(22 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; Cardiac (adult and pediatric); Peripheral Vascular; Musculo-skeletal Conventional and Superficial; Urology (including prostate); Transvaginal; and Intraoperative (abdominal, thoracic, vascular).
The LOGIQ P9 and LOGIQ P7 is a full featured, general purpose diagnostic ultrasound system which consists of a mobile console approximately 53 cm wide, 69 cm deep and 157 cm high that provides digital acquisition, processing and display capability. The user interface includes a computer keyboard, specialized controls, 10.4-inch LCD touch screen and color 21.5-inch LCD image display.
The provided text does not contain detailed acceptance criteria and a study proving the device meets those criteria in the traditional sense of a clinical performance study for an AI/ML device.
Instead, the document is a 510(k) premarket notification for a diagnostic ultrasound system (GE LOGIQ P9 and LOGIQ P7) and its various transducers. The "study" described is a non-clinical comparison to predicate devices to establish substantial equivalence, rather than a clinical trial demonstrating performance against specific metrics.
Here's a breakdown of the information that can be extracted, and where limitations exist based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not present a table of specific quantitative acceptance criteria or reported performance metrics in terms of accuracy, sensitivity, specificity, or other performance measures typically associated with AI/ML devices.
Instead, the "acceptance criteria" are implied by the comparison to legally marketed predicate devices and compliance with voluntary safety and performance standards. The "reported device performance" is framed as its "substantial equivalence" to these predicates.
Implied Acceptance Criteria (based on comparison to predicate and standards):
- Intended Use Equivalence: Same clinical intended uses as predicate devices.
- Imaging Capabilities Equivalence: Same imaging modes and similar capabilities (measurements, digital image capture, reviewing/reporting).
- Technological Equivalence: Employs the same fundamental scientific technology as predicate devices.
- Safety Standards Compliance: Acoustic output below FDA limits, compliance with AAMI/ANSI ES60601-1, IEC60601-1-2, IEC60601-2-37, NEMA UD 3, NEMA UD 2, ISO10993-1, ISO14971, and NEMA PS 3.1 3.20 (DICOM).
- Biocompatibility: Transducer materials and other patient contact materials are biocompatible.
- Quality Assurance: Adherence to risk analysis, requirements reviews, design reviews, unit testing, integration testing, performance testing, and safety testing.
Reported Device Performance (as stated in the document):
The LOGIQ P9 and P7 systems are "substantially equivalent to the predicate devices with regard to intended use, imaging capabilities, technological characteristics and safety and effectiveness."
Specific new features or transducers are noted to be "previously cleared by FDA" on other GE Healthcare devices, implicitly demonstrating their performance was already deemed acceptable.
2. Sample Size Used for the Test Set and Data Provenance
The document explicitly states: "The subject of this premarket submission, LOGIO P9 and LOGIO P7, did not require clinical studies to support substantial equivalence."
Therefore, there is no test set of patient data of a specific sample size used for performance evaluation in the context of an AI/ML study, nor is there information on data provenance (country of origin, retrospective/prospective). The substantiation is primarily based on engineering and performance testing against standards, and comparison to already cleared predicate devices.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Since no clinical studies or test sets with patient data were required for this submission, there is no mention of experts used to establish ground truth for such a test set.
4. Adjudication Method for the Test Set
As no clinical test set was required, there is no adjudication method described.
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
No MRMC comparative effectiveness study was done or reported in this document. The device is a diagnostic ultrasound system, not explicitly an AI-assisted diagnostic tool, and the submission focuses on substantial equivalence to existing ultrasound devices.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This submission is for an ultrasound imaging system. While it includes "software features" like STIC and OmniView, and a "general measurement tool" called Cardiac AFI, these are presented as capabilities of the ultrasound system itself, not as standalone AI algorithms whose performance is evaluated independently. The primary focus is the imaging hardware and its integrated software relative to predicate ultrasound devices.
7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)
For the new features or specific transducers mentioned as "previously cleared," their original submissions would have involved appropriate ground truth methods relevant to specific clinical applications (e.g., phantom studies for image quality, clinical data for specific measurements). However, for this specific 510(k) submission, since no new clinical studies were required, there is no ground truth established using patient data for the purpose of demonstrating performance of the LOGIQ P9/P7 as a complete system. The ground truth for proving safety and effectiveness here relies on compliance with engineering standards and demonstrated performance of predicate devices.
8. The Sample Size for the Training Set
Not applicable. This document describes a diagnostic ultrasound system, not an AI/ML algorithm that would undergo specific training on a data set.
9. How the Ground Truth for the Training Set Was Established
Not applicable. As there is no AI/ML training set explicitly discussed, the establishment of ground truth for such a set is not detailed.
§ 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.