(258 days)
The iTotal® Hip Replacement System is designed from a patient's pre-operative CT scan which must include certain necessary anatomic landmarks that are clearly identifiable. Total hip replacement using the iTotal® Hip Replacement System is indicated for use in skeletally mature individuals undergoing total hip replacement due to:
• A severely painful and/or disabled joint from osteoarthritis, traumatic arthritis, rheumatoid arthritis, avascular necrosis, or congenital hip dysplasia.
• Treatment of non-displaced non-unions of the hip, femoral neck fractures, and trochanteric fractures of the proximal femur with head involvement, unmanageable by other techniques.
• Revision procedures for failed previous hip surgery (excluding situations where hardware is present).
The iTotal® Hip Replacement System includes standard hip replacement components as well as the following patient specific components: femoral neck, acetabular cup, single use instrumentation.
The iTotal® Hip Replacement implants are intended for cementless fixation using an anterior or posterior surgical approach.
The iTotal® Hip Replacement System is a patient specific hip replacement system which consists of femoral and acetabular components and patient specific instrumentation (iJigs). The femoral component consists of a standard femoral stem body with an integrated (non-modular) patient specific neck, which connects with a standard femoral head. The acetabular component consists of a metal acetabular cup with two screw holes and polyethylene liners in standard sizes. Standard bone screws and apex hole plug may also be provided with the iTotal® Hip Replacement System.
The iTotal® Hip Replacement System is intended to treat skeletally mature patients who are candidates for total hip replacement surgery.
Using patient imaging (CT scan) and a combination of proprietary and off the shelf software, a patient specific hip replacement system is designed. The iTotal® Hip Replacement System consists of the following components:
a) Femoral Component:
The femoral stem, with an integrated patient specific neck, is manufactured from titanium alloy and has a plasma sprayed hydroxyapatite (HA) coating. The femoral stem is available in various sizes. Both metal (Cobalt Chromium alloy) and Ceramic femoral heads are available for use with the iTotal® Hip Replacement System. The femoral heads are available in various sizes and offsets.
b) Acetabular Component:
The acetabular cup is manufactured from titanium alloy. The acetabular cup features a plasma sprayed outer surface. The acetabular cups are available in various sizes. The acetabular liner is manufactured from highly cross-linked Vitamin E infused ultra-high molecular weight polyethylene (iPoly® XE). The liners are available in a range of sizes with varying internal diameters and offsets. Acetabular screws and the apex hole plug are manufactured from titanium alloy.
c) Ancillary orthopedic manual surgical instruments are provided with the iTotal® Hip Replacement system to assist with implantation. The ancillary instruments are provided sterile and for single-use only. These patient specific instruments are provided to assist in the positioning of total hip replacement components intra-operatively and in guiding the cutting/reaming of bone.
This is a 510(k) premarket notification for the iTotal® Hip Replacement System, a medical device, not an AI/ML device. Therefore, the requested information regarding acceptance criteria and studies for AI/ML performance is not applicable.
The document discusses non-clinical testing performed to establish substantial equivalence to predicate devices, which is standard for medical devices. The relevant section regarding testing is on page 7, under "Substantial Equivalence".
Here's why the AI/ML specific questions cannot be answered from this document:
- No AI/ML Component: The device description and summary of technological characteristics (pages 5 & 6) do not mention any artificial intelligence or machine learning components. The design is based on a patient's pre-operative CT scan and proprietary/off-the-shelf software to create patient-specific components and instrumentation, but this is described as a design and manufacturing process, not an AI/ML diagnostic or assistive tool.
- Focus on Substantial Equivalence: The entire document is geared towards demonstrating substantial equivalence to previously cleared predicate devices through traditional non-clinical testing methods (e.g., fatigue testing, wear testing, material characterization, cadaveric evaluation, software verification/validation). There is no mention of algorithms, performance metrics for diagnostic accuracy, reader studies, or ground truth establishment in the context of AI.
Summary of available information regarding acceptance criteria and studies (as applicable to a non-AI/ML device):
1. Table of acceptance criteria and reported device performance:
| Acceptance Criteria (Type of Test) | Reported Device Performance (Conclusion) |
|---|---|
| Femoral Stem Fatigue Testing | All testing demonstrated that the device is substantially equivalent to the predicate devices. |
| Femoral Neck Fatigue Testing | All testing demonstrated that the device is substantially equivalent to the predicate devices. |
| Femoral Taper-CoCr head Junction Testing | All testing demonstrated that the device is substantially equivalent to the predicate devices. |
| Femoral Taper-Ceramic Head Junction Testing | All testing demonstrated that the device is substantially equivalent to the predicate devices. |
| Acetabular Liner-Cup Disassembly Testing | All testing demonstrated that the device is substantially equivalent to the predicate devices. |
| Acetabular Liner Impingement Testing | All testing demonstrated that the device is substantially equivalent to the predicate devices. |
| Wear Testing: Adhesive and Abrasive Wear | All testing demonstrated that the device is substantially equivalent to the predicate devices. |
| Acetabular Bone Screw Testing | All testing demonstrated that the device is substantially equivalent to the predicate devices. |
| HA Coating Microstructure Characterization | All testing demonstrated that the device is substantially equivalent to the predicate devices. |
| HA Coating Bonding Strength (Tensile and Static Fatigue) Testing | All testing demonstrated that the device is substantially equivalent to the predicate devices. |
| HA Coating Shear Fatigue Testing | All testing demonstrated that the device is substantially equivalent to the predicate devices. |
| Range of Motion Testing | All testing demonstrated that the device is substantially equivalent to the predicate devices. |
| iJig Drop Testing | All testing demonstrated that the device is substantially equivalent to the predicate devices. |
| iJig Femoral Neck Resection Simulation | All testing demonstrated that the device is substantially equivalent to the predicate devices. |
| Characterization of iPoly XE | All testing demonstrated that the device is substantially equivalent to the predicate devices. |
| Cadaveric Evaluation | All testing demonstrated that the device is substantially equivalent to the predicate devices. |
| Software Verification/Validation | All testing demonstrated that the device is substantially equivalent to the predicate devices. |
| Bacterial Endotoxin Testing | All testing demonstrated that the device is substantially equivalent to the predicate devices. |
2. Sample size used for the test set and the data provenance: Not specified in the provided text. The document refers to "non-clinical testing" and implies laboratory-based or cadaveric evaluations, not patient data in the sense of AI/ML test sets.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. This is not an AI/ML diagnostic or assistive device that requires expert ground truth for interpretation. Cadaveric evaluations would involve expert surgeons, but their number and specific qualifications are not detailed.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
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 an AI-assisted device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is a physical medical device (implant and instruments), not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): For the non-clinical testing, ground truth would be based on established engineering and materials science standards, biomechanical principles, and potentially anatomical correctness assessed during cadaveric evaluations.
8. The sample size for the training set: Not applicable as this is not an AI/ML device in the context of the questions asked. The design process uses patient CT scans to design the specific components, but this is a design data set, not an AI training set for algorithm performance.
9. How the ground truth for the training set was established: Not applicable. The "training data" here would be the anatomical information from individual patient CT scans used for custom design, which by its nature is the patient's individual "ground truth" anatomy.
§ 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.