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The Clivia series Diagnostic Ultrasound System is applicable for adults, pediatric patients and neonates. It intended for use in Fetal/Obstetrics, Abdominal/GYN, Pediatrics, Small Organ(breast, thyroid, testes), Neonatal Cephalic, Adult Cephalic, Trans-rectal, Musculoskeletal (Conventional), Musculoskeletal (Superticial), Thoracic/Pleural, Cardiac Adult, Cardiac Pediatric), peripheral vessel and Urology exams.

The operator for Clivia series Diagnostic Ultrasound System is intended for professional clinical staff or the qualified and trained personnel with experience in the use of ultrasound diagnostic equipment. The device is intended to be used in hospital or clinics.

Modes of operation include: B-Mode, Color Mode, Power (Dirpower)-Mode, PW Doppler Mode, CW Doppler Mode, 3D/4D, Holo PW, Tissue Harmonic Imaging, Tissue Doppler Imaging(TDI), Anatomic M(AMM) and combined mode.

The proposed Clivia series Diagnostic Ultrasound System is a general-purpose, Track 3, diagnostic ultrasound device, intended for ultrasound imaging, measurement and analysis of the human body and fluid that provides digital acquisition, processing and display capabilities.

The Clivia series Diagnostic Ultrasound System can be controlled both by touch screen or the control panel. Its basic function is to acquire and display ultrasound data in B-Mode, M-Mode, Color-Mode, Power(Dirpower)-Mode, PW-Mode, 3D/4D, Holo PW, Anatomic M(AMM), Tissue Doppler Imaging(TDI) and the combined modes. The system can also measure anatomical structures and offer software analysis packages performance to provide information based on which the competent health care professionals can make the diagnosis.

Ten different models of probes are available for the Clivia series, that is C6-1B-H, C6-2-H, C9-3-H, L15-4NB-H, L22-10-H, LH15-6-H, SP5-1-H, P8-3-H, EV11-3-H, D7-2-H.

The Clivia series Diagnostic Ultrasound System has the capability for displaying the patient's ECG and trace synchronized to the scanned image. This allows the user to view an image from a specific time of the ECG signal. ECG is not intended for monitoring or diagnosis.

The Clivia series Diagnostic Ultrasound System has four batteries in total that allows for scanning or other operation without the need to plug in to an electrical outlet. The system is capable of wireless communication and a barcode reader is available to be used as an input device. System meets DICOM requirements to support users image storage and archiving needs and allows for output to printing devices.

The provided text describes the Clivia series Diagnostic Ultrasound System. However, it does not include details about acceptance criteria for performance metrics (such as sensitivity, specificity, accuracy, etc.) or a study that proves the device meets such criteria in terms of diagnostic performance.

The document primarily focuses on demonstrating substantial equivalence to a predicate device (GE Venue K180599) and adherence to general safety and regulatory standards.

Here's a breakdown of the specific information requested, based on the provided text:

1. A table of acceptance criteria and the reported device performance:
   The document does not provide a table of acceptance criteria related to diagnostic performance (e.g., sensitivity, specificity, or image quality metrics) or reported device performance against such criteria. It states that "The non-clinical data support the safety of the device and the performance testing report demonstrate that the Clivia series Diagnostic Ultrasound System should perform as intended in the specified use conditions." but does not elaborate on specific performance metrics.

2. Sample size used for the test set and the data provenance:
   The document explicitly states: "The subject of this premarket submission, Clivia series Diagnostic Ultrasound System, did not require clinical studies to support substantial equivalence." Therefore, there is no test set sample size or data provenance related to diagnostic performance presented.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
   As no clinical studies were performed for diagnostic performance, there were no experts mentioned for establishing ground truth for a test set.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
   As no clinical studies were performed for diagnostic performance, there is no mention of an adjudication method.

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 MRMC study was done, and the device is a diagnostic ultrasound system, not an AI-assisted device for improving human reader performance.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
   No standalone performance study for an algorithm was done, as this is a diagnostic ultrasound system, not an AI-driven image analysis algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
   No ground truth was established for diagnostic performance as no clinical studies are mentioned.

8. The sample size for the training set:
   Not applicable, as this document does not describe the development or testing of a machine learning algorithm that would require a training set.

9. How the ground truth for the training set was established:
   Not applicable, as this document does not describe the development or testing of a machine learning algorithm that would require a training set.

Summary of available performance data from the text:

The "Performance Data" section (Section 6) of the document details non-clinical performance data provided in support of substantial equivalence. These include:

• Biocompatibility testing: Conducted using ISO-10993 standards and included cytotoxicity, sensitization, and irritation tests.
• Electrical safety and electromagnetic compatibility (EMC) testing: Complies with IEC 60601-1, IEC 60601-2-37 for safety, and IEC 60601-1-2 for EMC.
• Software Verification and Validation Testing: Conducted in accordance with FDA guidance for "Moderate" level of concern software.
• Acoustic testing: Conducted in accordance with NEMA UD 2-2004 (R2009) acoustic output measurement standard, ensuring acoustic power levels are below FDA limits.

The document concludes that "The differences between the Clivia series Diagnostic Ultrasound System and its predicate device do not raise different questions of safety and effectiveness. The non-clinical data support the safety of the device and the performance testing report demonstrate that the Clivia series Diagnostic Ultrasound System should perform as intended in the specified use conditions."

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