(84 days)
The Bard LabSystem™ EP Laboratory is a computer and software driven data acquisition and analysis tool designed to facilitate the gathering, display, analysis by a physician, pace mapping and storage of cardiac electrophysiologic data.
When integrated with the Biosense Webster® CARTO™ 3 system, the Bard® LabSystem™ PRO EP Recording System is designed to: a) send patient demographics to Biosense Webster® CARTO™ 3, and b) acquire (from Biosense Webster® CARTO™ 3), store and display: i) synchronized 3D mapping events, ii) stimulation pacing data, and iii) images of completed 3D electro-anatomical maps of the human heart. The 3D mapping events and images are created by the Biosense Webster® CARTO™ 3 device and stored on the Bard® LabSystem™ PRO EP Recording System for review and insertion into the final clinical report. Integration also supports bidirectional communication of stimulation pacing channel selection and information sharing between the two systems.
The V2.6 software for the LabSystem™ PRO EP Recording System is a bidirectional software interface that links the Bard LabSystem PRO EP Recording System with the Biosense-Webster CARTO 3 mapping/navigation system. The V2.6 software also incorporates the core recording system functionality of the released V2.4b software for the LabSystem PRO EP Recording System. The joint integrated solution provides a single repository for the resulting CARTO 3D electro-anatomical map and procedure information collected by LabSystem PRO EP Recording System. This interface will enhance the usability of the two systems when used in tandem. This will result in a workflow improvement, more streamlined data management, and simpler review of case details. The information will be shared via a network link using a BWI communication protocol.
The V2.6 software is intended for use with the LabSystem PRO EP Recording System (K031000). The LabSystem™ PRO EP Recording System is a microprocessor based data acquisition system that is used during electrophysiology procedures to acquire ECG, intracardiac, pressure and digital data from other devices like fluoroscopic systems and RF generators. The ECG, intracardiac and pressure data are acquired by an amplifier that is connected to the patient via ECG leadwires and catheters. It does not transmit alarms nor does it have arrhythmia detection capabilities.
This document is a 510(k) summary for the V2.6 software for the Bard LabSystem PRO EP Recording System, which is a programmable diagnostic computer used in electrophysiology procedures. The submission focuses on demonstrating substantial equivalence to predicate devices and does not contain details about specific acceptance criteria or a clinical study in the format requested.
Therefore, much of the requested information cannot be extracted directly from this document.
Here's an attempt to answer the questions based on the provided text, highlighting what is not available:
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A table of acceptance criteria and the reported device performance
- Acceptance Criteria: The document states that "Software qualification is performed in-house on the System with results that meet acceptance criteria, thus confirming the safety and effectiveness of each functional aspect of the LabSystem™ PRO EP Recording System." However, the specific acceptance criteria (e.g., performance metrics, thresholds) are not detailed in this summary.
- Reported Device Performance: No specific performance metrics or quantitative results are provided in this summary. The document focuses on demonstrating functional equivalence and adherence to standards.
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Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- This information is not available in the provided 510(k) summary. It describes "Software qualification" being performed "in-house," but does not specify sample sizes for testing or data provenance.
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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)
- This information is not available. The document does not describe the establishment of ground truth by experts for a test set.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set
- This information is not available. No adjudication method is mentioned.
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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
- This is not applicable/not available. The device (LabSystem™ PRO EP Recording System software) is not an AI-assisted diagnostic tool that would typically undergo an MRMC study comparing human readers with and without AI. It's a data acquisition, display, and integration system.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not explicitly applicable in the context of an "algorithm-only" performance as one might see for an AI diagnostic tool. The "software qualification" mentioned is an in-house verification and validation process for the software's functionality and integration capabilities. The device itself is a system for acquiring and displaying data for physician analysis.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- This information is not available. The concept of "ground truth" as used in clinical performance studies is not detailed for this type of software verification. The testing would likely focus on functional accuracy (e.g., data transfer integrity, correct display of information, proper integration).
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The sample size for the training set
- This information is not available. This device's software (V2.6) for data acquisition and integration does not appear to involve a "training set" in the sense of machine learning algorithms. Its development and testing would involve traditional software engineering verification and validation.
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How the ground truth for the training set was established
- This information is not available, as no training set (in the machine learning sense) is mentioned or implies.
Summary of what is available regarding "acceptance criteria" and "study":
- Acceptance Criteria Mentioned: The document states that "Software qualification is performed in-house on the System with results that meet acceptance criteria, thus confirming the safety and effectiveness of each functional aspect of the LabSystem™ PRO EP Recording System."
- Study Described: The core study mentioned is "Software qualification performed in-house." This is not a clinical study but rather a non-clinical verification and validation process.
- Standards Referenced for Software Development/Testing:
- IEEE Standard 730-1995 Software Quality Assurance Plans
- IEEE Standard 829-1983 Software Test Documentation
- IEEE Standard 1012-1986 Software Verification and Validation Plans
- IEEE Standard 830-1993 Software Requirement Specifications
- IEEE Standard 1008-1987 Software Unit Testing
- EN 60601-1-2:2007 EMC, Radiated emissions and Conducted emissions requirements
- EN 60601-1:2005 Patient Leakage current (Section 19, Table IV, Type CF, 50uA)
- Conclusion of Study: The non-clinical testing confirmed the safety and effectiveness of each functional aspect of the system, supporting the claim of substantial equivalence to predicate devices based on "same Indications for Use, principles of operation, and the technological characteristics."
This 510(k) submission is for a software update to an existing electrophysiology recording system, primarily focusing on integration capabilities. The "study" referenced is standard software verification and validation, not a clinical performance study with "ground truth" and "readers" in the context of diagnostic AI.
§ 870.1425 Programmable diagnostic computer.
(a)
Identification. A programmable diagnostic computer is a device that can be programmed to compute various physiologic or blood flow parameters based on the output from one or more electrodes, transducers, or measuring devices; this device includes any associated commercially supplied programs.(b)
Classification. Class II (performance standards).