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1. Painful and disabled knee joint resulting from osteoarthritis, rheumatoid arthritis, or traumatic arthritis where one or more compartments are involved.
2. Failure of previous joint replacement procedure.
3. Correction of varus/valgus or post-traumatic deformity.
4. Correction or revision of unsuccessful osteotomy, or arthrodesis.
   . Device designed for use in patients with metal sensitivity.
   Standard surgical and rehabilitative procedures are indicated with this device. .
   . The device is a single-use device intended for use with bone cement.

The Vanguard™ Knee System Titanium Femoral Components have the same design as the predicate Vanguard™ femoral knee components originally cleared as the Maxim® Accel Knee System femoral components. The difference in material offers the opportunity for total knee replacement to those patients with metal sensitivity to the nickel element of the predicate Co-Cr-Mo Cobalt - Chromium alloy femoral knee components.

The provided 510(k) summary for the Biomet Vanguard™ Knee System Titanium Femoral Components does not describe acceptance criteria or a study proving the device meets them in the context of typical AI/software device evaluation metrics (e.g., sensitivity, specificity, AUC).

Instead, this document is a premarket notification for a medical device (a knee implant) that emphasizes "substantial equivalence" to predicate devices. The "testing" mentioned refers to non-clinical laboratory testing to ensure the device is functional for its intended use, rather than a clinical trial or performance study against specific acceptance criteria in the manner of AI/imaging diagnostics.

Here's a breakdown based on the information provided and what is missing:

1. Table of Acceptance Criteria and Reported Device Performance

Missing: Specific quantitative performance metrics (e.g., wear rates, mechanical strength thresholds, clinical outcomes) and numerical results demonstrating compliance with those thresholds. The document states "Non-clinical laboratory testing was performed to determine substantial equivalence," but does not detail the specific tests, their acceptance criteria, or the explicit results.

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

• Test Set Sample Size: Not applicable/Not provided. The document refers to "non-clinical laboratory testing," which would typically involve physical samples of the device undergoing mechanical or material tests, not a "test set" of patient data.
• Data Provenance: Not applicable/Not provided.

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

• Not applicable. No "ground truth" established by experts in the context of diagnostic performance is mentioned. The assessment is based on non-clinical engineering and material science evaluations.

4. Adjudication method for the test set

• Not applicable.

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

• No. This type of study is not mentioned as it is typically relevant for diagnostic imaging devices or algorithms where human interpretation is involved.

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

• Not applicable. This device is a physical knee implant, not an algorithm.

7. The type of ground truth used

• The "ground truth" here would be the physical and mechanical properties of the device meeting engineering specifications and biocompatibility requirements. This would be established by standard engineering and material science testing methods (e.g., ASTM standards), not by expert consensus, pathology, or outcomes data in the way typically associated with AI/diagnostic devices.

8. The sample size for the training set

• Not applicable. There is no training set for this type of physical medical device.

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

• Not applicable.

Summary of what the document focuses on instead:

The core of this 510(k) submission is to demonstrate substantial equivalence to already legally marketed predicate devices. This means the manufacturer shows that the new device has the same intended use, indications for use, and technological characteristics, or if there are differences, that those differences do not raise new questions of safety and effectiveness.

• The primary "study" mentioned is non-clinical laboratory testing to ensure the device is functional.
• Clinical testing was explicitly not provided as a basis for substantial equivalence. This is a common aspect of 510(k) submissions where substantial equivalence can be demonstrated through non-clinical data and comparisons to predicate devices.
• The key finding stated is that "The results indicated that the device was functional within its intended use." This is the broad "acceptance criterion" that the non-clinical testing aimed to meet.

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