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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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The Biocore9 Femoral Resurfacing Head Component, is indicated for the treatment of painful hip arthritis due to post-traumatic arthritis, or rheumatoid arthritis, as well as painful hip arthroplasty when sufficient femoral head and neck stock exist to stabilize a resurfacing femoral head. The Biocore9 Femoral Resurfacing Head Component is intended for cemented use only. This device is intended for hemi-arthroplasty only.

The Biocore9 Femoral Resurfacing Head component is a non-constrained orthopedic implant intended to replace the articular surface of the existing femoral head in the patient's hip joint. The Biocore9 Femoral Resurfacing Head Component is intended for in the reconstruction of painful and/or severely disabled hip joints resulting from osteoarthritis, rheumatoid arthritis, traumatic arthritis, avascular necrosis, or previously failed prosthesis. Sufficient bone stock on the femoral head and neck is necessary to stabilize a resurfacing femoral component. This device is intended for cemented use only. Components are available in thirteen sizes with available outside diameters 39.5, 41, 42.5, 47, 49, 51, and 52.5 mm.

The Biocore9 Femoral Resurfacing Head Component is manufactured from Ti-6Al-4V alloy (ASTM F136-13) with a Titanium Nitride (TiN) thin film ceramic coating. The titanium nitride coating is an inert, highly adherent, near diamond-hard surface coating.

The Femoral Resurfacing component is axisymmetric with a truncated spherical shell and a tapered central alignment stem. The component consists of a thin-walled spherical shell. The internal surface of the spherical shell is covered with a porous coating consisting of titanium beads. The stem is not porous coated.

This document describes a medical device, the Biocore9 Femoral Resurfacing Head Component, and its substantial equivalence to a predicate device. However, the provided text does not contain information about acceptance criteria or a study proving the device meets those criteria in the context of an AI/ML powered device.

The information provided pertains to the regulatory clearance of a physical medical implant, specifically a hip joint femoral resurfacing prosthesis. The performance testing mentioned (TiN coating characterization, porous coating characterization, wear testing, abrasion resistance, and fatigue testing) are typical for mechanical implants to demonstrate material properties and durability, not for evaluating the performance of an AI/ML algorithm.

Therefore, I cannot answer your request regarding:

1. A table of acceptance criteria and the reported device performance (for an AI/ML device).
2. Sample size used for the test set and data provenance.
3. Number of experts used to establish ground truth and their qualifications.
4. Adjudication method for the test set.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done.
6. If a standalone (algorithm only) performance was done.
7. The type of ground truth used.
8. The sample size for the training set.
9. How the ground truth for the training set was established.

This document is about a Class II medical device (orthopedic implant) that is cleared based on demonstrating substantial equivalence to a predicate device through material and mechanical testing, not through clinical or AI/ML performance evaluation.

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The Biocore9 Humeral Head Resurfacing Shoulder Component is intended for the reconstruction of painful and/or severely disabled shoulder joints resulting from osteoarthritis. For proper function of this device, the humeral head and neck must be of sufficient bone stock to support the loads on it. Also, the presence of an intact or reconstructable rotator cuff is important for proper functioning and dislocation resistance. Porous-coated components are intended for cemented use only. This device is indicated for hemi-arthroplasty only.

The Biocore9 Humeral Head Resurfacing Shoulder Component is intended for the reconstruction of painful and/or severely disabled shoulder ioints resulting from osteoarthritis and rheumatoid arthritis. For proper function of this device, the humeral head and neck must be of sufficient bone stock to support the loads on it. Also, the presence of an intact or reconstructable rotator cuff is important for proper functioning and dislocation resistance. Porous-coated components are intended for cemented use only. This device is indicated for hemi-arthroplasty only.

The Biocore9 Humeral Head Resurfacing component is a non-constrained orthopedic implant intended to replace the articular surface of the existing humeral head in the patient's shoulder joint. It is intended for the reconstruction of painful and or severely disabled shoulder joints resulting from osteoarthritis or rheumatoid arthritis for patients who would be candidates for total shoulder procedure, whose proximal humerus has not been excessively damaged by disease or trauma and where damage is primarily associated with the articular surface of the humeral head. It is primarily intended to articulate with intact, natural, glenoid. Components are available in five sizes with available outside diameters from 40 mm to 56 mm in 4 mm increments.

The Biocore9 Humeral Resurfacing Head Component is manufactured from Ti-6Al-4V alloy (ASTM F136-13) with a Titanium Nitride (TiN) thin film ceramic coating. The Humeral Resurfacing component is axisymmetric with a truncated shell and a tapered central stem. The component consists of a thin walled spherical shell. The Humeral resurfacing Component's rim is anatomical with a rounded relief. The exterior of the spherical surface is intended to articulate with the Glenoid.

The internal surface of the spherical shell is covered with a porous coating consisting of titanium beads. The stem is not porous coated.

This document describes the Biocore9 Humeral Resurfacing System, a medical device. However, it does not contain information about studies proving the device meets acceptance criteria related to a machine learning or AI model's performance. The sections detailing "Non-Clinical Performance Testing" relate to the physical properties and performance of the implant itself (e.g., tensile strength, wear resistance), not the evaluation of an AI model's output.

Therefore, I cannot provide the requested information about acceptance criteria and study details for an AI/ML device per your prompt. The provided text describes a traditional medical device (a prosthetic humeral head) and its materials, design, intended use, and non-clinical engineering performance testing for substantial equivalence to a predicate device.

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