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The HD-IVUS Ultrasound Imaging System (Console) is intended for ultrasound examination of coronary intravascular pathology only. Intravascular ultrasound imaging is indicated in patients who are candidates for transluminal coronary interventional procedures.

The HD-IVUS Ultrasound Imaging System is a minimally invasive intravascular ultrasound diagnostic imaging tool when used in conjunction with an intravascular ultrasound catheter. The System is a medical device for use by or on the order of a physician. The HD-IVUS Ultrasound Imaging System is comprised of a System Console with a touch screen monitor, a Roll Stand, or bed-rail swing arm mount, a Patient Interface Module (PIM), a Power Supply, and an Intravascular Ultrasound Catheter (510(k) cleared and sold separately). The Catheter emits sound energy from a transducer at the distal tip of the catheter, which is guided into the coronary arteries of the heart. Sound waves that reflect from the inner vascular tissues are received by the transducer and sent to the System Console where a high resolution, cross-sectional image is displayed in real time. The technique provides for in-vivo visualization of the coronary artery lumen, coronary artery wall morphology, and devices (such as stents) at or near the surface of the coronary artery wall.

The provided text does not contain information about acceptance criteria or specific study results for the HD-IVUS Ultrasound Imaging System or its Linear Translation System accessory. The document is a 510(k) summary for a submission that claims substantial equivalence to predicate devices, focusing on technical characteristics and compliance with general safety standards.

Therefore, I cannot provide the requested table of acceptance criteria and reported device performance, nor details about sample sizes, ground truth establishment, expert qualifications, adjudication methods, or MRMC studies.

The document indicates:

• The device is an HD-IVUS Ultrasound Imaging System with a Linear Translation System (LTS) accessory. The LTS is the subject of this 510(k) submission.
• The submission is a "Special 510(k) (accessory to device)", indicating it's for an accessory to an already cleared device, and thus likely focuses on demonstrating that the accessory does not raise new questions of safety or effectiveness compared to the existing system or predicate accessories.
• Non-clinical tests were conducted for determination of substantial equivalence. These included Electromagnetic Compatibility (compliant with IEC 60601-1-2) and Electrical Safety and Acoustic Safety (compliant with IEC 60601-1, IEC 60601-1-4, and IEC 60601-2-37). The results summarized are simply "Compliant" with these standards.
• Performance Data: The document explicitly states "Summary of Non-clinical tests Conducted for Determination of Substantial Equivalence" and under "Performance Test Summary - New Device" it lists standards and results, but these relate to safety and compatibility rather than clinical performance metrics of the imaging system itself.

In summary, the provided text lacks the detailed performance criteria and study results typically found for a standalone clinical performance evaluation. The focus of this 510(k) is on the substantial equivalence of an accessory (Linear Translation System) to predicate devices and compliance with relevant safety and electromagnetic standards.

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Silicon Valley Medical Instrument's Kodama Intravascular Ultrasound Catheter is intended for ultrasound examination of coronary intravascular pathology only. Intravascular ultrasound imaging is indicated in patients who are candidates for transluminal coronary interventional procedures.

The Kodama Intravascular Ultrasound Catheter is a minimally invasive intravascular ultrasound coronary imaging catheter. The Catheter is a medical device for use by or on the order of a physician. The Catheter emits sound energy from a transducer at the distal tip of the catheter, which is guided into the coronary arteries of the heart. Sound waves that reflect from the inner vascular tissues are received by the transducer and sent to the Console (SVMI's HD-IVUS Ultrasound Imaging System) where a high resolution, cross-sectional image is displayed in real time. The technique provides for in-vivo visualization of the coronary artery lumen, coronary artery wall morphology, and devices (such as stents) at or near the surface of the coronary artery wall.

The provided document pertains to a 510(k) premarket notification for the Kodama Intravascular Ultrasound Catheter. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than undergoing a de novo clinical study with strict acceptance criteria for diagnostic performance in the way AI/ML devices often do.

Therefore, much of the requested information regarding "acceptance criteria and the study that proves the device meets the acceptance criteria" in terms of diagnostic performance (e.g., sensitivity, specificity, reader studies, ground truth) is not applicable to this 510(k) submission.

