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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 Knee Revision Femur system augments are intended to be bolted to the femoral component and cemented to the prepared femur.

The Apex Knee™ Modular Tibia System is composed of a tibial baseplate that mates with a cap, keel or a stem. Additionally the baseplate may be used with tibial augments and pegs. The components are used together to form a prosthesis for implantation.

This document is a 510(k) summary for the Apex Knee™ Modular Tibia System. It outlines the device's description, indications for use, comparison to predicate devices, and non-clinical test summaries. It explicitly states that no clinical studies were performed for this submission.

Therefore, the requested information regarding acceptance criteria, device performance, sample sizes, expert involvement, adjudication methods, multi-reader multi-case studies, standalone performance, and ground truth for clinical studies cannot be provided, as none were conducted.

The acceptance criteria and study information provided in this document pertain exclusively to non-clinical testing.

Here's the information about the non-clinical tests mentioned:

Acceptance Criteria and Study Information for Non-Clinical Testing:

1. Table of Acceptance Criteria and Reported Device Performance (Non-Clinical)

Note: The specific quantitative acceptance criteria for each test are not detailed in this summary but are standard for the cited ASTM methods.

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

• Sample Size: Not specified in the provided summary for any of the non-clinical tests.
• Data Provenance: The tests are described as being conducted "internally" or by a certified lab for the manufacturer, OMNI life science, Inc., based in East Taunton, MA, USA. The data is thus considered prospective as it was generated specifically for this submission.

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

• Not applicable. These are engineering/mechanical tests, not clinical evaluations requiring expert interpretation of ground truth data. The "ground truth" is determined by the physical properties and performance measured against the ASTM standard specifications.

4. Adjudication Method for the Test Set

• Not applicable, as these are technical performance tests, not clinical evaluations requiring human adjudication.

5. Multi Reader Multi Case (MRMC) Comparative Effectiveness Study

• No MRMC study was done. The document explicitly states: "No clinical studies were performed."

6. Standalone (i.e., algorithm only without human-in-the-loop performance) Study

• Not applicable. This is a medical device (knee implant), not an algorithm or AI system.

7. Type of Ground Truth Used (Non-Clinical)

• Engineering specifications and recognized industry standards (ASTM): The "ground truth" for these non-clinical tests is adherence to the performance requirements outlined in the specified ASTM standards (e.g., F1929, F1800-07, F1814).

8. Sample Size for the Training Set

• Not applicable. This refers to a medical device, not a machine learning model.

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

• Not applicable. This refers to a medical device, not a machine learning model.

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The Apex Knee ™ Modular Tibia 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 Modular Tibial Baseplate is offered in sizes 1 thru 6 and is a symmetrical design. It is 5mm thick, and accepts Tibial Stems and Augment Blocks on its inferior surface. Modular Tibia Stems are available from 9-17mm diameter in lengths of 75,100 or 150mm. The stem mates to the Modular Tibial Baseplate via a Morse taper connection, secured by a Locking Bolt. Modular Tibia Augments are available in, size 1 thru 6. Each Augment is 4mm thick, and may be placed on either the medial or lateral side of the baseplate. They may be stacked up to three high in equal or descending sizes to create either a uniform or stepped lateral profile. Bone cement should not be used between stacked augments. Once stacked the augments must be secured to the tibial tray using a locking bolt of appropriate length to match the height of the augment stack. The Tibial tray (tibial baseplate) - augment assembly is then cemented to the prepared tibia.

Here's a breakdown of the acceptance criteria and study information for the Apex Knee ™ Modular Tibia System based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The provided text details non-clinical performance testing rather than clinical performance (e.g., diagnostic accuracy metrics). The acceptance criteria are implicit in that the samples must meet the standards.

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

The document does not specify the exact sample size for each non-clinical test (Augment Attachment Strength, Fretting Analysis, Stem Attachment, and Tray/Augment Attachment Strength).
The data provenance is from non-clinical bench testing, not human subjects. Therefore, details like country of origin for data or retrospective/prospective classification are not applicable.

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

This information is not applicable. The ground truth for this device (a knee implant system) is established through adherence to engineering standards and physical properties as assessed by bench testing, not expert interpretation of diagnostic images or clinical outcomes.

4. Adjudication Method for the Test Set

This information is not applicable. Adjudication methods like 2+1 or 3+1 refer to resolving discrepancies in human expert assessments, which is not relevant for non-clinical bench testing.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

A multi-reader multi-case (MRMC) comparative effectiveness study was not done. The document explicitly states: "No clinical studies were performed." This type of study would involve human readers and is relevant for diagnostic or AI-assisted medical devices, not for assessing the mechanical properties of an orthopedic implant.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

This information is not applicable. The Apex Knee ™ Modular Tibia System is a physical orthopedic implant, not a software algorithm or AI device. Therefore, a "standalone algorithm performance" study is irrelevant in this context. The standalone performance relates to the mechanical integrity and functionality of the implant itself, which was assessed through the non-clinical tests.

7. Type of Ground Truth Used

The ground truth used for this device's evaluation was adherence to specified ASTM (American Society for Testing and Materials) standards for mechanical and material properties. This is a type of engineering and material science ground truth, not clinical ground truth like pathology or outcomes data.

8. Sample Size for the Training Set

This information is not applicable. As a physical orthopedic implant, there is no "training set" in the context of machine learning or AI. The design and manufacturing processes are informed by engineering principles, material science, and prior successful designs.

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

This information is not applicable. There is no "training set" for physical implant devices in the way there is for AI/ML algorithms. The design and manufacturing are based on established engineering principles, material properties, and successful predicate device designs, all of which are validated through non-clinical testing.

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