(91 days)
The MyLab40 is a compact console ultrasound system used to perform diagnostic general ultrasound studies including Cardiac, Transesophageal, Peripheral Vascular, Neonatal Cephalic, Adult Cephalic, Small Organ, Musculoskeletal (Conventional and Superficial), Abdominal, Fetal, Transvaginal, Transrectal, Pediatric, Intraoperative Abdominal and Other: Urologic.
The MyLab40 is a compact console ultrasound system used to perform general diagnostic ultrasound studies. Its primary modes of operation are: B-Mode, M-Mode, Doppler, 3D/4D, Color Flow Mapping and on lower frequency probes, Tissue Enhancement Imaging (TEI). The system is equipped with a LCD color display and can drive Phased Array (PA), Convex Array (CA), Linear Array (LA) and Doppler probes. The MyLab40 is able to produce Real Time 2D images and 3D images in manual mode with all probes. The system in combination with the BC431 or BS230 probe, offer the possibility to also produce automatic 3D and Real Time 4D images. The MyLab40 is manufactured under an ISO9001:2000 and ISO13485:2003 certified quality system.
The provided text is a 510(k) summary for the MyLab40 Ultrasound System and does not contain information about acceptance criteria or a study proving that the device meets such criteria.
The document focuses on:
- Device Description: General purpose ultrasound system and its modes of operation.
- Intended Use: A broad range of diagnostic ultrasound studies.
- Technological Characteristics: A comparison table showing the MyLab40's technical specifications and indications for use against predicate devices (MyLab30 and MyLab20). This comparison primarily asserts substantial equivalence rather than detailing specific performance criteria or a study designed to meet them.
- Transducer Indications for Use: Detailed tables for various transducers outlining their applicable clinical applications and modes of operation.
Therefore, I cannot provide the requested information as it is not present in the given text.
To answer your request, the input document would need to include sections detailing:
- Acceptance Criteria: Specific performance thresholds the device must meet (e.g., accuracy, precision, sensitivity, specificity for a particular measurement or diagnostic task).
- Study Design and Results: A description of a study conducted to demonstrate the device's performance against these criteria, including:
- Sample size and data provenance for the test set.
- Details on ground truth establishment (number/qualifications of experts, adjudication method, type of ground truth).
- Whether MRMC or standalone performance studies were conducted, and their results.
- Training set details (sample size, ground truth establishment).
§ 892.1570 Diagnostic ultrasonic transducer.
(a)
Identification. A diagnostic ultrasonic transducer is a device made of a piezoelectric material that converts electrical signals into acoustic signals and acoustic signals into electrical signals and intended for use in diagnostic ultrasonic medical devices. Accessories of this generic type of device may include transmission media for acoustically coupling the transducer to the body surface, such as acoustic gel, paste, or a flexible fluid container.(b)
Classification. Class II.