This submission primarily relies on non-clinical performance testing to demonstrate that the new device meets established standards and performs comparably to its predicate device. The "acceptance criteria" here are compliance with these standards and comparable performance in specific engineering tests.

Here's a breakdown of the information available and what is not applicable:

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: This was a non-clinical study involving engineering and performance tests, not a clinical study with a patient test set. The document does not specify sample sizes for the engineering tests but states "Met all specifications."

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: There was no "ground truth" in the diagnostic sense for this type of submission. The "ground truth" here is the adherence to engineering specifications and international standards, which is assessed during laboratory testing and verification.

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

   • Not Applicable: No clinical test set requiring adjudication was used.

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 Intravascular Ultrasound Catheter, not an AI-based diagnostic tool. No MRMC study was performed, and human readers are not "improving with AI" in this context.

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

   • Not Applicable: This is a physical medical device (catheter) for ultrasound imaging, not an algorithm. Standalone performance as an algorithm is not relevant.

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

   • Not Applicable: The "ground truth" for this submission are the accepted engineering standards and specifications (e.g., ISO standards) against which the device's physical and functional performance was tested.

8. The sample size for the training set:

   • Not Applicable: This is not an AI/ML device; therefore, there is no "training set."

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

   • Not Applicable: As there is no training set, this question is not applicable.

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The HD-IVUS Ultrasound Imaging System (Console) is intended for ultrasound examination of coronary intravascular pathology only. Intravascular ultrasound imaging is indicated in patients who are candidates for transluminal coronary interventional procedures.

The HD-IVUS Ultrasound Imaging System is a minimally invasive intravascular ultrasound diagnostic imaging tool when used in conjunction with an intravascular ultrasound catheter. The System is a medical device for use by or on the order of a physician. The HD-IVUS Ultrasound Imaging System is comprised of a System Console with a touch screen monitor, a Roll Stand, a Patient Interface Module (PIM), a Power Supply, and an Intravascular Ultrasound Catheter (510(k) cleared and sold separately). The Catheter emits sound energy from a transducer at the distal tip of the catheter, which is guided into the coronary arteries of the heart. Sound waves that reflect from the inner vascular tissues are received bv the transducer and sent to the System Console where a high resolution, cross-sectional image is displayed in real time. The technique provides for in-vivo visualization of the coronary artery lumen, coronary artery wall morphology, and devices (such as stents) at or near the surface of the coronary artery wall.

The provided text describes the 510(k) Summary for the Silicon Valley Medical Instruments (SVMI) HD-IVUS Ultrasound Imaging System. It focuses on demonstrating substantial equivalence to a predicate device, rather than providing detailed acceptance criteria and a study proving device performance against those criteria as would be expected for an AI/CADe device.

Specifically, this document is a 510(k) summary for an imaging system, not an AI or CADe device. Therefore, it does not include acceptance criteria in terms of clinical performance metrics (like sensitivity, specificity, AUC) or a dedicated clinical study to prove the device meets such criteria. Instead, the "performance criteria" are focused on regulatory compliance and technical equivalence to a predicate device.

However, I can extract the information that is present and indicate where information is not available due to the nature of the submission.

1. Table of Acceptance Criteria and Reported Device Performance

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

• Not Applicable. This document describes a 510(k) submission for an imaging device (ultrasound system), not an AI/CADe device that would typically involve a "test set" of patient data for performance evaluation. The "studies" mentioned refer to technical tests for regulatory compliance (EMC, electrical/acoustic safety) and comparison with a predicate device's technical specifications.

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

• Not Applicable. See point 2. No clinical "ground truth" establishment by experts for a test set is described.

4. Adjudication method for the test set

• Not Applicable. See point 2.

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 is not an AI/CADe device 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 device is an ultrasound imaging system, not an algorithm, and is intended for use by a physician.

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

• Not Applicable. The "ground truth" in this context is the compliance with established electrical, acoustic, and electromagnetic standards, and the technical specifications of the legally marketed predicate device used for substantial equivalence comparison.

8. The sample size for the training set

• Not Applicable. This is an imaging device, not an AI/machine learning algorithm that requires a "training set."

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

• Not Applicable. See point 8.

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