(30 days)
The LOGIQ 700 with Harmonic Imaging is a general purpose ultrasound imaging system intended for use in the evaluation of soft tissue and vascular disease in the head, neck, chest, abdomen, pelvis, male and female reproductive organs, limbs and pregnant uterus. Specific indications are: fetal, abdominal; intraoperative abdominal and neurological; pediatric; small organ including breast, testes, thyroid; neonatal cephalic; cardiac adult and pediatric; TR; TV; urological; and conventional and superficial musculo-skeletal.
The LOGIQ 700 with Harmonic Imaging is a mobile console approximately 70 cm wide, 120 cm deep and 120 cm high that provides full 128 channel capability and assorted probes. The user interface is an adjustable height keyboard, small A/N display panel and a color video display monitor. Optional image storage or hard-copy devices are integrated into the design. Harmonic imaging enhances or highlights the imaging of nonlinear tissue characteristics.
This submission is a Special 510(k) Premarket Notification for a modification to an existing device (GE LOGIQ 700 Diagnostic Ultrasound with Harmonic Imaging Modification). In such cases, clinical studies are often not required if the new device is found to be substantially equivalent to a predicate device.
Based on the provided document, here's an analysis of the acceptance criteria and study information:
1. A table of acceptance criteria and the reported device performance
Since no clinical studies were required, the acceptance criteria and performance are established through substantial equivalence to the predicate device, not empirical performance metrics from a study. Therefore, the table cannot be populated with specific performance metrics from a new study.
| Acceptance Criterion | Reported Device Performance |
|---|---|
| Acoustic Output | Conforms with applicable medical device safety standards. |
| Biocompatibility | Conforms with applicable medical device safety standards. |
| Thermal Safety | Conforms with applicable medical device safety standards. |
| Electrical Safety | Conforms with applicable medical device safety standards. |
| Mechanical Safety | Conforms with applicable medical device safety standards. |
| Image Processing Technology | Harmonic imaging implemented with conventional digital image processing technology, deemed comparable to predicate. |
| Intended Uses | Consistent with traditional clinical practice, FDA guidelines, and established methods of patient examination. Substantially equivalent to predicate device for all specified clinical applications and modes of operation including the new "Harmonic Imaging" mode, across all specified transducers. |
| Quality Systems | Design and development process conforms with 21 CFR 820, ISO 9001 and EN 46001 quality systems. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
No clinical test set was used for this 510(k) submission. "Clinical Tests: None required."
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)
No clinical test set was used, therefore no experts were required to establish ground truth for a test set in this submission.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
No clinical test set was used, therefore no adjudication method was applicable or employed.
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
No MRMC comparative effectiveness study was conducted. This device is an ultrasound system with a new imaging mode, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
No standalone algorithm performance study was conducted. The device is a medical imaging system, not an independent algorithm. The harmonic imaging feature is integrated into the existing system.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
No new ground truth was established as no clinical studies were performed. The "ground truth" for this submission relies on the established safety and effectiveness of the predicate device and the conventional nature of the new feature.
8. The sample size for the training set
No training set was explicitly mentioned or used for the purpose of a clinical study or algorithm development as part of this 510(k) submission. The "training" for the device's development refers to its adherence to established engineering and quality standards.
9. How the ground truth for the training set was established
Not applicable, as no training set (in the context of machine learning/algorithm development) was used for this submission. The "ground truth" for the device's design and development comes from medical device safety standards, regulatory requirements, and established clinical practice as outlined in the "Conclusion" section.
§ 892.1560 Ultrasonic pulsed echo imaging system.
(a)
Identification. An ultrasonic pulsed echo imaging system is a device intended to project a pulsed sound beam into body tissue to determine the depth or location of the tissue interfaces and to measure the duration of an acoustic pulse from the transmitter to the tissue interface and back to the receiver. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II (special controls). A biopsy needle guide kit intended for use with an ultrasonic pulsed echo imaging system only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.