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The EP-4 Cardiac Stimulator is indicated for use during clinical cardiac electrophysiology procedures. The EP-4 Cardiac Stimulator is intended to be used for diagnostic electrical stimulation of the heart for the purpose of refractory measurements, initiation and termination of tachyarrhythmias, and measurements of electrical conduction.

The EP-4 Cardiac Stimulator consists of a touch-screen computer, an AC-powered stimulation module, which provides electrical stimulation to the heart during electrophysiology case studies. The EP-4 consists of a touch-screen computer that controls a two- or four-channel AC-powered stimulation module, and a keyboard. The stimulator is capable of performing single channel, simultaneous, or sequential stimulation at programmed output settings using existing/predicate programmed protocols. The device is independent and self-contained, with the exception of marker outputs and an external sync input connector. It can be configured as a stand-alone system or in conjunction with the EP-WorkMate™ Recording System. It may also be used with other EP recording systems.

The provided document is a 510(k) premarket notification for the EP-4™ Cardiac Stimulator, which is an external programmable pacemaker pulse generator. The purpose of this submission is to demonstrate substantial equivalence to a predicate device, the EP-4™ Clinical Stimulator (K040207).

The document does not contain acceptance criteria in terms of numerical performance metrics (e.g., sensitivity, specificity, accuracy, or specific physiological parameters with defined thresholds) or a formal study designed to "prove" the device meets such criteria through a statistical analysis against a ground truth.

Instead, the submission focuses on demonstrating substantial equivalence to a predicate device. This is a regulatory pathway where a new device is shown to be as safe and effective as a legally marketed device that is not subject to premarket approval (PMA). The "study" described is primarily bench testing to confirm that design changes did not adversely affect safety or efficacy.

Here's a breakdown of the requested information based on the provided text, highlighting what is present and what is not:

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

   The document does not provide a table of acceptance criteria with numerical performance metrics. The "acceptance criteria" in the context of this 510(k) submission are implicitly tied to demonstrating that the EP-4 Cardiac Stimulator is "substantially equivalent" to its predicate device (EP-4 Clinical Stimulator).

   The reported "performance" is described qualitatively:

   • "Bench testing was performed to confirm that the changes met design requirements and did not adversely affect the safety or efficacy of the product."
   • "Where design differences exist between the proposed device and the predicate device, performance testing demonstrated that these differences do not adversely affect the device's safety and effectiveness."
   • The device has the "same intended use and fundamental scientific technology" and "all technological characteristics... are substantially equivalent" to the predicate.

   No specific numerical performance values (e.g., stimulation accuracy within a certain mV or ms, battery life, etc.) that would typically be associated with explicit acceptance criteria are provided in this regulatory 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 applicable. The document describes "bench testing," which refers to laboratory testing of the device itself, not a clinical study involving patients or a dataset of patient data. Therefore, there is no "test set" in the context of patient data, nor is there information on data provenance.

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. As this was bench testing for substantial equivalence, clinical ground truth establishment in the traditional sense (e.g., by medical experts for diagnostic accuracy) was not the focus. The "ground truth" for bench testing would be engineering specifications and predicate device performance, verified by engineers and quality control personnel. No information on specific expert qualifications for this type of verification is provided.

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

   Not applicable, as there is no specific "test set" of patient data requiring clinical 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

   No. The EP-4 Cardiac Stimulator is a medical device for electrical stimulation, not an AI-assisted diagnostic tool. Therefore, an MRMC study and AI-related effectiveness are not relevant to this submission.

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

   Not applicable. This device is a hardware system with embedded software for cardiac stimulation, not an algorithm being tested in isolation. The device's functionality is inherently "standalone" in operation once programmed, but this is distinct from testing an AI algorithm's performance without human interaction.

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

   For bench testing, the "ground truth" would be established against the design requirements, engineering specifications, and performance characteristics of the predicate device. The goal was to confirm that the changes "met design requirements" and did not "adversely affect the safety or efficacy" when compared to the predicate. This is verified through a combination of standard engineering tests, electrical measurements, and functional checks.

8. The sample size for the training set

   Not applicable. The device's software is menu-driven and firmware-based, controlling stimulation functions. It's not described as a machine learning system that requires a "training set" in the AI sense. The software's development followed "St. Jude Medical's Quality System requirements" and "design controls requirements documented in 21 CFR 820.30," which dictate rigorous testing and verification, but not "training data" in the AI context.

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

   Not applicable, as there is no "training set" for an AI algorithm.

