(298 days)
The ONVOY™ Acetabular System is intended for use in reconstruction of the articulating surface of the acetabular portion of the hip that is severely disabled and/or very painful resulting from:
- Non-inflammatory degenerative joint disease including osteoarthritis, and avascular necrosis,
- Rheumatoid arthritis.
- Correction of functional deformity.
- Treatment of non-union, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement, unmanageable using other techniques.
- Revision of previously failed total hip arthroplasty.
The ONVOY™ Acetabular System is used in conjunction with Globus/Stelkast hip systems. The acetabular components of this system are intended for cementless fixation.
The ONVOY™ Acetabular System consists of shells, liners, and bone screws that are used as part of a complete total hip system in conjunction with a femoral head and femoral stem in total hip arthroplasty. Implants are available in various configurations and sizes to fit a wide variety of patient anatomy. Shells are available in a cluster hole design, liners are available in hooded and non-hooded designs used in conjunction with the shells, and bone screws provide additional fixation when inserted through the shell.
ONVOY™ acetabular shells are manufactured from titanium alloy, with a commercially pure titanium vacuum sintered coating. The liners are manufactured from ultra-high molecular weight polyethylene (UHMWPE) with Vitamin E. Bone screws are manufactured from titanium alloy.
This document is a 510(k) premarket notification from the FDA for a medical device called the ONVOY™ Acetabular System. A 510(k) submission is for demonstrating that a medical device is substantially equivalent to a legally marketed predicate device, not for proving that a device meets specific performance criteria beyond substantial equivalence. Therefore, the information typically requested in your prompt regarding acceptance criteria, specific studies to prove criteria, sample sizes, expert ground truth, adjudication methods, MRMC studies, standalone performance, and training data is not part of this type of regulatory submission.
This document confirms substantial equivalence through:
- Indications for Use: The ONVOY™ Acetabular System has the same intended use as its predicate devices, which is for reconstructing the articulating surface of the acetabular portion of the hip in cases of non-inflammatory degenerative joint disease, rheumatoid arthritis, functional deformity, certain fractures, and revision of failed hip arthroplasty. It is used with Globus/StelKast hip systems and intended for cementless fixation.
- Technological Characteristics: The subject implants possess the same technological characteristics as the predicate devices, including design, material composition (titanium alloy shells with commercially pure titanium vacuum sintered coating, UHMWPE liners with Vitamin E, and titanium alloy bone screws), and range of sizes.
- Performance Data (Mechanical Testing): Mechanical testing was conducted in accordance with several ASTM and ISO standards (F1820, F2582, ISO 7206-12, F543, F3090, ISO 21535). These tests cover aspects like push-out, torque-out disassembly, impingement, deformation, screw testing, shell fatigue, and range of motion. The results of these tests "demonstrate substantial equivalence to the predicate devices."
- Bacterial Endotoxin Testing (BET): BET was conducted in accordance with ANSI/AAMI ST-72:2011.
Therefore, it's not possible to provide the specific details you requested because a 510(k) summary focuses on demonstrating substantial equivalence to existing devices, rather than establishing and meeting novel acceptance criteria through independent performance studies. The document indicates that the performance data shows substantial equivalence, which is the "acceptance criteria" for a 510(k) submission itself.
Here's a breakdown based on the information provided and what is not provided in a 510(k) summary:
| Information Requested | Provided in Document? | Details from Document |
|---|---|---|
| 1. Table of Acceptance Criteria & Reported Device Performance | No* | The document states that "Performance data demonstrate substantial equivalence to the predicate devices." For a 510(k), demonstrating substantial equivalence is the acceptance criterion. Specific quantitative thresholds for various performance metrics would be assessed against the predicate device's established performance or relevant standards (e.g., ASTM/ISO). The document lists the types of mechanical tests performed (push-out, torque-out disassembly, impingement, deformation, screw testing, shell fatigue, range of motion) and standards (ASTM F1820, ASTM F2582, ISO 7206-12, ASTM F543, ASTM F3090, and ISO 21535), as well as Bacterial Endotoxin Testing (ANSI/AAMI ST-72:2011). However, the specific quantitative results of these tests and the precise acceptance criteria used to deem them "substantially equivalent" are not provided in this summary. |
| 2. Sample Size for Test Set & Data Provenance | No | Not specified in a 510(k) summary. These details would be in the full submission, but generally pertain to engineering tests, not clinical data for an AI/diagnostic device. |
| 3. Number of Experts & Qualifications for Ground Truth for Test Set | Not Applicable | This is a mechanical orthopedic device, not an AI/diagnostic device requiring expert interpretation of images or signals for ground truth. |
| 4. Adjudication Method for Test Set | Not Applicable | This is a mechanical orthopedic device, not an AI/diagnostic device. |
| 5. MRMC Comparative Effectiveness Study & Effect Size (Human + AI vs. Human only) | No | Not applicable. This is a medical device (hip prosthesis) and not an AI-assisted diagnostic or decision support tool. |
| 6. Standalone Performance Done (Algorithm Only) | No | Not applicable. This is a medical device (hip prosthesis), not an algorithm. |
| 7. Type of Ground Truth Used | Not Applicable | "Ground truth" in the context of this device would be established by physical measurements and test results according to specified standards, not typically by expert consensus or pathology in the way an AI diagnostic device would. |
| 8. Sample Size for Training Set | No | Not applicable. This is a mechanical device, not an AI/ML algorithm that requires a training set. |
| 9. How Ground Truth for Training Set Was Established | No | Not applicable. |
In summary, this document is a regulatory approval notice based on demonstrating substantial equivalence to existing predicate devices through comprehensive mechanical and material testing, rather than presenting a study against novel, pre-defined acceptance criteria for a new type of performance claim (like an AI model's accuracy).
§ 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.