(152 days)
The ICONACY I-Hip system is indicated for the following conditions: (1) a severely painful and/or disabled hip joint as a result of osteoarthritis, traumatic arthrius, theumatoid arthritis, or congenital hip dysplasia, (2) avascular necrosis of the femoral head, (3) acute traumatic fracture of the femoral head or neck, (4) failed previous hip surgery including joint reconstruction, internal fixation, arthrodesis, hemiarthroplasty, surface replacement arthroplasty, or total hip replacement, (5) certain cases of ankylosis, (6) nonunions, correction of functional deformity, and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques.
The ICONACY I-Hip system consists of femoral stem and acetabular cup (i.e., shell) porous coated components intended for cementless, press-fit fixation
The ICONACY I-Hip consists of a collarless, tapered, forged titanium alloy femoral stem, mated to a cobalt chrome modular femoral head. This femoral construct articulates with an acetabular device assembly. The acetabular device assembly consists of a hemispheric titanium alloy cup (i.e., shell) coupled with a highly cross linked ultra-high molecular weight polyethylene (HXL-UHMWPE) liner. Forty percent of the femoral stem is circumferentially coated with a titanium coating designed to attain a cementless, press fit fixation. The acetabular cup is machined from forged Ti-6Al-4V ELI alloy. The cup has a threaded polar hole for insertion and two screw holes to permit the use of screws for adjunct fixation. The outer hemispheric surface of the cup has a titanium plasma spray coating for cementless, press fit fixation. A titanium locking ring is fixed into a groove on the cup to engage the groove in the HXL-UHMWPE liner. Standard instrumentation is used to implant the device.
The provided text describes a 510(k) submission for the ICONACY I-Hip System, a total hip replacement device. It focuses on demonstrating substantial equivalence to predicate devices rather than proving performance against specific acceptance criteria through clinical studies. Therefore, much of the requested information about device performance, study details, and ground truth establishment is not available in the provided text.
Here's an breakdown of the available information:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Nonclinical Testing: | Outcome: Demonstrated substantial equivalency to predicate devices. |
| Characterization of HXL-UHMWPE | Performed |
| Testing of the locking mechanism between the cup and liner | Performed |
| Range of motion analysis | Performed |
| Impingement testing | Performed |
| Wear | Performed |
| Femoral head pull-off testing | Performed |
| Fatigue (endurance limits) for the femoral stem | Performed |
2. Sample Size Used for the Test Set and Data Provenance
Not applicable. No clinical test set or human subject data was used. The evaluation was based on nonclinical (bench) testing.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Experts
Not applicable. No expert-established ground truth for a test set was used, as no clinical testing was performed.
4. Adjudication Method for the Test Set
Not applicable. No clinical test set or adjudication process was described.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
No. A multi-reader multi-case comparative effectiveness study was not performed. The submission explicitly states "Clinical Testing: Clinical testing was not required for determining substantial equivalency with the predicate devices."
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is a physical orthopedic implant, not an algorithm or AI system.
7. The Type of Ground Truth Used
The "ground truth" for demonstrating substantial equivalence was derived from nonclinical (bench) testing results (e.g., measurements of material properties, mechanical performance under various loads, wear rates) compared against established performance characteristics of the predicate devices.
8. The Sample Size for the Training Set
Not applicable. There was no "training set" in the context of an AI/ML algorithm. The device's design and manufacturing processes are informed by engineering principles and existing knowledge of predicate devices.
9. How the Ground Truth for the Training Set was Established
Not applicable. As noted above, there was no "training set" for an algorithm. The design and manufacturing relied on established engineering standards and performance data from predicate devices.
§ 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.