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The GE LOGIQ 700 with CE is a general purpose ultrasound imaging system intended for use in the evaluation of soft tissue and vascular disease in the head, neck, chest, abdomen, pelvis, male and female reproductive organs, limbs and pregnant uterus. Specific indications are: fetal, abdominal; intraoperative abdominal and neurological; pediatric; small organ including breast, testes, thyroid: neonatal cephalic: cardiac adult and pediatric: TR: TV: PV; urological; and conventional and superficial musculo-skeletal.

The GE LOGIQ 700 with CE is a mobile console approximately 70 cm wide, 120 cm deep and 120 cm high that provides full 128 channel capability and assorted probes. 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. Coded Excitation is useful for enhancing B or M mode performance characteristics providing improved high frequency depth penetration without loss of spatial resolution.

The GE LOGIQ 700 Diagnostic Ultrasound with coded excitation (CE) modification is an ultrasonic pulsed echo imaging system. The submission documents indicate that this device is substantially equivalent to the currently marketed GE LOGIQ 700. The primary claim here is on substantial equivalence to an existing device, rather than new performance criteria being proven.

Here's an analysis of the provided information regarding acceptance criteria and studies:

1. Table of Acceptance Criteria and Reported Device Performance

Since this is a submission for substantial equivalence with a modification (coded excitation) to an already cleared device, the "acceptance criteria" are not framed as specific performance metrics to be met by a new algorithm or diagnostic capability. Instead, the acceptance criteria are met by demonstrating that the modified device has comparable technological characteristics, safety, and effectiveness to the predicate device.

The reported device performance, in this context, is that the Coded Excitation is useful for enhancing B or M mode performance characteristics, providing improved high frequency depth penetration without loss of spatial resolution, and it utilizes conventional digital image processing technology.

2. Sample Size for the Test Set and Data Provenance

• Sample Size for Test Set: Not applicable. No clinical test set was required for this submission.
• Data Provenance: Not applicable. No clinical studies were conducted to prove clinical efficacy. The assessment was based on non-clinical tests and a comparison of technological characteristics to a predicate device.

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

• Not applicable. No clinical test set with medical expert ground truth was required or performed.

4. Adjudication Method for the Test Set

• Not applicable. No clinical test set was utilized.

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, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. The device is a diagnostic ultrasound system, not an AI-assisted diagnostic tool in the sense of the query.

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

• Not applicable. The Coded Excitation is a hardware/software modification to enhance image quality in the ultrasound system, not a standalone diagnostic algorithm.

7. The Type of Ground Truth Used

• The "ground truth" for this submission primarily relies on non-clinical testing results demonstrating compliance with safety standards (acoustic output, biocompatibility, thermal, electrical, mechanical safety) and the established safe and effective performance history of diagnostic ultrasound technology in general and the predicate GE LOGIQ 700 system. The "ground truth" for the effectiveness of the Coded Excitation is described as enhancing B or M mode performance, providing improved high frequency depth penetration without loss of spatial resolution, which is a technical characteristic rather than a clinical diagnostic outcome.

8. The Sample Size for the Training Set

• Not applicable. The "Coded Excitation" technology is described as implemented with conventional digital image processing, and there is no mention of a machine learning model requiring a training set in the context of this 1999 submission.

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

• Not applicable, as no training set for a machine learning model was used.

Summary of the Study that Proves the Device Meets the Acceptance Criteria:

The study proving the device meets its acceptance criteria is primarily a non-clinical assessment and a comparison to a predicate device, rather than a clinical trial.

1. Non-clinical Tests: The device underwent evaluation for:

   • Acoustic output
   • Biocompatibility
   • Thermal safety
   • Electrical safety
   • Mechanical safety
     The device was found to conform with applicable medical device safety standards in these non-clinical tests.

2. Technological Comparison and Feature Description: The submission argues for substantial equivalence by stating that the modified GE LOGIQ 700 with CE has:

   • The same technological characteristics (with CE being a digital image processing enhancement).
   • Comparable key safety and effectiveness features to the predicate GE LOGIQ 700.
   • The same basic design, construction, and materials.
   • The same intended uses, operating modes, and probes.

3. Rationale for No Clinical Tests: "Clinical Tests: None required." This statement is based on the argument of substantial equivalence to an already cleared device, leveraging the long history of safe and effective performance of diagnostic ultrasound, and the fact that the coded excitation is an enhancement to an existing technology rather than a fundamentally new diagnostic modality. The claim is that the modification via Coded Excitation (providing improved high frequency depth penetration without loss of spatial resolution) is an inherent performance characteristic of the system rather than a new diagnostic capability that would require clinical validation.

In essence, the "study" for this 510(k) submission is the comprehensive documentation and testing showing that the modified device remains safe, performs as intended, and does not raise new questions of safety or effectiveness when compared to its existing, legally marketed predicate device.

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The LOGIQ 700 with Harmonic Imaging is a general purpose ultrasound imaging system intended for use in the evaluation of soft tissue and vascular disease in the head, neck, chest, abdomen, pelvis, male and female reproductive organs, limbs and pregnant uterus. Specific indications are: fetal, abdominal; intraoperative abdominal and neurological; pediatric; small organ including breast, testes, thyroid; neonatal cephalic; cardiac adult and pediatric; TR; TV; urological; and conventional and superficial musculo-skeletal.

The LOGIQ 700 with Harmonic Imaging is a mobile console approximately 70 cm wide, 120 cm deep and 120 cm high that provides full 128 channel capability and assorted probes. 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. Harmonic imaging enhances or highlights the imaging of nonlinear tissue characteristics.

This submission is a Special 510(k) Premarket Notification for a modification to an existing device (GE LOGIQ 700 Diagnostic Ultrasound with Harmonic Imaging Modification). In such cases, clinical studies are often not required if the new device is found to be substantially equivalent to a predicate device.

Based on the provided document, here's an analysis of the acceptance criteria and study information:

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

Since no clinical studies were required, the acceptance criteria and performance are established through substantial equivalence to the predicate device, not empirical performance metrics from a study. Therefore, the table cannot be populated with specific performance metrics from a new study.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

No clinical test set was used for this 510(k) submission. "Clinical Tests: None required."

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)

No clinical test set was used, therefore no experts were required to establish ground truth for a test set in this submission.

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

No clinical test set was used, therefore no adjudication method was applicable or employed.

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 conducted. This device is an ultrasound system with a new imaging mode, not an AI-assisted diagnostic tool.

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

No standalone algorithm performance study was conducted. The device is a medical imaging system, not an independent algorithm. The harmonic imaging feature is integrated into the existing system.

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

No new ground truth was established as no clinical studies were performed. The "ground truth" for this submission relies on the established safety and effectiveness of the predicate device and the conventional nature of the new feature.

8. The sample size for the training set

No training set was explicitly mentioned or used for the purpose of a clinical study or algorithm development as part of this 510(k) submission. The "training" for the device's development refers to its adherence to established engineering and quality standards.

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

Not applicable, as no training set (in the context of machine learning/algorithm development) was used for this submission. The "ground truth" for the device's design and development comes from medical device safety standards, regulatory requirements, and established clinical practice as outlined in the "Conclusion" section.

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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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