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General total knee arthroplasty indications include:

• Painful, disabling joint disease of the knee resulting from: degenerative arthritis ● or post-traumatic arthritis
• Post-traumatic loss of knee joint configuration and function .
• Moderate varus, valgus, or flexion deformity in which the ligamentous structures can be returned to adequate function
• Revision of previous unsuccessful knee replacement or other procedure, where soft tissue stability is ● adequate
• . Fracture of the distal femur and/or proximal tibia that cannot be stabilized by standard fracture management techniques
• The posterior stabilized variant is also indicated for PCL instability requiring implant bearing surface . geometries with increased anterior-posterior constraint and absent or non-functioning posterior cruciate ligament

The Unity Knee™ is intended for cemented use, single use only.

The Unity Knee™ is a fixed bearing total knee replacement system that consists of a Cobalt Chromium Allov (CoCr) femoral component, a UHMWPE polyethylene tibial insert, a Cobalt Chromium Alloy (CoCr) tibial tray with a Titanium Alloy keel extension and all-polyethylene patellar component for use in primary and revision total knee arthroplasty. The Unity Knee™ femoral component is provided in two variants, cruciate retaining (CR) and posterior stabilized (PS).

• . The Unity Knee™ CR femoral component is intended for use in conjunction with the CR tibial insert where the posterior cruciate ligament (PCL) is functional or in conjunction with a Unity Knee™ CS tibial insert only where the PCL is present but is lax or non-functioning or when the PCL is absent.
• The Unity Knee™ PS femoral component and tibial insert variant is indicated for use where the posterior cruciate ligament is non-functioning or absent, resulting in joint instability.

The Unity Knee™ patellar component is optional for use with either the CR or PS variant and is indicated for use where replacement of the articular surface of the patella is required. The system also provides Titanium Alloy augment components including femoral augments, tibial augments and stem extensions.

The Unity Knee™ is intended for use in total knee arthroplasty in skeletally mature patients, to provide increased mobility and reduce pain by replacing the damaged knee joint articulation where there is evidence of sufficient sound bone to seat and support the components.

The Unity Total Knee system was originally cleared in K113060. This submission is for the inclusion of an additional range of Unity Knee™ CS Tibial Inserts. The additional range of Tibial Insert has the same intended purpose as those cleared in the original 510(k) submission (K113060).

The provided text is a 510(k) Premarket Notification from the FDA for a medical device, the "Unity Total Knee System." It outlines the device's indications for use, its description, and its claim of substantial equivalence to predicate devices. Crucially, the document explicitly states that "Clinical testing was not necessary to determine substantial equivalence between the additional components of the Unity Knee™ CS tibial insert and the predicate devices."

Therefore, I cannot extract information regarding acceptance criteria or a study that proves the device meets those criteria, as no clinical study was performed or required for this 510(k) submission. The document focuses on demonstrating substantial equivalence through non-clinical testing and comparison to existing, legally marketed devices.

However, I can extract the information regarding the non-clinical testing performed:

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

2. Sample size used for the test set and the data provenance:

• Sample Size: Not specified for the non-clinical tests. These are typically material and mechanical tests performed on a defined number of device components, not human subjects or patient data.
• Data Provenance: The tests are performed in a laboratory setting per specified ASTM standards. The document does not specify the country of origin of the lab or if the data is retrospective or prospective, as it pertains to engineering and material testing, not clinical data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• This is not applicable as no clinical test set or ground truth established by experts was used. The substantial equivalence claim is based on non-clinical engineering testing.

4. Adjudication method for the test set:

• Not applicable as no clinical test set requiring human adjudication was used.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done:

• No, an MRMC comparative effectiveness study was not done. The document explicitly states: "Clinical testing was not necessary to determine substantial equivalence..."

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

• Not applicable. The device is a physical knee implant system, not a software algorithm.

7. The type of ground truth used:

• For the non-clinical testing, the "ground truth" is established by the specified ASTM standards and the performance of the predicate device (Stryker Triathlon® CS and Corin Unity Total Knee System CR tibial insert). The device's performance is compared against these engineering and material benchmarks to claim substantial equivalence.

8. The sample size for the training set:

• Not applicable. This is not a machine learning model, so there is no training set.

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

• Not applicable.

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