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The indications for use are:

A. Primary intervention of rheumatoid arthritis, osteoarthritis, post-traumatic arthritis, or degenerative arthritis

B. Failed osteotomy or unicompartmental replacements

C. Replacement of unsatisfactory cemented or press-fit knee components when sufficient bone stock exists

D. The non-porous (uncoated, coated with CoCr beads without Titanium, and uncoated with a TiNbN overcoat) components may only be used with cement

E. The porous coated (CoCr beads with Titanium) components may be used with or without cement

The femoral implants are provided in left and right-side versions and designed to replicate the natural anatomy of the femur. They are available in a single variant only - CR, with sizes ranging from 1 to 6. The femoral implants have a R.P design, which offers surgeon an option for patients where a more minimal anatomic design is preferred. The femoral implants are manufactured using cast CoCrMo alloy (ASTM F75). A monolayer of TiNbN coating (thickness: 3 to 7 microns) is applied to the femoral implants.

The tibial baseplates are provided in left and right-side versions and designed to replicate the natural anatomy of the tibial baseplates are available in three variants – holed, pegged, and pegless, with sizes ranging from 0 to 6. The tibial baseplates are manufactured using cast CoCMo alloy (ASTM F75). A monolayer of TiNbN coating (thickness: 3 to 7 microns) is applied to the entire surface of the tibial baseplates.

The provided text describes the regulatory clearance for the "Consensus Knee System with TiNbN" and discusses its substantial equivalence to predicate devices, primarily focusing on the addition of a TiNbN coating. However, this document does not contain information about acceptance criteria or a study proving the device meets acceptance criteria related to AI/software performance.

The text is a 510(k) summary for a medical device (knee prosthesis), which focuses on demonstrating substantial equivalence to existing devices. The "tests" mentioned are non-clinical, primarily material and mechanical tests (biocompatibility, wear performance, fatigue, range of motion) conducted for the physical implant and its new coating, not for any AI or software component.

Therefore, I cannot provide the requested information, as the input document does not contain details about:

• Acceptance criteria for AI/software performance.
• A study validating AI/software performance.
• Sample sizes for test sets (in the context of AI/software).
• Expert involvement in establishing ground truth for AI/software.
• Adjudication methods for AI/software test sets.
• MRMC studies.
• Standalone AI algorithm performance.
• Types of ground truth for AI/software.
• Training set sample sizes or ground truth establishment for an AI/software component.

The document is about a physical medical device (a knee implant), not an AI/software device.

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The Freedom® - 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 joint contour, 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 stock and soft tissue integrity are present.

The Freedom® - TiNbN Coated Knee is intended for cemented use only. This device is for single use only.

The Freedom® - 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.

The provided text does not describe a study involving an AI/ML powered medical device or a diagnostic device that would require the establishment of ground truth by experts or a comparative effectiveness study with human readers.

Instead, the document is a 510(k) premarket notification for the Freedom® - TiNbN Coated Knee, which is a knee joint prosthesis. The acceptance criteria and the "study" (referred to as "Non clinical Performance data") described in the document relate to the physical and material properties of this medical implant, not to a diagnostic or AI-driven system.

Therefore, I cannot answer your request based on the provided text, as the information you've asked for (such as ground truth establishment by experts, adjudication methods, multi-reader multi-case studies, and AI effect size) is irrelevant to the type of device described in the document.

The document discusses:

• Device Type: Knee joint prosthesis (mechanical implant).
• Purpose of Submission: Demonstrating substantial equivalence to legally marketed predicate devices for the purpose of market clearance.
• "Acceptance Criteria" / Performance Testing: Physical and material tests to ensure the implant meets safety and performance standards (e.g., wear resistance, coating adhesion, fatigue testing). This is not about diagnostic accuracy or AI performance.
• "Study" Data: Non-clinical (laboratory) performance data on the mechanical properties and coating characteristics of the knee implant.

If you have a document describing an AI/ML medical device, I would be happy to analyze it according to your criteria.

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The OMNI TiN Coated Apex Knee™ is intended for use as a primary or revision total knee replacement. This knee replacement system is intended for cemented single use implantation. This prosthesis may be used for the following conditions, as appropriate:

• · Non-inflammatory degenerative joint disease, including osteoarthritis and avascular necrosis;
• · Rheumatoid arthritis;
• · Correction of functional deformity;
• · Revision procedures where other treatments or devices have failed;
  The Apex Knee™ Modular Tibial Augments with TiN coating are intended to be bolted to the TiN coated Tibia Baseplate and cemented to the prepared tibia. The Apex Knee Revision Femur System Augments are intended to be bolted to the TiN coated femoral component and cemented to the prepared femur.

The change that is the subject of this 510(k) is to add a thin coating of Titanium Nitride (TiN) to all surfaces of all CoCrMo substrate metal components (Femoral(s), Tibial Baseplate(s), and Revision Tibia Augments) as listed in the above Predicates. The purpose of the TiN coating is to substantially reduce release of CoCrMo metal ions into body fluids, bone or soft tissues.
There is no change to the fundamental scientific technology of the referenced OMNI Predicate Knee Systems (5) with the modifications in this 510(k) submission. This includes no changes to the substrate materials, design, sterilization, packaging, or method(s) of manufacture.

I am sorry, but the provided text does not contain information about acceptance criteria or a study proving that a device meets those criteria. The text is a 510(k) premarket notification for a medical device called the "OMNI TiN Coated Apex Knee™ System."

While it discusses the device's indications for use, its description, predicate devices, and non-clinical testing performed on the Titanium Nitride (TiN) coating, it explicitly states:

"7. Clinical Testing: No clinical studies were performed."

