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Electroencephalograph (EEG) needle electrodes are needles intended to be inserted into the subdermal tissue of the scalp to sense the minute electrical signals (waveforms) of the brain. This device is an accessory to the electroencephalograph machine, which is for use in connection with neurological studies. EEG electrodes are indicated for use by or on the order of a licensed physician and intended for single patient use, only.

Disposable EEG Needle Electrode

This document is an FDA 510(k) clearance letter for a medical device: a Disposable EEG Needle Electrode. It primarily focuses on the regulatory determination of substantial equivalence to a predicate device.

Therefore, the document does not contain information about acceptance criteria, device performance studies, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth establishment for a new device.

The letter states that the FDA has "reviewed your Section 510(k) premarket notification... and have determined the device is substantially equivalent... to legally marketed predicate devices." This means the manufacturer demonstrated that their device is as safe and effective as a device already on the market, usually by comparing its technological characteristics and intended use.

In summary, none of the requested information regarding acceptance criteria and device performance studies can be extracted from this document because it is a regulatory clearance letter, not a clinical study report or technical specification document.

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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.

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EEG Electrodes Model "445 Series" will be used to record the surface EEG potentials of the brain.

Not Found

This document is a 510(k) clearance letter from the FDA for EEG Electrodes Model "445 Series". It confirms that the device is substantially equivalent to legally marketed predicate devices. However, this type of document typically does not contain the detailed information about acceptance criteria or a study proving device performance as requested.

510(k) submissions primarily focus on demonstrating substantial equivalence to a predicate device, and while they include performance data, the public letter does not detail the specific acceptance criteria, study methodologies, or outcomes in the granular way you've asked for.

Therefore, I cannot extract the following information from the provided text:

1. A table of acceptance criteria and the reported device performance: This is not present.
2. Sample sizes used for the test set and data provenance: This is not present.
3. Number of experts used to establish ground truth and their qualifications: This is not present.
4. Adjudication method: This is not present.
5. MRMC comparative effectiveness study details (effect size): This is not present.
6. Standalone performance study details: This is not present.
7. Type of ground truth used: This is not present.
8. Training set sample size: This is not present.
9. How ground truth for the training set was established: This is not present.

The document only states the device name ("EEG Electrodes Model "445 Series"") and its intended use ("to record the surface EEG potentials of the brain"). It also confirms the regulatory class (II) and product code (GXY).

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