(240 days)
The COREN® Total Hip System is intended for use in total or partial hip arthroplasty and in primary or revision surgery for the following conditions:
- Non-inflammatory degenerative joint disease, such as avascular necrosis, osteoarthritis, a. traumatic arthritis
- b. Inflammatory degenerative joint disease, such as rheumatoid arthritis
- Treatment of non-union, femoral neck fracture, and trochanteric fractures of the proximal c. femur with head involvement, unmanageable using other techniques
- d. Patients with failed previous surgery where pain, deformity, or dysfunction persists
- Revision of previously failed total hip arthroplasty. e.
The COREN Total Hip System is a cementless, metal-on-polyethylene hip system for hip arthroplasty. It consists of the following components: Femoral stem - Modified BL Coren Stem; Femoral head - Coren Metal Head; Acetabular system - Coren U Cup, Coren PE Insert and Coren Bone Screw; and Coren THR Instrumentation. The components are manufactured from the following materials: Ti-6A1-4V alloy conforming to ASTM F136 Standard Specification for Wrought Titanium-6 Aluminum-4 Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant Applications (UNS R56401); Co-Cr-Mo alloy conforming to ASTM F1537 Standard Specification for Wrought Cobalt-28-Chromium-6-Molybdenum Allovs for Surgical Implants (UNS R31537, UNS R31538, and UNS R31539); and ultra-high molecular weight polyethylene conforming to ASTM F648 Standard Specification for Ultra-High-Molecular-Weight Polyethylene Powder and Fabricated Form for Surgical Implants. COREN Total Hip System components are sterilized by gamma irradiation or ethylene oxide.
This 510(k) summary for the COREN® Total Hip System does not contain the acceptance criteria or a study demonstrating the device meets such criteria in the way typically expected for an AI/ML powered device.
Instead, this document describes a traditional medical device (a total hip system) and focuses on demonstrating substantial equivalence to existing legally marketed predicate devices through material comparisons, design similarities, and performance testing against recognized standards.
Here's a breakdown based on your requested information, highlighting where the information is present and where it is not applicable or unavailable in this type of submission:
Acceptance Criteria and Device Performance for COREN® Total Hip System
Given this is a 510(k) submission for a traditional implantable medical device (Total Hip System) and not an AI/ML powered device, the concept of "acceptance criteria" and "device performance" in the context of sensitivity, specificity, accuracy, etc., as one would expect for an AI algorithm's diagnostic or predictive capabilities, is not applicable here.
Instead, acceptance criteria relate to meeting specific engineering and materials standards to ensure safety and effectiveness comparable to predicate devices. The "performance" is demonstrated through adherence to these standards.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (from Standards Applied) | Reported Device Performance (Summary from Submission) |
|---|---|
| Material Specifications: Adherence to ASTM F136 (Ti-6A1-4V ELI), ASTM F1537 (Co-Cr-Mo alloy), ASTM F648 (UHMWPE) | Components manufactured from specified materials: Ti-6A1-4V alloy, Co-Cr-Mo alloy, and ultra-high molecular weight polyethylene, all conforming to respective ASTM standards. |
| Mechanical Performance Standards (Examples): |
- ISO 7206-4 (Fatigue test for stemmed femoral components)
- ISO 7206-8 (Endurance performance of stemmed femoral components)
- ASTM F543 (Test methods for metallic medical bone screws)
- ISO 14242-1, ISO 14242-2 (Wear of hip joint prostheses)
- ASTM F1820 (Porosity of coatings)
- ISO 7206-10 (Static and dynamic tests of UHMWPE inserts)
- ISO 7206-9 (Endurance performance of acetabular components)
- ISO 7206-2 (Static and dynamic tests of acetabular components)
- ASTM D638 (Tensile properties of plastics)
- ASTM F2183 (Test method for assessing attachment of porous coatings)
- ASTM F2214 (Pore size distribution)
- ASTM F2381 (Hydrodynamic wear of total hip prostheses)
- ASTM F1160 (Shear testing)
- ASTM F1044 (Scratch hardness)
- ASTM F1147 (Fatigue testing)
- ASTM F1978 (Test method for measuring attachment strength)
- ASTM F2582 (Oxidation of UHMWPE) | Performance testing was conducted to demonstrate substantial equivalence and included methods described in the numerous listed ISO and ASTM standards. Specific results are not detailed but the FDA's clearance implies these standards were met.
