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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, Transrectal, Peripheral Vascular, Musculo-skeletal Conventional, and Musculo-skeletal Superficial.

The SDU-1200Pro is a mobile diagnostic ultrasound system. This system has flat linear array, convex linear and sector probe with a frequency range of approximately 1.5 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 document is a 510(k) Summary for the SHIMADZU SDU-1200Pro Ultrasound Imaging System. It describes the device, its intended use, and indicates that it has been determined substantially equivalent to a predicate device. However, it does not contain information about specific acceptance criteria or a study proving the device meets those criteria, as typically found in clinical performance studies of AI-based devices.

The document primarily focuses on:

• Device Description: A mobile diagnostic ultrasound system with various probes and imaging modes (B mode, M mode, Pulsed Doppler, Continuous Doppler, Color mode, etc.).
• Intended Use/Indications for Use: A comprehensive list of clinical applications for which the SDU-1200Pro and its various transducers are intended (e.g., Fetal, Abdominal, Pediatric, Cardiac, Peripheral Vascular), and the specific imaging modes available for each application (marked with 'N' for new indication in this submission).
• Safety Considerations: Compliance with voluntary and measurement standards like IEC 60601-1, UL60601-1, AIUM NEMA UD2, and AIUM NEMA UD3.
• Substantial Equivalence: FDA's determination that the device is substantially equivalent to the predicate device, Shimadzu SDU-2200 (K003514).

Therefore, based solely on the provided text, I cannot complete a table of acceptance criteria and reported device performance or answer most of the specific questions about clinical studies, ground truth, and sample sizes. This type of detailed performance data is typically found in the full 510(k) submission, not necessarily in the publicly available summary or Indications for Use statement.

Here's a breakdown of what can and cannot be answered from the provided text:

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

Cannot be provided. The document does not describe specific numerical acceptance criteria (e.g., sensitivity, specificity, accuracy values) or reported performance metrics from a study. The FDA clearance is based on substantial equivalence to a predicate device, meaning its performance characteristics are deemed similar enough to an already cleared device, rather than requiring new, specific performance targets to be met via a clinical study with detailed metrics.

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

Cannot be provided. The document does not mention any test set, sample size, or data provenance for performance evaluation.

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)

Cannot be provided. The document does not mention ground truth establishment or expert involvement for a clinical study.

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

Cannot be provided. The document does not mention any adjudication method for a test set.

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

Cannot be provided. The SDU-1200Pro is a diagnostic ultrasound system (hardware and software for image generation), not an AI-assisted diagnostic software. Therefore, an MRMC comparative effectiveness study involving human readers and AI assistance would not be applicable or described for this type of device.

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

Cannot be provided. This is not an AI-algorithm-only device. It is a diagnostic ultrasound system.

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

Cannot be provided. No clinical study or ground truth information is presented in the document.

8. The sample size for the training set

Cannot be provided. As this is not an AI-based device, there is no mention of a training set.

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

Cannot be provided. As this is not an AI-based device, there is no mention of a training set or its ground truth.

Summary of what the document does provide regarding device clearance:

The SDU-1200Pro was cleared through the 510(k) pathway based on substantial equivalence to the predicate device, Shimadzu SDU-2200 (K003514). This means the FDA determined that the new device is as safe and effective as a legally marketed device and does not raise different questions of safety and effectiveness. This typically involves demonstrating that the device has the same intended use, technological characteristics, and similar performance to the predicate, or that any differences do not raise new safety or effectiveness concerns. The provided document details the broad clinical applications and imaging modes for which the device and its various transducers are cleared. It also lists compliance with relevant safety and acoustic output standards.

In essence, the document confirms regulatory clearance for a diagnostic ultrasound system based on substantial equivalence, but it does not contain the kind of clinical study details usually associated with novel AI device performance evaluation.

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