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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 is to 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 the Tibia baseplate and cemented to the prepared tibia.

The proposed devices are intended to be used for primary and revision total knee replacement.
The Pegged Tibial Baseplates offer additional torsional stability by adding pegs to the posterior end of the device. The material of the proposed Pegged Tibial Baseplates are Cobalt Chrome, CoCr (ASTM F75).
The ECiMa tibial inserts are machined from compression molded highly crosslinked polyethylene with Vitamin E (VE-XLPE) and attaches to the cobalt chrome tibial baseplate via dovetails and a retaining

The provided text describes a 510(k) premarket notification for the "Apex Knee™ System," a knee joint prosthesis. However, the document does not include information about acceptance criteria or a study proving the device meets those criteria in the context of an AI-powered medical device.

The document is a submission for a physical medical device (a knee implant), not an AI device. Therefore, the questions related to AI device performance (e.g., number of experts for ground truth, MRMC studies, standalone algorithm performance, training set details) are not applicable to this document.

The document focuses on demonstrating substantial equivalence to a predicate device for a physical implant, primarily through material characterization, mechanical testing, and biocompatibility testing. The "acceptance criteria" discussed are mainly related to the performance standards for the implant materials and design, such as wear testing, strength testing, and sterility assurance levels.

Here's a breakdown of what is and is not in the provided text:

Information NOT Found (as it pertains to an AI device):

• 1. Table of acceptance criteria and reported device performance for an AI device: Not present. The acceptance criteria relate to mechanical and biological properties of the implant.
• 2. Sample size and data provenance for an AI test set: Not applicable. The "test set" refers to mechanical samples and animal models, not patient data for AI evaluation.
• 3. Number of experts and qualifications for AI ground truth: Not applicable. Ground truth for an AI device (e.g., image annotation) is not relevant here.
• 4. Adjudication method for an AI test set: Not applicable.
• 5. Multi-reader multi-case (MRMC) comparative effectiveness study for AI: Not applicable.
• 6. Standalone (algorithm only) performance for AI: Not applicable.
• 7. Type of ground truth for an AI device: Not applicable. Ground truth here refers to engineering specifications and biological response, not diagnostic labels for AI.
• 8. Sample size for an AI training set: Not applicable.
• 9. How ground truth for an AI training set was established: Not applicable.

What the document does provide regarding the physical device's "studies":

The document broadly mentions "non-clinical testing" conducted to demonstrate the safety and effectiveness and substantial equivalence of the modified Apex Knee™ System. These tests are the "study" proving the device meets its acceptance criteria (though not presented in the AI-specific format requested).

• Testing for Pegged Tibial Baseplates:
  • FEA (Finite Element Analysis) simulation
  • Peg location templating study
• Testing for ECiMa Tibial Inserts & Patellae:
  • Material characterization
  • PS (Posterior Stabilized) post strength testing
  • Insert disassembly strength testing
  • Wear testing
• Biocompatibility Testing for ECiMa material:
  • Intramuscular implantation in animal models
  • Implant toxicity and subcutaneous implantation in animal models
• Sterility: Validated sterilization process using ethylene oxide (EO) to a Sterility Assurance Level (SAL) of 10-6. Endotoxin testing via Limulus amebocyte lysate (LAL) on a quarterly rotating basis for product groups.

Conclusion:

This document is a regulatory submission for a physical knee implant and does not contain the specific information requested regarding AI device acceptance criteria and study methodologies. The "studies" mentioned are engineering and biological tests demonstrating the physical device's performance and safety.

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The b-ONE Total Knee System is intended for total knee arthroplasty due to the following conditions:

· Painful, disabling joint disease of the knee resulting from: noninflammatory degenerative joint disease (including osteoarthritis, traumatic arthritis, or avascular necrosis), rheumatoid arthritis or post -traumatic arthritis,

· Post-traumatic loss of knee joint configuration and function.

· Moderate varus, valgus, or flexion deformity in which the ligamentous structures can be returned to adequate function and stability.

· Revision of previous unsuccessful knee replacement or other procedure.

• · Fracture of the distal femur and/or proximal tibia that cannot be standard fracture- management techniques.
  Additional indications for Posterior Stabilized (PS) and Posterior Stabilized Plus (PS+) components:

• · Ligamentous instability requiring implant bearing surface geometries with increased constraint.

• · Absent or nonfunctioning posterior cruciate ligament.

• · Severe anteroposterior instability of the knee joint.

The b-ONE Total Knee System is intended for implantation with bone cement only. b-ONE Total Knee System components are not intended for use with other knee systems.

The b-ONE Total Knee System is a modular artificial knee replacement system comprised of symmetric cemented femoral components with optional femoral distal pegs, symmetric cemented tibial baseplate, symmetric tibial inserts with locking wires, symmetric patellar resurfacing button, and reusable surgical instruments. The therapeutic effect is replacement of the diseased joint with artificial components to restore joint function. The system is a posterior stabilized device type and includes two options for posterior stabilization, a PS and a PS+. The PS+ is designed with additional constraint when more stability is required. Compatibility of the system components is only claimed with the b-ONE Total Knee System. There is no allowed interchangeability with systems manufactured by other companies.

The System includes left and right femoral components manufactured from cast cobalt chrome. The system includes 30 sizes. Sizes 1-10 are provided in right and left versions. Sizes 3-7 are provided in both standard and narrow configurations, with the narrow sizes having a relatively smaller aspect ratio of the medial-lateral to anterior-posterior widths when compared to the standard sizes. Optional modular distal pegs are included in the system.

