(95 days)
The device is a general-purpose ultrasound system. Specific clinical applications and exam types include: Fetal; Abdominal (renal & GYN/pelvic); Pediatric; Small Organ (breast, testes, thyroid); Neonatal Cephalic; Adult Cephalic; Cardiac (adult and pediatric); Peripheral Vascular (PV); Musculo-skeletal Conventional and Superficial; Urology (including prostate); Transesophageal (TE); Transrectal (TR); Transvaginal (TV); and Intraoperative (abdominal, thoracic, vascular and neuro).
Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
Clinical Application / Anatomy/Region of Interest: Ophthalmic; Fetal / Obstetrics; Abdominal; Pediatric; Small Organ; Neonatal Cephalic; Adult Cephalic; Cardiac; Peripheral Vascular; Musculo-skeletal Conventional; Musculo-skeletal Superficial; Other.
Exam Type, Means of Access: Transesophageal; Transrectal; Transvaginal; Transuretheral; Intraoperative; Intraoperative Neurological; Intravascular; Laparoscopic.
The subject device consists of a mobile console with keyboard, specialized controls, a color video LCD display with electronic-array transducers. It has the same general appearance, dimensions and weight as the unmodified device, it is a Track 3 general-purpose 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 P6/P6 Pro BT11 Ultrasound System. It outlines the device's intended use, substantial equivalence to predicate devices, and summary of non-clinical tests. However, it explicitly states that "The subject of this premarket submission, LOGIQ P6/P6 Pro, did not require clinical studies to support substantial equivalence."
Therefore, I cannot provide a table of acceptance criteria and reported device performance or information about a study proving the device meets acceptance criteria, as no clinical studies were conducted for this submission. The device's safety and effectiveness were determined based on non-clinical tests and comparison to predicate devices, not through a clinical study with acceptance criteria.
Below is a summary of the information that can be extracted from the document, relevant to your request, but focused on the absence of clinical studies:
1. Table of Acceptance Criteria and Reported Device Performance
Not applicable. The submission explicitly states: "The subject of this premarket submission, LOGIQ P6/P6 Pro, did not require clinical studies to support substantial equivalence." Therefore, there are no acceptance criteria for clinical performance and no reported device performance from a clinical study within this document.
2. Sample Size Used for the Test Set and Data Provenance
Not applicable. No clinical test set was used as no clinical studies were performed. The device's substantial equivalence was based on non-clinical tests and comparison to predicate devices.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
Not applicable. No clinical test set was used and therefore no ground truth established by experts for such a set.
4. Adjudication Method for the Test Set
Not applicable. No clinical test set was used.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No. The document explicitly states that clinical studies were not required. Therefore, an MRMC study was not performed.
6. Standalone (Algorithm Only Without Human-in-the-loop Performance) Study
Not applicable. This is an ultrasound imaging system, not an AI algorithm. No standalone performance study of an algorithm was conducted as part of this submission.
7. Type of Ground Truth Used
Not applicable. As no clinical studies were performed, no clinical ground truth (expert consensus, pathology, outcomes data, etc.) was established for the device's performance in patient care. The assessment was based on non-clinical evaluations and comparison to legally marketed predicate devices.
8. Sample Size for the Training Set
Not applicable. This document pertains to an ultrasound system, not an AI/machine learning device that would typically involve a training set. The device's safety and effectiveness were demonstrated through engineering tests and comparison to predicate devices.
9. How the Ground Truth for the Training Set Was Established
Not applicable. No training set for an algorithm was used. The device's evaluation relied on standard medical device engineering verification and validation processes, comparing its performance characteristics to established safety and performance standards and predicate devices.
In summary, the GE LOGIQ P6/P6 Pro BT11 Ultrasound System's 510(k) submission was based on non-clinical tests and a determination of substantial equivalence to predicate devices, rather than clinical studies with specific performance acceptance criteria.
§ 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.