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The Balanced Knee System Revision Offset Tibia is indicated for use in total knee arthroplasty procedures, for cemented use only.

Total knee arthroplasty is indicated for the following conditions:

1. Loss of 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.
6. Revision procedures where other treatments or devices have failed.

The proposed Balanced Knee System Revision Offset Tibia is a modular system intended for primary and revision knee surgery. It consists of an offset tibial tray, adapter, screw, and stem. All components are machined from titanium alloy (Ti-6Al-4V ELI).

The provided text is a 510(k) summary for a medical device (Balanced Knee System Revision Offset Tibia) and it details the regulatory process and claims of substantial equivalence. However, it does not contain information about acceptance criteria or a study proving the device meets specific acceptance criteria in the way described in the request.

The document discusses:

• Mechanical testing: "Mechanical testing shows that the Balanced Knee System Revision Offset Tibia can withstand anticipated in vivo loading and cycling."
• Tests for substantial equivalence: "The Tests for substantial equivalence include Tibial Tray fatigue and progressive static load mechanical tests, as well as assembly and disassembly tests."

These statements indicate that some form of testing was performed, likely to demonstrate the mechanical integrity and durability of the device in comparison to predicate devices. However, the document does not provide quantitative acceptance criteria or the reported device performance against such criteria. It also lacks details on:

• Sample size used for the test set or data provenance.
• Number of experts or their qualifications for establishing ground truth.
• Adjudication method for the test set.
• Multi-reader multi-case (MRMC) comparative effectiveness study.
• Standalone performance study.
• Type of ground truth used.
• Sample size for the training set (as this is a mechanical device, not an AI/algorithm-based one).
• How ground truth for the training set was established.

Therefore, I cannot populate the requested table and information as the provided text does not contain these specific details. The 510(k) process for this type of device relies on demonstrating substantial equivalence to existing legally marketed devices, primarily through engineering principles, material compatibility, and mechanical performance testing, rather than clinical efficacy studies with expert consensus or AI performance metrics.

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