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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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The ClearPath-UGI System is intended for irrigating or cleaning the upper digestive tract and evacuating the irrigation fluid, blood and bile in the upper GI tract during endoscopic procedures. It is for use only by trained medical personnel located in hospitals, clinics, and doctors' offices.

The ClearPath UGI's main purpose is to improve procedure reliability by improving procedural visualization during endoscopic procedures. The ClearPath UGI utilizes a suction / irrigation head for the purpose of irrigating or cleaning the upper digestive tract. The ClearPath UGI is composed of two major units: . The disposable Irrigator and . the reusable Control cabinet. The disposable Irrigator is attached to a standard endoscope by means of silicone bands and does not hinder the endoscope's functionality nor affects the procedure sequence in any way. The Control cabinet supplies the water flow and vacuum control using a peristaltic pump. The standard medical facility vacuum system is the vacuum source.

The provided text describes the ClearPath UGI device and its 510(k) submission for substantial equivalence. However, it does not contain information about a study that proves the device meets acceptance criteria in terms of clinical performance, efficacy, or specific performance metrics beyond simple engineering specifications.

Instead, the document focuses on demonstrating substantial equivalence to a predicate device based on:

• Identical indications for use.
• Identical technology.
• Identical patient-contact materials.
• Identical environment of use.
• Identical performance specifications (Air/Water pressure, Flow rate, Suction specifications).

Therefore, I cannot populate the table and answer several of your questions as the requested information (related to a clinical study, reader performance, ground truth, and training data) is not present in the provided text.

Here's the information that can be extracted or inferred based on the provided document:

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

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):

Not applicable. The document describes engineering specification comparisons, not a clinical test set.

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 applicable. Ground truth for clinical performance was not established in the provided context. The "ground truth" here is the published specifications of the predicate device.

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

Not applicable. No clinical test set or adjudication 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:

Not applicable. This device is not an AI diagnostic tool and no MRMC study is mentioned.

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

Not applicable. This is not an AI algorithm; it's a physical medical device accessory.

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

For the purpose of substantial equivalence, the "ground truth" used are the engineering specifications and performance characteristics of the predicate device (K091305 – Easy Glide – ClearPath). The new device's performance was compared against these established specifications.

8. The sample size for the training set:

Not applicable. No training set is mentioned as this is not an AI/machine learning device.

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

Not applicable. No training set or associated ground truth establishment is mentioned.

Summary of the Study (as described in the document):

The "study" described in the 510(k) summary is a benchtop comparison against a predicate device (K091305 – Easy Glide – ClearPath). The purpose was to demonstrate substantial equivalence for the modified ClearPath UGI device, which has a shorter disposable tubing set and a redesigned irrigation tip, but no modifications to the controller or software.

The study involved confirming that the key performance specifications of the proposed device (Air/Water pressure, Flow rate, Suction specifications) are identical to those of the predicate device. This was presented as "testing to demonstrate that the operating performance of the ClearPath UGI is equivalent to the predicate for flow rate, irrigation and vacuum pressures."

The acceptance criteria were simply that the new device's engineering performance for these specific parameters should match those of the legally marketed predicate device. The document states, "Performance specifications - Irrigation pressures, flow rate and suction pressures are identical to the predicate -. K091305 EasyGlide ClearPath."

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