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The EP-WorkMate® system with an EP-4 stimulator is intended to be used for diagnostic electrical stimulation of the heart for the purpose of refractory measurements, initiation and termination of tachy-arrhythmias, measurements of electrical conduction, and arrhythmia mapping.

MapMate™ is indicated for use during clinical electrophysiology procedures.

This application describes a modification to the EP-WorkMate® system that will be offered as an option to customers under the name MapMate™. MapMate™ is comprised of a software module and an electronic interconnection between the EPMedSystems EP-WorkMate® and the BioSense Webster CARTO™ XP Navigation System computer. When the MapMate™ option is utilized, clinicians enter patient data in one system instead of two. A procedure log is created containing the list of map points along with the EP signals. Therefore, valuable time and attention are conserved in the busy EP lab enabling clinicians to focus on the EP case.

The provided text is a 510(k) Summary for the EP-WorkMate® with MapMate™ device. It describes the device, its intended use, and indications for use, but does not contain information about acceptance criteria or a study proving the device meets acceptance criteria.

Therefore, I cannot provide the requested table and study details from the input text. The document focuses on establishing substantial equivalence to predicate devices, which is common for 510(k) submissions, rather than presenting detailed performance study results against specific criteria.

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The EP Deflectable Catheters are designed for one time single patient use for temporary use in electrophysiology studies. Models can be use in conjunction with EPMedSystems' EP Workmate.

EP Deflectable Catheters

I am sorry, but based on the provided document, there is no information available regarding acceptance criteria or a study that proves the device meets those criteria.

The document is a 510(k) clearance letter from the FDA for the "EP Deflectable Catheter." This letter primarily addresses the substantial equivalence of the device to legally marketed predicate devices, allowing it to proceed to market. It does not contain details about the specific performance metrics, clinical studies, or acceptance criteria that would typically be required to answer your request.

Therefore, I cannot provide:

1. A table of acceptance criteria and the reported device performance.
2. Sample size used for the test set and the data provenance.
3. Number of experts used to establish the ground truth for the test set and their qualifications.
4. Adjudication method.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, or its effect size.
6. If a standalone performance study was done.
7. The type of ground truth used.
8. The sample size for the training set.
9. How the ground truth for the training set was established.

To obtain this kind of information, you would typically need to consult the original 510(k) submission, scientific publications about the device, or contact EPMedSystems directly.

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The EP-WorkMate® Computerized Electrophysiology Recording System is intended for use during clinical electrophysiology procedures.

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I am sorry, but the provided text is a letter from the FDA regarding 510(k) clearance for a device named "EP WorkMate Computerized Electrophysiology Recording System". It states that the device is substantially equivalent to legally marketed predicate devices and outlines general regulatory information.

However, this document does not contain any information about acceptance criteria, device performance metrics, study designs, sample sizes, ground truth establishment, or expert qualifications. Therefore, I cannot fulfill your request to describe these aspects of a study.

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