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The Opulent TiNbN Coated Knee is indicated for the following:

· Severe knee joint pain, loss of mobility, and disability due to: rheumatoid arthritis, traumatic arthritis, and polyarthritis.

· Correction of functional deformities.

· Post-traumatic loss of knee join contcularly when there is patellofemoral erosion, dysfunction, and/or prior patellectomy.

• · Moderate valgus, varus, or flexion trauma.
• · Knee fractures untreatable by other methods.
• · Revision surgery where sufficient bone and soft tissue integrity are present.

The Opulent TiNbN Coated Knee is intended for cemented use only. This device is for single use only.

The Opulent TiNbN Coated Knee comprises of Femoral Component and Tibial Component as described below,

• Femoral Knee Component CR and PS (Left and Right) .
• . Tibial Component (Tibial Base Plate)

Each of these components is described below.

5.7.1 Femoral Component

The Femoral Component is fabricated from Cobalt-Chromium-Molybdenum (Co-Cr-Mo), coated with Titanium Niobium Nitride (TiNbN). The Femoral Component is available in two designs: Cruciate Retaining (CR) and Posterior Stabilized (PS). Each of these designs is further classified into Left and Right configurations. Each Left and Right configuration is available in eight different sizes (A to H) based on Anterior/Posterior (A/P) and Medial/Lateral (M/L) dimensions. Thus, a total of thirty two (32) models are available for the Femoral Component.

5.7.2 Tibial Component (Tibial Base Plate)

The Tibial Base Plate is fabricated from Cobalt-Chromium-Molybdenum coated with TiNbN. The tibial base plate is available in eight different sizes from 1 to 8 based on Anterior/Posterior (A/P) and Medial/Lateral (M/L) dimensions.

The provided text describes a medical device, the "Opulent TiNbN Coated Knee," and its submission for FDA clearance (K222816). However, the document does not contain information related to acceptance criteria, device performance metrics, sample sizes for test sets, data provenance, expert adjudication, MRMC studies, standalone performance, or ground truth establishment.

Instead, the document primarily focuses on:

• FDA Clearance Letter: Confirming the device's substantial equivalence to a predicate device.
• Indications for Use: Listing the medical conditions for which the device is intended.
• 510(k) Summary: Detailing the device information, predicate device comparison, manufacturing process, material, and non-clinical performance data (e.g., coating characteristics, wear resistance, biocompatibility testing).

The non-clinical performance data section lists the types of tests conducted (e.g., coating thickness, hardness, wear resistance, various biocompatibility tests), but does not provide specific acceptance criteria or the reported performance outcomes for these tests. Therefore, I cannot construct the requested table or answer the specific questions about acceptance criteria, study details, sample sizes, or ground truth.

The document states:
"The subject device was subjected to following non clinical performance testing to evaluate device function and mechanical performance." (Page 6)
and lists tests like "Coating characteristics of TiNbN Coating," "Wear resistance," and "Biocompatibility testing." While these indicate the areas of evaluation, they do not provide the results or the criteria for acceptance.

In summary, the information required to answer your request is not present in the provided text.

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The Opulent TiNbN Coated Knee is indicated for the following:

· Severe knee joint pain, loss of mobility, and disability due to: rheumatoid arthritis, traumatic arthritis, and polyarthritis.

· Correction of functional deformities.

• · Post-traumatic loss of knee join contour, particularly when there is patellofemoral erosion, dysfunction, and/or prior patellectomy.
• Moderate valgus, varus, or flexion trauma.
• · Knee fractures untreatable by other methods.
• · Revision surgery where sufficient bone and soft tissue integrity are present.

The Opulent TiNbN Coated Knee is intended for cemented use only. This device is for single use only.

The Opulent TiNbN Coated Knee comprises of a Femoral Component and Tibial Component as described below,

• Femoral Knee Component CR and PS (Left and Right) ●
• Tibial Component (Tibial Base Plate) ●

Each of these components is described below. These components are compatible with previously cleared components of the Destiknee Total Knee System (e.g., patellae, tibial inserts).

I am sorry, but the provided text does not contain information about the acceptance criteria or a study proving that a device meets acceptance criteria. The document is an FDA 510(k) clearance letter and a 510(k) summary for a knee prosthesis called "Opulent TiNbN Coated Knee."

This type of document primarily focuses on demonstrating substantial equivalence to a predicate device, as opposed to a detailed clinical study demonstrating meeting specific performance acceptance criteria for a novel device. While it mentions non-clinical performance data and mechanical tests, it doesn't provide specific acceptance criteria values or the detailed results of a study designed to prove the device meets those criteria in the context of the questions you've asked (e.g., sample size for test/training sets, expert ground truth establishment, MRMC studies, effect sizes, standalone performance).

The information provided includes:

• Device Name: Opulent TiNbN Coated Knee
• Regulation Number: 21 CFR 888.3560 (Knee Joint Patellofemorotibial Polymer Semi-Constrained Cemented Prosthesis)
• Regulatory Class: Class II
• Product Code: JWH
• Predicate Device: Freedom® - TiNbN Coated Knee (K200912) from Maxx Orthopedics Inc., USA, and Destiknee Total Knee System (K160771 and K172936) from Meril Healthcare Pvt. Ltd.
• Device Description: Comprises Femoral and Tibial Components, made of Cobalt-Chromium-Molybdenum (Co-Cr-Mo) coated with Titanium Niobium Nitride (TiNbN).
• Indications for Use: Severe knee joint pain, loss of mobility, disability due to various arthritis types, correction of functional deformities, post-traumatic loss of knee joint contour, moderate valgus/varus/flexion trauma, knee fractures untreatable by other methods, and revision surgery. Intended for cemented use only, single use.
• Comparison of Technological Characteristics: Stated to be substantially equivalent to the predicate device with same indications, design, materials, packaging, surgical implantation technique, intended use, TiNbN coating, and sterilization method.
• Non-clinical Performance Data: Mentions mechanical tests performed on TiNbN coating (Wear Resistance, Coating Chemical Composition, Coating Thickness, Coating Hardness, Coating Adhesion Strength, Roughness, Metal Ion Analysis) and leveraged mechanical tests from predicate devices (Tibial-Femoral Contact Area Stress and Surface Stress Testing, Tibial-Femoral Constraint Testing, Range of motion analysis, Patello-Femoral Lateral Subluxation, Patello-Femoral Contact Area Stress and Surface Stress Testing, Tibial Tray Locking Mechanisms Testing, Finite Element Analysis of Tibial Tray, Tibial base plate component fatigue testing, Tibial Post Fatigue Strength).

Therefore, I cannot populate the table or answer the specific questions related to acceptance criteria, ground truth, expert review, MRMC studies, or training data for a typical AI/software device evaluation, as this document pertains to a mechanical knee implant and a substantial equivalence review for a 510(k) clearance.

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