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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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Bencox Mirabo Cup System of Benox Total Hip System is intended for Cementless use in partial or total hip arthroplasty in primary or revision surgery for the following conditions:

a. Non-inflammatory degenerative joint disease, such as avascular necrosis, osteoarthritis, traumatic arthritis

b. Inflammatory degenerative joint disease, such as rheumatoid arthritis

c. Treatment of non-union, femoral neck fracture and trochantric fractures of the proximal femur with head involvement, unmanageable using other techniques

d. Patients with failed previous surgery where pain, deformity, or dysfunction persists

e. Revision of previously failed total hip arthroplasty

The Bencox Mirabo Cup System is a Cementless hip acetabular system (Metal on Poly Liner or Ceramic on Poly Liner) for hip arthroplasty. This submission consists of the following components:

• Acetabular Cup Bencox Mirabo Cup
• Acetabular Liner Bencox Mirabo PE Liner

Acetabular Cup: Bencox Mirabo Cup
The Bencox Mirabo Cup Spec. Inclusion is similar to Bencox Mirabo Cup cleared under K162127 & K120924 with respect to material - Titanium alloy (ASTM F136), coating with pure Titanium powder (ASTM F1580), design, locking system, manufacturing, packaging and sterilization. This submission is only for the inclusion of specification of acetabular cups with external diameter 44 mm.

Acetabular Liner: Bencox Mirabo PE Liner
The Bencox Mirabo PE Liner specification inclusion is similar to Bencox Mirabo PE Liner cleared under K162127 & K150007, with respect to material, conforming to ASTM F648, Type 2 (GUR 1050), and irradiated with average dose of 10.0 Mrad of gamma radiation, design, locking system, manufacturing, packaging and sterilization. This submission is only for the inclusion of specification of Liners with head size, 28/35 & 32/39 mm.

Bencox Hip Replacement System Instrumentation (Non Sterile)
Bencox Hip Replacement System Instrumentation is a set of accessories to be used with Bencox Hip Implants. The parts of the instruments are made of stainless steel and/or polymers and/or silicon and cleared for use in previous premarket notifications of Corentec. Bencox Hip System Instrumentation to be used with Bencox Mirabo Cup System is same with Instrumentation cleared under K162127 and K150007 & K120924 along with the inclusion of instruments specific to Bencox Mirabo Cup System components included in this submission.

This document is a 510(k) summary for the Bencox Mirabo Cup System, a hip acetabular system. The information provided outlines the system's specifications, indications for use, and a summary of performance testing to demonstrate substantial equivalence to predicate devices. However, it does not describe any acceptance criteria for "device performance" in terms of clinical outcomes or human-in-the-loop performance. Instead, it focuses on laboratory testing to ensure the device materials and design meet established engineering standards for orthopedic implants.

Therefore, many of the requested sections (acceptance criteria related to clinical performance, clinical study details, expert input, MRMC studies, standalone algorithm performance, and training set details) cannot be extracted from this document as it is focused on a medical device clearance based on substantial equivalence through material and mechanical testing, not a digital health or AI-based device's diagnostic performance.

Based on the provided text, here is what can be extracted:

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

Note: The document explicitly states "The results of this testing/analysis showed that the subject devices are expected to be safe and effective for the proposed indications and are substantially equivalent to the predicate devices." This implies that the device met the acceptance criteria defined by these standards, even if specific numerical thresholds aren't provided in this summary.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This information is not provided in the document. The document refers to "testing protocols" and "series of testing," which are typically laboratory-based mechanical and material tests for medical implants. These do not usually involve "test sets" in the same way clinical or AI performance studies do.

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 information is not provided and is not applicable to the type of testing described (mechanical and material performance of an orthopedic implant).

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

This information is not provided and is not applicable to the type of testing described.

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 is not applicable as the device described is a hip arthroplasty system, not an AI-based diagnostic tool or system that involves human readers.

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

This is not applicable as the device described is a hip arthroplasty system, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

For the performance data, the "ground truth" is established by adherence to recognized international and ASTM standards (e.g., ISO 14242-1, ASTM F1820, ISO 11137-1). For a medical implant, this means that the materials behave as expected under specified mechanical loads, wear conditions, and sterilization processes, demonstrating substantial equivalence to previously cleared devices.

8. The sample size for the training set

This information is not provided and is not applicable to the type of testing described (mechanical and material performance of an orthopedic implant), which does not involve a "training set" in the context of machine learning.

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

This information is not provided and is not applicable.

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