(78 days)
The device is intended for use by a qualified physician for ultrasound evaluation of Fetal; Abdominal; Pediatric; Small Organ (breast, testes, thyroid); Neonatal Cephalic; Adult Cephalic; Cardiac (adult and pediatric); Peripheral Vascular; Musculo-skeletal Conventional and Superficial; Urology (including prostate); Transrectal; Transvaginal and Intraoperative (abdominal, thoracic, vascular and neurosurgical).
The LOGIQ S7 Expert AND LOGIQ S7 Pro is a full featured, general purpose diagnostic ultrasound system which consists of a mobile console approximately 62 cm wide, 86 cm deep and 175 cm high that provides digital acquisition, processing and display capability. The user interface includes a computer keyboard, specialized controls, 7-inch LCD touch screen and color 19-inch LCD image display.
This document is a 510(k) Premarket Notification Summary for the GE Healthcare LOGIQ S7 Expert and LOGIQ S7 Pro Ultrasound System. It details the device's intended use and demonstrates its substantial equivalence to previously cleared predicate devices through non-clinical testing. It explicitly states that clinical studies were NOT required to support substantial equivalence.
Therefore, most of the requested information regarding acceptance criteria derived from a clinical study, sample sizes, expert ground truth establishment, adjudication methods, MRMC studies, and standalone algorithm performance cannot be provided from this document.
Here's the information that can be extracted based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
Since no clinical studies were performed, there are no specific acceptance criteria for diagnostic accuracy or performance metrics (like sensitivity, specificity, or AUC) that would typically be reported from a clinical study. The acceptance criteria focused on non-clinical aspects and compliance with established standards.
| Acceptance Criteria Category | Reported Device Performance (Compliance) |
|---|---|
| Acoustic Output | Conforms to applicable medical device safety standards and voluntary standards (NEMA UD 3, NEMA UD 2) |
| Biocompatibility | Conforms to applicable medical device safety standards and voluntary standard (ISO10993-1) |
| Cleaning and Disinfection Effectiveness | Conforms to applicable medical device safety standards |
| Thermal Safety | Conforms to applicable medical device safety standards and IEC60601-1, IEC60601-1-2, IEC60601-2-37 |
| Electrical Safety | Conforms to applicable medical device safety standards and IEC60601-1, IEC60601-1-2, IEC60601-2-37 |
| Electromagnetic Safety | Conforms to applicable medical device safety standards and IEC60601-1, IEC60601-1-2, IEC60601-2-37 |
| Mechanical Safety | Conforms to applicable medical device safety standards and IEC60601-1, IEC60601-1-2, IEC60601-2-37 |
| Risk Management | ISO14971 compliant (Application of risk management to medical devices) |
| Digital Imaging and Communications | NEMA, Digital Imaging and Communications in Medicine (DICOM) Set compliant |
| Overall (Substantial Equivalence) | Considered as safe, as effective, and performance is substantially equivalent to predicate devices. |
2. Sample size used for the test set and the data provenance
- Sample Size for Test Set: Not applicable, as no clinical performance testing was conducted.
- Data Provenance: Not applicable, as no clinical data was used for performance evaluation in this submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Number of Experts: Not applicable.
- Qualifications of Experts: Not applicable.
4. Adjudication method for the test set
- Adjudication Method: Not applicable.
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
- MRMC Study: No, an MRMC comparative effectiveness study was not done. The submission explicitly states "The subject of this premarket submission, LOGIQ S7 Expert and LOGIQ S7 Pro, did not require clinical studies to support substantial equivalence." This device is an ultrasound system, not an AI-powered diagnostic tool, so an MRMC study for AI assistance is not relevant to this submission.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Standalone Performance Study: No, a standalone performance study was not done. This device is an ultrasound system and not an algorithm for standalone diagnosis.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Type of Ground Truth: Not applicable, as no clinical performance testing requiring ground truth was conducted for this submission. The "ground truth" for this submission was compliance with established safety and performance standards for ultrasound devices, assessed through non-clinical means.
8. The sample size for the training set
- Sample Size for Training Set: Not applicable. Training sets are relevant for AI/machine learning models, which are not the subject of this 510(k) submission for an ultrasound system.
9. How the ground truth for the training set was established
- Ground Truth for Training Set Establishment: Not applicable.
§ 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.