(201 days)
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:
- A table of acceptance criteria and the reported device performance: Not available.
- Sample size used for the test set and the data provenance: Not available.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not available.
- Adjudication method for the test set: Not available.
- If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and the effect size: Not available.
- 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.
- The type of ground truth used: Not available.
- 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.
- How the ground truth for the training set was established: Not applicable.
§ 890.5360 Measuring exercise equipment.
(a)
Identification. Measuring exercise equipment consist of manual devices intended for medical purposes, such as to redevelop muscles or restore motion to joints or for use as an adjunct treatment for obesity. These devices also include instrumentation, such as the pulse rate monitor, that provide information used for physical evaluation and physical planning purposes., Examples include a therapeutic exercise bicycle with measuring instrumentation, a manually propelled treadmill with measuring instrumentation, and a rowing machine with measuring instrumentation.(b)
Classification. Class II (special controls). The device, when it is a measuring exerciser or an interactive rehabilitation exercise device for prescription use only, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 890.9.