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The Apex Knee™ System is intended for use as a primary or revision total knee replacement. 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 porous coated femoral component may be used cemented or uncemented (biological fixation). The porous coated tibial baseplate component may be used uncemented (biological fixation). All other femoral, tibial baseplate and patellar components are indicated for cemented use only.
The Apex Knee™ Modular Tibial Augments are intended to be bolted to the Tibia Baseplate and cemented to the prepared tibia. The Apex Revision Knee system augments are intended to be bolted to the femoral component and cemented to the prepared femur.

The proposed devices are intended to be used for primary and revision total knee replacement.
The Revision Tibia Baseplates offer enhanced torsional stability by adding keels to the posterior end of the device. This design is similar to keeled stem designs currently marketed.
The retaining bolt modifications offer additional bolt sizes that allow the cleared tibial inserts to lock into the proposed longer Revision tibial Baseplate.
The material of the proposed Revision Tibial Baseplate is Cobalt Chrome, CoCr (ASTM F75). The material if the proposed retaining bolts is Ti-6Al-4V E.L.I (ASTM F136)

This document describes the regulatory submission for the Apex Revision Knee System (K163332), a medical device. The information provided heavily emphasizes substantial equivalence to a predicate device (K153437) rather than providing detailed acceptance criteria and a study demonstrating the device meets those criteria in a traditional sense (e.g., performance metrics, statistical analysis).

Here's a breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The submission does not provide specific acceptance criteria in the form of performance metrics (e.g., accuracy, sensitivity, specificity) or a study with reported performance values. Instead, the basis for approval is "substantial equivalence" to a predicate device.

The study presented is a justification of substantial equivalence, not a performance study against specific acceptance criteria. The "reported device performance" is essentially that it is considered "as safe, as effective, and performs as well as or better than the legally marketed predicate."

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size: Not applicable in the traditional sense of a clinical or performance study with a test set of data. The "test set" here refers to the new proposed components and their interaction with existing components.
• Data Provenance: Not applicable. The "study" is a series of justifications and evaluations rather than a data-driven test.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts

• Number of Experts: Not mentioned.
• Qualifications of Experts: Not mentioned.

4. Adjudication Method for the Test Set

• Adjudication Method: Not mentioned, as this was not a study involving human interpretation or subjective assessment.

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

• MRMC Study: No. This device is a mechanical knee prosthesis, not an AI-assisted diagnostic tool.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done

• Standalone Performance: No. This device is a physical implant.

7. The Type of Ground Truth Used

The "ground truth" here is the established safety and effectiveness of the legally marketed predicate device (K153437). The new device is deemed equivalent because its modifications do not introduce new risks. The justifications listed are:

• "KTR-116 Tray Fatigue FEA" (Finite Element Analysis) - This indicates an engineering simulation was performed for fatigue, but the results or a direct comparison to acceptance criteria are not provided in this summary.

8. The Sample Size for the Training Set

• Sample Size: Not applicable. This is not a machine learning model.

9. How the Ground Truth for the Training Set Was Established

• Ground Truth Establishment: Not applicable.

Summary of Device Acceptance and Study:

The acceptance of the Apex Revision Knee System (K163332) is based on the demonstration of substantial equivalence to a previously cleared predicate device (K153437). The "study" is less of a traditional performance study and more of a technical justification.

Acceptance Criteria (Implied by Substantial Equivalence):

Key takeaways from the document regarding the "study":

• This was a Special 510(k) submission, used when modifications to a legally marketed device do not significantly alter its safety or effectiveness.
• The manufacturer explicitly states that "Testing was not conducted" in a hands-on sense for comparing the new device against the predicate. Instead, "justifications were written" and the devices were "evaluated."
• The primary justification is that the modifications (additional baseplate and retaining bolt types) maintain the "basic design, interface, fundamental technology, materials and intended use" of the cleared predicate device.
• The listed "study" is "KTR-116 Tray Fatigue FEA", which is a Finite Element Analysis for fatigue. This is a computational simulation, not a physical study with a test set of real-world data or human subjects. The details of the FEA results or acceptance criteria for fatigue are not included in this summary document.
• The "ground truth" for demonstrating equivalence is the established safety and effectiveness profile of the predicate device (K153437).

