Search Results

Measure and analyze 3D position and movement by placing markers on the knees of patients whose movement function is to be assessed.

The KneeKG measures and analyzes the 3D position and movement of electromagnetic markers placed on the knee of patients whose movement function is to be assessed. The movement data are acquired into a host PC which then analyses and displays the data on graphs and printed reports.

The provided text is a 510(k) summary for the KneeKG device. While it describes the device, its intended use, and comparison to predicate devices, it does not contain any information about acceptance criteria or a study that proves the device meets those criteria.

The document is a submission to the FDA for market clearance, stating that the device is substantially equivalent to predicate devices. This type of submission typically focuses on demonstrating equivalence rather than presenting detailed performance studies against specific acceptance criteria.

Therefore, I cannot fulfill the request to describe the acceptance criteria and the study proving the device meets them based on the provided text. The following points represent the missing information:

1. A table of acceptance criteria and the reported device performance: Not available.
2. Sample size used for the test set and the data provenance: Not available.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not available.
4. Adjudication method for the test set: Not available.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and the effect size: Not available.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable, as this is a physical measurement device, not an AI/algorithm-only product.
7. The type of ground truth used: Not available.
8. The sample size for the training set: Not applicable, as this is a physical measurement device and not described as relying on a "training set" in the context of machine learning.
9. How the ground truth for the training set was established: Not applicable.

Ask a specific question about this device