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The system is intended for use by a qualified physician for ultrasound evaluation of Fetal/obstetric, gynecological, Abdominal (renal, GYN/Pelvic), Pediatric, Small organ (thyroid, breast, testes, etc), Adult & Neonatal Cephalic, Trans-vaginal, Trans-cranial, Musculoskeletal (conventional & superficial), Cardiac-Adult/Pediatric/Fetal, Pelvic, Peripheral vascular, and harmonic tissue.

The candidate device, FUJIFILM Diagnostic Ultrasound System FAZONE CB, is a general purpose ultrasound diagnostic imaging equipment, which features the compact design suitable for easy transport. The FAZONE CB system generally includes a portable CB main unit, battery, and ultrasound probes. The FAZONE CB compatible ultrasound probes are connected directly to the CB main unit. The control panel of the CB main unit utilizes a touch panel for ease of use providing a virtual keyboard. Optional parts and other system components - for example, external monitor, printer, keyboard, etc. - can be connected to the CB main unit. The CB cart (optional) provides a docking station for the CB main unit and accommodates optional parts and other system components when they are connected to the CB main unit. The CB main unit can be used without the CB cart.

The provided document is a 510(k) summary for the FUJIFILM Diagnostic Ultrasound System FAZONE CB. It outlines the device's intended use and substantial equivalence to a legally marketed predicate device.

However, the document explicitly states: "No clinical test was conducted." (Page 1).

This means that there is no information available in the provided text to answer most of the questions regarding acceptance criteria and performance studies. The submission focuses on demonstrating substantial equivalence based on technical specifications, safety standards, and similar indications for use compared to a predicate device, rather than on clinical performance data from studies specifically designed to meet acceptance criteria.

Therefore, I cannot provide details on:

• A table of acceptance criteria and reported device performance.
• Sample size used for the test set and data provenance.
• Number of experts used to establish ground truth and their qualifications.
• Adjudication method for the test set.
• Whether a multi-reader multi-case (MRMC) comparative effectiveness study was done, or its effect size.
• Whether a standalone (algorithm only) performance study was done.
• The type of ground truth used (expert consensus, pathology, outcomes data, etc.) for any clinical study.
• The sample size for the training set.
• How the ground truth for the training set was established.

The study described is a demonstration of substantial equivalence to a predicate device, the ZONARE z.one Ultra Ultrasound System (K101091) (Page 1). This is not a performance study in the sense of establishing acceptance criteria against clinical outcomes or expert labels.

The primary method for demonstrating substantial equivalence was by comparing the candidate device's technical characteristics, safety features, design, construction, and indications for use to those of the predicate device. The document affirms that "The candidate and marketed devices utilize similar technology and materials, comparable safety and effectiveness features, and they are similar in design and construction. The Indications for Use and labeling are similar..." (Page 1).

The device was also evaluated for conformance with various safety and performance requirements, including:

• IEC 60601-1 (Medical electrical equipment - General safety requirements)
• IEC 60601-1-1 (Medical electrical equipment - Safety requirements for medical electrical systems)
• IEC 60601-1-2 (Medical electrical equipment - Electromagnetic compatibility)
• IEC 60601-2-37 (Medical electrical equipment - Basic safety and essential performance of ultrasonic medical diagnostic and monitoring equipment)
• IEC 62304 (Medical device software - Software life cycle processes)
• IEC 62366 (Medical devices - Application of usability engineering to medical devices)
• ISO 10993 (Biological evaluation of medical devices)
• DICOM (Digital Imaging and Communications in Medicine)
• ISO 14971 (Medical devices – Application of risk management to medical devices)

These standards primarily address safety, electrical compatibility, software lifecycle, usability, biological compatibility, and risk management, rather than clinical diagnostic performance metrics like sensitivity or specificity for specific conditions.

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