(41 days)
The device is intended for use by a qualified physician for ultrasound evaluation of Fetal/Obstetrics, Abdominal (including GYN), Pediatric, Small Organ (including breast, testes, thyroid), Neonatal Cephalic, Adult Cephalic, Cardiac (adult and pediatric), Peripheral Vascular, Intraoperative (abdominal, thoracic and peripheral), Musculo-sketal Conventional, Urology (including prostate), Transrectal and Transvaginal.
Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
Clinical Application/Anatomy/Region of Interest: Ophthalmic, Fetal / Obstetrics, Abdominal[1], Pediatric, Small Organ[2], Neonatal Cephalic, Adult Cephalic, Cardiac[3], Peripheral Vascular, Musculo-skeletal Conventional, Musculo-skeletal Superficial, Other[4].
Exam Type, Means of Access: Transesophageal, Transrectal, Transvaginal, Transuretheral, Intraoperative[5], Intraoperative Neurological, Intravascular, Laparoscopic.
Modes of Operation: B, M, PW Doppler, CW Doppler, Color Doppler, Color M Doppler, Power Doppler, Combined Modes*, Harmonic Imaging, Coded Pulse*, Other [Notes].
Notes: [1] Abdominal includes renal, GYN/Pelvic. [2] Small organ includes breast, testes, thyroid. [3] Cardiac is Adult and Pediatric. [4] Other use includes Urology/Prostate. [5] Intraoperative includes abdominal, thoracic (cardiac), and vascular (PV). [*] Combined modes are B/M, B/PWD, B/Color/PWD, B/Power/PWD. ["] Coded Pulse is for digitally encoded harmonics and B-flow.
The subject device consists of a mobile console with keyboard, specialized controls, a color video LCD display with electronicarray transducers. The proposed device is a console based device but predicated is a laptop based device. It is a Track 3 generalpurpose imaging and analysis system providing real-time digital acquisition, processing and display capability intended for general radiology imaging and evaluation with some cardiology and vascular applications.
The provided document is a 510(k) Premarket Notification Submission for the GE LOGIQ P3 Ultrasound System. This type of submission is used to demonstrate that a new device is substantially equivalent to a legally marketed predicate device. This typically does not involve clinical studies with acceptance criteria for device performance as would be seen in a clinical trial for a novel device. Instead, the focus is on showing equivalence through non-clinical tests and conformance to standards.
Therefore, the requested information about acceptance criteria and a study proving the device meets them, specifically with regards to sample size for test sets and training sets, expert consensus, adjudication methods, and MRMC studies, is not present in this document. The document explicitly states:
"The subject of this premarket submission, LOGIQ P3, did not require clinical studies to support substantial equivalence." (Page 2)
Instead, substantial equivalence is determined based on:
- Same fundamental scientific technology as its predicate devices. (Page 2)
- Non-clinical tests: Evaluation for acoustic output, biocompatibility, cleaning and disinfection effectiveness, thermal, electrical, electromagnetic, and mechanical safety, and conformance to applicable medical device safety standards. (Page 2)
- Quality assurance measures: Risk Analysis, Requirements Reviews, Design Reviews, Testing on unit level (Module verification), Integration testing (System verification), Final Acceptance Testing (Validation), Performance testing (Verification), Safety testing (Verification). (Page 2)
However, I can extract the following relevant information from the document as it pertains to the device and its intended use:
1. A table of acceptance criteria and the reported device performance
The document does not provide a table of acceptance criteria and reported device performance in the sense of clinical metrics like sensitivity, specificity, or accuracy. Instead, it demonstrates equivalence through non-clinical testing and adherence to standards. The "performance" is implicitly deemed equivalent to the predicate devices if it passes these non-clinical evaluations.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Not applicable. No clinical tests or test sets of patient data were required or performed for this 510(k) submission.
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. No clinical tests or ground truth establishment by experts were required for this 510(k) submission.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. No clinical tests were performed.
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. No MRMC study was performed.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is a diagnostic ultrasound system, not an algorithm being evaluated for standalone performance.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable. No clinical ground truth was established as clinical studies were not required. The "ground truth" for this submission are the established performance and safety profiles of the predicate devices and the relevant medical device safety standards.
8. The sample size for the training set
Not applicable. No AI/algorithm training set was involved.
9. How the ground truth for the training set was established
Not applicable. No AI/algorithm training set was involved.
Summary of Device, Predicate Devices, and Equivalence Basis:
- Device: GE LOGIQ P3 Ultrasound System
- Predicate Devices: K102256 LOGIQ e, K102104 Vivid P3 (Page 1)
- Summary of Substantial Equivalence: GE Healthcare considers the LOGIQ P3 to be as safe, as effective, and its performance substantially equivalent to the predicate device(s). This conclusion is based on non-clinical testing (acoustic output, biocompatibility, cleaning and disinfection, thermal, electrical, electromagnetic, and mechanical safety) and adherence to quality assurance measures and applicable medical device safety standards. (Page 2)
The document focuses on the technical specifications and intended uses of the various transducers available with the LOGIQ P3 system, comparing them to previously cleared indications (marked 'P' for previously cleared by FDA) or new ('N') indications for each clinical application and mode of operation. This detailed breakdown by transducer and application (pages 6-18) serves to demonstrate the specific areas where the LOGIQ P3, with its various transducers, aligns with or appropriately expands upon the cleared indications of predicate devices.
§ 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.