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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:

1. Non-inflammatory degenerative joint disease including osteoarthritis, traumatic arthritis, and avascular necrosis.
2. Rheumatoid arthritis.
3. Correction of functional deformity.
4. Treatment of non-union, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement, unmanageable using other techniques.
5. Revision of previously failed total hip arthroplasty.
6. Dislocation risks.

The ONVOY Acetabular System is used in conjunction with Globus/StelKast Hip Systems. The acetabular components of this hip system are intended for cementless fixation.

The ONVOY™ additional implants consist of acetabular shells, liners, and dual mobility liners and bearings that are used as part of a complete total hip system in conjunction with a femoral head and femoral stem in total hip arthroplasty. New femoral head sizes are also being introduced. 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, non-hooded, and lateralized designs used in conjunction with ONVOY shells. Dual mobility polyethylene bearings are used with dual mobility liners.

ONVOY™ acetabular shells are additively manufactured from titanium alloy powder per ASTM F3001. Acetabular liners and dual mobility bearings are manufactured from highly crosslinked ultra-high molecular weight polyethylene (UHMWPE) with Vitamin E. Dual mobility liners are manufactured from Cobalt Chrome (CoCr) alloy and femoral heads are manufactured from alumina matrix composite ceramic.

This document is an FDA 510(k) clearance letter for a medical device called the "ONVOY™ Acetabular System." It details the device's purpose, indications for use, and the basis for its substantial equivalence to other legally marketed devices.

However, it does not contain information about acceptance criteria and a study proving a device meets those criteria for an AI/Software as a Medical Device (SaMD).

This clearance is for an orthopedic implant (hip prosthesis components: acetabular shells, liners, dual mobility implants, and femoral heads), not a software device or an AI application. Therefore, the questions related to MRMC studies, ground truth establishment, training sets, and expert adjudication are not applicable to the content provided in this FDA 510(k) letter.

The "Performance Data" section solely refers to mechanical and material testing standards relevant to orthopedic implants (fatigue, wear, range of motion, material composition, etc.) and states that "Performance data demonstrate substantial equivalence to the predicate devices." It does not describe any clinical study involving human readers or AI performance metrics.

In summary, based on the provided text, I cannot describe acceptance criteria and a study that proves a device meets those criteria, as the document pertains to an orthopedic implant and not an AI/SaMD.

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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:

1. Non-inflammatory degenerative joint disease including osteoarthritis, and avascular necrosis,
2. Rheumatoid arthritis.
3. Correction of functional deformity.
4. Treatment of non-union, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement, unmanageable using other techniques.
5. 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:

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).

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