Search Results

The Globe PF System is indicated for catheter-based cardiac anatomical and electrophysiological mapping and stimulation of cardiac tissue.

The Globe Pulsed Field System (Globe PF System) comprises the following components and accessories to support anatomical and electrophysiological mapping, and pacing stimulation of cardiac tissue:

• Globe Controller: Used for the acquisition and processing of signals for cardiac anatomical and electrophysiological mapping, generation of mapping energy and stimulation pulses.

• Globe Workstation: A PC workstation configured with the Globe Software, which the clinician uses to assess contact between the mapping catheter electrodes and the atrial wall, map the atrial electrical activity, and apply stimulation pulses for diagnostic purposes.

• Globe Positioning System (GPS™) Electrodes and GPS Cable: Surface electrodes and cables for localization of the mapping catheter.

The provided FDA 510(k) clearance letter and summary for the Globe® Pulsed Field System do not contain the detailed information required to answer all parts of your request. This document primarily focuses on establishing substantial equivalence to a predicate device based on intended use, indications for use, and a high-level comparison of technological characteristics.

Specifically, the document does not include:

• Specific acceptance criteria values (e.g., minimum sensitivity, specificity, or accuracy targets).
• The reported device performance against such criteria.
• Detailed information about the study design for clinical or performance evaluation (e.g., test set sample size, provenance, expert qualifications, ground truth establishment methods, or whether MRMC studies were conducted).
• Training set details.

Therefore, I can only provide information directly extractable from the given text.

Here's what can be extracted and what is not available:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: NOT PROVIDED. The document mentions "performance testing" but does not specify the sample size for any clinical or test data used to evaluate the device.
• Data Provenance: NOT PROVIDED. No information is given regarding the country of origin of data or whether it was retrospective or prospective.

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

• NOT PROVIDED. The document does not detail any expert involvement for ground truth establishment in performance testing.

4. Adjudication method for the test set

• NOT PROVIDED. No information is available regarding any adjudication methods (e.g., 2+1, 3+1) for establishing ground truth or evaluating test results.

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. The document does not mention any MRMC comparative effectiveness study or any evaluation of human reader improvement with AI assistance. The device description focuses on its mapping and stimulation capabilities, not AI-assisted interpretation.

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

• NOT PROVIDED. While software verification and validation were performed, the document does not specify whether "standalone" performance (without human-in-the-loop) was a distinct part of the performance evaluation, or what specific algorithms were evaluated in such a manner. The device is a "Programmable diagnostic computer" that aids clinicians.

7. The type of ground truth used

• NOT PROVIDED. The general "performance testing" and "software verification and validation" are mentioned, but the specific type of ground truth (e.g., expert consensus, pathology, outcomes data) used for evaluation is not described. For the CONTACT and FLOW maps, it mentions they are "based on the same principles of operation as the reference device (Swan-Ganz catheter, K160084)" and that "the scientific methods used to evaluate the safety and effectiveness... are adequate." This suggests a comparison to established methods or a reference standard, but not explicit "ground truth" as you might see for diagnostic classifications.

8. The sample size for the training set

• NOT PROVIDED. The document does not mention a "training set" or any details about it. This submission is for a medical device that includes software, but it doesn't specify if it employs machine learning or requires a distinct "training set" in the common understanding of AI/ML development.

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

• NOT PROVIDED. As no training set is mentioned, naturally, no information on its ground truth establishment is available.

Summary of Device and Study Information (based on available text):

• Device Name: Globe® Pulsed Field System
• Intended Use/Indications for Use: Catheter-based cardiac anatomical and electrophysiological mapping and stimulation of cardiac tissue.
• Study Type: Performance testing (bench, biocompatibility, usability, electrical safety, EMC, software V&V, cybersecurity, packaging validation) to demonstrate substantial equivalence to a predicate device.
• Predicate Device: Affera Integrated Mapping System; Impedance Localization Patch Kit (K241828)
• Reference Device: Swan-Ganz Catheter (K160084) (for CONTACT and FLOW maps)
• Key Finding for Equivalence: "The Globe PF System meets the performance criteria for its intended use and does not raise new questions on safety or effectiveness compared to the predicate device."

The FDA 510(k) clearance letter and summary are high-level documents focused on regulatory substantial equivalence. They typically do not delve into the granular details of performance study designs, such as specific sample sizes, expert qualifications, or ground truth methodologies, to the extent that you are asking. Such detailed information would typically be found in the full 510(k) submission itself, which is not publicly released in its entirety.

Ask a specific question about this device

The Globe Introducer is intended for percutaneous catheter introduction into the vasculature and into the chambers of the heart, including the left side of the heart through the interatrial septum.

