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Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: General, OB, Gynecology, Abdomen, Fetal Heart, Renal, Neonatal, Pediatric, Vascular, Cardiac, Urology, Breast, Small Parts, Musculoskeletal applications. The system also provides for the measurement of anatomical structures and for analysis packages that provide information that is used for clinical diagnosis purposes.

The SONOACE PICO is a general purpose, mobile, software controlled, diagnostic ultrasound system with on-screen display for themal and mechanical indices related to potential bioeffect mechanisms. Its function is to acquire ultrasound data and to display the data as B-mode, M-mode, Color Doppler, Pulsed (PW) Doppler, Power Doppler, Harmonic imaging and 3D imaging , or as a combination of these modes on the LCD monitor.

The provided document is a 510(k) summary for the SONOACE PICO Diagnostic Ultrasound System, dated May 16, 2006. This type of document is primarily concerned with establishing substantial equivalence to a predicate device, rather than presenting a detailed clinical study demonstrating the device's performance against specific acceptance criteria.

The information provided outlines the device's intended use and technological characteristics, and relies on its similarity to previously cleared devices (K013627, SA8000 Ultrasound system and K043455, SA8000 SE Ultrasound system) to demonstrate safety and effectiveness. It does not include a description of a specific study to prove that the device meets defined acceptance criteria in terms of diagnostic performance (e.g., sensitivity, specificity for a particular clinical condition). Instead, it lists the product safety standards it has been designed to meet.

Therefore, many of the requested sections (e.g., table of acceptance criteria and reported device performance, sample size for test set, number of experts, adjudication method, MRMC study, standalone performance, ground truth types, training set sample size, and ground truth establishment for training set) cannot be extracted from this document as they are not typically part of a 510(k) summary focused on substantial equivalence for a diagnostic ultrasound system.

However, I can extract the safety acceptance criteria mentioned:

1. Table of Acceptance Criteria and Reported Device Performance

This document focuses on compliance with general safety and performance standards for diagnostic ultrasound equipment, rather than specific clinical performance metrics. The "reported device performance" in this context refers to the device being designed to meet these standards.

The specific "study that proves the device meets the acceptance criteria" is not detailed in this 510(k) summary. For devices cleared through the 510(k) process, especially for ultrasound systems, substantial equivalence to a predicate device often serves as the basis for demonstrating safety and effectiveness, rather than new extensive clinical performance studies. The document states that "The SONOACE PICO is substantially equivalent to the SA8000 Diagnostic Ultrasound System, cleared via K013627, and the SA8000 SE Diagnostic Ultrasound System, cleared via K043455." This implies that the previous clearance of these predicate devices, based on their safety and performance data, is sufficient to demonstrate the new device's compliance.

A post-clearance special report is required for acoustic output measurements based on production line devices (Appendix G, "Information for Manufacturers Seeking Marketing Clearance of Diagnostic Ultrasound Systems and Transducers"), which is a verification step of manufacturing compliance rather than a clinical performance study.

The following information cannot be extracted from the provided document as it relates to clinical performance studies which are not typically required for 510(k) clearance of these types of devices based on substantial equivalence:

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): Not provided.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience): Not provided.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not provided.
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: Not provided (this is not an AI device).
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable (this is an ultrasound imaging system, not an algorithm for diagnosis).
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not provided.
8. The sample size for the training set: Not applicable (this is a hardware/software system, no AI training specified).
9. How the ground truth for the training set was established: Not applicable.

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