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Diagnostic ultrasound imaging or Doppler analysis of the human body as follows: Fetal and urological, Musculoskeletal, Abdominal. Pediatric. Small Organ including breast, testes and thyroid, Neonatal Cephalic, Cardiac Adult, Cardic Pediatric, Trans-rectal, Trans-vaginal, and Peripheral vessel.

The modified GE LOGIQ 700 diagnostic ultrasound system consists of a mobile console approximately 70 cm wide, 120 cm deep and 120 cm high that provides full 128 channel capability, and assorted transducers. 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

The provided document, a 510(k) summary for the modified GE LOGIQ 700 Diagnostic Ultrasound System, does not describe quantitative acceptance criteria or a specific study proving the device meets performance claims. Instead, it focuses on demonstrating substantial equivalence to a predicate device already on the market.

Therefore, the following information, relating to performance studies with specific quantitative acceptance criteria, cannot be extracted from the provided text:

• A table of acceptance criteria and the reported device performance
• Sample size used for the test set and the data provenance
• Number of experts used to establish the ground truth for the test set and the qualifications of those experts
• Adjudication method for the test set
• If a multi-reader multi-case (MRMC) comparative effectiveness study was done, or the effect size of human readers improving with/without AI assistance.
• If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
• The type of ground truth used (expert consensus, pathology, outcomes data, etc)
• The sample size for the training set
• How the ground truth for the training set was established

Description of the Acceptance Criteria and Study to Prove Device Meets Acceptance Criteria:

The acceptance criteria for the modified GE LOGIQ 700 Diagnostic Ultrasound System are implicitly based on demonstrating that it is substantially equivalent to a predicate device, the GE Medical Systems LOGIQ 700 diagnostic ultrasound system (510(k) Number K930768).

The study performed to demonstrate this substantial equivalence involved:

• Comparison of safety and effectiveness features: The modified device was deemed comparable to the predicate regarding "key safety and effectiveness features."
• Design, construction, and materials: The new device uses "similar design, construction, and materials."
• Intended uses and operating modes: The modified device has "the same intended uses and operating modes."
• Compliance with safety standards: The device underwent evaluation for "acoustic output, biocompatibility, and thermal, electrical and mechanical safety" and was found to conform with applicable medical device safety standards.
• Compliance with GMP standards: The manufacturer's design and development process conforms with "GMP standards."

The core of the "study" is a comparison to the predicate device and adherence to general medical device safety standards and manufacturing practices, rather than a specific clinical performance study with predefined quantitative endpoints. The FDA's letter further reinforces this by stating, "The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus permits your device to proceed to market."

The FDA's clearance (K960527) is granted on the condition that the manufacturer submits a post-clearance special report containing "acoustic output measurements based on production line devices," as requested in Appendix G of the 1993 "Revised 510(k) Diagnostic Ultrasound Guidance." This indicates that ongoing acoustic output performance would be an acceptance criterion to maintain clearance.

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