(50 days)
Electromyographic (EMG) needle electrodes are intended to be placed into the muscle or nerve tissue to sense bioelectrical signals. This monopolar needle is an accessory to the electromyography machine, which is used for assessing a series of skeletal muscles. EMG electrodes are for use under the proper direction of a licensed physician and intended for single patient use, only.
Detachable Monopolar EMG Needle Electrode
The provided document is a 510(k) clearance letter from the FDA for a Detachable Monopolar EMG Needle Electrode. This letter is a regulatory document and does not contain information about studies proving the device meets acceptance criteria in the way typically found in a scientific publication or a detailed submission like a PMA.
Therefore, most of the requested information regarding acceptance criteria, study details, sample sizes, expert qualifications, and ground truth establishment cannot be extracted from this document. The FDA's 510(k) clearance process focuses on demonstrating 'substantial equivalence' to a predicate device, rather than detailed performance studies and acceptance criteria as would be required for a novel device or a PMA.
Here's what can be gathered based on the document and the nature of a 510(k) submission:
1. A table of acceptance criteria and the reported device performance
- Cannot be extracted. This document does not specify performance acceptance criteria or report device performance data. A 510(k) submission primarily relies on demonstrating that the new device has the same intended use and technological characteristics as a legally marketed predicate device, or that any differences do not raise new questions of safety and effectiveness. Typically, performance data submitted for a 510(k) are bench tests or limited clinical data demonstrating equivalence, not extensive studies against detailed acceptance criteria.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Cannot be extracted. This information is not present in the FDA clearance letter. Any testing data would have been part of the 510(k) submission, not the clearance letter itself.
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)
- Cannot be extracted. This document does not describe any human-read ground truth establishment.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Cannot be extracted. This document does not describe any test set or adjudication.
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
- Highly unlikely, and not mentioned. The device is a "Detachable Monopolar EMG Needle Electrode." This is a physical medical instrument used to record bioelectrical signals during electromyography. It is not an AI-powered diagnostic imaging device. Therefore, an MRMC study comparing human readers with and without AI assistance is irrelevant and was almost certainly not performed or submitted for this type of device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable and not mentioned. As stated above, this is a physical medical device, not an algorithm or AI system.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Cannot be extracted. This document does not describe any ground truth methodology. For a device like an EMG needle, performance is typically assessed by electrical characteristics, biocompatibility, sterility, and mechanical integrity, rather than a diagnostic "ground truth" in the sense of an imaging or diagnostic algorithm.
8. The sample size for the training set
- Not applicable and not mentioned. This is a physical medical device, not a machine learning model requiring a training set.
9. How the ground truth for the training set was established
- Not applicable and not mentioned. As above, this is not an AI/ML device.
In summary: The provided FDA 510(k) clearance letter confirms that the Detachable Monopolar EMG Needle Electrode has been found substantially equivalent to a predicate device. It does not contain the detailed study information, acceptance criteria, or performance data that would typically be part of a scientific publication or a more comprehensive regulatory submission like a PMA, especially for a device that is not an AI/ML diagnostic.
§ 882.1350 Needle electrode.
(a)
Identification. A needle electrode is a device which is placed subcutaneously to stimulate or to record electrical signals.(b)
Classification. Class II (performance standards).