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Fsaote's MyLab15/MyLab20 is a compact console ultrasound system intended to be used by a physician to perform general diagnostic ultrasound studies including Fetal, Abdominal, Pediatric, Small organ, Neonatal Cephalic, Cardiac, Transrectal, Transvaginal, Peripheral Vascular, Musculoskeletal (Conventional and Superficial).

The MyLab15/MyLab20 is a compact console ultrasound system intended to be used by a physician to perform general diagnostic ultrasound studies. Its primary modes of operation are: B-Mode, M-Mode, PW Doppler and Color Flow Mapping and Tissue Enhancement Imaging (TEI). The MyLab15/MyLab20 is equipped with either an LCD TFT color display or a CRT color monitor. The full alphanumeric keyboard allows complete on-screen data entry of patient information and on-screen annotations. The MyLab15/MyLab20 can drive convex (CA) and linear array (LA) probes. The MyLab15/MyLab20 permits storage of images on a USB memory stick. The MyLab15/MyLab20 also saves fetal biometry data, acquired during obstetric examinations, into a database in the internal memory of the system, in order to track the fetal growth through different examinations during the same gestation. Optional accessories available for the MyLab15/MyLab20 include an S-VHS video recorder and a monochrome or color printer.

This document is a 510(k) summary for the MyLab 15 / MyLab 20 Ultrasound Imaging Systems. It lists the device's intended uses and compares it to predicate devices. However, it does not contain information about acceptance criteria or a study proving the device meets those criteria, nor does it refer to an AI/algorithm-based device. The document is for an ultrasound imaging system, which is a hardware device.

Therefore, I cannot extract the requested information from the provided text.

Specifically, the following information is not available in the provided document:

• A table of acceptance criteria and the reported device performance: This document does not establish specific performance metrics or acceptance criteria for an algorithm or AI. It describes the general capabilities and intended uses of the ultrasound systems.
• Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): No test set, data provenance, or sample sizes for testing an algorithm are mentioned.
• 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): Ground truth establishment for an AI algorithm is not discussed as no AI is described.
• Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable as there is no algorithm or test set mentioned in this context.
• 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: This document predates widespread AI in medical imaging and does not refer to any AI assistance or MRMC studies.
• If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
• The type of ground truth used (expert concensus, pathology, outcomes data, etc): Not applicable.
• The sample size for the training set: Not applicable.
• How the ground truth for the training set was established: Not applicable.

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