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Ambu General Purpose Disposable ECG Electrodes are intended for use in all Standard ECG Applications. Electrodes are made for single patient use only.

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This is a 510(k) premarket notification for a medical device (Ambu Disposable ECG Electrode) and as such, it does not typically contain detailed studies with acceptance criteria and performance metrics in the same way a clinical trial report would for a novel device. The primary purpose of a 510(k) is to demonstrate substantial equivalence to a legally marketed predicate device.

Therefore, many of the requested fields cannot be directly answered from the provided text. However, I can extract the information that is present and explain why other information is not available.

Here's a breakdown based on the provided document:

1. A table of acceptance criteria and the reported device performance

This document (510(k) summary) does not include a direct table of acceptance criteria and reported device performance for a study. The 510(k) process primarily relies on demonstrating substantial equivalence to a predicate device, which usually involves comparing design, materials, indications for use, and performance characteristics. The performance is typically demonstrated through bench testing and often, but not always, limited clinical testing, which are then compared to the predicate device's known performance. The specific performance data and criteria would be in the full submission, not usually in the publicly available summary.

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 in the provided document. A 510(k) summary typically doesn't detail the sample size or provenance of specific test data unless it's a critical part of demonstrating substantial equivalence for a novel aspect. It's likely that a variety of bench tests were performed on a sample of electrodes, but specifics are not mentioned.

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/available. For an ECG electrode, ground truth for performance is established through objective electrical and biocompatibility testing (e.g., impedance, adhesion, irritation) against established standards or predicate device performance, not typically by expert review of "truth" in the same way an imaging AI algorithm would be.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable/available. Adjudication methods are typically used in studies where human interpretation of medical data is being evaluated, such as in imaging or clinical diagnoses. For an ECG electrode, objective test results are generally compared to pre-defined thresholds or predicate device results.

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. MRMC studies, especially those involving AI assistance, are relevant for diagnostic devices that interpret complex data, such as imaging. An ECG electrode is a passive measurement device; it doesn't "interpret" data in a way that would involve human readers or AI assistance in this context.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. There is no algorithm in the "Ambu Disposable ECG Electrode" to perform standalone analysis. It is a physical device used to acquire physiological signals.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

The "ground truth" for an ECG electrode would generally refer to specific performance metrics established through validated testing methods, such as:

• Electrical Performance: Impedance, DC offset, combined offset instability, defibrillation overload recovery (as per ANSI/AAMI EC12:2000 standard).
• Adhesion: Adhesion strength over time.
• Biocompatibility: Absence of cytotoxicity, irritation, sensitization (as per ISO 10993 standards).

These "ground truths" are verified through standardized bench tests and potentially limited human use studies for skin irritation, but not through expert consensus on diagnostic interpretation or pathology, as the device doesn't make a diagnosis. The document does not specify which of these were used or the details of the testing.

8. The sample size for the training set

Not applicable. This device does not use an algorithm that requires a "training set" in the machine learning sense.

9. How the ground truth for the training set was established

Not applicable. As there is no training set for an algorithm, there is no ground truth established for it.

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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 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.

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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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LMI Medical considers their ElectroBlue® ECG Electrodes to be safe and effective for use with electrocardiograph monitors which are used for recording the electric activity of the myocardium to detect abnormal transmission of small electrical impulses through the conductive tissue surrounding the heart, when used according to the intended procedures as related in the instructions accompanying the product. The function of the LMI Medical ElectroBlue® Electrodes is to detect and transmit these small electrical impulses to the electrocardiograph monitors where they are processed and plotted.

The products are all the same in their construction using medical grade foam, polypropylene cloth, clear vinyl, medical grade adhesive, silver coated carbon loaded ABS snaps, and a conductive hydrogel with a polyurethane cover release liner.

This document is a 510(k) Premarket Notification for ElectroBlue® ECG Electrodes. It describes the safety and effectiveness of the device by comparing it to an established standard and existing market products.

Here's an analysis of the provided text based on your request:

1. A table of acceptance criteria and the reported device performance

2. Sample size used for the test set and the data provenance

The document does not explicitly state the sample size used for the test set (i.e., the number of ElectroBlue® ECG Electrodes tested). It also does not provide details on the data provenance (e.g., country of origin, retrospective or prospective nature of the testing). It only states that the "results are on file at LMI Medical."

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This information is not applicable and not provided. The "ground truth" for this device's performance is established by meeting the objective, standardized physical and biological requirements outlined in the ANSI/AAMI EC12-1991 standard, not by expert consensus on interpretations of data.

4. Adjudication method for the test set

Not applicable. As mentioned above, the performance is measured against objective standards, not subject to expert adjudication.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This type of study is typically used for diagnostic devices where human interpretation is involved. For ECG electrodes, the effectiveness is determined by their adherence to electrical and biological performance standards.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done

This question is not applicable to an ECG electrode. An ECG electrode is a passive device; it does not have an "algorithm" or standalone "performance" in the sense of AI or software. Its performance is measured by its material properties and ability to conduct electrical signals and be biologically safe.

7. The type of ground truth used

The "ground truth" for demonstrating the device's safety and effectiveness is compliance with the established technical and biological performance requirements of the ANSI/AAMI standard EC12-1991. This standard specifies objective, measurable criteria for various aspects like electrical performance, biological response, and packaging/shelf life.

8. The sample size for the training set

This concept is not applicable to the evaluation of this device. A "training set" is relevant for machine learning algorithms. The ElectroBlue® ECG Electrodes are physical medical devices, and their performance is proven through direct testing against a standard.

9. How the ground truth for the training set was established

Not applicable. As explained above, there is no "training set" in the context of this device's evaluation.

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