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The ECG electrodes is applied to surface of the body to transmit the electrical signal at the body surface to a processor that produce an electrocardiogram or vectorcardiogram. For single patient use only. The electrode is designed for measuring ECG under Anaesthesia.

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This is a 510(k) premarket notification for an ECG Electrode and not a clinical study report. Therefore, the detailed information requested regarding acceptance criteria, device performance, and study methodology is not available in the provided text. The document primarily concerns the FDA's determination of substantial equivalence for marketing the device.

However, based on the information provided, we can infer some general aspects:

• Device: ECG Electrode for Anaesthesia use
• Purpose: To transmit electrical signals from the body surface to a processor for producing an electrocardiogram or vectorcardiogram.

The FDA's review in a 510(k) process primarily focuses on demonstrating that a new device is "substantially equivalent" to a legally marketed predicate device. This typically involves showing that the new device has the same intended use and the same technological characteristics as the predicate, or if there are differences, that those differences do not raise new questions of safety and effectiveness. This often relies on performance data comparing the new device to the predicate, but specific acceptance criteria and detailed study designs are usually found in the sponsor's submission, not the FDA's decision letter itself.

No study is described in this document that proves the device meets specific acceptance criteria as if it were a novel, higher-risk device requiring extensive clinical trials. The FDA's letter indicates a finding of "substantial equivalence" to a predicate device.

Given the limitations of the provided text:

1. A table of acceptance criteria and the reported device performance: Not available. The document is an FDA clearance letter, not a study report. For an ECG electrode, general performance criteria would relate to signal quality, impedance, adhesion, biocompatibility, and electrical safety, usually benchmarked against a predicate device.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): Not available.
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): Not applicable for an ECG electrode's 510(k) clearance, as "ground truth" in this context would likely refer to the accuracy of ECG signal transmission, not diagnostic interpretation by experts.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not available.
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: Not applicable. This device is an electrode, not an AI-powered diagnostic system.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This device is an electrode, not an algorithm.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc): For an ECG electrode, "ground truth" would generally refer to the accurate and clear transmission of the heart's electrical activity, often verified against established physiological standards and predicate device performance. Specific methodologies are not detailed here.
8. The sample size for the training set: Not available (training sets are more relevant for AI/machine learning models).
9. How the ground truth for the training set was established: Not applicable.

Summary based on available information:

The provided text is an FDA 510(k) clearance letter for an ECG electrode. It states that the device is "substantially equivalent" to legally marketed predicate devices. This means the manufacturer submitted information (likely including performance data) demonstrating that the ECG electrode for anesthesia use is as safe and effective as a previously cleared device. However, the specific details of that submitted data, including acceptance criteria, study design, sample sizes, and expert involvement, are not contained within this document.

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The Neuroline Subdermal Needle Electrode is intended for use with recording, monitoring and stimulation equipment for the purpose of recording of biopotential signals for example: Electromyography (EMG), Electroencephalograph (EEG) and Nerve potentials signals. The electrodes are sterile and for single patient use only.

Not Found

The provided document is a 510(k) clearance letter from the FDA for the Neuroline Subdermal Needle Electrode. This type of letter declares substantial equivalence to a predicate device and permits marketing. It is not a study report or a summary of acceptance criteria and performance data.

Therefore, the requested information (acceptance criteria, device performance table, sample sizes, expert qualifications, adjudication methods, details of comparative effectiveness studies, ground truth establishment, training set size) is not available within this document.

The document primarily focuses on regulatory approval based on substantial equivalence, rather than detailing the technical specifications and clinical study results that would typically contain the information you've requested.

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Ask a specific question about this device

Ask a specific question about this device

The ECG electrode is applied to the surface of the body to transmit the electrical signal at the body surface to a processor that produce an electrocardiogram or vectorcardiogram. For single patient use only. The electrode is designed for resting ECG.

Not Found

This document is a 510(k) premarket notification letter from the FDA regarding the "Blue Sensor SUPtab ECG Electrode." It indicates that the device has been found substantially equivalent to a legally marketed predicate device.

However, the provided text DOES NOT contain specific information about acceptance criteria or a study proving the device meets acceptance criteria.

The document primarily focuses on:

• The FDA's determination of substantial equivalence (K983689).
• The regulatory classification of the device (Class II).
• The general controls provisions of the Act that apply.
• The allowed indications for use (transmitting electrical signals for ECG/vectorcardiogram, for single patient use, designed for resting ECG).
• Contact information for further regulatory advice.

Therefore, I cannot extract the requested information (acceptance criteria, device performance, study details, sample sizes, expert qualifications, etc.) from this document. This kind of detail would typically be found in the 510(k) submission itself, which is not provided here.

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Recording muscle activity for Electromyography (EMG) applications. For single patient use only.

Neuroline, Disposable Concentric Needle Electrode

The provided document is a 510(k) clearance letter from the FDA for a device called "Neuroline, Disposable Concentric Needle Electrode." It states that the device is substantially equivalent to legally marketed predicate devices.

However, this document does not contain any information regarding acceptance criteria, device performance studies, sample sizes, expert qualifications, or ground truth establishment relevant to an AI/ML device performance study. It is a regulatory clearance document for a physical medical device.

Therefore, I cannot fulfill your request for the specific information points as they are not present in the provided input.

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Ask a specific question about this device