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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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1. Painful hip arthritis refractory to medical management resulting from post-traumatic arthritis, osteoarthritis, or rheumatoid arthritis.

2. Painful femoral head. cup arthroplasty, or bi-polar or universal type femoral head replacement.

3. Cases where more conventional arthroplasty techniques or arthrodesis are contraindicated because of a difficult clinical management problem, age, sex, occupation, or height of the patient

The Biocore9 Acetabular Cup System components are intended for use in total hip arthroplasty in primary or revision surgery of skeletally mature patients. The Biocore9 Acetabular Cup System shells and liners are single use implants intended for cemented or cementless arthroplasty.

The subject Biocore9 Acetabular Cup System includes acetabular shells, liners, and acetabular bone screws. Components are intended to replace the articular surface of the acetabular socket in the patient's hip joint. It is intended for the reconstruction of painful and/or severely disabled hip joints resulting from osteoarthritis or rheumatoid arthritis for patients who would be candidates for total hip procedure, whose acetabular socket has not been excessively damaged by disease or trauma and where damage is primarily associated with the articular surface damage. Acetabular components are available in nine sizes with available outside diameters from 50 mm to 66 mm in 2 mm increments. Bearing components are available in fourteen sizes from 39 mm to 52 mm ID in 1 mm increments. Screw components are available in 6.5 mm diameter in five sizes from 15 mm to 50 mm lengths.

Biocore9 Cancellous Bone screws are manufactured from Ti6A14V alloy (ASTM F136) with low profile screw heads designed to fit the Acetabular shells with nominal diameter of 6.5 mm.

The acetabular shell components are manufactured from Ti-6A1-4V alloy (ASTM F136) with a single radius spherical outer geometry coated with three layers of Commercially Pure (CP)-Ti (ASTM F67) spherical bead porous coating allowing for cemented or cementless fixation and an anatomical shaped rim to limit impingement with the femoral side of the joint or the psoas muscle. A crescent peripheral groove provides for assembly interlock and three rim tabs provide anti rotational interlock with the bearing liner. The acetabular shells are available in two configurations: one with no screw holes and a second with five screw holes for supplemental bone screw fixation. All surfaces are coated with Titanium Nitride (TiN) thin film ceramic coating. Porous structured acetabular shells are intended for cemented fixation.

The acetabular cup bearing liner components are manufactured from UHMWPe (ASTM F648), GUR 1020 Highly cross linked UHMWPe (75KGy MRad /post irradiation annealed) which locks into the acetabular cup shell with ten flexible lip tabs and has three rotation resisting tabs. The liners have inner diameters (ID) intended for use with modular, unipolar, self-centering (bipolar), metallic or ceramic femoral heads within the 39-52 mm OD range and articulate with a femoral head of an appropriate corresponding diameter.

The components of the subject device are compatible with the BioPro PSL Hip System femoral head and stems.

The 510k numbers for the compatible BioPro devices are listed below:

• BioPro PC Femoral Hip Component (K882146), O
• O BioPro Hemi-Endo Modular Head (K895886),
• BioPro Ziralloy Modular Femoral Head (K912641 & K925682), O
• BioPro PSL Total Hip Replacement System (K922500), O
• BioPro Hemi-Endo Modular Ceramic Head (K954768), O
• BioPro BiPolar Head (K100761) O

This document is a 510(k) premarket notification for a medical device called the "Biocore9 Acetabular Cup System." As such, it does not contain the type of detailed study data and acceptance criteria information (such as AI model performance, expert ground truth establishment, or mMRMC studies) that would be found in a submission for an AI-powered device or diagnostic tool.

The document primarily focuses on demonstrating substantial equivalence to predicate devices through non-clinical performance testing of the physical components (e.g., material strength, wear simulation, screw testing). It does not describe an AI/ML component or a study to prove AI model performance.

Therefore, I cannot provide the requested information regarding acceptance criteria and a study proving the device meets those criteria in the context of an AI/ML device, as those details are not present in the provided text.

The information provided is relevant to the safety and effectiveness of the physical hip implant components, not to the performance of an algorithm or AI model.

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Exeter X3 RimFit Cup: The indications for use for total hip arthroplasty include: Painful, disabling joint disease of the hip resulting from: degenerative arthritis, post-traumatic arthritis or late stage avascular necrosis. Revision of previous unsuccessful femoral head replacement, cup arthroplasty or other procedure. Clinical management problems where arthrodesis or alternative techniques are less likely to achieve satisfactory results. Where bone stock is of poor quality or madequate for other reconstructive techniques, such as cementless fixation, as indicated by deficiencies of the acetabulum. The Exeter X3 RimFit Cup is intended for cemented use only.

Exeter V40 Femoral Stem: The indications for use for total and hemi hip arthroplasty include: noninflammatory degenerative joint disease including osteoarthritis and avascular necrosis; rheumatoid arthritis; correction of functional deformity; revision procedures where other treatments or devices have failed; and, treatment of nonunion, femoral neck and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques. The Exeter V40 Femoral Stem is intended for use in total or hemi hip replacement. It is intended for cemented use only.

