(28 days)
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.
§ 892.1550 Ultrasonic pulsed doppler imaging system.
(a)
Identification. An ultrasonic pulsed doppler imaging system is a device that combines the features of continuous wave doppler-effect technology with pulsed-echo effect technology and is intended to determine stationary body tissue characteristics, such as depth or location of tissue interfaces or dynamic tissue characteristics such as velocity of blood or tissue motion. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II.