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The Diagnostic Ultrasound System is applicable for adults, pregnant women, pediatric patients and neonates. It is intended for use in gynecology, obstetric, abdominal, pediatric, small parts (breast, testes, thyroid, etc.), neonatal cephalic, transcranial, cardiac, transvaginal, peripheral vascular, urology, orthopedic, and musculoskeletal (conventional and superficial) exams.

The Piloter Exp/ Piloter P Diagnostic Ultrasound System is a touch screen controlled ultrasonic system. Its function is to acquire and display ultrasound data in B-Mode, Color Flow Doppler, Pulsed Wave Doppler, Continued Wave Doppler, Power/Dirpower mode or the combination of these 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.

The Piloter Exp/ Piloter P Diagnostic Ultrasound System consists of the main unit named Piloter series, ultrasound probes, probe extender, power adapter, connecting cable and mobile trolley.

Three models for the main units are included in this submission, that is Piloter Exp. Piloter and Piloter P. there are three different models of probes are available for the Piloter series.

The provided text is a 510(k) summary for the Piloter Exp/Piloter/Piloter P Diagnostic Ultrasound System. This document focuses on demonstrating substantial equivalence to a predicate device, rather than proving a new device meets specific, novel acceptance criteria through a clinical study or performance study with a defined test set, ground truth, and expert adjudication.

Therefore, the document does not contain the information requested regarding acceptance criteria and a study proving the device meets those criteria, as typically understood for AI/ML devices or novel diagnostic tools. Instead, it relies on non-clinical data and comparison to a legally marketed predicate device.

Specifically, the document states:

• "The subject of this premarket submission, Piloter/ Piloter/ Piloter P Diagnostic Ultrasound System, did not require clinical studies to support substantial equivalence." (Page 27, Section 8)
• "Performance testing was conducted on the Piloter Exp/ Piloter P Diagnostic Ultrasound System, to evaluate the clinic measurement accuracy and system sensitivity, and all of the tested parameters met the predefined acceptance criteria." (Page 26, Section 7, Performance testing)

While it mentions "predefined acceptance criteria" for performance testing, it does not provide the specifics of these criteria or the reported device performance in the format requested, nor does it detail a study that would involve a test set, ground truth established by experts, or MRMC studies. The "performance testing" described is likely technical verification against engineering specifications and industry standards for ultrasound devices, not a clinical validation as would be performed for a deep learning model.

Therefore, I cannot populate the requested table and answer the questions based on the provided text. The document's purpose is to demonstrate substantial equivalence of a conventional ultrasound system, not to validate an AI/ML component with a test set, ground truth, and expert review.

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