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The Dolphin Medical Imaging USB Ultrasound System is intended for diagnostic ultrasound imaging in B mode. It is indicated for diagnostic ultrasound imaging in the following applications:

• · Fetal/Obstetric
• Abdominal Pediatric
• · Small Organ
• · Musculo-skeletal (conventional)
• · Musculo-skeletal (superficial)
• · Urology
• · Gynecology
• · Pelvic Floor
• · Neuro-muscular
• · Peripheral Vessel

The system is intended for use by trained registered nurses and other trained healthcare professional healthcare environment.

The Dolphin Medical Imaging Ultrasound System ("DMI US") is a self-contained, solid-state portable ultrasound imaging system, physically comprised of the FDA-cleared Interson SP-L01 USB ultrasound probe (K163443), which is used in connection with the DMI US application software. The system contains an ultrasound generator/receiver, analog to digital converter, microcontroller, control logic, USB 2.0 interface, B-mode imaging and application software providing the user interface.

The DMI US application software provides a task-oriented graphical user interface that runs on a personal computer with a USB 2.0 (or greater) port and the Windows 10 operating system. The user-selectable tasks supported are peripheral intravenous access and central venous access. The software application displays the ultrasound B-mode image at a depth appropriate for the selected task.

The initial operational settings of the probe and/or application are preprogrammed in the system. User-customized parameter settings for each probe and/or application may be set by the operator and stored for recall as needed via the software user interface. Customization includes changing image brightness (gain), changing depth and freezing/unfreezing the ultrasound image. The system uses a probe with solid-state ultrasound array transducers which provide high resolution, high penetration performance

The provided text is a 510(k) premarket notification for the Dolphin Medical Imaging USB Ultrasound System. It details the device's technical specifications, intended use, and comparison to a predicate device (Interson USB Ultrasound System K163443).

However, the document specifically states under "Summary of Clinical Tests":

"The Dolphin Medical Imaging USB Ultrasound System introduces no new modes, features, or technologies relative to the predicate device (Interson K163443) that require clinical testing. The clinical safety and effectiveness of ultrasound systems with these characteristics are well accepted for both predicate and subject devices."

This means that no clinical studies were conducted or required for the 510(k) clearance of this specific device. The clearance was based on demonstrating substantial equivalence to a legally marketed predicate device through non-clinical performance data (compliance with various electrical safety, electromagnetic compatibility, usability, risk management, and biocompatibility standards), and the established safety and effectiveness of ultrasound technology for its stated indications.

Therefore, I cannot provide the information requested in your prompt regarding acceptance criteria and the study proving the device meets them, as no such clinical study was performed or documented in this 510(k) submission.

To answer your specific points based on the provided text:

1. A table of acceptance criteria and the reported device performance: Not applicable. No clinical performance acceptance criteria and reported clinical performance are provided because no clinical study was conducted. The non-clinical performance data refers to compliance with standards (e.g., NEMA UD 2-2004 for acoustic output, IEC 60601 series for safety and EMC), not performance metrics in a clinical setting.
2. Sample sizes used for the test set and the data provenance: Not applicable. No clinical test set.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No clinical test set.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable. No clinical 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: Not applicable. No MRMC study was done, nor does the device describe any AI features for reader assistance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is an ultrasound imaging system, not an AI algorithm for standalone performance evaluation.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable. No clinical study requiring ground truth was conducted.
8. The sample size for the training set: Not applicable. The document does not describe any machine learning or AI components that would require a training set.
9. How the ground truth for the training set was established: Not applicable. No training set described.

In summary, this 510(k) relies on the substantial equivalence pathway, asserting that the new device is fundamentally similar to an already cleared device and that the existing evidence for the predicate device, supplemented by non-clinical engineering and safety compliance tests, is sufficient to demonstrate the safety and effectiveness of the new device.

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