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Diagnostic ultrasound imaging or Doppler analysis of the human body as follows: Fetal, Abdominal, Pediatric, Small Organs (Thyroid, Testicles, Breast), Neonatal Cephalic, Adult Cephalic, Cardiac, Transvaginal, Peripheral Vascular, Musculo-skeletal Superficial and Musculo-skeletal Conventional, Transrectal.
Mode of Operation: A, B, M, PWD, CWD, Color Doppler, Power (Amplitude) Doppler, Color Velocity Imaging, Combined (B/M, B/PWD, CFM(B)/PWD, CFM(B)/CFM(M), B/CWD, CFM(B)/CWD), Tissue Harmonic Imaging.

The SDU-2200Pro is a mobile diagnostic ultrasound system. This system has flat linear array, convex linear and sector probe with a frequency range of approximately 2 to 15 MHz. It has B mode, M mode, Pulsed Doppler mode, Continuous Doppler mode, Color mode, or in a combination of modes.

The provided text is a 510(k) summary for the SHIMADZU MEDICAL SYSTEMS SDU-2200Pro Ultrasound Imaging System. This document outlines the device's intended use and compliance with safety standards, but it does not contain information about acceptance criteria for performance, a study proving device performance against acceptance criteria, or details regarding sample sizes, ground truth establishment, or expert involvement for such a study.

The tables within the document (pages 5-20) are "Ultrasound Device Indications Statements" for various transducers. These tables indicate whether certain imaging modes (such as B-mode, M-mode, PWD, CWD, Color Doppler, Power Doppler, Color Velocity Imaging, Combined modes, and Tissue Harmonic Imaging) are "new indications" (N) for specific clinical applications (e.g., Fetal, Abdominal, Pediatric, Small Organ, Cardiac, Transvaginal, Peripheral Vascular, Musculo-skeletal). This is a statement of intended use and cleared functionalities, not a performance study result.

The 510(k) process is primarily a premarket notification demonstrating substantial equivalence to a legally marketed predicate device, rather than requiring extensive new performance studies with specific acceptance criteria that would typically be described in an efficacy trial.

Therefore, based solely on the provided text, the requested information cannot be fully extracted.

Here's a breakdown of what can be inferred or what is explicitly missing:

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

• Acceptance Criteria: Not explicitly stated in terms of quantitative performance metrics for a specific clinical task. The acceptance criteria for 510(k) clearance generally revolve around compliance with recognized safety and performance standards (like IEC 60601-1, AIUM NEMA UD2, UD3) and demonstrating substantial equivalence to a predicate device in terms of intended use, technology, and safety/effectiveness.
• Reported Device Performance: No quantitative performance data (e.g., sensitivity, specificity, accuracy, image quality scores) is provided in the document. The "performance" described is in terms of the range of clinical applications and imaging modes supported by the device and its various transducers, which were deemed "substantially equivalent" to the predicate device (Shimadzu SDU-2200, K003514).

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

• Sample Size: Not mentioned.
• Data Provenance: Not mentioned; it's implicit that any comparative data would have been from internal testing or comparison with the predicate device, but no specifics are given.

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

• Number of Experts: Not mentioned.
• Qualifications of Experts: Not mentioned.

4. Adjudication method for the test set:

• Adjudication Method: Not 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:

• MRMC Study: No MRMC study is mentioned. This device is an ultrasound imaging system, not an AI-assisted diagnostic tool as described in the context of improving human reader performance.

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

• Standalone Performance: Not applicable for this device as it's an imaging system, not an algorithm being tested for standalone diagnostic performance.

7. The type of ground truth used:

• Type of Ground Truth: Not applicable, as no performance study requiring ground truth is described.

8. The sample size for the training set:

• Training Set Sample Size: Not applicable, as this is an ultrasound imaging system, not an AI model requiring a training set.

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

• Ground Truth for Training Set: Not applicable.

Summary of available information related to "acceptance criteria" and "study":

The acceptance criteria for this 510(k) clearance are primarily based on:

1. Safety Compliance: Adherence to voluntary and measurement standards like IEC 60601-1, UL60601-1:2003, AIUM NEMA UD2, and AIUM NEMA UD3. The document explicitly states the device "has been designed to meet" these standards.
2. Substantial Equivalence: The FDA's determination that the SDU-2200Pro is "substantially equivalent" to a legally marketed predicate device (Shimadzu SDU-2200, K003514) for the stated indications for use. This means it has similar intended use, technological characteristics, and raises no new questions of safety and effectiveness.

The "study" or evidence provided to meet these criteria is the submission package itself, which typically includes:

• Comparison of technological characteristics to the predicate device.
• Documentation of compliance with safety standards and acoustic output measurements.
• Statement of intended use (as seen in the tables from pages 5-20).

There is no detailed clinical performance study with specific quantitative acceptance criteria or results presented in this 510(k) summary. This is typical for traditional hardware medical devices demonstrating substantial equivalence, as extensive clinical trials with performance metrics are often not required unless significant new technological features or intended uses are introduced that raise new safety or effectiveness concerns.

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