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1. Painful and disabled knee joint resulting from osteoarthritis, rheumatoid arthritis, r and "alsublished one or more compartments are involved.
2. Correction of varus, valgus, or posttraumatic deformity.
3. Correction or revision of possible of possible of failure of previous joint replacement procedure.

The device is a single use implant intended for implantation with bone cement.

The Maxim® Accel (Vanguard™) PS+ Bearing is intended to replace the articular portions of the knee joint. The system is posterior stabilized (PS) that limits axial and varus/valgus rotation.

This document is a 510(k) summary for the Maxim® Accel (Vanguard™) PS+ Bearings, a knee implant device. It does not contain information about acceptance criteria or a study proving the device meets acceptance criteria in the way a clinical study for an AI/ML device would. Instead, it focuses on demonstrating substantial equivalence to a predicate device through non-clinical testing.

Here's an analysis based on the provided text, highlighting the absence of the requested information:

1. A table of acceptance criteria and the reported device performance

• Not provided. This document is a 510(k) summary, which focuses on demonstrating "substantial equivalence" to a predicate device rather than presenting specific performance metrics against pre-defined acceptance criteria from a clinical trial.
• The "Non-Clinical Testing" section states, "Non-clinical laboratory testing was performed to determine substantial equivalence. The results indicated that the device was functional within its intended use." This is a general statement, not a table of criteria and performance.

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)

• Not applicable / Not provided. Since no clinical testing was performed or reported as a basis for substantial equivalence, there is no clinical "test set" in the context of human data. The testing mentioned is "non-clinical laboratory testing."

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)

• Not applicable / Not provided. This information pertains to studies where human expert consensus is used to establish ground truth for evaluating a device's performance, typically in diagnostic or prognostic AI/ML applications. This is not reported for this medical device submission.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set

• Not applicable / Not provided. As no clinical test set using human data and requiring ground truth adjudication is mentioned, this information is not relevant to this document.

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, an MRMC study was NOT done. This type of study is relevant for evaluating the impact of AI on human performance, often in diagnostic imaging. This submission deals with a physical implant, not an AI/ML diagnostic tool.

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

• Not applicable. This question pertains to the performance of an algorithm without human intervention, again typically for AI/ML devices. This submission concerns a physical knee implant.

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

• Not applicable / Not provided for clinical ground truth. For the "Non-Clinical Testing," the "ground truth" would be the engineering specifications and performance benchmarks for mechanical equivalence. The document states "The results indicated that the device was functional within its intended use," implying it met engineering and functional requirements compared to the predicate.

8. The sample size for the training set

• Not applicable / Not provided. The concept of a "training set" applies to machine learning models, which are not involved in this 510(k) submission for a physical knee implant.

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

• Not applicable / Not provided. Similar to point 8, this question is for AI/ML device development and is not relevant to this document.

In summary: The provided document is a 510(k) summary for a knee implant, which demonstrates substantial equivalence primarily through non-clinical laboratory testing. It does not contain the kind of clinical study data, acceptance criteria, or ground truth establishment details requested, which are typically found in submissions for diagnostic devices, especially those utilizing AI/ML. The basis for clearance is the demonstration that the modified device (Maxim® Accel (Vanguard™) PS+ Bearings) is as safe and effective as the previously cleared predicate device (Maxim® Accel Knee System - K023546) through non-clinical testing.

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