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The device is a general-purpose ultrasound system. Specific clinical applications remain the same as previously cleared: Fetal/OB; Abdominal (including renal and GYN/pelvic); Pediatric; Small Organ (breast, testes, thyroid, salivary gland, lymph nodes, pediatic and neonatal patients); Neonatal and Adult Cephalic; Cardiac (adult and pediatric); Peripheral Vascular (PV); Musculo-skeletal Conventional and Superficial; Transrectal (Including Urology and Prostate) (TR); Transvaginal (TV).

Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

The systems are full-featured Track 3 ultrasound systems, primarily for general radiology use and specialized for OB/GYN with particular features for real-time 3D/4D acquisition. They consist of a mobile console with keyboard control panel; color LCD display, color video display and optional image storage and printing devices. They provide high performance ultrasound imaging and analysis and have comprehensive networking and DICOM capability. They utilize a variety of linear, curved linear, matrix phased array transducers including mechanical and electronic scanning transducers, which provide accurate real-time three-dimensional imaging supporting all standard acquisition modes.

The provided text is related to a 510(k) premarket notification for the GE Healthcare Voluson P6 and Voluson P8 ultrasound systems. It primarily focuses on demonstrating substantial equivalence to previously cleared predicate devices rather than proving the device meets specific acceptance criteria through clinical studies.

Therefore, the document explicitly states: "The subject of this premarket submission, Voluson P6 / Voluson P8, did not require clinical studies to support substantial equivalence."

This K-submission demonstrates equivalence based on:

• Identical Intended Use: The Voluson P6/P8 has the same general-purpose ultrasound system indications for use as the previously cleared predicate (K160162 Voluson P Series; Voluson P6/P8 Diagnostic Ultrasound System).
• Similar Technology: It employs the same fundamental scientific technology.
• Comparison to Predicates: The systems are determined to be substantially equivalent in intended use, imaging capabilities, technological characteristics, safety, and effectiveness. This includes having the same clinical intended use, imaging modes, identical transducers, same indications for use, similar capabilities in measurements, digital image capture, review, and reporting.
• Compliance with Safety Standards: The device has undergone non-clinical tests for acoustic output, biocompatibility, cleaning and disinfection effectiveness, thermal, electrical, electromagnetic, and mechanical safety, and conforms to applicable medical device safety standards. It also complies with voluntary standards like AAMI/ANSI ES60601-1, IEC60601-1-2, IEC60601-2-37, ISO10993-1, NEMA UD 2, ISO14971, and NEMA PS 3.1 - 3.20 (DICOM).
• Quality Assurance Measures: The development included risk analysis, requirements reviews, design reviews, unit-level testing, integration testing, performance testing, and safety testing.
• Biocompatibility: Transducer materials and other patient contact materials are biocompatible.

Since no clinical studies were performed, there is no information available in this document to populate the following requested sections:

1. A table of acceptance criteria and the reported device performance: No specific performance metrics for clinical accuracy are provided as clinical studies were not required. Acceptance criteria would primarily relate to safety and functionality matching the predicate device.
2. Sample sizes used for the test set and the data provenance: No test set of clinical images/data was used for performance evaluation.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: No ground truth was established from experts for a clinical test set.
4. Adjudication method: Not applicable as no clinical images were adjudicated.
5. MRMC comparative effectiveness study: Not conducted.
6. Standalone (algorithm only without human-in-the-loop performance) study: Not applicable as this is an ultrasound system, not an AI algorithm.
7. Type of ground truth used: Not applicable.
8. Sample size for the training set: Not applicable as there's no mention of an algorithm or training set for clinical performance.
9. How the ground truth for the training set was established: Not applicable.

In summary, this document is a 510(k) premarket notification for a general-purpose ultrasound system. Its "acceptance criteria" for FDA clearance are primarily based on demonstrating substantial equivalence to existing devices through non-clinical testing and shared intended use, not on specific performance metrics derived from clinical studies or AI algorithm validation.

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