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Esaote's Model 6200 is a mainframe ultrasound system used to perform diagnostic general ultrasound studies including Cardiac, Transesophageal, Peripheral Vascular, Neonatal Cephalic, Adult Cephalic, Small organ, Musculoskeletal (Conventional and Superficial), Abdominal, Fetal, Transvaginal, Transrectal, Pediatric, Intraoperative (Abdominal), Laparoscopic and Other: Urologic. The 6200 system provides imaging for guidance of biopsy and imaging to assist in the placement of needles in vascular or other anatomical structures as well as peripheral nerve blocks in Musculoskeletal applications.

The Virtual Navigator is a MyLab optional license that provides additional image information from a second modality like CT or MR, during a clinical ultrasound session. The second modality provides additional security in assessing the morphology of the ultrasound image.

Virtual Navigator can be used in the' following application: Abdominal. Musculo-skeletal. Urologic, and Vascular,

The second modality image is not intended to be used as a standalone diagnostic image since it represents information of a patient that could not be congruent with the current (actual) patient position and shall therefore always been seen as an additional source of information.

The Virtual Navigator tracking system should not be used on or around persons with a cardiac pacemaker, and should not be used around life supporting equipment.

The 6100 is a mainframe ultrasound system, used to perform diagnostic general ultrasound studies. Its primary modes of operation are: B-Mode, XView, Multi View (MView), Trapezoidal View (TPView), Doppler, Color Flow Mapping, Amplitude Doppler (AD), Tissue Velocity Mapping (TVM) and Tissue Enhancement Imaging (TEI). The system is equipped with a LCD Color Display, a control panel and is capable of operating Linear, Convex, and Phased array probes.

The 6100 system has been cleared by FDA via K051837, K060827 and K081386.

The modified 6100, with respect to the cleared version 6100 via K051837, K060827 and K081386, is due to the improvements of the system. These modifications, that do not affect the intended use or alter the fundamental scientific technology of the device, are the following:

• a. New keyboard (control panel), where some control keys (knobs and keys) have been replaced by a touch screen.
• b. New plastic housing of the system both to include the touch screen and to give a new style
• c. New keyboard group PCBs lay out to interface the touch screen and to match the new organization of the panel keys.
• d. Software/Firmware modification to translate the touch screen information for the software: main software characteristics and performances have not been changed.

The 6200 is the model name of the modified 6100. The set of probes of the 6100 is exactly the same.

The 6200 system is manufactured under an ISO 9001:2000 and ISO 13485 certified quality system.

The provided text is a Special 510(k) Summary for the Esaote 6200 Ultrasound Imaging System. It describes modifications to an existing device (6100) and confirms that these modifications do not alter the intended use or fundamental scientific technology. The document focuses on demonstrating substantial equivalence to predicate devices and lists various clinical applications and operation modes for different transducers.

However, the provided text does not contain any information about acceptance criteria, device performance studies, sample sizes for test or training sets, data provenance, expert ground truth, adjudication methods, multi-reader multi-case (MRMC) studies, or standalone algorithm performance.

The tables within the document primarily indicate:

• "P" (Previously cleared by FDA): This means the indication and mode of operation for a specific transducer were already approved based on prior submissions (K051837, K060827, K081386, or K091009). For these, new performance studies are generally not required to re-demonstrate safety and effectiveness unless the modification changes the fundamental scientific technology or intended use.
• "N" (New indication): This indicates an indication not previously cleared for a specific transducer. For these, the applicant would typically provide data to support the new indication, but this data is not included in the provided text.
• "E" (Added under Appendix): This also refers to expanded or new indications. Similar to "N," supporting data would be submitted, but it's not present here.

Therefore, I cannot fulfill your request for an acceptance criteria table and the details of a study proving the device meets those criteria, as this information is not present in the provided document. The 510(k) summary focuses on justifying substantial equivalence through a comparison of technological characteristics and intended uses rather than presenting new performance data for device modifications that are deemed not to significantly affect safety or effectiveness.

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