- Attachment strength between UHMWPE liner and acetabular shell was tested by measuring torque out and lever out strengths.
- Residual free radical content in crosslinked UHMWPE was assessed by electron spin resonance (ESR). |
| Biocompatibility/Sterilization: ISO 10993-7 (Ethylene oxide sterilization residuals) | Device components are sterilized by gamma irradiation or ethylene oxide. Implied compliance with ISO 10993-7 for ETO sterilization. |
| Design Principles: Similarities in geometry, sizes, surface finishes, neck angles, porous coatings, internal taper mechanisms, modularity. | The submission details extensive similarities in design principles, materials, manufacturing processes, and component features (e.g., grit-blasted surface finish, neck angles, plasma-sprayed porous coatings, UHMWPE cross-linked material, tapered interfaces) to several predicate devices. |
Summary of the Study:
The study proving the device meets the acceptance criteria is a series of engineering and materials performance tests conducted in accordance with a comprehensive list of international and national standards relevant to orthopedic implants. This type of submission relies on demonstrating that the new device performs at least as well as, and is as safe and effective as, legally marketed predicate devices by conforming to established engineering and material specifications.
Detailed Responses to Specific Questions:
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size: Not explicitly stated as a "sample size" in the context of patient data. The "sample size" here refers to the number of test articles (implants, materials) subjected to various engineering and mechanical tests. The specific number of test articles for each standard would be defined by the standard itself or the internal test protocols, but it's not detailed in the 510(k) summary.
- Data Provenance: The tests are laboratory-based engineering and material tests, not clinical data from patients. The data would originate from Corentec Co., Ltd. or its contracted testing laboratories, likely in South Korea or other countries where such testing houses are located. These are prospective tests performed on newly manufactured 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)
- This question is not applicable to this type of device submission. No "ground truth" based on expert clinical assessment (like radiologists) is established here. The "ground truth" is defined by the technical specifications and performance limits set by the international and national standards (e.g., ISO, ASTM). The "experts" involved would be engineers, materials scientists, and quality assurance personnel performing and interpreting the results of these technical tests against the defined standards.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- This question is not applicable. Adjudication methods like 2+1 or 3+1 are used in clinical studies or image interpretation where human experts evaluate patient data to establish a consensus "ground truth." For engineering performance testing, conformance to the specified standard is objectively measured and evaluated.
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
- This question is not applicable. MRMC studies are relevant for AI/ML-driven diagnostic or image analysis tools that assist human readers. This device is a physical orthopedic implant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- This question is not applicable. This device is a physical orthopedic implant, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- The "ground truth" in this context is adherence to established engineering, material, and biocompatibility standards (e.g., ISO 7206 series, ASTM F136, ASTM F1537, ASTM F648, ASTM F10993 series). The device's performance is compared against the requirements and specifications within these standards and against the characteristics of the predicate devices.
8. The sample size for the training set
- This question is not applicable. There is no "training set" in the context of an AI/ML algorithm for this physical implant. The design of the COREN® Total Hip System would have been informed by established orthopedic design principles, clinical experience with similar implants (predicate devices), and engineering knowledge, rather than a data training set.
9. How the ground truth for the training set was established
- This question is not applicable as there is no training set for an AI/ML algorithm. The "ground truth" for the design and manufacturing of the hip system is based on the long-standing understanding of orthopedic biomechanics, material science, clinical outcomes of existing hip implants, and the regulatory requirements outlined in the various ISO and ASTM standards.
§ 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.