(26 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.
Novation® press-fit femoral stems are intended for press-fit fixation.
Press-fit femoral stems without hydroxyapatite (HA) coating may also be used with bone cement at the discretion of the surgeon.
The proposed Exactech Novation 12/14 Press-Fit Femoral Components are a modification of the AcuMatch P-Series Plasma Press-Fit Femoral Stems cleared through premarket notifications #K041906.
The predicate and proposed products have the same intended use and the same basic fundamental scientific technology.
The modified Novation femoral stems share the following similarities to the predicate AcuMatch femoral stems:
- the same indications for use, .
- similar design features (e.g. neck angle, femoral head taper design (12/14), neck . flat geometry (angled), offsets - standard and extended).
- the same materials (titanium alloy, commercially pure titanium plasma spray and . hydroxyapatite coating)
- 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 10").
This Special 510k application supports the following design changes:
- The trapezoidal cross-sectional area was modified to a circulo-trapezoidal . geometry.
- A change to the sizing range and differential. .
- A distally "splined" model was added to the product line. .
- Change in plasma coating application area. .
Here's an analysis of the provided text regarding the acceptance criteria and study for the Exactech Novation 12/14 Press-Fit Femoral Stems:
The provided document is a 510(k) summary for a Special 510(k) submission, meaning it's for a modification of an already cleared device. As such, the "acceptance criteria" here are generally focused on demonstrating that the modified device remains substantially equivalent to its predicate device, rather than proving performance against novel, independently established clinical endpoints.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria / Performance Aspect | Reported Device Performance (Exactech Novation 12/14 Press-Fit Femoral Stems) |
|---|---|
| Primary Goal: Substantial Equivalence to predicate device (#K041906 AcuMatch P-Series Plasma Press-Fit Femoral Stems) | Concluded: "We propose that they are substantially equivalent to the Exactech AcuMatch 12/14 P-Series Plasma Press-Fit Femoral Stems cleared through premarket notification #K041906." |
| Indications for Use (Same as predicate) | "the same indications for use" |
| Basic Fundamental Scientific Technology (Same as predicate) | "the same basic fundamental scientific technology" |
| Design Features (Similar to predicate: neck angle, taper, flat geometry, offsets) | "similar design features (e.g. neck angle, femoral head taper design (12/14), neck flat geometry (angled), offsets - standard and extended)" |
| Materials (Same as predicate: titanium alloy, Ti plasma spray, HA coating) | "the same materials (titanium alloy, commercially pure titanium plasma spray and hydroxyapatite coating)" |
| Shelf Life (Same as predicate) | "the same shelf life (5 years)" |
| Packaging & Sterilization (Same as predicate: gamma radiation to SAL 10^-6) | "are packaged and sterilized using the same materials and processes (gamma radiation sterilization to a sterility assurance level (SAL) of 10^-6)" |
| Risk Analysis (Impact of modifications on safety) | "A risk analysis was performed to assess the impact of the modifications on the safety of the Novation femoral stem design." (Implied successful completion and favorable outcome) |
| Mechanical Performance (Fatigue testing) | "Supporting verification activities include ISO 7206-8 empirical fatigue testing" |
| Engineering Analyses | "and engineering analyses." |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: The document does not specify a "test set" in the context of human clinical data or images. The testing mentioned is ISO 7206-8 empirical fatigue testing on the device itself.
- Data Provenance: The data comes from laboratory testing (empirical fatigue testing) and engineering analyses performed on the manufactured device. It is not derived from human subjects or retrospective/prospective clinical data for this specific submission.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts
- This information is not applicable to this 510(k) submission. The "ground truth" here is based on engineering standards (ISO 7206-8) and risk analysis, not expert consensus on clinical cases.
4. Adjudication Method for the Test Set
- This information is not applicable. No clinical adjudication method is mentioned or required for this type of engineering-focused Special 510(k) submission.
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
- No, an MRMC comparative effectiveness study was not done. This device is a passive orthopedic implant, not an AI-assisted diagnostic or therapeutic tool. Therefore, the concept of "human readers improve with AI vs without AI assistance" does not apply.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
- No, a standalone algorithm performance study was not done. This device is a physical medical implant, not an algorithm, so this concept is not applicable.
7. The Type of Ground Truth Used
- The "ground truth" for the device's acceptable performance is primarily based on:
- Engineering standards: Specifically, ISO 7206-8 for empirical fatigue testing.
- Risk analysis: To evaluate the impact of design modifications.
- Demonstrated equivalence: To the predicate device's established safety and effectiveness.
8. The Sample Size for the Training Set
- This information is not applicable. There is no "training set" in the context of machine learning or AI as this is a physical medical device. The "training" for the device's design would be through established engineering principles and prior device iterations, but not in a machine learning sense.
9. How the Ground Truth for the Training Set Was Established
- This information is not applicable for the reasons stated in point 8. The "ground truth" for the predicate device (AcuMatch P-Series) would have been established through its own 510(k) clearance process, likely involving similar engineering and potentially earlier clinical data or references to existing standards for femoral stems. For this specific Special 510(k), the ground truth for comparison is the predicate device's already cleared status.
§ 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.