(109 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, vascular and neurosurgical).
The LOGIQ E9 is a full featured, general purpose diagnostic ultrasound system which consists of a mobile console approximately 58 cm wide, 86cm deep and 141 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 19-inch LCD image display.
The GE LOGIQ E9 Diagnostic Ultrasound System is a full-featured, general-purpose diagnostic ultrasound system. It consists of a mobile console and provides digital acquisition, processing, and display capabilities. The user interface includes a computer keyboard, specialized controls, a 10-inch LCD touch screen, and a 19-inch LCD image display.
Here's an analysis of the provided information regarding acceptance criteria and the study that proves the device meets them:
1. Table of Acceptance Criteria and Reported Device Performance
The provided document does not explicitly state specific quantitative acceptance criteria or numerical performance metrics for the LOGIQ E9 system's image quality or diagnostic accuracy. Instead, the "acceptance criteria" are implied through the statement of substantial equivalence to its predicate device(s).
The reported device performance is that it is considered "as safe, as effective, and performance is substantially equivalent to the predicate device(s)."
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Safety (electrical, thermal, mechanical, biocompatibility etc.) | Conforms with applicable medical device safety standards. |
| Effectiveness (general ultrasound imaging capabilities) | Substantially equivalent to predicate device(s). |
| Performance (image quality, functionality across indications) | Substantially equivalent to predicate device(s). |
| Conformance to voluntary standards | Complies with voluntary standards detailed in sections 9, 11, and 17. |
2. Sample Size Used for the Test Set and Data Provenance
The document explicitly states: "The subject of this premarket submission, LOGIQ E9, did not require clinical studies to support substantial equivalence."
Therefore, there is no test set of clinical data from human subjects mentioned in this 510(k) summary. The evaluation focused on non-clinical tests.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
Since no clinical studies were performed on a test set, no experts were used to establish ground truth for a test set in the context of clinical performance evaluation. The evaluation was primarily engineering and performance testing against standards and the predicate device.
4. Adjudication Method for the Test Set
As no clinical test set was utilized, there was no adjudication method described for clinical data.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No MRMC comparative effectiveness study was done. The submission explicitly states no clinical studies were required.
6. Standalone Performance Study (Algorithm Only Without Human-in-the-Loop Performance)
Since the LOGIQ E9 is a diagnostic ultrasound system and not an AI-powered algorithm for image interpretation, the concept of "standalone (algorithm only without human-in-the-loop performance)" as typically applied to AI/ML devices is not directly applicable.
The "performance" evaluation for this device was based on engineering verification and validation, demonstrating that the system's technical specifications and imaging capabilities were comparable to its predicate devices, rather than a standalone AI performance study.
7. Type of Ground Truth Used
For the non-clinical tests, the "ground truth" would be established by:
- Engineering specifications and test standards: For acoustic output, thermal, electrical, electromagnetic, and mechanical safety.
- Biocompatibility testing results: Conformance to established biocompatibility protocols.
- Cleaning and disinfection effectiveness testing results: Verification against established protocols.
- Comparison to predicate device's established performance: The predicate device serves as a benchmark for "substantial equivalence."
No pathology, expert consensus on images, or outcomes data were used as ground truth for clinical performance, as clinical studies were not performed.
8. Sample Size for the Training Set
The LOGIQ E9 is a traditional diagnostic ultrasound system, not an AI/ML device that requires a "training set" of data in the same way. Therefore, there is no mention of a training set sample size.
9. How the Ground Truth for the Training Set Was Established
As there is no mention of an AI/ML training set, this question is not applicable to this 510(k) submission.
Summary of Device Evaluation Approach:
The GE LOGIQ E9 Diagnostic Ultrasound System received 510(k) clearance based on its substantial equivalence to previously cleared predicate devices (K092271 GE LOGIQ E9 Diagnostic Ultrasound System and K052441 GE LOGIQ 7 Diagnostic Ultrasound System). This determination was made primarily through non-clinical tests and verification activities, rather than clinical studies. The non-clinical tests included evaluations for acoustic output, biocompatibility, cleaning and disinfection effectiveness, and various safety aspects (thermal, electrical, electromagnetic, mechanical). The device also underwent a series of internal quality assurance measures such as risk analysis, requirements reviews, design reviews, and various levels of testing (unit, integration, performance, safety, and final acceptance). The core argument for substantial equivalence rested on the device employing the "same fundamental scientific technology as its predicate device(s)" and conforming to applicable safety standards and voluntary 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.