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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:

1. 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.

2. 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.

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)

   • This information is not available. The document does not describe the establishment of ground truth by experts for a test set.

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

   • This information is not available. No adjudication method is mentioned.

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

   • 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.

6. 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.

7. 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).

8. 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.

9. 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.

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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 Philips EP navigator system, the BARD® LabSystem™ PRO EP Recording System is designed to acquire, analyze, and display 3D electroanatomical maps of the human heart. The maps are constructed using intracardiac electrograms with their respective cardiac locations taken from live x-ray overlay on a patient's 3D cardiac anatomy. Maps may be displayed as electrical activation maps, voltage maps, dominant frequency maps and location maps with user defined measurement values.

The LabSystem 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.

The provided document is a 510(k) Summary for the Bard LabSystem™ PRO EP Recording System, specifically for its V3.1 software. It focuses on demonstrating substantial equivalence to predicate devices and does not contain detailed information about a study proving device performance against specific acceptance criteria. This type of regulatory submission typically relies on a comparison to existing, legally marketed devices rather than presenting novel performance studies with acceptance criteria, especially for software updates to established systems.

Therefore, many of the requested details about acceptance criteria, specific performance metrics, sample sizes, ground truth establishment, and expert involvement are not present in this document.

Here's a breakdown of what can and cannot be answered based on the provided text:

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

• Not available in the document. The document does not describe specific acceptance criteria or report quantified device performance metrics (e.g., sensitivity, specificity, accuracy) for the V3.1 software. The submission aims to show "substantial equivalence" to predicate devices, implying that its performance is comparable, but it doesn't present a study with specific targets.

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 document. There is no mention of a test set, its sample size, or the provenance of the data.

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 available in the document. Given no test set is described, there's no information on experts establishing ground truth for it.

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

• Not available in the document. No information on an adjudication method for a test set is provided.

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/Not available in the document. This device is an EP recording system for acquiring, analyzing, and displaying cardiac electrophysiologic data and 3D electroanatomical maps during electrophysiology procedures. It does not appear to be an AI-driven diagnostic system that assists human readers in the way an MRMC study typically assesses for AI. The document does not describe any MRMC study.

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

• Not applicable/Not available in the document. The device is a "computer and software driven data acquisition and analysis tool" that "facilitate[s] the gathering, display, analysis by a physician." It is inherently designed for use by a physician, not as a standalone, fully autonomous diagnostic algorithm. No standalone performance study is mentioned.

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

• Not available in the document. Since no specific performance study or test set is described, there's no information on the type of ground truth used.

8. The sample size for the training set

• Not available in the document. This document does not discuss a training set. The device appears to be a software update for an existing system, and the submission emphasizes regulatory compliance and substantial equivalence rather than a machine learning model's training and validation process.

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

• Not available in the document. Since no training set is mentioned, there's no information on how its ground truth was established.

Summary of Non-Clinical Testing Section (Relevant to the overall submission but not specific performance metrics):

The document states: "The LabSystem™ PRO EP Recording System is developed and produced in accordance with 21 CFR 820.30 Quality System Regulations. The software product is developed and tested in accordance with the following industry standards." While this indicates quality control and development processes, it doesn't provide specific device performance acceptance criteria or study results against those criteria. The "Summary of Non-Clinical Testing" is a high-level statement about adherence to quality systems and standards, rather than a detailed report of a performance study.

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Bard PTFE Coated Guide Wires are indicated for percutaneous entry of a guiding catheter into a vessel using standard percutaneous methods (Seldinger's Technique). Generally, Guide Wires which are 100cm or longer are indicated for use with vascular catheters and balloon dilatation catheters in angiographic or interventional procedures. The guide wire may be inserted through an [18g] needle, introducer, or catheter. A guide wire with an outer diameter of .018" or smaller may be used with open ended guide wires.

Guide wires which are shorter than 100cm are generally indicated for non-vascular use. Guide wires with an outer diameter of .018" or smaller may be inserted into the target organ through a [22g] needle or an open-ended guide wire (60cm or shorter). Larger guide wires may be inserted through larger gauge needles or an introducer for placement of dilators and/or drainage catheters.

