(235 days)
Diagnostic ultrasound imaging or Doppler analysis of the human body as follows: Fetal, Abdominal, Intra-operative of abdominal organs, Neurosurgical, Pediatric, Small Organ including breast, testes, thyroid, Neonatal Cephalic, Cardiac Adult, Cardic Pediatric, Trans-rectal, Transvaginal, and Peripheral vessel.
The LOGIQ 700 including intra-operative and neurosurgical uses is the same in all other aspects as the currently marketed LOGIQ 700, consisting 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 text describes a 510(k) summary for the GE LOGIQ 700 diagnostic ultrasound system, not a study proving device performance against acceptance criteria. A 510(k) submission primarily demonstrates substantial equivalence to a legally marketed predicate device, rather than providing detailed clinical study results with specific acceptance criteria and performance metrics typically seen in studies for novel high-risk devices or AI/ML-driven diagnostics.
Therefore, many of the requested elements for a study proving device performance against acceptance criteria are not available in this document.
However, I can extract information related to the device's intended use and the nature of the submission.
Here's a breakdown of what can and cannot be answered based on the provided document:
1. A table of acceptance criteria and the reported device performance
- Not applicable/Not available. This document is a 510(k) summary demonstrating substantial equivalence to a predicate device. It does not contain specific performance metrics with acceptance criteria for a clinical study comparing the device's diagnostic accuracy against a ground truth. The submission confirms the device has been evaluated for "acoustic output, biocompatibility, and thermal, electrical and mechanical safety" and found to conform with applicable medical device safety standards, but no comparative performance data is presented.
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/Not available. No clinical test set or data provenance is mentioned as this is a 510(k) for substantial equivalence, not a performance study.
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/Not available. No ground truth establishment or expert involvement for a test set is discussed in this 510(k) summary.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable/Not available. No test set or adjudication method is discussed.
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/Not available. This device is a diagnostic ultrasound system from 1997, predating widespread AI/ML integration in such systems. No MRMC study or AI assistance is mentioned.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Not applicable/Not available. This is a hardware/software system, not an algorithm-only device.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
- Not applicable/Not available. No ground truth is discussed in the context of a performance study for this 510(k) summary.
8. The sample size for the training set
- Not applicable/Not available. This document describes a traditional medical device, not an AI/ML system requiring a training set in the modern sense.
9. How the ground truth for the training set was established
- Not applicable/Not available. See point 8.
Summary of what is known from the document regarding the device and its clearance:
- Device Name: GE LOGIQ 700 Diagnostic Ultrasound System.
- Date of Submission: June 18, 1997.
- Regulatory Class: II (21 CFR 892.1550/Procode: 90 IYN, 21 CFR 892.1570/Procode: 90 ITX).
- Predicate Device: GE Medical Systems LOGIQ 700 diagnostic ultrasound system (510(k) Number K930768).
- Key Basis for Clearance: Substantial Equivalence to the predicate device.
- Evaluations Mentioned: "The device has been evaluated for acoustic output, biocompatibility, and thermal, electrical and mechanical safety, and has been found to conform with applicable medical device safety standards." This suggests engineering and safety testing, not clinical performance studies comparing accuracy against a ground truth.
- Intended Uses: Diagnostic ultrasound imaging or Doppler analysis for Fetal, Abdominal, Intra-operative (of abdominal organs), Neurosurgical, Pediatric, Small Organ (breast, testes, thyroid), Neonatal Cephalic, Cardiac Adult, Cardiac Pediatric, Trans-rectal, Transvaginal, and Peripheral vessel applications.
- Conditions of Clearance: Submission of a postclearance special report containing complete information, including acoustic output measurements based on production line devices, as requested in Appendix G of the Center's February 17, 1993 "Revised 510(k) Diagnostic Ultrasound Guidance for 1993." This is a post-market requirement related to safety, not a pre-market clinical performance study.
§ 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.