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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). 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 posterior stabilized system offers a femoral component and two tibial inserts (PS (K102578) and PS-C (subject device)) offering different levels of constraint. The PS-C Insert post is approximately 1 mm larger than the PS Insert (K102578). The slightly larger post is designed to produce more varus/valgus and internal/external rotational constraint.

The provided text describes a 510(k) summary for the Apex PS Knee System PS-C Insert and its comparison to a predicate device, the Apex PS Knee System, PS Insert (K102578). The document focuses on demonstrating substantial equivalence through non-clinical testing rather than clinical studies using patient data. Therefore, many of the requested categories related to clinical study design, such as sample size, expert ground truth, and reader studies, are not applicable in this context.

Here's a breakdown of the available information:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are implicitly met by demonstrating that the subject device's performance characteristics are either identical to or within acceptable variations of the predicate device, as determined by specific ASTM standards. No explicit numerical "acceptance criteria" are stated for performance metrics in the table; rather, the subject device's design and mechanical properties are compared to the predicate.

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

• Sample Size: Not specified in terms of number of devices or units tested. The document refers to "the following tests were conducted," implying a sufficient number of samples were used for the mechanical tests to be representative and meet the requirements of the ASTM standards.
• Data Provenance: Not applicable as no clinical data (patient data) was used. The tests were non-clinical, likely bench testing performed by the manufacturer or a contract lab.

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

• Not Applicable: No clinical studies were performed, and thus no "ground truth" based on expert medical evaluation of patient data was established for a test set. The "ground truth" for non-clinical testing refers to the accepted standards (ASTM F2083-08, ASTM F1223-03) and FDA guidance.

4. Adjudication Method for the Test Set

• Not Applicable: No human review or adjudication of clinical outcomes was involved.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

• No: No MRMC study was performed. The evaluation was based on non-clinical, mechanical testing.

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

• Not Applicable: This device is a mechanical implant, not an algorithm or AI system.

7. The Type of Ground Truth Used

• Standards and Guidance: The "ground truth" or reference for performance was established by recognized industry standards (ASTM F2083-08, ASTM F1223-03) and FDA guidance documents specific to knee joint prostheses. These standards define the methods and expected performance characteristics for evaluating such devices.

8. The Sample Size for the Training Set

• Not Applicable: No training set was used as this involved mechanical testing of a physical device, not an AI or algorithm.

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

• Not Applicable: No training set was used.

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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). All other femoral, tibial baseplate and patellar components are indicated for cemented use only.
The Apex Knee™ Modular Tibia System Tibial Augment are intended to be bolted to the Tibia baseplate and cemented to the prepared tibia.

The APEX PS Knee System includes a posterior stabilized Femur Component incorporating a proportionally sized box. The Femur Component has the same bone cuts as the Apex Knee™ System (K060192) with the addition of a cut for the Femur Component box. Femur Components will be available in both cemented and uncemented versions. Size ranges, high flex, and all other design features of the Apex Knee System are retained. The PS Insert has a medio-lateral constraint and utilizes the Apex Knee System Tibial Baseplate. For each PS Insert, a range of UHMWPE thicknesses are available to aid in obtaining the proper soft tissue balance across the knee joint.

The acceptance criteria and study proving the device meets them for the Apex PS Knee™ System are as follows:

1. Table of Acceptance Criteria and Reported Device Performance

Study Proving Device Meets Acceptance Criteria:

The device's performance was evaluated through a series of non-clinical tests as listed above. The provided document states, "All samples tested met the acceptance criteria." This indicates that for each specific test, the Apex PS Knee™ System demonstrated performance within the predefined limits or adherence to the specified standards, thereby proving the device meets its acceptance criteria.

Detailed Information on the Study:

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

• Sample Size: The document does not specify the exact sample size for each non-clinical test. It generally states, "All samples tested met the acceptance criteria," implying that a sufficient number of samples were tested to demonstrate compliance with the standards.
• Data Provenance: The tests are non-clinical, likely laboratory-based. The country of origin of the data is not explicitly stated, but given the submitter is OMNIlife science, Inc. in E. Taunton, MA, USA, the testing was likely conducted in the US or by US-affiliated labs. The nature of these tests makes them prospective in that they are conducted specifically to evaluate the new device against established standards.

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 question is not applicable to this type of submission. The "ground truth" for non-clinical performance criteria of a medical device like a knee implant is established by recognized national and international engineering standards (e.g., ASTM, ISO) and FDA guidance documents, not by individual expert consensus on specific cases. The tests are designed to objectively measure physical and mechanical properties.

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

• This question is not applicable as the evaluation involves objective physical and mechanical tests against predefined standards, not subjective clinical assessments requiring adjudication.

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 submission is for a knee implant, a physical medical device, not an AI-assisted diagnostic or therapeutic tool. Therefore, MRMC studies involving human readers or AI assistance are not relevant to this submission.

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

• This question is not applicable. This is a physical medical device, not an algorithm or software.

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

• The "ground truth" for the non-clinical tests are the specified engineering and performance criteria established by national and international standards (ASTM F2083-08, ASTM F1223-03, ISO 14243-3, ISO 14243-2, ASTM F1877, ISO 21536, ISO 7207-2, ISO 21534) and relevant FDA Guidance Documents. These standards define acceptable ranges or behaviors for various mechanical and material properties of knee prostheses.

8. The sample size for the training set

• This question is not applicable. There is no "training set" in the context of this submission, as it's for a physical device undergoing non-clinical mechanical and material testing, not a machine learning model.

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

• This question is not applicable for the reason stated above.

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