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The Balanced Knee® System High Flex PS is intended for use in cemented total knee arthroplasty procedures.

Total knee arthroplasty is indicated for the following conditions:

1. Loss of knee joint configuration and joint function.
2. Osteoarthritis of the knee joint.
3. Rheumatoid arthritis of the knee joint.
4. Post-traumatic arthritis of the knee joint.
5. Valgus, varus, or flexion deformities of the knee joint.
6. Revision procedures where other treatments or devices have failed.

The Balanced Knee System High Flex PS (High Flex PS) is designed to accommodate increased range of motion up to 150° of flexion. The High Flex PS includes a highly polished Co-Cr-Mo PS femoral component and a compression molded UHMWPE PS tibial insert component. The High Flex PS femoral and insert components may be used in conjunction with the Balanced Knee System (BKS) standard and modular tibial trays, tibial augments, stems, and patellae to complete the semi-constrained modular knee prosthesis.

Here's an analysis of the provided text regarding the acceptance criteria and study for the Balanced Knee System High Flex PS, structured as requested:

1. Table of Acceptance Criteria and Reported Device Performance

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

This document describes a 510(k) premarket notification for a medical device (a knee replacement prosthesis). The "Performance Data" section primarily focuses on mechanical testing results rather than clinical study data from a "test set" of patients.

• Test Set Sample Size: Not applicable in the context of clinical patient data. The sample sizes for the mechanical tests (e.g., number of components tested for fatigue) are not specified in the provided summary.
• Data Provenance: Not applicable for patient data. The "Performance Data" describes laboratory mechanical testing of the device components.

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

Not applicable. As described above, this document refers to mechanical testing for device performance, not clinical studies requiring expert-established ground truth for a test set.

4. Adjudication Method for the Test Set

Not applicable. This is not a clinical study involving human readers or expert consensus for adjudication.

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

No. This document does not mention or describe a multi-reader multi-case (MRMC) comparative effectiveness study. It focuses on the mechanical equivalence of a knee prosthesis to predicate devices.

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

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

7. The Type of Ground Truth Used

The "ground truth" in this context refers to established engineering and biomechanical principles, and the performance characteristics of predicate devices. The device's performance is compared against:

• Mechanical benchmarks: Sufficient strength for in-vivo loading for fatigue tests.
• Predicate device characteristics: Similarity in range of motion, constraint, and contact areas to the Balanced Knee System (BKS) and LPS-Flex predicate devices.

8. The Sample Size for the Training Set

Not applicable. This document pertains to a physical medical device and its mechanical testing, not a machine learning model requiring a training set.

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

Not applicable. As this is not a machine learning context, there is no "ground truth for the training set." The performance
evaluation relies on mechanical testing against defined standards and comparison with predicate device characteristics.

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