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The ViewMate® System is intended to be used to visualize cardiac structures and blood flow within the heart.

The ViewMate® System is indicated for use in adult and adolescent pediatric patients to visualize cardiac structures and blood flow within the heart.

The ViewMate® System is a portable, computerized, ultrasound imaging system used to display and capture intracardiac ultrasound images. The ViewMate® System is comprised of three components: ViewMate® console, patient isolation module and the ViewFlex® PLUS ultrasound catheter. The ViewMate® ultrasound console comprises a personal computer (PC), ultrasound imaging beam former and a digital frame grabber with storage. The system software is used to control imaging modes, image quality, image acquisition, storage, and retrieval of patient records (i.e., images, ECG, and notes). The system software enables multiple imaging modes: two dimensional (B mode and color Doppler) and time-motion mode (spectral Doppler/puise wave Doppler and M Mode) Additional software functionality includes zoom, labeling, image storage, retrieval and review. ViewMate® may be used in interventional cardiology, specifically in the interventional EP laboratory. The ViewMate® connects with an ultrasound catheter called ViewFlex® PLUS that is inserted into the heart via intravascular access. The ViewFlex® PLUS catheter is a single use, temporary, intracardiac ultrasound catheter indicated for use in adult and adolescent pediatric patients. The catheter shaft is 9 French, approximately 90 cm long, constructed of radio-opaque tubing. The catheter offers bi-directional steerability that can be manipulated with one hand. The catheter consists of a 64-element linear phased array, wideband transducer with an imaging frequency range of 4.5 MHz to 8.5 MHz, user-selectable magnification, 86° viewing angle on the ViewMate® I system and a viewing angle of 90° on the ViewMate® II system.

This document does not contain information about studies conducted to prove the device meets acceptance criteria. The document describes a 510(k) submission for a modification to an existing medical device, the ViewFlex® catheter, now branded as ViewFlex® PLUS. It focuses on the mechanical design changes, their reasons, and the fact that the ultrasound transducer, its performance, and the intended use/indications for use are not affected by these proposed changes.

Therefore, the requested information regarding acceptance criteria, study details, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, and ground truth establishment cannot be extracted from the provided text because no such studies are described for this modification.

The document primarily serves as a notification for modifications to a previously cleared device, asserting that the core functionality related to ultrasound imaging remains unchanged from the predicate device.

Key takeaway from the document: The submission explicitly states "No changes have been made to the ultrasound or electronics design of the catheter; the ultrasound transducer and its performance is not affected by the proposed changes." This implies that the performance characteristics relating to imaging (which would typically be evaluated against acceptance criteria) are assumed to be equivalent to the predicate device and no new studies are presented to re-evaluate them.

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The ViewMate® System is indicated for use in adult and adolescent pediatric patients to visualize cardiac structures and blood flow within the heart.

The ViewMate® System is a portable, computerized, ultrasound imaging system used to display and capture intracardiac ultrasound images. The ViewMate® System illustrated in Figure 1 is comprised of three components: ViewMate® console, patient isolation module and the ViewFlex™ ultrasound catheter.

The provided text is a 510(k) summary for a catheter modification, not a study report demonstrating acceptance criteria for a device's performance. Therefore, most of the requested information cannot be extracted directly from this document.

The document describes a modification to the ViewFlex™ catheter, which is part of the ViewMate® System. The primary purpose of this submission is to notify the FDA of mechanical design changes to the catheter, explicitly stating that "intended use and indications for use are not affected. No changes have been made to the ultrasound or electronics design of the catheter; the ultrasound transducer and its performance is not affected by the proposed changes."

The document details the device, its intended use, and the specific changes made to the catheter's materials and manufacturing process (e.g., replacement of PEBAX® with silicone, addition of Nitinol wire). It mentions that "EPMedSystems employed design controls, verification and validation in the design change process," but it does not provide a study or specific acceptance criteria for the performance of the device in terms of its ability to visualize cardiac structures and blood flow. The focus is on the mechanical properties and manufacturing improvements.

Therefore, I cannot provide a table of acceptance criteria and reported device performance or information about sample sizes, ground truth, expert qualifications, or MRMC studies, as these details are not present in this 510(k) summary.

Here's what can be extracted based on the document's content:

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

   • Not provided within this document. This document focuses on mechanical modifications and asserts that the "ultrasound transducer and its performance is not affected." It does not report specific performance metrics against acceptance criteria for visualization capabilities.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

   • Not provided within this document. The document mentions "verification and validation" but does not detail any specific clinical or performance testing, test set sizes, or data provenance.

