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• Osteoarthritis, rheumatoid arthritis or traumatic arthritis 1.
• Failure of a previously failed joint replacement procedure 2.
• Correction of varus, valgus or post-traumatic deformity 3.
• Correction or revision of unsuccessful osteotomy or arthrodesis 4 .
  The device is intended for use with bone cement (USA)

The AGC V2 Revision Knee System is an extension of Biomet's knee families. Specifically, the devices are similar to the AGC Primary Knee cleared through 510(k) K833921, the AGC Revision (posterior stabilized) Knee cleared through 510(k) K912245 and Maxim Knee System cleared through K915132. The device consists of a femoral component with modular stems that articulates with a one-piece tibial component. The AGC V2 system employs Biomet's standard all polyethylene patella button.
Unique features of the AGC V2 System included the femoral stem angle being built into the stem itself rather than the boss of the femoral component like other systems. The device expands Biomet's existing AGC product line by providing a device with more constraint than current components and additional augments for the femoral component.
The AGC V2 tibial component provides a one-piece molded component with a high post posterior stabilized option. Pegs on the bottom of the tray provide stability for the augmentations.

This document focuses on the substantial equivalence of the AGC V2 Revision Knee System to previously cleared devices, rather than presenting a study with specific acceptance criteria and performance data. The FDA 510(k) approval process for devices like this typically relies on demonstrating that the new device is as safe and effective as a legally marketed predicate device, rather than on new clinical performance studies with predefined acceptance criteria.

Therefore, many of the requested elements for a detailed study description are not available in the provided text.

Based on the provided text, here's what can be inferred:

1. Table of acceptance criteria and reported device performance:

This information is not provided in the document. The document primarily focuses on establishing "substantial equivalence" to predicate devices, not on presenting specific performance metrics against defined acceptance criteria.

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

This information is not provided. The document does not describe a "test set" in the context of a performance study.

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

This information is not provided. The concept of "ground truth" established by experts for a test set is not applicable to this type of submission.

4. Adjudication method for the test set:

This information is not provided.

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:

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not conducted. This device is a knee implant, not an AI-assisted diagnostic tool.

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

No, a standalone algorithm-only performance study was not done. This device is a physical knee implant.

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

The concept of "ground truth" as it relates to evaluating an algorithm's performance is not applicable here. Instead, the "truth" for this regulatory submission is the established safety and effectiveness of the predicate devices to which the AGC V2 Revision Knee System is compared.

8. The sample size for the training set:

This information is not provided. There is no mention of a "training set" in the context of a machine learning model.

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

This information is not applicable as there is no training set for a machine learning model.

Summary regarding acceptance criteria and studies:

The provided K984054 document is a 510(k) premarket notification for a medical device (AGC V2 Revision Knee System). The core of a 510(k) submission is to demonstrate substantial equivalence to a device already legally marketed in the U.S. (a predicate device). This process typically involves:

• Comparison of technological characteristics: Showing that the new device has similar design, materials, and operational principles to the predicate.
• Discussion of intended use: Confirming the new device's indications for use are the same as or comparable to the predicate.
• Performance data (often non-clinical): This might include bench testing, mechanical testing, or material characterization to show that the device performs as intended and is as safe and effective as the predicate. In this case, the document states, "In function and overall design, Biomet's AGC V2 Revision Knee System is equivalent to almost all knee components on the market."

The document lists several Biomet knee systems as comparators (predicate devices):

• AGC 2000 Total Knee Prosthesis (K833921)
• AGC Revision Knee Prosthesis (K912245)
• MCK (Maxim) Knee System (K915132)

The "study" in this context is the comparison to these predicate devices to establish substantial equivalence. Specific quantitative acceptance criteria for clinical performance are generally not a requirement for this type of 510(k) pathway, as the safety and effectiveness are established by reference to the predicate.

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