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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.

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