(198 days)
Intended Use The OR3O Dual Mobility System is intended for use in primary and revision total hip arthroplasty in skeletally mature patients.
Indications
- · Advanced degeneration of the hip joint as a result of degenerative, post-traumatic, or rheumatoid arthritis.
- · Fracture or avascular necrosis of the femoral head.
· Failure of previous hip surgery: joint reconstruction, arthrodesis, hemiarthroplasty, surface replacement arthroplasty, or total hip replacement.
- · All forms of osteoarthritis.
- · Patients with hips at risk of dislocation.
- · Femoral neck fracture or proximal hip joint fracture.
The OR30 Dual Mobility System is intended for single use only. The modular OR30 Liners and Inserts are to be implanted without bone cement.
Mating components may be indicated for use without bone cement.
The OR30 Hip System is a modular dual mobility implant system. The system consists of diffusion hardened, oxidized zirconium alloy liners with a highly polished inner surface of zirconia and a machined locking taper and backside of Zr-2.5Nb alloy. The locking taper and machined outside profile is designed to mate with a dedicated Ti 6Al 4V R3 or REDAPT Modular Press-fit acetabular shell with OD sizes 48mm to 74mm. For each assembled OR30 Liner and R3 and REDAPT Modular Shell size from 48mm to 74mm, a dedicated plastic insert made of highly crosslinked ultrahigh-molecular-weight polyethylene (10Mrad irradiated and remelt-annealed UHMWPE (XLPE) according to ISO 5834-2/ASTM F648) is available. These can be combined with oxidized zirconium or CoCr alloy femoral heads of sizes 22mm (for size 48mm-52mm) and 28mm (for size 54mm-74mm). The final OR30 Dual Mobility construct will include an acetabular shell, an OXINIUM DH Liner, an XLPE Insert and a femoral head.
The purpose of this 510(k) submission is to add additional options of dual mobility implants to the Smith & Nephew collection of hip implants.
This document is a 510(k) premarket notification for a medical device, the OR30 Dual Mobility System, and focuses on demonstrating substantial equivalence to previously cleared devices. It does not contain information about acceptance criteria and study data for a diagnostic device in the usual sense (e.g., performance metrics like sensitivity, specificity, or AUC). Instead, the performance data provided is for biocompatibility and mechanical testing of the implantable device.
Therefore, many of the requested categories for a diagnostic device's acceptance criteria and study data (such as sample size for test sets, data provenance, number of experts for ground truth, adjudication methods, MRMC studies, standalone performance, training set details) are not applicable to the information provided in this 510(k) summary.
I will interpret the request within the context of the provided document, focusing on the "acceptance criteria" for the mechanical testing of the OR30 Dual Mobility System, as this is the closest equivalent to performance evaluation in this type of submission.
Here's the information based on the document:
1. Table of Acceptance Criteria and Reported Device Performance
| Performance Metric (Mechanical Testing) | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Push Out Testing | Pre-determined acceptance criteria (not explicitly defined in document) | Met pre-determined acceptance criteria |
| Torque to Failure Testing | Pre-determined acceptance criteria (not explicitly defined in document) | Met pre-determined acceptance criteria |
| Lever-Out Testing | Pre-determined acceptance criteria (not explicitly defined in document) | Met pre-determined acceptance criteria |
| Environmental Fatigue Testing | Pre-determined acceptance criteria (not explicitly defined in document) | Met pre-determined acceptance criteria |
| Deformation Testing | Pre-determined acceptance criteria (not explicitly defined in document) | Met pre-determined acceptance criteria |
| Wear Testing | Pre-determined acceptance criteria (not explicitly defined in document) | Met pre-determined acceptance criteria |
| Pull-Out Testing | Pre-determined acceptance criteria (not explicitly defined in document) | Met pre-determined acceptance criteria |
| Neck Impingement Testing | Pre-determined acceptance criteria (not explicitly defined in document) | Met pre-determined acceptance criteria |
| Range of Motion | Pre-determined acceptance criteria (not explicitly defined in document) | Met pre-determined acceptance criteria |
| Jump Distance | Pre-determined acceptance criteria (not explicitly defined in document) | Met pre-determined acceptance criteria |
| Biocompatibility | In accordance with FDA's Draft Guidance for ISO-10993 | Report evaluation completed and rationales provided |
| Non-Pyrogenicity Endotoxin Testing | Met acceptable endotoxin limits per FDA Guidance and ANSI/AAMI ST72 | Met acceptable endotoxin limits |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- The document does not specify sample sizes for any of the mechanical or biocompatibility tests.
- Data provenance is not mentioned. It can be inferred that testing was conducted as part of the device development and submission process, likely by the manufacturer or a contracted lab. This is industrial testing, not clinical data collection.
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. This is a physical device intended to be implanted. "Ground truth" for mechanical testing is based on engineering specifications and adherence to standards, not expert clinical interpretation of data.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable, as this refers to clinical evaluation and consensus building for diagnostic accuracy, which is not part of this submission.
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 a physical implantable device, not a diagnostic AI system or a system requiring human interpretation.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This is a physical implantable device, not an algorithm.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
- For mechanical testing: The "ground truth" or reference for performance is established by pre-determined acceptance criteria based on engineering standards (e.g., ASTM, ISO), regulatory guidelines, and comparison to predicate devices, ensuring the device meets safety and performance requirements for its intended use. The document states the device "met the pre-determined acceptance criteria for each intended output."
- For biocompatibility: Ground truth is adherence to international standards like ISO-10993.
- For non-pyrogenicity: Ground truth is adherence to established endotoxin limits in FDA Guidance and ANSI/AAMI ST72.
8. The sample size for the training set
- Not applicable. This is a physical implantable device; there is no "training set" in the context of machine learning or diagnostic device development.
9. How the ground truth for the training set was established
- Not applicable, as there is no training set mentioned in this context.
§ 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.