The Bard PTFE (Teflon®) coated guide wires, subject of this 510(k), like their predicate device counterparts, are manufactured from stainless steel wire, tin/silver solder, and PTFE (Teflon®) coating, or Benzalkonium Heparin (BH) coating applied over the PTFE (Teflon®) coating. The guide wire construction consists of a safety wire, a core wire, and a wound spring for flexibility. The features that distinguish individual wires consist of the core type (fixed or moveable), a straight or "J" tip configuration, diameters, lengths, and coating types. Each guide wire is subsequently packaged, labeled, and sterilized.

The provided text describes a 510(k) summary for Bard PTFE (Teflon®) Coated Guide Wires, which aims to demonstrate substantial equivalence to predicate devices, rather than establishing acceptance criteria and conducting a study to prove performance against those criteria in the context of a new, significantly different device or an AI/ML product.

The submission focuses on a process change for the Teflon® coating due to environmental concerns regarding PFOA, not a new device design or a novel AI algorithm. Therefore, the information provided does not align with the typical structure for reporting acceptance criteria and a study proving device performance as envisioned for an AI/ML product.

However, I can extract the relevant "performance specifications" and the "testing performed" to address your request as best as possible within the context of this document.

Understanding the Context:
The "acceptance criteria" here are essentially that the modified guide wires maintain the same performance characteristics as the predicate devices, despite a change in the manufacturing process of the PTFE coating. The study's purpose is to demonstrate that this change in coating material does not adversely affect the safety, biocompatibility, and functional performance of the guide wires.

Here's the information structured to fit your requested format, with caveats where the document's content deviates from a typical AI/ML performance study:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size Used for the Test Set and Data Provenance

The document does not specify a numerical sample size for the test set. It refers to "representative samples" for inhibition/enhancement testing, "representative products" for coating application, and "representative guide wire items" for functional performance testing.

• Sample Size: Not explicitly stated as a number; referred to as "representative samples/products/items."
• Data Provenance: Not explicitly stated (e.g., country of origin). The testing was conducted internally by Bard or outsourced to labs for specific tests (e.g., biocompatibility to ISO standards). It is retrospective in the sense that the new material's performance is being compared to the established performance of the predicate device.

3. Number of Experts Used to Establish Ground Truth and Qualifications

This is not applicable in the context of this 510(k) submission. The "ground truth" for this submission is established through validated laboratory tests and engineering evaluations against existing performance specifications and standards (e.g., ISO, USP, FDA guidelines). There's no clinical "ground truth" established by human experts in the way an AI/ML study would require for diagnostic accuracy.

4. Adjudication Method for the Test Set

Not applicable. This is a scientific and engineering performance study, not a clinical trial requiring expert adjudication of results. Each test (e.g., biocompatibility, friction, durability) has its own pass/fail criteria based on standards and internal specifications.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No. This type of study is relevant for diagnostic devices where human readers interpret results, often comparing AI-assisted vs. unassisted performance. This submission is for a physical medical device (guide wire) and its material change.

6. If a Standalone Study (algorithm only without human-in-the-loop performance) was done

Yes, in a conceptual sense. All the testing performed (biocompatibility, chemical analysis, mechanical testing) is "standalone" in that it evaluates the physical properties and safety of the device itself, without human interpretation as part of the performance metric for this type of device. There is no AI algorithm involved.

7. The Type of Ground Truth Used

The "ground truth" for this submission is based on:

• Established Standards: International Standard ISO 10993 for biocompatibility.
• Regulatory Guidelines: FDA-modified testing matrix (G95-1) for biocompatibility.
• Pharmacopeial Standards: USP Physiochemical analysis (replacement material meets USP 604 requirements).
• Internal Product Specifications: Performance specifications (e.g., for coefficient of friction, durability, stiffness, tensile, torque) that are the same as those for the predicate devices.
• Chemical Analysis: FTIR analysis.

8. The Sample Size for the Training Set

Not applicable. There is no training set as this is not an AI/ML product. The "development" of the new coating process was driven by supplier changes, and the "validation" involves ensuring the finished product performs equivalently.

9. How the Ground Truth for the Training Set was Established

Not applicable, as there is no training set for an AI/ML model. The "ground truth" for the device's performance characteristics (biocompatibility, mechanical properties) was established over time for the predicate devices through robust engineering, testing, and compliance with medical device regulations and standards. The purpose of this submission is to demonstrate that the new process for the coating maintains this existing ground truth.

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