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 provided within this document. There is no mention of expert involvement in establishing ground truth for a test set.

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

   • Not provided within this document.

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 provided within this document. This device is an imaging catheter, not an AI-assisted diagnostic tool.

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

   • Not provided within this document. This is not an algorithmic device.

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

   • Not provided within this document.

8. The sample size for the training set

   • Not provided within this document.

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

   • Not provided within this document.

Summary of what the document DOES provide:

• Device Name: ViewMate® System with ViewFlex™ Catheter
• Purpose of Submission: Premarket notification for mechanical modifications to the ViewFlex™ catheter.
• Key Modification Claims: Intended use and indications for use are not affected. Ultrasound transducer and its performance are not affected.
• Modifications:
  • Replace PEBAX® with silicone in distal transfer section.
  • Change transfer section adhesive to silicone adhesive Med1511.
  • Add silicone expander OS-10 for assembly with silicone.
  • Addition of Nitinol round wire (0.018 in.) in main shaft to maintain length and avoid kinking.
  • Modification of manufacturing steps for Nitinol wire.
  • Addition of Nitinol flat wire (0.005 x 0.020 in.) in distal bending section to maintain curvature after many deflections.
  • Modification of manufacturing steps for Nitinol wire.
• Stated Improvements from Modifications: Improve production yield and throughput, improve curvature distribution and bond strength of the transfer (bending) section, and stabilize the steering (deflection) range.
• Design Controls: EPMedSystems employed design controls, verification and validation in the design change process.

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The EP-WorkMate® is intended to be used with an EP-3 [K935590] or EP-4 {K0401442] stimulator for diagnostic electrical stimulation of the heart for the purpose of refractory measurements, initiation and termination of tachy-arrhythmias measurements of electrical conduction.

NurseMate™ with Physio Module is indicated for use during clinical electrophysiology procedures.

NurseMate™ with Physio Module is a simple modification to EP-WorkMate® with NurseMate™ that allows data from an OEM (Original Equipment Manufacturer) physiologic monitoring device (connected to NurseMate™) to be logged into the current EP-WorkMate® database. The benefit of this product is reduced manual data entry and improved data management. NurseMate™ with Physio Module PC workstation is connected to the EP-WorkMate® system; it may also be connected to an OEM physiologic monitor. Interconnection of NurseMate™ with Physio Module to a physiologic monitor is accomplished using a serial data cable. Use of an OEM physiologic monitoring device is not affected in any way by integration with NurseMate™; users follow the monitor's IFU and operate the device in accordance with its intended use.

Here's a breakdown of the acceptance criteria and study information for the NurseMate™ with Physio Module based on the provided 510(k) summary:

Acceptance Criteria and Reported Device Performance

The provided document is a 510(k) summary for a modification to an existing device (EP-WorkMate®) called NurseMate™ with Physio Module. A 510(k) summary primarily focuses on demonstrating substantial equivalence to a predicate device rather than presenting detailed clinical trial results with specific acceptance criteria and performance metrics in the way a PMA submission might.

Therefore, the "acceptance criteria" here are implicitly related to demonstrating that the modified device does not raise new questions of safety and effectiveness and performs as intended without adverse effects on patient care or data integrity. The performance reported is primarily functional.

• EP-WorkMate® (PC) to NurseMate™ (PC) connection: client-server operation, CAT 5 networking cable, TCP/IP protocol. NurseMate™ can issue start/stop recording commands to WorkMate®.
• NurseMate™ (PC) to EP-WorkMate® (Amp/SCU) connection: LAN connection hardware, Packet Driver protocol for viewing real-time EP waveforms.
• NurseMate™ (PC) to OEM Physiologic Monitor: standard serial cable, DB-9 to USB connectors, basic serial data communications protocol.
  The system is designed to allow independent charting and monitoring by a nurse while the physician controls the EP study. |
  | 3. Safety & Control: NurseMate™ with Physio Module does not interfere with the control or primary functions of the EP-WorkMate® or the OEM physiologic monitor. | "NurseMate™ with Physio Module does not control the patient monitor and it does not control cardiac stimulation."
  "NurseMate™ with Physio Module controls only start/stop recording in the EP-WorkMate®; it does not control any aspect of other devices interconnected with the EP-WorkMate®."
  "NurseMate™ with Physio Module does not control the OEM physiologic monitor in any way. NurseMate™ with Physio Module has no alarms or real time physiologic data display; these functions remain separately resident on the physiologic monitor."
  "Use of an OEM physiologic monitoring device is not affected in any way by integration with NurseMate™; users follow the monitor's IFU and operate the device in accordance with its intended use." |
  | 4. Maintenance of Intended Use: The device retains the intended diagnostic use of the predicate EP-WorkMate®. | The Indications for Use for NurseMate™ with Physio Module remains "indicated for use during clinical electrophysiology procedures," consistent with the original EP-WorkMate®. The modification is presented as an enhancement to workflow and data management rather than a change in diagnostic function. |
  | 5. Software and Hardware Equivalence: Software and hardware modifications are appropriately implemented and do not introduce new risks. | Software: "modified version of the EP-WorkMate® with NurseMate™ application software," using the same Microsoft Visual C++ 6.0 Integrated Development Environment. Program code was added, indicating high similarity.
  Hardware: "identical to that of the original NurseMate™ system; these were designed and built using similar PC technology employed in the EP-WorkMate®." Comprises standard PC components. |