The system includes a Patella Component offered in seven sizes of variable diameter and thicknesses. The bone fixation surface incorporates three fixation pegs. The Patella Components are made from Conventional UHMWPE.

The system includes Tibial Inserts which are offered in 40 sizes, size A/1-4 through HJ/7-10 with 8 thicknesses and 48 sizes for PS+ inserts, size A1-2+ through HJ/7-10+ with 8 thicknesses. The Tibial Inserts are made from Conventional UHMWPE. The Tibial Inserts are pre-assembled with a locking wire which is manufactured from Cobalt Chrome alloy.

The system includes Tibial Baseplates offered in 9 sizes ranging from A-J. Tibial Baseplates are manufactured from forged titanium alloy.

All system components are supplied sterile and are single use devices.

This document is a 510(k) Pre-Market Notification from the FDA for a medical device called the b-ONE Total Knee System. This type of document is used to demonstrate that a new device is "substantially equivalent" to an existing, legally marketed device (predicate device) and therefore does not require a full Pre-Market Approval (PMA).

It is important to understand that a 510(k) summary for a prosthetic joint like a knee replacement does NOT involve clinical studies or "acceptance criteria" related to diagnostic performance as would be found in AI/ML medical devices.

Instead, the "acceptance criteria" for a knee replacement relate to the performance of the physical components (e.g., strength, fatigue life) and their biocompatibility, demonstrating that the new device functions as safely and effectively as the predicate devices. The "study that proves the device meets the acceptance criteria" refers to non-clinical (bench) tests of the device's materials, design, and mechanical properties.

Therefore, the requested information elements related to AI/ML device evaluations (such as sample size for test sets, data provenance, number of experts for ground truth, adjudication methods, MRMC studies, standalone performance, training set details) are not applicable to this type of device and submission.

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

1. Table of acceptance criteria and the reported device performance

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. This is a physical medical device (knee implant), not a diagnostic algorithm. The "test sets" refer to individual device components or representative samples subjected to specific engineering tests, not patient data sets. The data provenance would be laboratory testing results.

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" in this context refers to established engineering standards, material specifications, and mechanical performance criteria, not expert consensus on medical images or diagnoses. These tests are conducted by engineers and technicians.

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

• Not Applicable. Adjudication methods are relevant for subjective interpretations of data, typically in clinical evaluations or AI/ML ground truth establishment. These are objective engineering tests.

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. This is a physical knee implant, not an AI/ML diagnostic or assistive device. MRMC studies are not relevant.

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

• No. This is a physical knee implant, not an AI/ML algorithm.

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

• The "ground truth" for the non-clinical tests is based on established engineering standards, material specifications, mechanical performance criteria, and comparison to the predicate devices' known performance and specifications.

8. The sample size for the training set

• Not Applicable. This is a physical medical device. There is no "training set" in the context of machine learning. The design and manufacturing processes are developed through engineering and materials science principles.

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

• Not Applicable. As there is no training set for an AI/ML algorithm, this question is not relevant. The "ground truth" for the device's design and manufacturing is established through adherence to recognized industry standards, regulatory requirements, and engineering principles.

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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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The Apex Knee System Tibial Baseplate Augment is intended for use with the Apex Knee System as a primary or revision total knee replacement. This knee replacement system is intended for cemented fixation and 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 Augments are used as optional spacers and are cemented below the Tibial Tray using PMMA bone cement.

The Tibial Baseplate Augment is available in the following Sizes:
• Size 1 x 8mm
• Size 2 x 8mm
• Size 3 x 8mm
• Size 4 x 8mm
• Size 5 x 8mm

This document describes the 510(k) submission for the OMNI life science Apex Knee System Tibial Baseplate Augment. It is a premarket notification to demonstrate substantial equivalence to previously marketed devices, not a study proving device safety and effectiveness through clinical trials with specific acceptance criteria as might be expected for an AI/clinical diagnostic device. Therefore, much of the requested information regarding AI device evaluation is not applicable here.

Here's a breakdown of the available information:

1. Table of acceptance criteria and the reported device performance

The document does not specify quantitative acceptance criteria in terms of performance metrics (sensitivity, specificity, accuracy, etc.) because this is a mechanical medical device (a knee implant component). Instead, the acceptance criteria are related to mechanical and material properties and a demonstration of substantial equivalence to predicate devices.

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

This information is not applicable. The device is a mechanical implant, and its evaluation does not involve "test sets" or "data provenance" in the way an AI diagnostic device would. The "performance testing" and "bench testing" mentioned are likely mechanical tests performed in a lab setting, not on patient data.

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 is not applicable. Ground truth for mechanical device performance is established through engineering specifications, material properties, and physical testing, performed by engineers and technicians, not clinical experts establishing diagnostic ground truth from patient data.

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

This is not applicable. Adjudication methods are used for resolving disagreements in expert opinions, typically in diagnostic or clinical trial settings. Mechanical testing results are objective measurements.

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. An MRMC study is relevant for evaluating the impact of AI on human reader performance in diagnostic tasks. This device is an implant, not an AI diagnostic tool.

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

This is not applicable. This device is not an algorithm or AI system.

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

The "ground truth" for this device's acceptance is based on engineering specifications, material standards, and the results of the bench testing demonstrating mechanical integrity, fit, and function as being equivalent to legally marketed predicate devices. This is a regulatory pathway (510(k)) focused on demonstrating substantial equivalence, rather than proving clinical efficacy through extensive outcomes data, which would typically be required for a PMA application.

8. The sample size for the training set

This is not applicable. There is no AI model or "training set" involved in the development or evaluation of this mechanical device.

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

This is not applicable, as there is no training set for an AI model.

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