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The Apex Knee™ System is intended for use as a primary or revision total knee replacement. 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 porous coated femoral component may be used cemented (biological fixation). The porous coated tibial baseplate component may be used uncemented (biological fixation). All other femoral, tibial baseplate and patellar components are indicated for cemented use only.

The Apex Knee™ Modular Tibial Augments are intended to be bolted to the Tibia Baseplate and cemented to the prepared tibia. The Apex Revision Knee system augments are intended to the femoral component and cemented to the prepared femur.

The proposed devices are intended to be used for primary and revision total knee replacement.

The fluted femoral stems and the keeled femoral stems are slight modifications of the existing designs. The femoral stems offer enhanced press-fit implantation and torsional stability by adding longitudinal raised ribs similar to most stems designs currently marketed.

The notched 10mm posterior femoral augment has been created to increase the product offerings when using posterior augments. The new notched augment will allow a 10mm distal augment and 10mm posterior augment to be used together.

The femoral Locking Bolt functions similarly to the tibial locking bolt. It was designed for femoral use for enhanced fixation of the stem to the femur.

The current tibial peg offers additional torsional stability when added to the modular tibial baseplate. The proposed revision tibial Peg is a slight modification of that existing tibial peg and is improved in size and torque strength. The Augment Peg Bolt is similar to the tibial peg and can be used to add additional torsional stability to the modular tibia baseplate when augments are used.

The material of each new component is titanium alloy Ti-6Al-4V E.L.I (ASTM F136)

The provided document is a 510(k) premarket notification for a medical device called the "Apex Revision Knee System." It details the device's indications for use, its description, and the manufacturer's assertion of substantial equivalence to previously cleared devices.

Crucially, this document does not contain information about acceptance criteria or a study that proves the device meets specific performance criteria for artificial intelligence (AI) or software-based medical devices.

This 510(k) is for a physical medical device (a knee prosthesis), not a diagnostic AI system or a decision support software. The "study" referenced in the document (KTR-102 Femur Stem Bolt Testing Justification, KTR-100 Revision Knee Fluted Stem FEA Comparison, etc.) are engineering justifications and comparisons to existing predicate devices, primarily through finite element analysis (FEA) and design comparisons, not clinical trials or performance assessments against specific numerical acceptance criteria for an AI system.

Therefore, I cannot fulfill your request for the tables and study details related to AI device performance based on the provided text. The information you are seeking (AI acceptance criteria, human reader improvement with AI, ground truth establishment, sample sizes for training/test sets, expert qualifications, etc.) is simply not present in this type of regulatory submission for a physical orthopedic implant.

If you have a document describing an AI medical device, please provide that, and I would be happy to assist with your request.

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The Apex Knee™ System is intended for use as a primary or revision total knee replacement. 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 porous coated femoral component may be used cemented or uncemented (biological fixation). The porous coated tibial baseplate component may be used uncemented (biological fixation). All other femoral, tibial baseplate and patellar components are indicated for cemented use only.
The Apex Knee™ Modular Tibia System Tibial Augments are intended to be bolted to the Tibia Baseplate and cemented to the prepared tibia. The Apex Revision Knee System augments are intended to be bolted to the femoral component and cemented to the prepared femur.

