(225 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, rheumatoid 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 ultrahigh 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-UHMVPE liner. Standard instrumentation is used to implant the device.
The current submission adds angled face, lateralized and extended wall acetabular liners and an apex hole plug to the I-Hip Total Hip System. The compatible femoral heads, acetabular cups, locking rings and bone screws were cleared in K121034. Additional compatible acctabular cups and locking rings were cleared in K131279.
The provided text describes a 510(k) premarket notification for a medical device, the ICONACY™ I-Hip™ System. This type of submission is for demonstrating substantial equivalence to a legally marketed predicate device, not for proving a device meets specific acceptance criteria through clinical or standalone performance studies like those common for AI/ML-enabled devices.
Therefore, most of the requested information regarding acceptance criteria, study details, sample sizes, ground truth establishment, expert qualifications, and MRMC studies is not applicable to this document. The device is a total hip system, which is a physical implant, not an AI/ML-enabled device or software.
Here's a breakdown of what can be extracted and what is not relevant:
1. A table of acceptance criteria and the reported device performance
- Not Applicable. This document does not describe specific numerical acceptance criteria typical for AI/ML performance metrics (e.g., sensitivity, specificity, AUC). Instead, it relies on demonstrating substantial equivalence to a predicate device.
- Reported Device Performance: The only performance data explicitly mentioned is:
- "Range of motion analyses were completed for the acetabular liners to ensure that adequate range of motion was maintained."
- "Characterization and biocompatibility data for color additives is provided in a Master File."
- No specific quantitative results from these analyses are provided in this summary.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not Applicable. No test set in the context of AI/ML evaluation is mentioned or performed. The demonstration of substantial equivalence is based on design, materials, function, and indications for use compared to predicate devices.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not Applicable. There is no "ground truth" establishment in the context of an AI/ML test set mentioned.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Applicable. No test set or adjudication method is described.
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. MRMC studies are relevant for evaluating AI-assisted diagnostic tools. This device is a physical orthopedic implant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable. This device is a physical implant, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not Applicable. Ground truth in the context of AI/ML validation is not applicable here.
8. The sample size for the training set
- Not Applicable. There is no AI/ML model, hence no training set.
9. How the ground truth for the training set was established
- Not Applicable. No training set or ground truth for it exists in this submission.
Summary of Device Acceptance and Study:
The ICONACY™ I-Hip™ System met the criteria for substantial equivalence to its predicate device (ICONACY I-Hip Total Hip System, K121034) by demonstrating similarities in design, materials, function, and indications for use.
- Acceptance Criteria (for regulatory clearance): Substantial Equivalence to a legally marketed predicate device.
- Study Proving Acceptance: The regulatory submission (510(k)) itself, which included comparisons of the device's characteristics to the predicate.
- Performance Data Mentioned:
- Range of motion analyses for acetabular liners to ensure adequate range of motion.
- Characterization and biocompatibility data for color additives (referenced in a Master File).
- Clinical Testing: Explicitly stated as "Clinical testing was not required for determining substantial equivalence with the predicate devices."
In essence, the "study" for this type of device clearance is a comparative analysis against a predicate device based on technical specifications and existing regulatory precedents, not a performance study in the same vein as those for AI/ML-enabled 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.