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