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The device is intended for use by a qualified physician for ultrasound evaluation of Fetal/Obstetrics; Abdominal; Adult Cephalic; Cardiac (adult and pediatric); Peripheral Vascular; Musculo-skeletal Conventional and Superficial; Urology (including prostate); Transvaginal; Transesophageal and Intraoperative (abdominal, thoracic, vascular).

The LOGIQ S8 is a full featured, general purpose diagnostic ultrasound system which consists of a mobile console approximately 520 mm wide (keyboard), 865 mm deep and 1760 mm high that provides digital acquisition, processing and display capability. The user interface includes a computer keyboard, specialized controls, 10.1-inch LCD touch screen and color widescreen monitor.

The provided text describes a 510(k) premarket notification for the GE LOGIQ S8 ultrasound system. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving novel claims or establishing new acceptance criteria through extensive clinical studies.

Therefore, the document does not provide specific acceptance criteria in terms of analytical or clinical performance metrics (e.g., sensitivity, specificity, accuracy for a particular disease or measurement), nor does it detail a study performed to prove such metrics against acceptance criteria. Instead, it demonstrates substantial equivalence based on technological characteristics, intended use, and compliance with recognized safety and performance standards.

Here's an breakdown of the information that can be extracted based on your request, as well as indications of what is not present in this type of regulatory filing:

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

This information is not provided in the document as it is a 510(k) summary for showing substantial equivalence, not a clinical trial report establishing new performance criteria. The "performance" described relates primarily to equivalence with predicate devices and compliance with general safety and performance standards.

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

This information is not provided. The document explicitly states: "The subject of this premarket submission, LOGIQ S8, did not require clinical studies to support substantial equivalence." The testing mentioned is for acoustic output, biocompatibility, cleaning/disinfection, and safety standards.

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)

This information is not provided as no clinical studies are reported to have been conducted for this submission.

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

This information is not provided as no clinical studies are reported to have been conducted for this submission.

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

This information is not provided. The device is an ultrasound imaging system, and there's no mention of AI assistance or MRMC studies in this document.

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

This information is not provided. The device is a diagnostic ultrasound imaging system, not an AI algorithm for standalone interpretation.

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

This information is not provided as no clinical studies are reported to have been conducted for this submission. The "ground truth" for the device's claims are the safety and performance characteristics of its predicate devices and compliance with recognized standards.

8. The sample size for the training set

This information is not provided as no machine learning or AI training is mentioned as being part of this submission's substantial equivalence argument.

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

This information is not provided as no machine learning or AI training is mentioned.

Summary of what the document does provide regarding device performance and compliance:

The document focuses on demonstrating that the GE LOGIQ S8 is substantially equivalent to legally marketed predicate devices. This is achieved by:

• Intended Use Equivalence: Stating that the LOGIQ S8 has the same clinical intended use as the predicate LOGIQ S8 (K152195).
• Technological Equivalence: Declaring that it employs the same fundamental scientific technology as its predicate device(s).
• Imaging Modes: Noting that it has the same imaging modes as the predicate LOGIQ S8, with additions of Fibroscan elastography and CAP (Controlled Attenuation Parameter), which are equivalent to features found on the reference predicate FibroScan (K160524).
• Safety and Standards Compliance:
  • Manufactured with materials evaluated and found safe.
  • Acoustic power levels are below applicable FDA limits.
  • Designed in compliance with approved electrical and physical safety standards.
  • Compliance with voluntary standards:
    • AAMI/ANSI ES60601-1 (Medical Electrical Equipment - General Requirements for Safety)
    • IEC60601-1-2 (Electromagnetic Compatibility)
    • IEC60601-2-37 (Ultrasonic Medical Diagnostic and Monitoring Equipment Safety)
    • ISO10993-1 (Biological Evaluation of Medical Devices)
    • ISO14971 (Application of risk management to medical devices)
    • NEMA UD 2 (Acoustic Output Measurement Standard)
    • NEMA UD 3 (Real Time Display of Thermal and Mechanical Acoustic Output Indices)
    • NEMA, Digital Imaging and Communications in Medicine (DICOM) Set.
  • Quality assurance measures applied to development (Risk analysis, Requirements Reviews, Design Reviews, Testing on unit level, Integration testing, Final Acceptance Testing, Performance testing, Safety testing).
  • Transducer and patient contact materials are biocompatible.

The document lists various transducers cleared with the system and for which clinical applications and modes of operation they are "previously cleared" (P), "new" (N), or "added under Appendix E" (E), primarily based on equivalence to other GE Ultrasound systems (e.g., LOGIQ E9, VIVID E90/E95).

In conclusion, for this specific 510(k) submission, the "acceptance criteria" are compliance with established medical device safety and performance standards and demonstration of substantial equivalence to predicate devices, rather than predefined performance thresholds from new clinical trials.

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The device is intended for use by a qualified physician for ultrasound evaluation of Fetal/Obstetrics; Abdominal; Adult Cephalic; Cardiac (adult and pediatric); Peripheral Vascular; Musculo-skeletal Conventional and Superficial; Urology (including prostate); Transvaginal; Transesophageal and Intraoperative (abdominal, thoracic, vascular).

