatigue strength equivalent to other comparable legally marketed femoral stems (specifically, the predicate device). | An engineering evaluation was conducted that determined "the proposed device has fatigue strength equivalent to other comparable legally marketed femoral stems." This indicates the heat treatment change for new sizes did not compromise the fatigue strength compared to the predicate. |
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
Not applicable. This submission relies on engineering analyses and comparisons to a predicate device, not a test set of patient data.
3. 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)
Not applicable. No ground truth was established by experts for a test set of data. The evaluation was based on engineering principles and comparisons.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
Not applicable. No test set was used requiring adjudication.
5. 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
Not applicable. This is not an AI-assisted device and no MRMC study was conducted.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a medical implant, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
Not applicable in the context of a "ground truth" for a dataset. The "ground truth" here is the established safety and effectiveness of the predicate device, against which the modifications are compared through engineering analysis.
8. The sample size for the training set
Not applicable. This is a medical implant, not a machine learning model, so there is no training set.
9. How the ground truth for the training set was established
Not applicable. There is no training set.
Summary of the Study that Proves the Device Meets Acceptance Criteria (Substantial Equivalence):
The "study" proving the device meets the acceptance criteria (which, in this context, is substantial equivalence to the predicate device) consisted of engineering analyses.
- Engineering Evaluation for Geometric Features: This evaluation determined that the geometric features of the proposed device (with its new sizing range and increments) correspond appropriately to the anatomical features of the femur. This is crucial for proper fit and function.
- Engineering Evaluation for Fatigue Strength: This evaluation determined that the proposed device (which includes a heat treatment change for the additional stem sizes) possesses fatigue strength equivalent to the predicate device and other comparable legally marketed femoral stems. Maintaining equivalent fatigue strength is critical for the long-term durability and safety of the implant, preventing premature failure.
The results of these engineering analyses were deemed sufficient by the FDA to demonstrate substantial equivalence to the predicate device (Exactech Novation 12/14 Press-Fit Femoral Stems, K042842). This conclusion is based on the premise that the proposed changes (sizing and heat treatment for new sizes) do not alter the fundamental scientific technology or raise new safety/effectiveness questions that would require comprehensive clinical data.
§ 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.