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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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The Ortho Development Balanced Knee® System is indicated for patients suffering from severe knee pain and disability. Specific indications include femoral, tibial and patellar replacement due to:

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 Balanced Knee® System is indicated in the salvage of previously failed surgical attempts where femoral bone loss does not require the use of augments or stem extensions and where collateral ligaments may be relied upon for medial/lateral (M/L) stability.

The Balanced Knee System Ultracongruent Tibial Insert may be used in conjunction with the Balanced Knee System CR femorals, standard and modular tibial trays, tibial augments, stems, and patellae. The Ultracongruent Tibial Insert has an anterior lip and tighter anterior curvature to stabilize the knee in the anterior direction and are snap fitted into the tibial trays and locked in place by mating features, the circumferential rim of the tray, and tabs on the anterior and posterior sides. The Ultraconqruent Tibial Insert is available in seven sizes to fit the majority of patients encountered. The sizes match each size of the Balanced Knee System tibial trays cleared under Premarket Notifications K994370, K020383, and K031201. The insert is symmetric, not left/right specific. It is supplied in thicknesses of 7, 8, 9, 10, 11, 12, 13. 14. 16. 18. and 20mm.

Materials: The device is manufactured from Compression Molded Ultra High Molecular Weight Polyethylene (UHMWPE, ASTM F-648).

Function: The system functions to provide restoration of function as a replacement for diseased and arthritic knees.

The provided text does not contain specific acceptance criteria or detailed study results that would allow for the construction of a table with reported device performance or a comprehensive description of a study as requested. The document is a 510(k) summary for a medical device (Balanced Knee System® Ultracongruent Tibial Insert) and focuses on demonstrating substantial equivalence to predicate devices, rather than presenting a detailed performance study with acceptance criteria.

The key information regarding performance testing is as follows:

• Performance Testing: "The Food and Drug Administration have established no performance standards applicable to the Ultracongruent Tibial Insert, however biomechanical testing and analysis of the device was performed with results included as part of the submission. Clinical data and conclusion were not needed for this device."
• Basis for substantial equivalency: "Testing met all acceptance criteria and verifies that the performance of the Ultracongruent Tibial Insert is substantially equivalent in design, function, material and intended use to the predicate devices."

Based on the available information, I can only provide a limited response:

Acceptance Criteria and Study Details for K090705: Balanced Knee System® Ultracongruent Tibial Insert

1. Table of Acceptance Criteria and Reported Device Performance

The 510(k) summary does not explicitly state specific numerical acceptance criteria or detail the reported device performance. It only states that "Testing met all acceptance criteria." Therefore, a table detailing these cannot be created from the provided text. The submission relied on biomechanical testing and analysis to demonstrate substantial equivalence, rather than specific performance standards established by the FDA for this device type.

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

The document mentions "biomechanical testing and analysis," but does not specify the sample size used for any test set or the data provenance (e.g., country of origin, retrospective/prospective).

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

This information is not applicable as the submission states that "Clinical data and conclusion were not needed for this device." This implies that the evaluation for substantial equivalence did not rely on human expert interpretation of clinical outcomes or images to establish a 'ground truth' in the way a diagnostic AI device would. The evaluation focused on engineering and material characteristics.

4. Adjudication Method

This information is not applicable for the same reasons as point 3.

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

An MRMC comparative effectiveness study was not conducted as this is a knee implant device, not a diagnostic imaging or AI-assisted interpretation device that would involve human readers.

6. Standalone (Algorithm Only) Performance Study

A standalone performance study of an algorithm was not conducted as this is a physical medical device (knee implant), not a software algorithm.

7. Type of Ground Truth Used

The "ground truth" for the biomechanical testing would have been based on established engineering and material science principles and physical measurements/simulations of the device's performance against defined parameters (e.g., strength, durability, wear resistance) compared to predicate devices. It was not clinical, pathological, or outcomes data in the traditional sense for a diagnostic device.

8. Sample Size for the Training Set

This is not applicable as there is no mention of an algorithm or machine learning model that would require a training set.

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

This is not applicable as there is no mention of an algorithm or machine learning model.

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