The Globe® Introducer is a single use, ethylene oxide sterilized medical device used to facilitate percutaneous access to the vasculature and into the heart chambers. The device consists of a 16 Fr (5.3 mm) inner diameter (ID) steerable sheath with a hydrophilic coating, a dilator compatible with 0.89 mm (0.035 in) guidewires, and a dilator loader.

The proximal end of the sheath includes a handle with an integrated steering knob for bidirectional deflection control of the sheath tip, a steering indicator, and a slider. The slider contains a loader connection port for the dilator loader and a compatible catheter loader. The slider provides a hemostatic seal and a saline flushing line with a standard Luer fitting stopcock, for air removal and management.

The provided FDA 510(k) clearance letter and summary for the Globe® Introducer primarily focus on demonstrating substantial equivalence to a predicate device, the FARADRIVE™ Steerable Sheath. The information details the device's technical specifications and the non-clinical tests performed to support its safety and performance.

However, the document does not contain the specific information requested about acceptance criteria and studies that prove the device meets those criteria, particularly within the context of a clinical performance study with human subjects, AI involvement, or specific ground truth methodologies.

The provided document describes bench testing to demonstrate performance, but not clinical studies involving patients for performance metrics like sensitivity, specificity, accuracy, or human reader improvement with AI assistance. Therefore, many of the requested fields cannot be directly extracted from this document.

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

Information NOT available in the document:

• A table of acceptance criteria and reported device performance from a clinical study. The document only lists bench test types and states they meet performance criteria, but doesn't provide specific criteria or quantifiable results for each.
• Sample size used for the test set (clinical data).
• Data provenance (country of origin, retrospective/prospective).
• Number of experts used to establish ground truth or their qualifications.
• Adjudication method for the test set.
• Whether a multi-reader, multi-case (MRMC) comparative effectiveness study was done, or the effect size of human readers improving with AI assistance.
• Whether a standalone (AI algorithm only) performance study was done.
• Type of ground truth used (expert consensus, pathology, outcomes data) for clinical performance.
• Sample size for the training set (if an AI/ML device).
• How the ground truth for the training set was established (if an AI/ML device).

Information that can be partially inferred or is available from the document (though not clinical performance-related):

1. A table of acceptance criteria and the reported device performance (Non-clinical Bench Testing)

The document mentions various bench tests conducted to demonstrate performance. While it doesn't state specific numerical acceptance criteria or reported values, it does state that the device "meets the performance criteria for its intended use" for each test.

Specific Bench Tests Mentioned:

• Biocompatibility Testing
• Sterilization Validation
• Packaging Validation
• Shelf-Life Testing
• Particulate Test
• Deployment-Retraction Force Test
• Flushing Test
• Pressure Withstand Test
• Corrosion Resistance Test
• ISO 80369 Luer Test
• Introducer Health Check Test
• Dimensional Inspection Test
• Steering Knob Torque Test
• Sheath Tensile Test
• Mechanical Performance Test
• Torque Test
• Lubricity Test
• Radiopacity Test
• Dilator Performance Test
• Air Egress Test

2. Sample sized used for the test set and the data provenance: Not applicable/Provided. This document focuses on a hardware device (catheter introducer) and its substantial equivalence to a predicate device based on non-clinical (bench) testing, not on a clinical test set with patient data for an AI/ML component.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable/Provided. Ground truth establishment with experts is typical for AI/ML diagnostic devices evaluated with clinical images/data. This document does not describe such a study.

4. Adjudication method for the test set: Not applicable/Provided. This document does not describe a test set requiring adjudication by experts.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done: No. The document does not mention any clinical study involving human readers or AI assistance.

6. If a standalone (i.e. algorithm only, without human-in-the loop performance) was done: No. This device is a medical instrument (catheter introducer), not an AI algorithm.

7. The type of ground truth used: Not applicable/Provided in a clinical context. For the bench tests, the "ground truth" would be established by engineering specifications and expected physical performance parameters.

8. The sample size for the training set: Not applicable/Provided. This device does not appear to be an AI/ML device requiring a training set.

9. How the ground truth for the training set was established: Not applicable/Provided. This device does not appear to be an AI/ML device requiring a training set.

Summary based on the provided document:

The FDA 510(k) clearance for the Globe® Introducer is based on demonstrating substantial equivalence through non-clinical bench testing. The document comprehensively lists the types of tests performed (e.g., biocompatibility, sterilization, mechanical performance tests like torque, tensile strength, flushing, etc.) and states that these tests confirm the device meets performance criteria and does not raise new safety or effectiveness concerns compared to its predicate. There is no information in this document regarding clinical studies, AI involvement, specific acceptance criteria beyond a general statement of meeting performance, or details on ground truth establishment, as these are typically associated with clinical performance evaluations or AI/ML devices.

Ask a specific question about this device