(14 days)
The device is intended for use by a qualified physician for ultrasound evaluation of Fetal; Abdominal; Pediatric; Small Organ (breast, testes, thyroid); Neonatal Cephalic; Adult Cephalic; Cardiac (adult and pediatric); Peripheral Vascular; Musculo-skeletal Conventional and Superficial; Urology (including prostate); Transrectal; Transvaginal; Transesophageal and Intraoperative (abdominal, thoracic and vascular).
The LOGIQ E9 is a full featured, general purpose diagnostic ultrasound system which consists of a mobile console approximately 58 cm wide, 87cm deep and 130 cm high that provides digital acquisition, processing and display capability. The user interface includes a computer keyboard, specialized controls, 10-inch LCD touch screen and color wide screen image display.
Here's a breakdown of the requested information based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
The provided document (a 510(k) summary) does not detail specific quantitative acceptance criteria or corresponding reported device performance metrics in the way one might expect for a clinical study comparing an AI algorithm's diagnostic accuracy to a threshold. Instead, the document focuses on demonstrating substantial equivalence to a predicate device.
The "acceptance criteria" here are implicitly related to meeting safety and performance standards, and having comparable intended use, imaging capabilities, and technological characteristics to the predicate device. The "reported device performance" is the conclusion that the device is "as safe, as effective, and performance is substantially equivalent."
Here's an interpretation based on the document's content:
| Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|
| Equivalent intended use to predicate device | The LOGIQ E9 and predicate LOGIQ E9 systems have the same clinical intended use. |
| Equivalent imaging capabilities to predicate device | The LOGIQ E9 and predicate LOGIQ E9 systems have the same imaging modes. |
| Equivalent technological characteristics to predicate device | The LOGIQ E9 employs the same fundamental scientific technology as its predicate device(s). |
| Safe materials | The systems are manufactured with materials which have been evaluated and found to be safe for the intended use of the device. |
| Acoustic power levels below FDA limits | The systems have acoustic power levels which are below the applicable FDA limits. |
| Similar capability in measurements, image capture, review, reporting | The LOGIQ E9 and predicate LOGIQ E9 systems have similar capability in terms of performing measurements, capturing digital images, reviewing and reporting studies. |
| Compliance with electrical and physical safety standards | The LOGIQ E9 and predicate systems have been designed in compliance with approved electrical and physical safety standards. |
| Transducer equivalence | The LOGIQ E9 and predicate LOGIQ E9 systems transducers are identical. |
| Software feature functionality (Parametric Imaging) | Parametric Imaging is an evolution of the previously cleared TIC feature on LOGIQ E9. |
| Compliance with specific voluntary standards (e.g., AAMI/ANSI ES60601-1, IEC60601-1-2, etc.) | The device has been evaluated for acoustic output, biocompatibility, cleaning and disinfection effectiveness as well as thermal, electrical, electromagnetic and mechanical safety, and has been found to conform with applicable medical device safety standards. The LOGIQ E9 and its applications comply with voluntary standards (listed). |
2. Sample Size Used for the Test Set and Data Provenance
The document states: "The subject of this premarket submission, LOGIQ E9, did not require clinical studies to support substantial equivalence." This indicates that no specific test set of patient data was used to evaluate the substantial equivalence of this device in a clinical context. The evaluation was based on non-clinical tests and comparison to a predicate device.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
As no clinical studies were required, there was no test set for which expert ground truth would have been established.
4. Adjudication Method for the Test Set
Not applicable, as no clinical test set was used.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No MRMC comparative effectiveness study was done, as the document explicitly states that clinical studies were not required to support substantial equivalence. Therefore, there is no effect size of human readers improving with or without AI assistance to report.
6. Standalone (Algorithm Only) Performance Study
Not applicable. The document describes an ultrasound system (hardware and integrated software features), not a standalone AI algorithm. The evaluation was for the entire system's substantial equivalence.
7. Type of Ground Truth Used
Not applicable, as no clinical studies were required and no ground truth from patient data was established for the purpose of demonstrating substantial equivalence. The "ground truth" in this context would be adherence to safety and performance standards and demonstrable equivalence to the predicate device through non-clinical testing.
8. Sample Size for the Training Set
Not applicable. This document describes a medical device (ultrasound system), not an AI algorithm that requires a training set in the conventional sense. The "training" for the device's functionality would be embedded in its design, engineering, and adherence to established physical principles of ultrasound imaging.
9. How the Ground Truth for the Training Set Was Established
Not applicable. As noted above, this summary does not pertain to an AI algorithm that was "trained" on data to learn a task. Its "ground truth" is its compliance with a predefined design and manufacturing process that ensures safety and performance in line with a predicate device and industry standards.
§ 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.