Study Information:

This 510(k) summary describes a modification to an existing device, and the documentation provided does not detail a clinical study in the traditional sense (e.g., patient trials with statistically significant outcomes). Instead, it focuses on the design controls, verification, and validation processes used in integrating physiologic monitors with NurseMate™ with Physio Module to ensure the functional requirements outlined above are met and that the device remains substantially equivalent to its predicate.

1. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):

   • Not explicitly stated. The document refers to "design controls, verification and validation processes in the integration of physiologic monitors." This implies internal testing and validation of the software and hardware interfaces. No specific patient data test set or its provenance is mentioned as this device is an IT infrastructure modification for data handling, not a new diagnostic algorithm.

2. 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/not stated. As there isn't a specific diagnostic "ground truth" establishment in the context of a clinical study, this information is not provided. The "ground truth" for this type of submission would relate to the correct function and data integrity of the system during its operation.

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

   • Not applicable/not stated. Adjudication methods are typically used when there's a subjective assessment involved (e.g., image interpretation). This submission focuses on the functional performance and data integrity of a monitoring system interface, which would be verified through technical testing rather than expert adjudication of clinical outcomes.

4. 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:

   • No. An MRMC study is not mentioned as this device is not an AI-powered diagnostic tool, but rather a system for data capture and display that integrates with existing diagnostic equipment.

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

   • This is not an AI algorithm. The performance is assessed based on the correct functionality of the software and hardware interfaces within the broader clinical workflow. The device does not operate in a standalone diagnostic capacity.

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

   • The "ground truth" in this context would be the accurate and reliable transfer/logging of data from the OEM physiologic monitor to the EP-WorkMate® database, as well as the correct display of EP waveforms and the ability to initiate/stop recording. This would be established through technical verification and validation testing against specified functional requirements, likely involving engineering and clinical experts in system operation and data integrity, rather than a clinical ground truth like pathology.

7. The sample size for the training set:

   • Not applicable. This device is not an AI/machine learning model, so there is no "training set."

8. How the ground truth for the training set was established:

   • Not applicable. See above.

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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-WorkMate® with an EP-3 (K935590) or EP-4 (K041442) 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. The addition of NurseMate™ does not change intended use of the EP-WorkMate®.
Indications for Use Statement
EP-WorkMate® is indicated for use during clinical electrophysiology procedures. The addition of NurseMate™ does not change the indications for use.
NurseMateTM is indicated for use during clinical electrophysiology procedures.

This application describes a modification to the EP-WorkMate® computer that will be offered as an option to customers under the name NurseMate™. NurseMate™ is a PC (Personal Computer) workstation that when connected to the EP-WorkMate® system can be used for real-time patient charting, physiologic monitoring, and data analysis during electrophysiology (EP) studies.

The provided 510(k) summary for K063113 describes the NurseMate™, a modification to the EP-WorkMate® system. This document is focused on demonstrating substantial equivalence to a predicate device (EP-WorkMate® K994011) rather than a de novo submission. As such, the study described is primarily a comparison of functionalities and specifications to show that the new device, NurseMate™, does not introduce new safety or effectiveness concerns.

Therefore, the typical acceptance criteria and detailed study design (sample size, ground truth, expert adjudication, MRMC, standalone performance) that would be expected for a de novo submission or a device with new clinical claims are not explicitly present or elaborated upon in this 510(k) summary. The summary emphasizes that the addition of NurseMate™ does not change the intended use or indications for use of the EP-WorkMate®.

