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510(k) Data Aggregation
(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.
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(28 days)
The iTotal CR Knee Replacement System (KRS) is intended for use as a total knee replacement in patients with knee joint pain and disability whose conditions cannot be solely addressed by the use of a prosthetic device that treats only one or two of the three knee compartments, such as a unicondylar, patellofemoral or bicompartmental prosthesis.
The Indications for Use include:
· Painful joint disease due to osteoarthritis, traumatic arthritis, rheumatoid arthritis or osteonecrosis of the knee.
· Post traumatic loss of joint function.
· Moderate varus, valgus or flexion deformity in which the ligamentous structures can be returned to adequate function and stability.
· Failed osteotomies, hemiarthroplasties, and unicondylar, patellofemoral or bicompartmental implants.
· Revision procedures provided that anatomic landmarks necessary for alignment and positioning of the implant are identifiable on patient imaging scans.
This implant is intended for cemented use only.
The iTotal® CR Knee Replacement System (hereafter referred to as the "iTotal CR KRS") is a patient specific tricompartmental faceted posterior cruciate ligament (PCL) retaining knee replacement system. The iTotal® CR KRS is a semi-constrained, cemented knee implant which consists of a femoral, tibial, and patellar component.
Using patient imaging and a combination of proprietary and off the shelf software a patient specific implant is designed, that best meets the geometric and anatomic requirements of the specific patient. The femoral component is manufactured from cobalt chromium molybdenum (CoCrMo) alloy. The tibial component includes a metal tray manufactured from CoCrMo alloy and either one or two polyethylene inserts. The polyethylene inserts may be manufactured from either UHMWPE or iPoly XE™ (a highly cross-linked vitamin E infused polyethylene) The patellar component is also manufactured from either UHMWPE or iPoly XE.
For user convenience, and similar to the predicate iTotal CR KRS, patient specific accessory orthopedic manual surgical instruments designed for use with the proposed iTotal CR KRS are provided to assist in the positioning of the total knee replacement components intraoperatively and in guiding the cutting of bone. In addition, reusable orthopedic manual surgical instruments are provided separately.
The function and general design features of the patient specific implants and ancillary instruments remain similar to those described in the predicate 510(k), K160025.
The provided document is a 510(k) summary for the ConforMIS iTotal® Cruciate Retaining (CR) Knee Replacement System (iTotal CR KRS). It focuses on establishing substantial equivalence to a predicate device, specifically for an additional sterilization method (Ethylene Oxide) for certain components.
The information requested, which typically relates to the acceptance criteria and study data for device performance in relation to its intended clinical use (e.g., accuracy, sensitivity, specificity, or effects on human readers for AI/diagnostic devices), is not present in this document. This submission primarily deals with changes in manufacturing (sterilization methods) and material properties, rather than clinical efficacy or diagnostic performance. Therefore, the requested information about device performance against acceptance criteria for a "study that proves the device meets the acceptance criteria" in a clinical/diagnostic sense cannot be extracted from this text.
However, I can provide information on the acceptance criteria and supporting "study" (validation testing) related to the sterilization process as outlined in the document:
Here's the information regarding the sterilization validation:
1. Table of Acceptance Criteria and Reported Device Performance (related to sterilization)
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Sterility Assurance Level (SAL) of 1.0 x 10^-6 for all components post-sterilization (VHP or Ethylene Oxide) | Meets Criteria: Sterilization Validation was performed to confirm an SAL of 1.0 x 10^-6 for all components, including those sterilized via Ethylene Oxide. The iPoly XE components, previously cleared for VHP, are now also cleared for EO sterilization to an SAL of 1.0 x 10^-6. |
| Acceptable Ethylene Oxide (EO) Residuals | Meets Criteria: EO Residual Testing was performed. (Specific residual values are not detailed, but the conclusion of substantial equivalence implies acceptable levels). |
| Retention of Mechanical, Material, and Chemical Properties Post-EO Sterilization for iPoly XE | Meets Criteria: Testing was performed to demonstrate that the iPoly XE material retains its mechanical, material, and chemical properties after EO sterilization. (Specific tests/results are not detailed, but the conclusion of substantial equivalence implies satisfactory results). |
| Non-pyrogenic status ( |
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