(90 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: Transesophageal and Intraoperative (abdominal, thoracic, and vascular).
The LOGIQ S8 is a full featured, general purpose diagnostic ultrasound system which consists of a mobile console approximately 62 cm wide, 88 cm deep and 175 cm high that provides digital acquisition, processing and display capability. The user interface includes a computer keyboard, specialized controls, 9-inch LCD touch screen and color 19-inch LCD image display.
The GE LOGIQ S8 Ultrasound System and its associated transducers did not require clinical studies to support substantial equivalence. Instead, the submission relies on the fact that existing features and probes have been migrated from predicate devices that were previously cleared by the FDA, and new features and probes demonstrate equivalence to existing cleared technologies through non-clinical testing.
Here's a breakdown of the information based on the provided text:
1. Table of Acceptance Criteria and the Reported Device Performance:
Since no clinical studies were performed for the LOGIQ S8 itself, there are no specific 'acceptance criteria' in terms of clinical performance metrics (like sensitivity, specificity) or 'reported device performance' from clinical trials. The device's performance is demonstrated through compliance with established safety and performance standards for diagnostic ultrasound equipment, and the substantial equivalence to predicate devices.
The acceptance criteria are implicitly met by demonstrating compliance with the following voluntary standards and quality assurance measures for the non-clinical tests:
| Acceptance Criteria (Compliance with Standards/Measures) | Reported Device Performance (Compliance Status) |
|---|---|
| AAMI/ANSI ES60601-1 (Medical Electrical Equipment - Part 1: General Requirements for Safety) | Conforms |
| IEC60601-1-2 (Medical Electrical Equipment - Part 1-2: General Requirements for Safety - Collateral Standard: EMC) | Conforms |
| IEC60601-2-37 (Medical Electrical Equipment – Part 2-37: Particular Requirements for the Safety of Ultrasonic MD&ME) | Conforms |
| NEMA UD 3 (Standard for Real Time Display of Thermal and Mechanical Acoustic Output Indices on Diagnostic Ultrasound) | Conforms |
| ISO10993-1 (Biological Evaluation of Medical Devices- Part 1: Evaluation and Testing- Third Edition) | Biocompatible (for patient contact materials) |
| NEMA UD 2 (Acoustic Output Measurement Standard for Diagnostic Ultrasound Equipment) | Conforms |
| ISO14971 (Application of risk management to medical devices) | Conforms |
| NEMA, Digital Imaging and Communications in Medicine (DICOM) Set. (Radiology) | Conforms |
| Risk Analysis, Requirements Reviews, Design Reviews, Testing on unit level (Module verification) | Applied (quality assurance measures) |
| Integration testing (System verification), Final Acceptance Testing (Validation), Performance testing (Verification) | Applied (quality assurance measures) |
| Safety testing (Verification) | Applied (quality assurance measures) |
2. Sample Size Used for the Test Set and the Data Provenance:
No clinical test sets or associated human data are mentioned as the basis for this 510(k) submission. The evaluation is primarily based on non-clinical tests and substantial equivalence claims to predicate devices. Therefore, there is no information on sample size or data provenance from a clinical test set.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts:
Not applicable, as no clinical test set requiring expert-established ground truth was part of this submission. The device's safety and effectiveness were demonstrated through compliance with regulatory standards and comparison to previously cleared predicate devices.
4. Adjudication Method for the Test Set:
Not applicable, as no clinical test set requiring adjudication was part of 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:
Not applicable. This submission is for a general-purpose diagnostic ultrasound system that does not appear to incorporate AI functionality for interpretation or diagnostic assistance to human readers. Therefore, an MRMC study on AI assistance is not relevant to this submission.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. The LOGIQ S8 is a diagnostic ultrasound system, not a standalone algorithm. Its performance is intrinsically tied to human operation and interpretation.
7. The Type of Ground Truth Used:
For the non-clinical tests, the "ground truth" would be established by the specifications and benchmarks defined within the cited industry standards (e.g., NEMA UD 2 for acoustic output, IEC 60601 series for safety). For the substantial equivalence claim, the "ground truth" is the established safety and effectiveness of the predicate devices.
8. The Sample Size for the Training Set:
Not applicable, as this submission does not describe a machine learning or AI-based device that would require a training set.
9. How the Ground Truth for the Training Set was Established:
Not applicable, as there is no training set for this device.
§ 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.