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510(k) Data Aggregation
(31 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 E9 is a full featured, general purpose diagnostic ultrasound system which consists of a mobile console approximately 58 cm wide, 87cm deep and 130 cm high that provides digital acquisition, processing and display capability. The user interface includes a computer keyboard, specialized controls, 10-inch LCD touch screen and color wide screen image display.
The provided text is a 510(k) Premarket Notification Submission for the GE LOGIQ E9, LOGIQ E9 XDclear 2.0 Diagnostic Ultrasound System. This document focuses on establishing substantial equivalence to previously cleared devices rather than presenting a new clinical study with acceptance criteria and device performance. Therefore, much of the requested information regarding acceptance criteria and performance studies in the traditional sense of a clinical trial for a novel device is not directly available in this document.
However, I can extract information related to the device's intended use, comparison to predicates, and the non-clinical tests performed.
Important Note: The acceptance criteria and performance data requested in the prompt typically refer to a clinical study demonstrating the efficacy and safety of a novel device. As this submission is for substantial equivalence to existing devices (K142160 GE LOGIQ E9, K131527 GE LOGIQ S8, K131514 GE Vivid E9), the "acceptance criteria" here are met by demonstrating that the new device shares the same intended use, imaging capabilities, technological characteristics, and safety and effectiveness as the predicate devices, and complies with applicable safety standards. There is no new clinical study presented that would define novel acceptance criteria and then report performance against them.
Here's the information based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
As this is a substantial equivalence submission, the "acceptance criteria" are implied by the features and performance of the predicate devices and compliance with relevant standards. The "reported device performance" is the demonstration that the LOGIQ E9, LOGIQ E9 XDclear 2.0 system performs equivalently to the predicates for its intended uses and complies with safety standards.
| Acceptance Criteria (Implied by Substantial Equivalence and Standards) | Reported Device Performance (Claimed in Submission) |
|---|---|
| Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body for specified clinical applications (Fetal, Abdominal, Pediatric, Small Organ, Neonatal Cephalic, Adult Cephalic, Cardiac, Peripheral Vascular, Musculo-skeletal, Urology, Transrectal, Transvaginal, Transesophageal, Intraoperative). | The device is stated to have the same clinical intended use as the predicate LOGIQ E9. The individual Intended Use Forms for various transducers (e.g., 3CRF, 3CRF-D, 6S-D, 6Tc, 9L-D, 11L-D, C1-5-D, IC5-9-D, L8-18i-D, M4S-D, M5S-D, M6C-D, ML6-15-D, P2D, P6D, RAB2-5-D, RAB4-8-D, RIC5-9-D, RNA5-9-D, RSP6-16-D, S1-5, S4-10, S4-10-D, C2-9-D, RAB6-D, S1-5-D, C1-6-D, C2-9VN-D, C1-6VN-D, C2-7-D, C2-7VN-D, L3-9i-D, C3-10-D, C2-6b-D) detail the specific applications and modes (B, M, PW Doppler, CW Doppler, Color Doppler, Color M Doppler, Power Doppler, Combined Modes, Harmonic Imaging, Coded Pulse, 3D/4D Imaging, Needle Guidance, Volume Navigation, Elastography Imaging, Shear Wave Elastography). |
| Imaging Capabilities: Similar imaging modes and capabilities as predicate devices. | The LOGIQ E9 and predicate LOGIQ E9 systems have the same imaging modes. The LOGIQ E9 and predicate LOGIQ E9 systems have similar capability in terms of performing measurements, capturing digital images, reviewing, and reporting studies. |
| Technological Characteristics: Employ the same fundamental scientific technology. | The LOGIQ E9 employs the same fundamental scientific technology as its predicate device(s). New transducers (C2-7-D, C2-7VN-D, C3-10-D, L3-9i-D) are described as "incremental improvements to the existing transducers and are equivalent." Two new software features (AutoEF and AFI) have been migrated from a predicate (Vivid E9 K131514). |
| Safety and Effectiveness: Compliance with safety standards and acoustic power limits. | The device has been evaluated for acoustic output, biocompatibility, cleaning and disinfection effectiveness, as well as thermal, electrical, electromagnetic, and mechanical safety. It has been found to conform with applicable medical device safety standards (AAMI/ANSI ES60601-1, IEC60601-1-2, IEC60601-2-37, NEMA UD 3, ISO10993-1, NEMA UD 2, ISO14971). Acoustic power levels are below applicable FDA limits. The system has been designed in compliance with approved electrical and physical safety standards. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This document explicitly states: "The subject of this premarket submission, LOGIQ E9, did not require clinical studies to support substantial equivalence." Therefore, there is no test set, sample size, or data provenance from a new clinical study provided in this submission for device performance evaluation. The substantial equivalence relies on demonstrating that the new device operates similarly and safely as the predicate devices, which were previously cleared.
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, as no new clinical study (and thus no "test set" and "ground truth" to establish) was required for this substantial equivalence submission.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable, as no new clinical study was conducted.
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 device is a diagnostic ultrasound system, not an AI-assisted diagnostic tool in the sense of image interpretation. The "AutoEF and AFI" mentioned are software features but there's no MRMC study detailed here to show improved human reader performance.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable, as this is a diagnostic ultrasound imaging system, not a standalone algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable, as no new clinical study was required for this substantial equivalence submission. The "ground truth" for the predicate devices' clearance would have been established through methods appropriate for diagnostic ultrasound systems at the time of their original clearance (e.g., comparison to other imaging modalities, clinical correlation).
8. The sample size for the training set
Not applicable. This document describes a medical device, not a machine learning algorithm that requires a training set.
9. How the ground truth for the training set was established
Not applicable, as there is no training set for an algorithm described in this submission.
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