The Apex Revision Knee System includes the Revision Femoral Component, PS-R Insert, Retaining bolts, Femoral Augments and Femoral Stems. The Revision system is compatible with the previously cleared Modular Tibial Baseplates (K101994) and Patella component (K060192). The PS-R Insert has one level of medio-lateral constraint. The Revision Femoral component incorporates a proportionally sized box that is higher than the Apex PS Knee design (K102578). The Revision Femoral Component has the same bone cuts as the Apex CR Knee System and the Apex PS Knee System (K060192 and K102578). Size ranges, high flex and all other key design features of the Apex CR Knee System (K060192) have been retained in the Apex Revision Knee System. The Femoral Augments and Femoral Stems are available for use with the Revision Femoral Component.

The provided text describes the submission of the Apex Revision Knee System for 510(k) clearance. This is a medical device application, not an AI/ML device, and therefore the concepts of "acceptance criteria," "device performance," "sample size for test set," "data provenance," "number of experts," "adjudication method," "MRMC comparative effectiveness study," "standalone performance," "ground truth," and "sample size for training set" in the context of AI/ML models are not directly applicable.

The document focuses on demonstrating substantial equivalence to predicate devices through non-clinical testing.

Here's an interpretation of the request using the information available and noting where AI/ML concepts do not apply:

Description of Acceptance Criteria and Study to Prove Device Meets Acceptance Criteria

The Apex Revision Knee System's acceptance criteria are framed within the context of demonstrating substantial equivalence to legally marketed predicate devices, primarily through non-clinical performance testing. The study supporting this is a series of in vitro mechanical and wear tests conducted according to recognized industry standards.

1. Table of Acceptance Criteria and Reported Device Performance

Given that this is a mechanical medical device, the "acceptance criteria" are implied by adherence to specified ASTM and ISO standards for properties such as flexion range of motion, constraint, contact area, insert post strength, stem testing, augment testing, patello-femoral contact area and stability, and wear. The "reported device performance" is that these tests were conducted and the device "met the acceptance criteria." Specific numerical values for the criteria or performance are not detailed in this summary.

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size for Test Set: The document does not specify the exact number of samples (e.g., knee implants) used for each non-clinical test. It generally refers to "All samples tested."
• Data Provenance: The data provenance is from non-clinical, in vitro laboratory testing performed by the manufacturer, OMNIlife science, Inc. The country of origin of the data is not explicitly stated but is implicitly the United States, where the company is located. The tests are prospective in nature, as they are specifically conducted to support the 510(k) submission.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

• This question is not applicable as the evaluation is based on objective, quantifiable engineering and material science performance test standards (ASTM, ISO) and FDA guidance documents, not on expert interpretation of medical images or patient data.
• The "ground truth" is defined by the requirements of the standards themselves (e.g., specific load conditions, displacement parameters, acceptable wear rates, etc.).

4. Adjudication Method for the Test Set

• This question is not applicable. There is no "adjudication method" in the sense of reconciling differing expert opinions, as the tests are objective mechanical assessments against pre-defined engineering standards. The pass/fail criteria are inherent in the test standards.

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 question is not applicable. The device is a mechanical knee implant, not an AI/ML diagnostic or assistive tool for human readers. No MRMC study was conducted.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

• This question is not applicable. The Apex Revision Knee System is a mechanical device, not an algorithm. Therefore, "standalone performance" in the context of AI/ML is not relevant.

7. The Type of Ground Truth Used

• The "ground truth" for this device's evaluation is defined by adherence to established engineering and materials science standards (e.g., ASTM F2083-08, ASTM F1223-03, ISO 14243-3, ISO 14243-2, ASTM F1877) and FDA guidance documents for total knee prostheses. These standards specify test methods, conditions, and performance requirements.

8. The Sample Size for the Training Set

• This question is not applicable. As a mechanical medical device, there is no "training set" in the context of machine learning. The device design is based on engineering principles and previous designs, not on statistical learning from a dataset.

9. How the Ground Truth for the Training Set Was Established

• This question is not applicable for the same reasons as #8. There is no training set for this type of device. The "ground truth" for its development is based on established biomechanical knowledge, material science, and the performance characteristics of previously cleared predicate devices.

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