(28 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.
AcuMatch Press-Fit components are intended for use in press-fit applications. Components without the optional hydroxyapatite (HA) coating may also be used with bone cement.
AcuMatch P-Series Porous Femoral Stems are composed of titanium alloy (Ti-6A1-4V) conforming to ASTM F1472-99. The stems have a trapezoidal cross-sectional geometry, distal taper, and calcar collar option. There are two offset options available. The porous bead coating on the proximal portion of the stem is composed of titanium beads meeting the specifications of ASTM F67-95, Grade 2. An optional hydroxyapatite (HA) coating is also available. The products are provided as sterile, single use only with a sterility assurance level (SAL) of 10-0.
This 510(k) summary describes a premarket notification for a new femoral component for hip replacement, not an AI/ML device, therefore, the requested information elements related to AI/ML device performance and study design are not applicable.
Here's a breakdown based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance:
The document for the Exactech AcuMatch Integrated Hip System P-Series Porous Femoral Components is a 510(k) summary, which focuses on demonstrating substantial equivalence to legally marketed predicate devices, rather than establishing acceptance criteria and reporting performance in the same way an AI/ML device might.
For this medical device, the "acceptance criteria" are implied by the demonstration of substantial equivalence through:
- Common Design Features: The new device shares design attributes with predicate devices.
- Material Properties: The new device uses materials consistent with predicate devices (titanium alloy (Ti-6Al-4V) conforming to ASTM F1472-99, titanium beads conforming to ASTM F67-95).
- Fatigue Testing: Performed to verify adequate implant performance for anticipated in vivo loading. This is the closest equivalent to a performance metric, though specific numerical criteria and results are not detailed in this summary.
| Acceptance Criteria (Implied by Substantial Equivalence) | Reported Device Performance |
|---|---|
| Common design features with predicate devices | "The predicate and proposed devices share common design features." |
| Consistent material properties with predicate devices | Composed of titanium alloy (Ti-6Al-4V) conforming to ASTM F1472-99. Porous bead coating composed of titanium beads meeting ASTM F67-95, Grade 2. (Matches industry standards for these materials). |
| Adequate performance for in vivo loading | "Fatigue testing was performed to verify that the implant performance would be adequate for anticipated in vivo loading." (Specific quantitative results or thresholds not provided in this summary) |
2. Sample Size Used for the Test Set and Data Provenance:
Not applicable. This is a physical medical device (femoral component for hip replacement), not a software or AI/ML device that uses test sets or data. The "testing" referred to is mechanical fatigue testing of the physical implant.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications:
Not applicable. Ground truth, in the context of expert review, is not relevant for this type of physical device's substantial equivalence determination.
4. Adjudication Method for the Test Set:
Not applicable. Adjudication methods are typically for evaluating subjective expert opinions on data, which isn't the case for a physical implant's mechanical testing.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:
Not applicable. MRMC studies are for evaluating human performance, often with or without AI assistance, which is not relevant for this physical device.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:
Not applicable. This is not an algorithm or software device.
7. The Type of Ground Truth Used:
For a physical orthopedic implant, the "ground truth" for demonstrating substantial equivalence and safety/effectiveness typically involves:
- Engineering Standards and Specifications: Adherence to established ASTM standards for materials (F1472-99 for titanium alloy, F67-95 for titanium beads).
- Mechanical Testing Results: Data from fatigue testing that demonstrates the device can withstand anticipated physiological loads and cycles. While the summary states testing was done, the specific results or definition of "adequate" are not provided.
- Historical Performance of Predicate Devices: The long-term clinical success and safety profile of the legally marketed predicate devices serve as the "ground truth" for the new device's expected performance, given its substantial equivalence in design and materials.
8. The Sample Size for the Training Set:
Not applicable. There is no "training set" as this is not an AI/ML device.
9. How the Ground Truth for the Training Set Was Established:
Not applicable. There is no "training set" for this physical medical 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.