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The Katecho external electrodes are indicated for use in external pacing, defibrillation, cardioversion and monitoring applications as a non-sterile, disposable device for single patient use only. The KDP-85 Electrodes provide the conductive interface between the defibrillator and/or the external transcutaneous (noninvasive) cardiac pacemaker and the patient's skin. The electrode is intended for use on adult patients. When a patient requires defibrillation, cardioversion or external pacing, these electrodes will be applied to the patient and connected to the instrument. This device is intended for use on defibrillators whose output is classified as low power (360 joule maximum). The Katecho KDP-85 Defib/Pace Electrodes are designed for, and to be used, with Agilent Technologies defibrillation devices.

Katecho KDP-85 Adult Defib/Pace Multifunction Electrode. The Katecho external electrodes are indicated for use in external pacing, defibrillation, cardioversion and monitoring applications as a non-sterile, disposable device for single patient use only. The KDP-85 Electrodes provide the conductive interface between the defibrillator and/or the external transcutaneous (noninvasive) cardiac pacemaker and the patient's skin.

I am sorry, but based on the provided text, there is no information about acceptance criteria, device performance, or any studies conducted on the Katecho KDP-85 Adult Defib/Pace Electrodes. The document is a 510(k) clearance letter from the FDA, which primarily states that the device is substantially equivalent to legally marketed predicate devices and outlines the regulatory requirements for marketing it. It does not contain details about performance studies, sample sizes, ground truth establishment, or expert reviews.

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The Katecho External Electrodes are indicated for use in external pacing, defibrillation and monitoring applications as a non-sterile, disposable device for single patient use only. The KDP-80 electrodes provide the conductive interface between the defibrillator and/or the external transcutaneous (noninvasive) card1ac pacemaker and the patients skin. The electrode is intended for use on adult patients. When a patient requires defibrillation, cardioversion or external pacing, these electodes will be applied to the patient and connected to the instrument. This device is intended for use on defibrillators whose output is classified as low power (360 Joule maximum). The Katecho KDP-80 Defilb/Pace Electrodes are designed for, and to be used interchangeably with Physio Control Defibrillation Devices that use Quik Combo Electrodes.

KATECHO KDP-80 Defib/Pace Electrodes

I'm sorry, but without further context or additional documents, I cannot provide a detailed description of the acceptance criteria and the study that proves the device meets them. The provided text is a 510(k) clearance letter from the FDA for the "K-Defib/Pace Adult Electrode, Model KDP-80."

While the letter states that the device is "substantially equivalent" to legally marketed predicate devices, it does not contain the acceptance criteria, study details, or performance results that would allow me to populate the table and answer the specific questions you've asked. The letter confirms clearance based on a determination of substantial equivalence, which is a regulatory pathway, but it doesn't elaborate on the underlying performance data.

To provide the requested information, I would need access to the actual 510(k) submission or supporting performance studies conducted by Katecho, Inc.

Therefore, I cannot fulfill your request at this time.

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The Katecho External Radiolucent electrode is indicated for use in external Pacing, Defibrillation and Monitoring applications as a non-sterile, disposable device, for single patient use, only. The KRT-60 Radiolucent electrode provides the conductive interface between the defibrillator and/or the external transcutaneous (noninvasive) cardiac pacemaker and the patients skin. The electrode is intended for use on adult patients.

When a patient requires defibrillation, cardioversion or external pacing, these electrodes will be applied to the patient and connected to the instrument. This device is intended for use on defibrillators whose output is classified as low power (360 Joule maximum).

This device has been tested to the ANSI/AAMI DF2-1996 standard for use with equipment: Laerdal, Heartstream, Marquette, Physio Control, Survivalink, First Medic, and Hewlett-Packard.

K-Defib/Pace Radio Lucent Adult Electrode Model KRT-60

This letter is a 510(k) premarket notification for the K-Defib/Pace Radio Lucent Adult Electrode Model KRT-60. It states that the device is substantially equivalent to legally marketed predicate devices. The document does not contain information about the acceptance criteria and the study proving the device meets said criteria. Therefore, I cannot answer the request.

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The Katecho "K-Defib/Pace Adult Electrode it is indicated for use in external Pacing. Defibrillation and Monitoring applications as a non-sterile, disposable device, for single patient use, only. The KDP-60 K-Defib/Pace Adult Electode provides the conductive interface between the defibrillator and/or the external transcutaneous (noninvasive) cardiac pacemaker and the patients skin. The electrode is intended for use on adult patients.

When a patient requires defibrillation or external pacing these electrodes will be applied to the patient and connected to the instrument. This device is intended for use on defibrillators whose output is classified as low power (360 Joulc maximum).

This device has been tested to the ANSI/AAMI DIF39-1993 standard for use with equipment by the following manufacturers; Laerdal, Heartstream, Marquette, Physio Control, Survivalink, First Medic, and Hewlett-Packard.

Not Found

This document is a 510(k) clearance letter for the "K-Defib/Pace Adult Electrode." It does not contain information about acceptance criteria or a study proving device performance in the context of an AI/ML medical device. Instead, it describes clearance based on substantial equivalence to predicate devices and adherence to a specific standard.

Therefore, I cannot provide the requested information. The document does not describe:

1. A table of acceptance criteria and reported device performance.
2. Sample size used for a test set, data provenance, or number of experts.
3. Adjudication method.
4. MRMC comparative effectiveness study.
5. Standalone algorithm performance.
6. Type of ground truth used.
7. Sample size for a training set.
8. How ground truth for a training set was established.

The document indicates that the device has been tested to the ANSI/AAMI DF39-1993 standard for use with equipment by specific manufacturers. This suggests compliance with an existing industry standard, rather than a novel study to establish performance against new acceptance criteria.

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