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LOGIQ 700 with 3D is a general purpose ultrasound imaging system intended for use by, or under the direction of, a qualified physician in the evaluation of soft tissue and vascular disease of the head, neck chest, abdomen pelvis, male and female reproductive organs, limbs and pregnant uterus of the adult, pediatric or neonatal patient.

Diagnostic ultrasound imaging or Doppler analysis of the human body as follows: Fetal and other (includes urological), Abdominal, Cardiac Adult, Cardiac Pediatric, Pediatric, Small Organ (includes breast, testes, thyroid), Neonatal Cephalic, Peripheral vessel, Trans-rectal, Trans-vaginal. Combined modes are B/M, B/Color, B/PWD, B/Color/PWD.

The LOGIQ 700 diagnostic ultrasound system with 3D is the same in all other aspects as the currently marketed LOGIQ 700, consisting of a mobile console approximately 70 cm wide, 120 cm deep and 120 cm high that provides full 128 channel capability, and assorted transducers. The user interface is an adjustable height keyboard, small A/N display panel and a color video display monitor. Optional image storage or hard-copy devices are integrated into the design.

The provided text is a 510(k) summary for the GE LOGIQ 700 3D Cine diagnostic ultrasound system, submitted in 1996. This document evaluates the device for substantial equivalence to a predicate device, focusing on safety and effectiveness.

Here's an analysis of the requested information based only on the provided text, recognizing that some modern AI/ML device study criteria may not apply to a 1996 submission for an ultrasound system.

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of quantitative acceptance criteria or specific performance metrics in the way a modern AI/ML device submission would. Instead, the acceptance criteria are implicitly tied to demonstrating "substantial equivalence" to a predicate device. The performance is reported in a qualitative manner, confirming adherence to safety standards.

2. Sample Size Used for the Test Set and Data Provenance

The document does not provide information regarding a specific "test set" in the context of an AI/ML algorithm. The evaluation described refers to acoustic output, biocompatibility, and thermal, electrical, and mechanical safety, which typically involve testing of the physical device components rather than a dataset of clinical cases. Therefore, there is no mention of sample size or data provenance (country of origin, retrospective/prospective).

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts

This information is not applicable or not provided in the document. The submission is for a diagnostic ultrasound system and its transducers, not an AI/ML algorithm that requires expert-annotated ground truth for a test set of clinical images. The "ground truth" in this context would likely be physical measurements, engineering specifications, and established medical device safety limits.

4. Adjudication Method for the Test Set

This information is not applicable or not provided in the document. As there is no described test set requiring human interpretation for ground truth, no adjudication method is mentioned.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of Human Improvement with AI vs. Without AI Assistance

This information is not applicable or not provided in the document. The device is a diagnostic ultrasound system, not an AI-assisted diagnostic tool. Therefore, a MRMC comparative effectiveness study comparing human readers with and without AI assistance was not performed or mentioned.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

This information is not applicable or not provided in the document. The device is a diagnostic ultrasound system, which inherently involves human operation and interpretation. It is not a standalone AI algorithm.

7. The Type of Ground Truth Used

The ground truth used for this type of medical device submission (a diagnostic ultrasound system in 1996) centers around:

• Engineering Specifications and Safety Standards: The device's acoustic output, electrical safety, thermal safety, mechanical safety, and biocompatibility are measured against established industry and regulatory standards.
• Predicate Device Comparison: The "ground truth" for demonstrating effectiveness is the substantial equivalence to a legally marketed predicate device (GE Medical Systems LOGIQ 700, K930768) with a known history of safe and effective performance. This implies that the predicate device's established performance serves as the benchmark.

8. The Sample Size for the Training Set

This information is not applicable or not provided in the document. The GE LOGIQ 700 is a hardware and software system for image acquisition and display, not an AI/ML algorithm that is "trained" on a dataset in the modern sense.

9. How the Ground Truth for the Training Set Was Established

This information is not applicable or not provided in the document, as there is no "training set" for an AI/ML algorithm associated with this device submission.

