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6VT-D is intended for use by a qualified physician for use with GE Diagnostic Ultrasound Systems for ultrasound evaluation of Cardiac anatomy of adults through Transesophageal means of access, having imaging capabilities in 2D as well as in real-time 3D / 4D mode.

The 6VT-D is an ultrasound-imaging device that is attached to a GE ultrasound imaging system and used for diagnostic imaging. 6VT-D does not directly control energy delivered to the patient nor does it contain any software. The 6VT-D is a transducer for imaging cardiac anatomy in adults with transesophageal means of access.

The provided document is a 510(k) summary for the GE Healthcare 6VT-D Diagnostic Ultrasound Transducer. It describes a modification to an existing transducer, specifically the replacement of a patient contact material.

The document does not contain information about acceptance criteria or a study proving the device meets acceptance criteria in the context of advanced AI/ML performance metrics (such as sensitivity, specificity, or AUC) as it is a submission for a hardware modification of an ultrasound transducer.

Here's a breakdown of why this information is missing and what is available:

• Type of Device: The 6VT-D is an ultrasound transducer, a hardware component that attaches to an ultrasound imaging system. It "does not directly control energy delivered to the patient nor does it contain any software" (Page 1). This explicitly states it's not a software device with AI/ML capabilities, which would typically undergo performance studies with acceptance criteria based on diagnostic accuracy.
• Nature of the Submission: This 510(k) submission is for an "incremental improvement where one patient contact material of the endoscope is replaced by another" (Page 1). The focus of the submission is on demonstrating "substantial equivalence" to a predicate device, particularly regarding the safety and biocompatibility of the new material.

What the document does provide in relation to "acceptance criteria" and "study" are engineering and safety standards:

• Acceptance Criteria (Safety and Performance Standards): The device's "acceptance criteria" are compliance with various international standards for medical electrical equipment, acoustic output, biocompatibility, and risk management. These are the "general requirements for safety" and "particular requirements for the safety of ultrasonic medical diagnostic and monitoring equipment."
  • IEC60601-1 (General Safety)
  • IEC60601-1-2 (EMC)
  • IEC60601-2-37 (Ultrasonic Medical Equipment Safety)
  • NEMA UD 3 (Acoustic Output Display)
  • ISO10993-1 (Biocompatibility Evaluation)
  • NEMA UD 2 (Acoustic Output Measurement)
  • ISO14971 (Risk Management)
• Study/Evaluation (Non-Clinical Tests): The "study" mentioned for these acceptance criteria are "Non-Clinical Tests," which include:
  • Acoustic output evaluation
  • Biocompatibility evaluation
  • Cleaning and disinfection effectiveness
  • Thermal, electrical, electromagnetic, and mechanical safety testing
  • Quality assurance measures: Risk Analysis, Requirements Reviews, Design Reviews, Unit-level testing, Integration testing, Performance testing, Safety testing, Final Acceptance testing (Validation).
• Clinical Studies: The document explicitly states: "The subject of this premarket submission, 6VT-D Transducer, did not require clinical studies to support substantial equivalence." (Page 2). This further confirms that no performance study involving human subjects or diagnostic accuracy metrics was conducted or deemed necessary for this specific submission.

Therefore, the requested information elements related to AI/ML performance (sample size for test/training set, data provenance, number of experts, adjudication method, MRMC studies, standalone performance, ground truth types) are not applicable to and cannot be extracted from this document.

Summary of available information as per your request, framed by the context of this device:

1. Table of acceptance criteria and the reported device performance:

2. Sample size used for the test set and the data provenance: Not applicable. No clinical or performance accuracy test set was used for this hardware modification submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No ground truth for diagnostic performance was established for this hardware modification.
4. Adjudication method for the test set: Not applicable.
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. This device is an ultrasound transducer, not an AI-enabled software.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is a hardware component.
7. The type of ground truth used: Not applicable. Ground truth for diagnostic performance was not relevant for this hardware modification. For biocompatibility, the ground truth was conformance to ISO10993-1 using laboratory testing.
8. The sample size for the training set: Not applicable.
9. How the ground truth for the training set was established: Not applicable.

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