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The diagnostic ultrasound system (U50) is applicable for adults, pregnant women, pediatric patients' ultrasound evaluation in hospitals and clinics. It is intended for use in abdominal, obstetrics, gynecology, pediatric, small parts, urology, peripheral vascular, musculoskeletal (conventional and superficial), endovaginal and cardiac clinical applications, by or on the order of a physician or similarly qualified health care professional.

The U50 is a portable Diagnostic Ultrasound System, which applies advanced technologies. Various image parameter adjustments, 12.1 inch LCD and diverse probes are configured to provide clear and stable images. The R2.2 version of the U50 utilizes the Linux operating system, which enables additional printer drivers and the inclusion of an USB DVD drive.

The provided document is a 510(k) summary for the Edan Instruments U50 Diagnostic Ultrasound System, dated November 15, 2017. It demonstrates substantial equivalence to a predicate device (U50 Diagnostic Ultrasound System / K142511 / Edan Instruments, Inc.) and does not describe a study involving an AI or algorithm.

Therefore, many of the requested points related to AI/algorithm studies (like sample size for test/training sets, data provenance, number of experts for ground truth, adjudication methods, MRMC studies, or standalone algorithm performance) cannot be answered from this document.

The document primarily focuses on bench testing and compliance with recognized standards to demonstrate the safety and effectiveness of the ultrasound system itself, and its substantial equivalence to the previously cleared predicate device.

Here's what can be extracted from the document regarding acceptance criteria and device performance:

1. Table of Acceptance Criteria (Performance Specifications) and Reported Device Performance:

The document provides a comparison of specifications between the subject device (U50 R2.2) and the predicate device (U50 R2.0), showing they are "Same." This implies that the predicate's performance serves as the acceptance criteria for the subject device.

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

• Test set sample size: Not applicable (N/A) for an AI/algorithm study as this document describes a traditional medical device (ultrasound system). Performance was demonstrated through engineering and manufacturing verification and validation, including compliance with international standards for safety and acoustic output.
• Data provenance: N/A. The testing involved technical evaluations rather than clinical data sets in the context of an AI study.

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

• N/A. Ground truth in the context of AI/ML is not relevant here as it's a traditional ultrasound system. Performance evaluation relies on engineering specifications and standard compliance.

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

• N/A. Not relevant for this type of device submission.

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:

• No. This is a traditional diagnostic ultrasound system, not an AI or AI-assisted device.

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

• No. This is an ultrasound imaging system that requires a human operator for its intended use.

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

• N/A. For this device, "ground truth" relates to the accuracy of physical measurements and compliance with established industry and regulatory standards, rather than clinical diagnostic outcomes requiring expert consensus or pathology. Performance is demonstrated against objective technical specifications.

8. The sample size for the training set:

• N/A. This is not an AI/ML device.

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

• N/A. This is not an AI/ML device.

Study Proving Device Meets Acceptance Criteria:

The study proving the device meets the "acceptance criteria" (which are effectively its technical specifications and regulatory compliance requirements) is detailed in Section 10, "Effectiveness and Safety Considerations: Non-clinical test" of the 510(k) summary (page 22).

The document states:
"Verification and validation testing has been conducted on the U50 Ultrasound Imaging System. This premarket notification submission demonstrates that U50 Ultrasound Imaging System is substantially equivalent to the predicate devices."

Specifically, the device's performance was evaluated by demonstrating compliance with various national and international standards:

• Electrical Safety: IEC 60601-1:2005/A1:2012
• Electromagnetic Compatibility (EMC): IEC 60601-1-2 Edition 3:2007-03
• Specific Requirements for Medical Diagnostic Ultrasound: IEC 60601-2-37 Edition 2.0 2007
• Acoustic Output:
  • NEMA UD 3, Edition 2004 (Standard for real-time display of thermal and mechanical acoustic output Indices)
  • FDA guideline "Information for Manufacturers Seeking Marketing Clearance of Diagnostic Ultrasound Systems and Transducers' dated September 9, 2008.
  • NEMA, UD2, Edition 2004 for acoustic output measurement methodology.
• Biocompatibility: ISO 10993-1:2009, ISO 10993-5:2009 and ISO 10993-10:2010

These non-clinical tests and compliance with recognized standards are the "studies" that demonstrate the device meets its acceptance criteria for safety and effectiveness, affirming its substantial equivalence to the predicate device. No clinical testing was required for this particular submission.

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The diagnostic ultrasound system (U50) is applicable for adults, pregnant women, pediatric patients' ultrasound evaluation in hospitals and clinics. It is intended for use in abdominal, obstetrics, gynecology, pediatric, small parts, urology, peripheral vascular, musculoskeletal (conventional and superficial), endovaginal and cardiac clinical applications, by or on the order of a physician or similarly qualified health care professional.

The modifications are listed as below:
Addition of CW mode – the basic system architecture previously supported CW mode.
3 new transducers C5-2b, P5-1b and L15-7b – The C5-2b and the L15-7b are new transducers. The P5-1b is the initial offering of a phased array device on this system.
Addition of HPRF to PW mode
Minor changes to the user interface

Here's an analysis of the provided text regarding the U50 Diagnostic Ultrasound System, structured according to your requested information:

1. A table of acceptance criteria and the reported device performance

The document does not explicitly state acceptance criteria in quantitative terms for the device's diagnostic performance (e.g., sensitivity, specificity for specific conditions). Instead, it relies on demonstrating that the device meets safety and performance standards equivalent to predicate devices. The reported device performance is that it "passed all testing" and is "substantially equivalent" to predicate devices.

The tables for each transducer (U50, C352UB, L1042UB, L742UB, E612UB, C612UB, C6152UB, C422UB, L552UB, C5-2b, P5-1b, L15-7b) outline the intended clinical applications and modes of operation supported by each transducer. These can be considered the functional performance criteria ("what it can do").

Here's an example table for the main U50 system based on the "U50 Diagnostic Ultrasound System" table in the document, as it aggregates the general capabilities:

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

The document explicitly states: "Clinical testing is not required." This implies that there was no specific "test set" of patient data used for clinical validation in the traditional sense (e.g., to measure diagnostic accuracy). The evaluation was primarily based on non-clinical performance (safety, EMC, acoustic output, biocompatibility) and a comparison to predicate devices, leveraging their established clinical utility.

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, as no clinical test set requiring ground truth established by experts was used.

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

Not applicable, as 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 is a submission for a diagnostic ultrasound system (hardware and basic software functions), not an AI-powered diagnostic algorithm. No MRMC study was conducted.

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

Not applicable. This is a diagnostic ultrasound system, not an AI algorithm. Its performance is intrinsically linked to human operation.

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

Not applicable, as no clinical test set requiring ground truth was used for evaluation of the system's diagnostic accuracy. The ground truth for safety and performance (e.g., acoustic output, EMC) would be the established international and national standards and their specific test methodologies.

8. The sample size for the training set

Not applicable. This is a medical device (ultrasound system), not an AI/Machine Learning algorithm that requires a "training set" in the computational sense. The design and engineering would have been informed by general ultrasound physics, medical imaging principles, and experience with prior devices.

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

Not applicable, as no training set for an AI/ML algorithm was used.

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