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Diagnostic ultrasound imaging or Doppler analysis of the human body as follows: Fetal, Abdominal, Intra-operative of abdominal organs, Neurosurgical, Pediatric, Small Organ including breast, testes, thyroid, Neonatal Cephalic, Cardiac Adult, Cardic Pediatric, Trans-rectal, Transvaginal, and Peripheral vessel.

The LOGIQ 700 including intra-operative and neurosurgical uses is the same in all other aspects as the currently marketed LOGIQ 700, consisting of a mobile console approximately 70 cm wide, 120 cm deep and 120 cm high that provides full 128 channel capability, and assorted transducers. The user interface is an adjustable height keyboard, small A/N display panel and a color video display monitor. Optional image storage or hard-copy devices are integrated into the design.

The provided text describes a 510(k) summary for the GE LOGIQ 700 diagnostic ultrasound system, not a study proving device performance against acceptance criteria. A 510(k) submission primarily demonstrates substantial equivalence to a legally marketed predicate device, rather than providing detailed clinical study results with specific acceptance criteria and performance metrics typically seen in studies for novel high-risk devices or AI/ML-driven diagnostics.

Therefore, many of the requested elements for a study proving device performance against acceptance criteria are not available in this document.

However, I can extract information related to the device's intended use and the nature of the submission.

Here's a breakdown of what can and cannot be answered based on the provided document:

1. A table of acceptance criteria and the reported device performance

• Not applicable/Not available. This document is a 510(k) summary demonstrating substantial equivalence to a predicate device. It does not contain specific performance metrics with acceptance criteria for a clinical study comparing the device's diagnostic accuracy against a ground truth. The submission confirms the device has been evaluated for "acoustic output, biocompatibility, and thermal, electrical and mechanical safety" and found to conform with applicable medical device safety standards, but no comparative performance data is presented.

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/Not available. No clinical test set or data provenance is mentioned as this is a 510(k) for substantial equivalence, not a performance study.

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/Not available. No ground truth establishment or expert involvement for a test set is discussed in this 510(k) summary.

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

• Not applicable/Not available. No test set or adjudication method is discussed.

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/Not available. This device is a diagnostic ultrasound system from 1997, predating widespread AI/ML integration in such systems. No MRMC study or AI assistance is mentioned.

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

• Not applicable/Not available. This is a hardware/software system, not an algorithm-only device.

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)

• Not applicable/Not available. No ground truth is discussed in the context of a performance study for this 510(k) summary.

8. The sample size for the training set

• Not applicable/Not available. This document describes a traditional medical device, not an AI/ML system requiring a training set in the modern sense.

9. How the ground truth for the training set was established

• Not applicable/Not available. See point 8.

Summary of what is known from the document regarding the device and its clearance:

• Device Name: GE LOGIQ 700 Diagnostic Ultrasound System.
• Date of Submission: June 18, 1997.
• Regulatory Class: II (21 CFR 892.1550/Procode: 90 IYN, 21 CFR 892.1570/Procode: 90 ITX).
• Predicate Device: GE Medical Systems LOGIQ 700 diagnostic ultrasound system (510(k) Number K930768).
• Key Basis for Clearance: Substantial Equivalence to the predicate device.
• Evaluations Mentioned: "The device has been evaluated for acoustic output, biocompatibility, and thermal, electrical and mechanical safety, and has been found to conform with applicable medical device safety standards." This suggests engineering and safety testing, not clinical performance studies comparing accuracy against a ground truth.
• Intended Uses: Diagnostic ultrasound imaging or Doppler analysis for Fetal, Abdominal, Intra-operative (of abdominal organs), Neurosurgical, Pediatric, Small Organ (breast, testes, thyroid), Neonatal Cephalic, Cardiac Adult, Cardiac Pediatric, Trans-rectal, Transvaginal, and Peripheral vessel applications.
• Conditions of Clearance: Submission of a postclearance special report containing complete information, including acoustic output measurements based on production line devices, as requested in Appendix G of the Center's February 17, 1993 "Revised 510(k) Diagnostic Ultrasound Guidance for 1993." This is a post-market requirement related to safety, not a pre-market clinical performance study.

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