Summary of Information based on K063113:

1. Table of Acceptance Criteria and Reported Device Performance

Since this is a modification to an existing device (EP-WorkMate®) and the claim is that the NurseMate™ does not change intended use, the "acceptance criteria" revolve around demonstrating that the new functionalities of NurseMate™ do not negatively impact the safety and effectiveness established for the predicate device. The performance reported is primarily functional comparison.

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

• Not explicitly stated. The document describes the system's function and a functional comparison. It doesn't detail a specific "test set" in terms of subject data for performance claims. The comparison is primarily against the established functionalities and components of the predicate EP-WorkMate®.

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

• Not applicable / Not explicitly stated. This type of information is typically required for studies demonstrating clinical diagnostic accuracy through expert interpretation of medical images or data. For a functional modification to a diagnostic computer that maintains its original intended use, expert-established ground truth on a test set is not detailed in this 510(k) summary. The demonstration relies on functional validation and comparison to the predicate.

4. Adjudication method for the test set

• Not applicable / Not explicitly stated. See point 3.

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

• No. An MRMC study is not mentioned. Such studies are typically performed to assess the impact of AI on human reader performance for diagnostic tasks, which is not the primary claim of this submission. The NurseMate™ acts as an additional workstation for charting and monitoring, not as a diagnostic aid that enhances physician interpretation in an MRMC context.

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

• Implicitly, "yes," in terms of functional validation. The NurseMate™ software (modified EP-WorkMate® application) and hardware components are described as functioning independently as a workstation, receiving data and allowing input. However, "standalone performance" in the context of diagnostic accuracy (e.g., sensitivity/specificity) is not applicable as the NurseMate™ is not an independent diagnostic algorithm. Its function is to display data and record charting information, with the diagnostic function residing with the physician and the main EP-WorkMate® system. The key functional performance described is its ability to display accurate physiological data and to record patient charting information without error.

7. The type of ground truth used

• Functional Specification/Predicate Device Comparison. The "ground truth" for this submission are the functional specifications of the NurseMate™ and the established performance of the predicate EP-WorkMate®. The NurseMate™ is intended to accurately display data transmitted from the Amp/SCU and the EP-WorkMate®, and to accurately record user input as patient charting data on the EP-WorkMate®. The ground truth for this would be that the displayed data matches the source data, and the recorded data matches the input data, both validated through internal testing and verification activities against the device's design specifications.

8. The sample size for the training set

• Not applicable / Not explicitly stated. There is no mention of a "training set" in the context of machine learning or AI models, as this device is a software modification and hardware addition for data display and charting, not a learning algorithm.

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

• Not applicable. See point 8.

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The EP-4 Clinical Stimulator is intended to be used for diagnostic electrical Stimulation of refractory measurements, initiation and termination of tachyarrhymias, and measurements of electrical conductions.

Not Found

I am sorry. I cannot answer your question. The document does not describe the acceptance criteria, the study details, or the performance of the device. It is a 510(k) clearance letter and an "Indications for Use" statement for a medical device called the "EP-4 Clinical Stimulator." It confirms that the device is substantially equivalent to legally marketed predicate devices and outlines its intended uses.

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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-4 Clinical Stimulator is intended to be used for diagnostic electrical Stimulation of the heart for the purpose of refractory measurements, initiation and termination of tachyarrhymias, and measurements of electrical conductions,

Not Found

The provided text is a 510(k) clearance letter from the FDA for a device called the "EP-4 Clinical Stimulator." This document confirms that the FDA has reviewed the premarket notification and found the device to be substantially equivalent to legally marketed predicate devices.

However, this document does not contain any information about acceptance criteria, device performance results, sample sizes, ground truth establishment, or study designs (like MRMC or standalone studies). This letter is a regulatory approval document, not a clinical study report or a technical performance specification.

Therefore, I cannot fulfill your request for the detailed information about acceptance criteria and the study that proves the device meets them based on the provided text. The requested information would typically be found in a separate submission, such as an engineering report, validation study report, or clinical trial documentation, which is not part of this 510(k) clearance letter.

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The ViewMate System is indicated for use in adult and adolescent pediatric patients to visualize cardiac structures and blood flow within the heart.

Not Found

This document is a 510(k) clearance letter from the FDA for the EP MedSystems ViewMate® System and ViewFlex™ Ultrasound Catheter. It declares the device substantially equivalent to legally marketed predicate devices.

The document does not contain information about acceptance criteria or a study that proves the device meets specific performance criteria. It primarily focuses on the regulatory clearance process, the intended use of the devices, and the associated regulations.

Therefore, I cannot provide the requested information from the given input.

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