(88 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 arthritis, 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 System consists of a collarless, tapered, forged titanium alloy femoral stem mated to a cobalt chrome alloy modular femoral head. This femoral construct articulates with an acetabular device assembly. The acetabular device assembly consists of a hemispherical 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. 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 grooves on the cup to engage grooves on the HXL-UHMWPE liner. Standard instrumentation is used to implant the device.
The current submission adds stems with additional offsets to the I-Hip System. Compatible femoral heads, acetabular cups, acetabular liners, locking rings and bone screws were cleared in K121034 and K131279.
Here's an analysis of the provided text regarding the acceptance criteria and study for the ICONACY™ I-Hip™ System:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Proximal Stem Fatigue (ISO 7206-6) | Met pre-determined criteria |
| Distal Stem Fatigue (ISO 7206-4) | Met pre-determined criteria |
| Range of Motion Analysis | Did not create a new worst case compared to the original I-Hip Femoral Stems. |
2. Sample Size Used for the Test Set and Data Provenance:
The document describes performance data conducted on the device components (femoral stems) and does not refer to a "test set" in the context of diagnostic or clinical evaluation. Instead, it refers to biomechanical testing. The sample sizes for these specific tests are not provided in the document. The data provenance is also not specified (e.g., country of origin, retrospective/prospective). It can be inferred that these were laboratory-based engineering tests.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications:
This information is not applicable as the described studies are biomechanical engineering tests on device components, not studies requiring expert interpretation of clinical data for ground truth establishment.
4. Adjudication Method for the Test Set:
This information is not applicable for the same reasons as #3.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size:
No, an MRMC comparative effectiveness study was not done. The document explicitly states: "CLINICAL TESTING: Clinical testing was not required for determining substantial equivalence with the predicate devices."
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done:
This information is not applicable. This device is a physical orthopedic implant, not an AI algorithm or software. Therefore, the concepts of "standalone performance" or "human-in-the-loop performance" do not apply.
7. The Type of Ground Truth Used:
The "ground truth" for the performance data in this context refers to established engineering standards and specifications (ISO 7206-6, ISO 7206-4) for mechanical properties and the performance of the predicate device for range of motion.
8. The Sample Size for the Training Set:
This information is not applicable as the device is a physical orthopedic implant, not a machine learning model.
9. How the Ground Truth for the Training Set Was Established:
This information is not applicable for the same reasons as #8.
§ 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.