This immediately indicates that there will be no information regarding:

• A table of acceptance criteria and reported device performance (as this would typically come from clinical or comprehensive performance studies).
• Sample sizes for test sets, data provenance, or details about training sets (as these are relevant to studies, especially those involving AI/ML or extensive clinical trials).
• Numbers of experts, their qualifications, or adjudication methods for ground truth (again, these are related to studies, particularly those involving human interpretation or AI model validation).
• MRMC studies, effect sizes for human readers, or standalone AI performance.
• Types of ground truth established.

The document focuses on demonstrating substantial equivalence to predicate devices through

• Indications for Use,
• Material changes (addition of TiN coating), and
• Non-clinical testing of the coating properties (Chemical Composition, Thickness, Hardness, Adhesion Strength, Surface Roughness, and Wear Resistance).

Therefore, I cannot fulfill your request based on the provided text, as the necessary information for describing acceptance criteria and a study proving device performance is not present.

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The EVOLUTION® NitrX™ Medial-Pivot Knee is indicated for use in knee arthroplasty in skeletally mature patients with the following conditions:

1. Non-inflammatory degenerative joint disease: including osteoarthritis, traumatic arthritis, or avascular necrosis
2. Inflammatory degenerative joint disease, including rheumatoid arthritis;
3. Correction of functional deformity
4. Revision procedures where other treatments or devices have failed; and treatment of fractures that are unmanageable using other techniques.

The EVOLUTION® Medial-Pivot Total Knee System Nonporous implants are for cemented use only.

The EVOLUTION® NitrX™ Medial-Pivot Knee is a line extension of the EVOLUTION® MP Total Knee System product line. The device is intended to be used as a medial pivot option in total knee arthroplasty (TKA). The subject device is composed of a femoral component to replace the distal surface of the patient's natural femur and a tibial baseplate component to replace the proximal surface of the patient's natural tibia. The design features are summarized below:

• Manufactured from Cobalt Chrome Alloy
• Coated with Titanium Niobium Nitride
• Sizes 1-8, left and right

This document is a 510(k) Premarket Notification for the EVOLUTION® NitrX™ Medial-Pivot Knee. It focuses on demonstrating substantial equivalence to existing predicate devices rather than providing an independent study to prove the device meets acceptance criteria as would be done for a novel AI/software medical device.

Therefore, the requested information regarding acceptance criteria, reported device performance, sample sizes for test and training sets, ground truth establishment, expert qualifications, adjudication methods, and MRMC studies is not applicable in this context.

Here's why and what information is available:

• Device Type: The EVOLUTION® NitrX™ Medial-Pivot Knee is a physical orthopedic implant (knee prosthesis), not an AI/software medical device. The "acceptance criteria" for such a device are typically met through demonstrating substantial equivalence to a legally marketed predicate device in terms of indications for use, technological characteristics, and safety and effectiveness information.
• Study Focus: The submission is a "Traditional 510(k)" which aims to show the new device is as safe and effective as an already cleared device. This is done through nonclinical testing (e.g., biocompatibility, mechanical testing) and comparison to predicate devices, rather than clinical efficacy studies against specific performance metrics for diagnostic or prognostic tasks.
• Clinical Testing: The document explicitly states: "Clinical data was not provided for the subject devices." This further confirms that a prospective clinical study with human readers and ground truth, as implicitly requested by your prompt's structure, was not conducted or submitted for this specific device clearance.

Available Information from the document, rephrased to fit the prompt's categories where possible but noting the lack of direct applicability:

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

   • Acceptance Criteria (Implicit for 510(k) clearance): Substantial equivalence to predicate device(s) regarding indications for use, technological characteristics, and safety and effectiveness.
   • Reported Device Performance:
     • Nonclinical Testing Performed on Subject Device: Biocompatibility evaluation/testing, Tibial baseplate component fatigue testing, Wear analysis (Mode 1 and aggressive Mode 3), Morphological analysis, Metal ion analysis.
     • Nonclinical Predicate Test Results Used to Support Subject Device: Range of motion analysis, Stability/Constraint, Contact area/stress, MR Assessments (Field Interactions, Torque, Displacement, RF Heating), Gravimetric Analysis, Bioburden Testing.
     • (Specific quantitative performance values for these tests are not provided in this summary document.)

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

   • Not applicable in the context of mechanical and material testing for an implant. The "samples" would be the manufactured device components subjected to various engineering tests. No test set of patient data is described.

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):

   • Not applicable. Ground truth for an AI/software device involving human interpretation is not relevant for this orthopedic implant. The "ground truth" for mechanical testing would be established by industry standards, engineering principles, and validated test methods.

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

   • Not applicable. This is a concept used for human reader studies, not for mechanical device testing.

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:

   • No MRMC study was done (not applicable for this device type).

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

   • Not applicable. This is not an algorithm-based device.

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

   • For the nonclinical testing, the "ground truth" implicitly relies on established engineering principles, material science standards, and accepted testing methodologies (e.g., ISO standards for wear testing, biocompatibility standards).

8. The sample size for the training set:

   • Not applicable. There is no AI model or training set for this physical implant.

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

   • Not applicable. There is no AI model or training set for this physical implant.

In summary, this document is a regulatory submission for a physical medical device (a knee implant) cleared via the 510(k) pathway, which fundamentally differs from the type of device (e.g., AI/ML-based software) that would involve the specific "acceptance criteria" and "study" details requested in your prompt regarding human reader performance or algorithm-specific metrics.

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