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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.

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Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Fetal; Abdominal; Pediatric; Small Organ (breast, testes, thyroid); Neonatal Cephalic; Cardiac (adult and pediatric); Peripheral Vascular; Musculo-skeletal Conventional and Superficial: Urology (including prostate): Transesophageal (TE): Transrectal (TR); Transvaginal (TV); and Intraoperative (abdominal, thoracic, vascular and neurological).

The GE LOGIQ P6 is full-featured, general-purpose diagnostic ultrasound system consisting of a mobile console approximately 49 cm wide, 64 cm deep and 135-141 cm high that provide digital acquisition, processing and display capability. The user interface includes a computer keyboard. specialized controls and color video LCD display. The modification combines features of the unmodified system with additional features from other systems currently marketed by GE Healthcare to provide users with improved imaging capability and acoustic control.

The provided text describes a Special 510(k) Premarket Notification for the GE LOGIQ P6 Ultrasound System. This type of submission focuses on demonstrating substantial equivalence to a predicate device, rather than on proving performance against specific acceptance criteria for a new medical indication through clinical trials.

Therefore, the document explicitly states "Clinical Tests: None required." This means a study proving the device meets acceptance criteria as typically understood for new clinical claims was not performed or deemed necessary for this submission. The substantial equivalence argument relies on the device being comparable to an existing, legally marketed device (GE LOGIQ P5 Diagnostic Ultrasound System).

Here's an analysis based on the information provided, specifically addressing why certain criteria cannot be met:

Acceptance Criteria and Device Performance

Since no clinical tests demonstrating performance against specific acceptance criteria were required or conducted for this 510(k) submission, a table of acceptance criteria and reported device performance cannot be generated from the provided text. The submission focuses on demonstrating "substantial equivalence" based on technological characteristics and intended uses, rather than empirical performance metrics for a novel clinical claim.

Study Information (Based on provided document)

1. 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 test set was used, as "Clinical Tests: None required." The device's safety and effectiveness were established by comparison to a predicate device.

2. 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 test set requiring expert ground truth was established, as "Clinical Tests: None required."

3. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

   • Not applicable. No test set requiring an adjudication method was used, as "Clinical Tests: None required."

4. 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. An MRMC comparative effectiveness study was not done. The device is a diagnostic ultrasound system, not an AI-based interpretation tool that assists human readers.

5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

   • Not applicable. The GE LOGIQ P6 is a diagnostic ultrasound system operated by a qualified physician, not a standalone algorithm. Its performance is inherent to its image acquisition and processing capabilities.

6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

   • Not applicable. No ground truth for clinical performance was established, as "Clinical Tests: None required." The ground for substantial equivalence is the safety and effectiveness of the predicate device (GE LOGIQ P5).

7. The sample size for the training set:

   • Not applicable. This document pertains to regulatory clearance for an ultrasound system, not the development or training of an AI algorithm. Therefore, there is no mention of a "training set" in the context of machine learning.

8. How the ground truth for the training set was established:

   • Not applicable. As above, no training set for an AI algorithm is referenced in this regulatory document.

In summary: The GE LOGIQ P6 Ultrasound System gained market clearance through a Special 510(k) pathway by demonstrating substantial equivalence to a predicate device (GE LOGIQ P5). This pathway does not typically require new clinical studies to establish individual performance metrics against acceptance criteria for novel clinical claims. Instead, it relies on the established safety and effectiveness of the predicate device and the new device's comparable technological characteristics and intended uses. The document explicitly states "Clinical Tests: None required."

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