The subject Exeter X3 RimFit Cup sterilized by ethylene oxide (EtO) is referred to throughout this submission as the Exeter X3-EtO RimFit Cup. The subject Exeter X3-EtO RimFit Cup is a modified version of the predicate Exeter X3 RimFit Cup and features an alternate terminal sterilization method with EtO, an additional polyethylene resin consolidation method (conventional method which meets the specifications of ASTM F648), an alternate cement spacer material in Acrylic Resin Colacryl® TS2270 PMMA, minor dimensional changes related to flange diameter and blow hole locations, and newly introduced Magnetic Resonance (MR) Conditional labeling. The geometry and design of the subject Exeter X3-EtO RimFit Cup is similar to the predicate Exeter X3 RimFit Cup. There are minor modifications to the flange diameter and blow hole locations between the subject Exeter X3-EtO RimFit Cup and predicate Exeter X3 RimFit Cup. The alternate terminal sterilization method and polyethylene resin consolidation method were previously cleared for Stryker Orthopaedics knee devices in K173849 and Stryker Orthopaedics hip devices in K182468. The alternate cement spacer material was previously cleared in K191414. The MR Conditional labeling was previously cleared in K171768.

The subject Exeter X3 RimFit Cup sterilized via gas plasma (GP) is referred to throughout this submission as the Exeter X3-GP RimFit Cup and has device designs identical to the predicate Exeter X3 RimFit Cup in terms of design and geometry. In comparison to the predicate Exeter X3 RimFit Cup, the only change to the subject Exeter X3-GP RimFit Cup is that the labeling is updated to add MR Conditional information. The MR Conditional language was previously cleared in K171768.

The subject Exeter V40 Femoral Stem is a modified version of the predicate Exeter V40 Femoral Stem in that the stem component is packaged with two polymethyl methacrylate (PMMA) centralizers that are manufactured from an alternate PMMA material (Acrylic Resin Colacryl® TS2270 PMMA). The alternate PMMA material was previously cleared in K191414. The subject device is identical to the predicate device in terms of design and geometry. The labeling for the subject device maintain the MR Conditional designation that was previously cleared in K171768 and K174399 (certain sizes of Exeter V40 Femoral Stem only).

This document, K193429, is a 510(k) premarket notification for hip replacement devices (Exeter V40 Femoral Stem, Exeter X3 RimFit Cup). It does not describe an AI/ML powered device or a study involving human readers or expert ground truth establishment for a diagnostic output. Instead, it focuses on demonstrating substantial equivalence of modified conventional medical devices to legally marketed predicate devices through non-clinical bench testing, material testing, biocompatibility evaluation, sterilization validation, and MRI compatibility analysis.

Therefore, many of the requested criteria related to AI/ML device performance, reader studies, and ground truth establishment are not applicable.

Here's an attempt to address the applicable parts of your request based on the provided document:

1. A table of acceptance criteria and the reported device performance:

The document outlines non-clinical testing to demonstrate substantial equivalence, rather than a clinical performance study with acceptance criteria for a diagnostic output. The "acceptance criteria" here are implicitly tied to the successful completion and positive results of the listed non-clinical tests, demonstrating the modified devices meet established standards and are safe and effective.

2. Sample sizes used for the test set and the data provenance:

• Test Set Sample Sizes: The document does not specify exact sample sizes for each non-clinical test (e.g., how many material samples were tested, how many centralizers). This level of detail is typically found in the full test reports referenced by these summaries.
• Data Provenance: The data provenance is from non-clinical laboratory testing conducted by the manufacturer (Stryker Orthopaedics/Howmedica Osteonics Corp). The document doesn't specify the country of origin for the data, but the company is based in Mahwah, New Jersey, USA. All data would be prospective in the sense that these tests were conducted specifically for this submission.

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 a study requiring expert readers to establish ground truth for a diagnostic output. The "truth" in this context is determined by the physical, chemical, and mechanical properties of the device as measured by standardized engineering and material science tests.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

• Not Applicable. This is not a study involving human readers or subjective interpretations requiring adjudication.

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 document is for a conventional hip implant and does not involve AI/ML or comparative effectiveness studies with human readers.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

• Not Applicable. This document is for a conventional hip implant and does not involve an algorithm.

7. The type of ground truth used:

• The "ground truth" for the non-clinical tests is established by objective, quantitative measurements against recognized industry standards (e.g., ASTM, ISO) and FDA guidance documents. Examples include:
  • Material properties (e.g., tensile strength, wear rates)
  • Biocompatibility assessments (e.g., cytotoxicity, sensitization)
  • Sterilization effectiveness (e.g., sterility assurance level)
  • Mechanical performance (e.g., centralizer retention force)
  • MRI compatibility (e.g., induced heating, image artifact).

8. The sample size for the training set:

• Not Applicable. This is not an AI/ML product; therefore, there is no training set mentioned or implied.

9. How the ground truth for the training set was established:

• Not Applicable. As there is no training set for an AI/ML product, this question is not relevant.

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