(95 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 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 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 a groove on the cup to engage a groove on the HXL-UHMWPE liner. Standard instrumentation is used to implant the device.
The current submission is for modifications to the acetabular cups and locking rings cleared in K121034, and the addition of spiked and finned acetabular cups in the same sizes and materials as those cleared in K120134. The compatible femoral heads, acetabular liners and bone screws are unchanged from those cleared in K121034.
Here's a breakdown of the acceptance criteria and the study information for the ICONACY™ I-Hip™ System, based on the provided document:
This 510(k) submission (K131279) is for modifications to existing components and the addition of new acetabular cups, not for an entirely new device. Therefore, the "study" described focuses on demonstrating substantial equivalence to a predicate device rather than presenting a clinical trial for novel device performance.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (What was measured) | Reported Device Performance (Results) |
|---|---|
| Mechanical Performance of Modified Designs | |
| Push-out testing (of modified acetabular cups/locking rings) | Performed, and results contributed to a determination of substantial equivalence (specific numerical values are not provided in this summary document). |
| Lever-out testing (of modified acetabular cups/locking rings) | Performed, and results contributed to a determination of substantial equivalence (specific numerical values are not provided in this summary document). |
| Torque-out testing (of modified acetabular cups/locking rings) | Performed, and results contributed to a determination of substantial equivalence (specific numerical values are not provided in this summary document). |
| Equivalence to Predicate Device (K121034) | |
| Similarity in design | Demonstrated to be similar. |
| Similarity in materials | Demonstrated to be similar. |
| Similarity in function | Demonstrated to be similar. |
| Similarity in indications for use | Demonstrated to be similar. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify a "test set" in the context of a traditional clinical study with patient samples. The performance data is derived from in vitro mechanical testing of the device components.
- Sample Size for Mechanical Testing: Not explicitly stated (e.g., number of cups tested, number of forces applied).
- Data Provenance: This is an in vitro engineering study, not human or animal data. The origin would be the testing facility of ICONACY Orthopedic Implants, LLC.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. The "ground truth" for this type of submission is based on engineering principles and established mechanical testing protocols. There is no mention of external human experts establishing a ground truth for the in vitro test results in this 510(k) summary.
4. Adjudication Method for the Test Set
Not applicable, as this was an in vitro mechanical testing study, not a clinical study requiring adjudication of patient outcomes or imaging interpretations. The determination of "substantial equivalence" based on these tests would be made internally by the sponsor and reviewed by the FDA.
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
Not applicable. This is not a study involving AI, human readers, or medical imaging. It is a submission for an orthopedic implant.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an algorithmic device.
7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for this submission's performance data is based on mechanical testing standards and engineering specifications designed to ensure the modified components are as robust and perform similarly to the predicate device. The goal is to demonstrate that the physical properties and performance under stress (push-out, lever-out, torque-out) meet acceptable thresholds for orthopedic implants of this type and are comparable to the previously cleared predicate.
8. The Sample Size for the Training Set
Not applicable. There is no concept of a "training set" in this 510(k) submission, as it does not involve machine learning or AI.
9. How the Ground Truth for the Training Set was Established
Not applicable, as there is no training set for this device submission.
§ 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.