(24 days)
AcuMatch M-Series Femoral Components are indicated for use in skeletally mature individuals undergoing primary surgery for total hip replacement due to osteoarthritis, osteonecrosis, congenital hip dysplasia, rheumatoid arthritis, ankylosing spondylitis, and/or post-traumatic degenerative problems. M-Series components are also potentially indicated for revision of failed previous reconstructions where sufficient bone stock is present.
AcuMatch M-Series components are intended to be used in press-fit and cemented applications.
The Exactech Modular Stem is a four-piece system consisting of a proximal neck segment, metaphyseal segment, diaphyseal segment and a locking screw. All of the components are interchangeable, therefore allowing for many sizing combinations to meet varying anatomical situations. The components are composed of titanium alloy. Design changes were made to the original neck segments cleared through premarket notification #K993736:
- A. High Offset Neck Segments
- Material was added to the lateral radius of all neck segments. 1.
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- A new "-5 Neck Segment" model was added.
B. Low Offset Neck Segments
A new "Low Offset" Neck version of neck is proposed. These models represent a reduction in horizontal offset of 5mm as compared to the predicate design (#K993736):
- Low Offset -- 5 Neck Segment 1.
- Low Offset Standard (+0) Neck Segment 2.
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- Low Offset +10 Neck Segment
The provided document is a 510(k) summary for the Exactech AcuMatch Integrated Hip System M-Series Femoral Stem Component, focusing on high and low off-set neck segments. It does not describe a study involving device performance for diagnostic purposes, or any human-in-the-loop or standalone AI performance. Instead, it describes a Finite Element Analysis to demonstrate substantial equivalence for a medical implant. Therefore, most of the requested information about acceptance criteria, detailed study design, sample sizes, ground truth establishment, and expert involvement for a diagnostic device is not applicable to this submission.
Here's a breakdown of the relevant information from the document:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Performance adequate for anticipated in-vivo loading. | Finite Element Analysis (FEA) showed the proposed devices have "performance characteristics similar to or better than Exactech's predicate M-Series neck design." |
2. Sample Size Used for the Test Set and Data Provenance
Not applicable. The study was a Finite Element Analysis (FEA), which is a computational simulation, not a clinical study with a test set of human subjects or patient data.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of those Experts
Not applicable. FEA is a computational method; it does not involve expert readers establishing ground truth in the same way a diagnostic image interpretation study would. The 'ground truth' in FEA is based on engineering principles and material properties.
4. Adjudication Method for the Test Set
Not applicable. There was no test set requiring adjudication in the context of human readers.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
No, an MRMC comparative effectiveness study was not done. The submission relies on a computational analysis (FEA) to demonstrate substantial equivalence.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not a diagnostic algorithm; it's a structural component for a hip implant. The "standalone performance" was evaluated through FEA, which is a simulation of the device's mechanical behavior.
7. The Type of Ground Truth Used
The "ground truth" for the Finite Element Analysis (FEA) would be the established engineering principles, material properties (e.g., titanium alloy characteristics), and biomechanical loading conditions used in the simulation, as compared to the predicate device. The goal was to show that the new designs performed similarly or better under these simulated conditions.
8. The Sample Size for the Training Set
Not applicable. As FEA is a simulation, there isn't a "training set" in the sense of machine learning algorithms. The FEA model is built based on the design specifications of the device.
9. How the Ground Truth for the Training Set was Established
Not applicable. The FEA model's "ground truth" (i.e., its accuracy in predicting real-world behavior) is established through validation against physical testing data or established engineering benchmarks for the materials and design principles used. This document references the predicate device's performance as a benchmark.
§ 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.