(32 days)
Esaote's MyLabFive is a compact 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, Laparoscopic, Intraoperative Abdominal, and Other Urologic. The system 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 MyLabFive is a portable ultrasound system used to perform diagnostic general ultrasound studies. Its primary modes of operation are: B-Mode. M-Mode, Multi View (MView), Amplitude Doppler (AD), Tissue Velocity Mapping (TVM) and Tissue Enhancement Imaging (TEI). Optional is Doppler and Color Flow Mapping (CFM). The MyLabFive is equipped with a LCD Color Display. The full alphanumeric keyboard allows complete on-screen data entry of patient information and on-screen annotations. The MyLabFive can drive phased (PA), convex (CA), linear array (LA) and Doppler probes. The MyLabFive is equipped with an internal Hard Disk and with an optional external DVD-RW disk drive that can be used for image storage. Data can also be stored directly to external archiving media (hard-disk, PC, server) via a LAN/USB port. Optional accessory devices available for the MyLabFive include an S-VHS video recorder, a monochrome or color page printer and a mobile trolley equipped with an insulation transformer.
The provided text is a 510(k) summary for the Esaote MyLabFive Ultrasound System. It focuses on demonstrating substantial equivalence to predicate devices (Esaote MyLab40 and MyLab30 Gold Cardiovascular) rather than presenting a standalone study with acceptance criteria and performance data for the MyLabFive itself.
Therefore, the requested information cannot be fully extracted as there isn't a dedicated "study that proves the device meets the acceptance criteria" in the format typically used for performance validation of new algorithms or diagnostic tests. Instead, the document asserts equivalence based on shared technical capabilities, software, safety standards, acoustic output, and measurement accuracy with previously cleared devices.
However, I can extract information related to the claimed performance and what would typically constitute acceptance criteria in such a submission:
1. Table of acceptance criteria and the reported device performance
The document does not explicitly state quantitative "acceptance criteria" or "reported device performance" in terms of specific metrics like sensitivity, specificity, accuracy, or quantitative measurements that would be expected for a new diagnostic algorithm. Instead, it relies on the concept of substantial equivalence to predicate devices. The implicit acceptance criterion is that the MyLabFive performs as well as or is equivalent to the predicate devices for its intended uses and various operational modes.
The stated performance claim is:
- "The MyLabFive, ESAOTE 7340 (MyLab30 Gold Cardiovascular) and the ESAOTE Europe MyLab40 provide a similar measurements and analysis package, with equal accuracy and precision."
This statement implies that the accuracy and precision of the MyLabFive are considered acceptable if they are equal to those of the predicate devices. However, no specific numerical values for accuracy or precision are provided for either the MyLabFive or its predicates in this summary.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided in the 510(k) summary. The document does not describe any specific clinical or technical test sets used to independently validate the MyLabFive's performance. The basis for equivalence is the shared design, software, and established performance of the predicate devices.
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)
This information is not provided. As no specific test set is described, there is no mention of experts or ground truth establishment in this context.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not provided.
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
A multi-reader multi-case (MRMC) comparative effectiveness study was not done and is not mentioned. The MyLabFive is an ultrasound imaging system, not an AI-assisted diagnostic tool in the sense of providing automated interpretations or modifications to human reader performance. The document focuses on the imaging capabilities and operational modes.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
A standalone performance study of an algorithm is not discussed or presented. The device is an ultrasound system that produces images for human interpretation.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
This information is not provided. Since no specific performance study for the MyLabFive is detailed, the type of ground truth is not applicable. The basis for clearance is substantial equivalence, implying that the predicate devices' performance was considered adequate and that the MyLabFive performs similarly.
8. The sample size for the training set
This information is not provided. The MyLabFive is an imaging system, not an AI/ML device that would typically involve a "training set" in the context of machine learning.
9. How the ground truth for the training set was established
This information is not provided for the reason stated in point 8.
§ 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.