(56 days)
The device is intended for use by a qualified physician for ultrasound evaluation of Fetal/Obstetrics; Abdominal; Adult Cephalic; Cardiac (adult and pediatric); Peripheral Vascular; Musculo-skeletal Conventional and Superficial; Urology (including prostate); Transvaginal; Transesophageal and Intraoperative (abdominal, thoracic, vascular).
The LOGIQ S8 is a full featured, general purpose diagnostic ultrasound system which consists of a mobile console approximately 520 mm wide (keyboard), 865 mm deep and 1760 mm high that provides digital acquisition, processing and display capability. The user interface includes a computer keyboard, specialized controls, 10.1-inch LCD touch screen and color widescreen monitor.
The provided text describes a 510(k) premarket notification for the GE LOGIQ S8 ultrasound system. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving novel claims or establishing new acceptance criteria through extensive clinical studies.
Therefore, the document does not provide specific acceptance criteria in terms of analytical or clinical performance metrics (e.g., sensitivity, specificity, accuracy for a particular disease or measurement), nor does it detail a study performed to prove such metrics against acceptance criteria. Instead, it demonstrates substantial equivalence based on technological characteristics, intended use, and compliance with recognized safety and performance standards.
Here's an breakdown of the information that can be extracted based on your request, as well as indications of what is not present in this type of regulatory filing:
1. A table of acceptance criteria and the reported device performance
This information is not provided in the document as it is a 510(k) summary for showing substantial equivalence, not a clinical trial report establishing new performance criteria. The "performance" described relates primarily to equivalence with predicate devices and compliance with general safety and performance standards.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided. The document explicitly states: "The subject of this premarket submission, LOGIQ S8, did not require clinical studies to support substantial equivalence." The testing mentioned is for acoustic output, biocompatibility, cleaning/disinfection, and safety standards.
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)
This information is not provided as no clinical studies are reported to have been conducted for this submission.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not provided as no clinical studies are reported to have been conducted for this submission.
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
This information is not provided. The device is an ultrasound imaging system, and there's no mention of AI assistance or MRMC studies in this document.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not provided. The device is a diagnostic ultrasound imaging system, not an AI algorithm for standalone interpretation.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
This information is not provided as no clinical studies are reported to have been conducted for this submission. The "ground truth" for the device's claims are the safety and performance characteristics of its predicate devices and compliance with recognized standards.
8. The sample size for the training set
This information is not provided as no machine learning or AI training is mentioned as being part of this submission's substantial equivalence argument.
9. How the ground truth for the training set was established
This information is not provided as no machine learning or AI training is mentioned.
Summary of what the document does provide regarding device performance and compliance:
The document focuses on demonstrating that the GE LOGIQ S8 is substantially equivalent to legally marketed predicate devices. This is achieved by:
- Intended Use Equivalence: Stating that the LOGIQ S8 has the same clinical intended use as the predicate LOGIQ S8 (K152195).
- Technological Equivalence: Declaring that it employs the same fundamental scientific technology as its predicate device(s).
- Imaging Modes: Noting that it has the same imaging modes as the predicate LOGIQ S8, with additions of Fibroscan elastography and CAP (Controlled Attenuation Parameter), which are equivalent to features found on the reference predicate FibroScan (K160524).
- Safety and Standards Compliance:
- Manufactured with materials evaluated and found safe.
- Acoustic power levels are below applicable FDA limits.
- Designed in compliance with approved electrical and physical safety standards.
- Compliance with voluntary standards:
- AAMI/ANSI ES60601-1 (Medical Electrical Equipment - General Requirements for Safety)
- IEC60601-1-2 (Electromagnetic Compatibility)
- IEC60601-2-37 (Ultrasonic Medical Diagnostic and Monitoring Equipment Safety)
- ISO10993-1 (Biological Evaluation of Medical Devices)
- ISO14971 (Application of risk management to medical devices)
- NEMA UD 2 (Acoustic Output Measurement Standard)
- NEMA UD 3 (Real Time Display of Thermal and Mechanical Acoustic Output Indices)
- NEMA, Digital Imaging and Communications in Medicine (DICOM) Set.
- Quality assurance measures applied to development (Risk analysis, Requirements Reviews, Design Reviews, Testing on unit level, Integration testing, Final Acceptance Testing, Performance testing, Safety testing).
- Transducer and patient contact materials are biocompatible.
The document lists various transducers cleared with the system and for which clinical applications and modes of operation they are "previously cleared" (P), "new" (N), or "added under Appendix E" (E), primarily based on equivalence to other GE Ultrasound systems (e.g., LOGIQ E9, VIVID E90/E95).
In conclusion, for this specific 510(k) submission, the "acceptance criteria" are compliance with established medical device safety and performance standards and demonstration of substantial equivalence to predicate devices, rather than predefined performance thresholds from new clinical trials.
§ 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.