(80 days)
The multifunctional ultrasound scanner MyLabX75 Family is used to collect, display, and analyze ultrasound images during ultrasound imaging procedures in combination with supported echographic probes
-Cardiac [Adult and Pediatric]
-Vascular [Neonatal, Adult Cephalic, Vascular generic] -General Imaging [Abdominal, Breast, Musculo-skeletal, Neonatal, Pediatric, Small Organs (Testicles), Thyroid, Urological ] with invasive access Intraoperative (Abdominal), Laparoscopic, Transrectal. -Women Health [OB/Fetal, Gynecology with invasive access (Transrectal, Transvaginal)]
The equipment provides imaging for guidance of biopsy and imaging to assist in the placement of needles and catheters in vascular or other anatomical structures as well as peripheral nerve blocks in Musculoskeletal applications. The ultrasonic medical diagnostic equipment is intended to mechanical and electronic ultrasound probes (convex array, linear array and phased array) and Doppler probes.
The Fiber Guidance option assists ultrasound guidance in the phases of insertion and positioning of the introducer needle and optical fiber and procedure monitoring.
Model 6430, commercial names MyLabX75 and MyLab XPro75, is a mainframe ultrasound system used to perform diagnostic general ultrasound studies. The primary modes of operation are: B-Mode, Tissue Enhancement Imaging (TEI), M-Mode, Multi View (MView), Doppler (both PW and CW), Color Flow Mapping (CFM), Amplitude Doppler (AD), Tissue Velocity Mapping (TVM), 3D and 4D, Qualitative Elastosonography (ElaXto) and Quantitative Elastosonography (QElaXto).
Model 6430 has a software option integrated, called PLA, designed to support a radiological clinical ultrasound examination (first modality) and follow a percutaneous procedure providing additional image information from a second imaging modality (CT, MR, US and PET). The user is helped in assessing the patient anatomy by displaying the image generated by the 2nd modality.
Model 6430 is equipped with a LCD color display where acquired images and advanced image features are shown. Model 6430 control panel is equipped with a pull-out Qwerty alphanumeric keyboard that allows data entry. The touchscreen has an emulation of the Qwerty alphanumeric keyboard that allows data entry and has additional controls and mode-depending keys, integrated in the touchscreen.
Model 6430 can drive Phased Array (PA), Convex Array (LA), Linear Array (LA), Doppler and Volumetric probes.
Model 6430 is equipped with an internal Hard Disk Drive. Data can also be stored directly to external archiving media (Hard-Disk, PC, on server) via a LAN/USB port.
6430 project is mainly design change of 6450 devoted to reducing cost and to differentiate design and performances, 6430 will introduce in the Esaote's Mid-ultrasound tier functionalities that, at the moment are present only in our High -End Ultrasound tier, such as 2D Shear Wave Elastography (2D-SWE) and Virtual Navigator.
The marketing names for Model 6430 will be MyLabX75 and MyLab XPro75.
The difference between MyLab XPro75 is only in the licenses configuration: on MyLab XPro75 all the options are included while in the MyLabX75 some licenses can be ordered by customer.
The provided text is a 510(k) summary for the Esaote MyLabX75 and MyLab XPro75 ultrasound systems. It explicitly states that no clinical tests were performed to demonstrate that the device meets acceptance criteria. The submission relies entirely on non-clinical data and equivalence to a predicate device.
Therefore, many of the requested details about acceptance criteria and study design are not applicable or cannot be extracted from this document.
Here's what can be extracted based on the information provided:
1. A table of acceptance criteria and the reported device performance
The document does not specify quantitative acceptance criteria for performance; rather, it focuses on safety and technological equivalence.
| Acceptance Criteria (High-Level) | Reported Device Performance |
|---|---|
| Safety (Acoustic output, biocompatibility, cleaning, thermal, electrical, electromagnetic, mechanical) | Conforms to recognized medical device safety standards (IEC 60601-1, -1-2, -1-6, -2-37, NEMA UD-2) |
| Intended Use/Functionality | Performs as intended in specified use conditions (based on verification and validation) |
| Technological Characteristics | Employs the same fundamental technological characteristics as the predicate device (Esaote Model 6450, K192157) |
| Accuracy and Precision of Measurements and Analysis Packages | Provides similar measurements and analysis packages with equal accuracy and precision to predicate. |
2. Sample size used for the test set and the data provenance
- Not Applicable. No clinical test set was used as "No clinical tests were performed." The submission relies on non-clinical data, typically engineering verification and validation.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not Applicable. No clinical test set was used, and thus no expert ground truth establishment for a clinical study.
4. Adjudication method for the test set
- Not Applicable. No clinical test set was used.
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. No clinical effectiveness study, and specifically no MRMC study, was performed. This device is an ultrasound system, not an AI-assisted diagnostic tool in the context of human reader improvement.
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 a standalone diagnostic algorithm. The performance evaluation was based on non-clinical engineering tests and comparison to a predicate device's technological characteristics and safety standards.
7. The type of ground truth used
- Not Applicable. As no clinical studies were performed, there was no ground truth for patient outcomes or expert consensus on diagnostic accuracy required in this submission. The "ground truth" for the non-clinical tests would be the compliance with engineering specifications and safety standards.
8. The sample size for the training set
- Not Applicable. This document does not describe the development or training of any machine learning algorithms. It is a traditional 510(k) for an ultrasound imaging system.
9. How the ground truth for the training set was established
- Not Applicable. As no machine learning training set is mentioned.
§ 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.