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The device is intended for use by a qualified physician for ultrasound evaluation of Fetal/OB; Abdominal (GYN & Urology); Pediatric; Small Organ (breast, testes, thyroid); Neonatal Cephalio; Cardiac (adult and pediatric); Peripheral Vascular; Musculo-skeletal Conventional; Transrectal; and Transvaginal.

The GE LOGIQbook is a compact and portable diagnostic ultrasound system with integrated keyboard, fold-up LCD type display and interchangeable electronic-array transducers. It has an overall size approximately 33 cm wide, 27 cm deep and 7 cm high in transport configuration and provides digital acquisition, processing and display capability. The user interface includes a computer keyboard, an intuitive layout of specialized controls, color GUI display and Doppler audio.

The provided document is a 510(k) premarket notification for the GE LOGIQbook Diagnostic Ultrasound System, dated December 20, 2001. It describes the device and claims substantial equivalence to a predicate device, the GE LOGIQ 100.

Within this document, it explicitly states:

"2. Clinical Tests: None required."

Therefore, based on the provided information:

1. A table of acceptance criteria and the reported device performance:

No specific acceptance criteria for clinical performance are reported, as no clinical tests were required or performed for this premarket notification. The company's conclusion states that "Intended uses and other key features are consistent with traditional clinical practice, FDA guidelines, and established methods of patient examination," and that "Diagnostic ultrasound has accumulated a long history of safe and effective performance."

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):

Not applicable. No clinical test set was used.

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):

Not applicable. No clinical test set was used, and therefore no experts were required to establish ground truth for such a set.

4. Adjudication method (e.g. 2+1, 3+1, none) 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. This device is a diagnostic ultrasound system, not an AI-assisted diagnostic tool. No MRMC study was conducted.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

Not applicable. This device is a diagnostic ultrasound system, not an AI algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):

Not applicable. No specific ground truth related to clinical performance was established because no clinical studies were required. The submission relies on the established safe and effective performance of diagnostic ultrasound in general and the substantial equivalence to a predicate device.

8. The sample size for the training set:

Not applicable. This submission does not describe an AI or machine learning model that would require a training set.

9. How the ground truth for the training set was established:
Not applicable. No training set was used.

In summary, the FDA clearance for the GE LOGIQbook Diagnostic Ultrasound System was based on demonstrating substantial equivalence to a predicate device (GE LOGIQ 100) and adherence to non-clinical safety and performance standards for medical devices, rather than on new clinical performance data or studies.

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