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Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
Fetal OB/GYN, Abdominal, Small Organs (breast, thyroid, testicle), Pediatric, Neonatal Cephalic, Trans-Vaginal, Trans-Rectal, Peripheral Vascular, Cardiac.
Typical examinations performed using the system are: General abdominal and pelvic studies including organ surveys, assessment, and retroperitoneal cavity studies. Study of small parts and superficial structures including breasts, shoulders, thyroid, and the abdominal wall. Pediatric scans of organs, superficial, and bony structures. Monitoring procedures for infertility studies (other than in vitro fertilization). First, second and third trimester pregnancy studies. Neonatal head studies. Podiatry scans of superficial structures including muscles, tendons and bones. General cardiac studies in adults. Prostate, bladder and rectum visualization.

The SonoAce SA-9900 scanner is a multiple-mode, multiple-application ultrasound imaging system. The cart-mounted console contains an ultrasound generator/receiver offering a full complement of conventional operating modes, software-based parameter controls, and recording. The selection of eight transducers to be offered with the system permits a wide range of clinical applications. The various transducers adapt the system for the specific imaging tasks. Eight different models of transducers are available. In addition to the initial operational settings for each transducer preprogrammed in the system, usercustomized parameter settings for each transducer may be inserted by the operator and stored for recall as needed via the system control panel. Customization includes transmit focusing, filtering, image enhancement processing, dynamic window curve selection. Controls are also provided to select display format (single and various combinations), to activate zoom features, and to utilize the cine loop function. Patient contact materials have been tested for biocompatibility in accordance to their intended use and are used for each individual transducer. The SonoAce SA-9900 uses digital beamforming technology. The SonoAce SA-9900 supports a variety of Linear and Convex probes for wide variety of applications. It is an ultrasound scanner, which provides high resolution, high penetration performance, and various measurement functions. Probes are supported in frequencies from 1.0 MHz to 20.0 MHz. The SonoAce SA-9900 provides high quality images and various measuring functions. Biopsy guidelines are provided on screen to assist in the collection of tissue samples, using biopsy guide adapters offered as an optional accessory. Operating Modes of the SonoAce SA-9900 are B-Mode, M-Mode, Tissue Harmonic Imaging (THI), Color-flow Doppler, Continuous (CW) Doppler, Pulsed (PW) Doppler and Power Doppler. Management of patient history is possible by image-filing function. High-resolution images are provided by utilizing a technology called digital dynamic receive focusing.

This looks like a 510(k) premarket notification for an ultrasound system, not an AI device. The document describes the technical characteristics and intended uses of the SonoAce SA-9900 Diagnostic Ultrasound System and its various transducers. It establishes substantial equivalence to other legally marketed ultrasound devices.

Therefore, the requested information regarding acceptance criteria, study details, sample sizes, expert ground truth, adjudication methods, MRMC studies, standalone performance, and training set information is not applicable to this type of medical device submission. These details are typically required for AI/ML-driven devices where the algorithm's performance needs to be rigorously validated against a defined ground truth.

The acceptance criteria for this ultrasound system would typically involve meeting established performance standards for diagnostic ultrasound equipment (e.g., acoustic output limits, image quality, measurement accuracy), and demonstrating substantial equivalence to predicate devices, which is what this document primarily focuses on.

Here's a breakdown of why each requested point is not present or relevant in this context:

1. A table of acceptance criteria and the reported device performance: While the document mentions acoustic output limits (ISPTAd, TIS/TIB/TIC, MI) as being "the same as predicate Track 3 devices," it does not provide a comprehensive table of acceptance criteria for image quality, diagnostic accuracy, or specific performance metrics that would be expected for an AI device.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): Not applicable. This document does not describe a test set or data used for algorithm validation.
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 applicable. Ground truth for an AI algorithm is not established for an ultrasound system itself in this manner.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
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 applicable, as this is not an AI device being submitted.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc): Not applicable.
8. The sample size for the training set: Not applicable.
9. How the ground truth for the training set was established: Not applicable.

The document focuses on:

• Substantial Equivalence: Comparing the SonoAce SA-9900 to predicate devices like Medison/Kretztechnik Combison 530D, SonoAce SA-8800, and SonoAce 6000C/Ultramark 400C.
• Device Description: What the system is and how it works (multiple-mode, multiple-application ultrasound imaging system with various transducers and operating modes).
• Intended Use: Listing the clinical applications (Fetal OB/GYN, Abdominal, Small Organs, Pediatric, Neonatal Cephalic, Trans-Vaginal, Trans-Rectal, Peripheral Vascular, Cardiac, Muscular-Skeletal).
• Technological Characteristics: Describing the digital beamforming technology, frequency range of probes, and acoustic output limits.
• Indications for Use Tables: Detailed tables for each transducer showing which clinical applications and modes are supported, including new indications (marked 'N') compared to previously cleared ones ('P').

In summary, this submission is for a conventional diagnostic ultrasound system, not an AI-powered one, and therefore the requested AI-specific validation details are not part of this documentation.

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