(52 days)
The LOGIQ F8 Expert / LOGIQ F6 / LOGIQ F6 are general purpose ultrasound imaging and analysis systems providing digital acquisition, processing and display capability, clincal applications including: Abdominal, Obsterical, Gnall parts, Vascular/Peripheral Vascular, Transcranial, Pediatic, Musculoskeletal, Cardiac, Transvaginal, Transrectal, and Biopsy.
Intended Use: Ultrasound imaging, measurement and analysis of the human body as follows:
The LOGIQ F8 Expert / LOGIQ F8 / LOGIQ F6 are general purpose diagnostic ultrasound systems which consists of a mobile console approximately 1600mm high, 810mm in width and 720mm deep that provides digital acquisition, processing and display capability. The user interface includes a computer keyboard, 19 or 17 inch color LCD display and Touch panel. LOGIQ F8 Expert / LOGIQ F8 / LOGIQ F6 have the same hardware and system features.
Based on the provided FDA 510(k) summary for the GE LOGIQ F8 Expert / LOGIQ F8 / LOGIQ F6 ultrasound system (K160277), here's an analysis of the acceptance criteria and the study proving it meets those criteria:
Important Note: This document is a 510(k) summary, which focuses on demonstrating "substantial equivalence" to legally marketed predicate devices, rather than proving novel safety and effectiveness through extensive clinical trials for new technologies. Therefore, many points typically expected in a comprehensive study proving device efficacy (like detailed performance metrics against a defined ground truth, specific sample sizes for testing a new algorithm, or multi-reader studies with effect sizes) are generally not present for this type of submission. The "study" here refers to the testing and comparisons done to support substantial equivalence.
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria in a 510(k) are primarily demonstrating that the new device is as safe and effective as a predicate device and performs as intended without raising new questions of safety or effectiveness. For an ultrasound system, this largely revolves around compliance with general safety standards and maintaining image quality.
There isn't a table of specific numerical "acceptance criteria" for clinical performance metrics in this document, as the submission focuses on substantial equivalence based on fundamental scientific technology, intended use, imaging modes, and features migrated from previously cleared predicate devices. The "performance" is implicitly deemed equivalent if the device meets recognized standards and functions comparably to predicates.
| Acceptance Criterion (Implicit in 510(k)) | Reported Device Performance (as stated in the document) |
|---|---|
| Safety: | |
| Acoustic power levels below FDA limits | "The system has acoustic power levels which are below the applicable FDA limits." |
| Biocompatibility of materials | "Transducer materials and other patient contact materials are biocompatible." |
| Compliance with electrical & physical safety standards | "The LOGIQ F8 Expert / LOGIQ F8 / LOGIQ F6 and the predicate LOGIQ F series have been designed in compliance with approved electrical and physical safety standards." |
| Compliance with quality assurance measures | "The following quality assurance measures were applied to the development of the system: Risk Analysis, Requirements Reviews, Design Reviews, Testing on unit level (Module verification), Integration testing (System verification), Performance testing (Verification), Safety testing (Verification), Simulated use Testing (Validation)." |
| Effectiveness/Performance: | |
| Same fundamental scientific technology as predicates | "The LOGIQ F8 Expert / LOGIQ F8 / LOGIQ F6 employ the same fundamental scientific technology as its predicate devices." |
| Same clinical intended use (with minor addition) | "The LOGIQ F8 Expert / LOGIQ F8 / LOGIQ F6 and the predicate LOGIQ F series have the same clinical intended use except the addition of the transrectal application that is on the LOGIQ e predicate (K151028)." |
| Same imaging modes as predicates | "The LOGIQ F8 Expert / LOGIQ F8 / LOGIQ F6 and the predicate LOGIQ F series have the same imaging modes." |
| Comparable capabilities (measurements, image capture, reporting) | "The LOGIQ F8 Expert / LOGIQ F8 / LOGIQ F6 and the predicate LOGIQ F series have the same capability in terms of performing measurements, capturing digital images, reviewing and reporting studies." |
| Compliance with specific voluntary standards | AAMI/ANSI ES60601-1, IEC60601-1-2, IEC60601-2-37, NEMA UD 3, ISO10993-1, NEMA UD 2, ISO14971, NEMA PS 3.1 3.20 (DICOM Set). |
| Cleaning and disinfection effectiveness | Device was evaluated and found to conform for cleaning and disinfection effectiveness. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: The document explicitly states: "The subject of this premarket submission, LOGIQ F8 Expert / LOGIQ F8 / LOGIQ F6, did not require clinical studies to support substantial equivalence." This means there was no specific "test set" of patient data for a clinical performance evaluation in the typical sense (e.g., measuring diagnostic accuracy against ground truth). The testing conducted was primarily non-clinical (engineering, safety, performance standard compliance).
- Data Provenance: Not applicable, as no clinical test set was used for a de novo performance evaluation.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Experts
- Not applicable, as no clinical test set requiring expert ground truth establishment was used. The focus was on engineering and design verification.
4. Adjudication Method for the Test Set
- Not applicable, as no clinical test set was used.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
- No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. The document explicitly states that clinical studies were not required. The comparison is made at a technological and functional level to previously cleared predicate devices.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done
- The device is an ultrasound system, not a standalone AI algorithm. While it includes "features migrated" from other systems (e.g., Auto-EF, TUI, Stress Echo advance 3D, Curved AMM, Sonobiometry), these are generally integrated functionalities of the ultrasound system itself, not separate "algorithms" that would have standalone performance evaluation. The typical "standalone performance" concept usually applies to AI/CAD algorithms that provide an automated output. The evaluation here is of the integrated functionality of the ultrasound machine when performing these tasks.
7. The Type of Ground Truth Used
- Not applicable for clinical performance evaluation. For non-clinical validation (e.g., acoustic output, electrical safety), the "ground truth" would be the established engineering specifications and industry standards.
8. The Sample Size for the Training Set
- Not applicable. This is not an AI/ML device that underwent a training phase on a dataset of patient images. The "training" here refers to the development process of the ultrasound hardware and software via established engineering practices, not machine learning model training.
9. How the Ground Truth for the Training Set Was Established
- Not applicable. As this device is not an AI/ML system trained on a dataset, there is no "training set" or "ground truth" established for it in that context.
§ 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.