The LOGIQ S8 is a full featured, general purpose diagnostic ultrasound system which consists of a mobile console approximately 620 mm wide, 880 mm deep and 1720 mm high that provides digital acquisition, processing and display capability. The user interface includes a computer keyboard, specialized controls, 9-inch LCD touch screen and color widescreen monitor.

The provided document is a 510(k) Premarket Notification from GE Healthcare for their LOGIQ S8 ultrasound system. This document focuses on demonstrating substantial equivalence to previously cleared predicate devices, rather than presenting a study to prove acceptance criteria for a novel device or AI algorithm.

Therefore, many of the requested details about acceptance criteria metrics, sample sizes, ground truth establishment, and expert involvement are not applicable or explicitly stated in the context provided. The document primarily attests to the device's technical specifications and safety and effectiveness being equivalent to existing cleared devices.

However, I can extract information related to the device's intended use and the non-clinical tests performed to support its substantial equivalence.

1. Table of Acceptance Criteria and Reported Device Performance

Since this is a 510(k) submission demonstrating substantial equivalence, specific quantitative acceptance criteria and performance metrics (e.g., sensitivity, specificity for a diagnostic task) are generally not provided in the same way they would be for a novel device or an AI algorithm proving clinical utility. Instead, performance is established by demonstrating equivalence to a legally marketed predicate device.

The "acceptance criteria" here relate to conforming to recognized safety and performance standards and maintaining the same intended use. The "reported device performance" is implicitly considered equivalent to the predicate device(s) for the listed clinical applications and imaging modes.

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

The document explicitly states: "The subject of this premarket submission, LOGIQ S8, did not require clinical studies to support substantial equivalence." This means there was no specific clinical "test set" and associated sample size in the traditional sense of a clinical trial for performance evaluation against a defined ground truth. Instead, the equivalence argument is based on technical and performance similarity to existing cleared devices.

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

Not applicable, as no dedicated clinical test set with independent ground truth establishment was conducted for this 510(k) submission.

4. Adjudication Method for the Test Set

Not applicable, as no dedicated clinical test set with ground truth establishment was conducted.

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. The LOGIQ S8 is a diagnostic ultrasound system, not an AI-assisted diagnostic tool that would typically involve human readers interpreting images with and without AI assistance to show an "effect size" of improvement. The document does mention "Shear Wave Elastography" which is an advanced imaging mode, but not an AI-driven interpretation tool in the context of this submission.

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

Not applicable, as the LOGIQ S8 is a hardware and software system for image acquisition and display, not a standalone AI algorithm.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

Not applicable, as no new clinical studies requiring external ground truth were performed for this substantial equivalence submission. The ground truth for proving substantial equivalence to predicate devices typically involves technical specifications, engineering measurements, and adherence to recognized standards.

8. The Sample Size for the Training Set

Not applicable. The document describes a diagnostic ultrasound system, not a device primarily driven by a machine learning or AI algorithm that would require a "training set" for its core function.

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

Not applicable, as there was no training set for an AI algorithm in the context of this 510(k) submission.

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The device is intended for use by a qualified physician for ultrasound evaluation of Fetal; Abdominal; Pediatric; Small Organ (breast, testes, thyroid); Neonatal Cephalic; Adult Cephalic; Cardiac (adult and pediatric): Peripheral Vascular; Musculo-skeletal Conventional and Superficial: Urology (including prostate); Transrectal; Transvaginal: Transesophageal and Intraoperative (abdominal, thoracic, and vascular).

The LOGIQ S8 is a full featured, general purpose diagnostic ultrasound system which consists of a mobile console approximately 62 cm wide, 88 cm deep and 175 cm high that provides digital acquisition, processing and display capability. The user interface includes a computer keyboard, specialized controls, 9-inch LCD touch screen and color 19-inch LCD image display.

The GE LOGIQ S8 Ultrasound System and its associated transducers did not require clinical studies to support substantial equivalence. Instead, the submission relies on the fact that existing features and probes have been migrated from predicate devices that were previously cleared by the FDA, and new features and probes demonstrate equivalence to existing cleared technologies through non-clinical testing.

Here's a breakdown of the information based on the provided text:

1. Table of Acceptance Criteria and the Reported Device Performance:

Since no clinical studies were performed for the LOGIQ S8 itself, there are no specific 'acceptance criteria' in terms of clinical performance metrics (like sensitivity, specificity) or 'reported device performance' from clinical trials. The device's performance is demonstrated through compliance with established safety and performance standards for diagnostic ultrasound equipment, and the substantial equivalence to predicate devices.

The acceptance criteria are implicitly met by demonstrating compliance with the following voluntary standards and quality assurance measures for the non-clinical tests:

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

No clinical test sets or associated human data are mentioned as the basis for this 510(k) submission. The evaluation is primarily based on non-clinical tests and substantial equivalence claims to predicate devices. Therefore, there is no information on sample size or data provenance from a clinical test set.

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

Not applicable, as no clinical test set requiring expert-established ground truth was part of this submission. The device's safety and effectiveness were demonstrated through compliance with regulatory standards and comparison to previously cleared predicate devices.

4. Adjudication Method for the Test Set:

Not applicable, as no clinical test set requiring adjudication was part of this submission.

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 submission is for a general-purpose diagnostic ultrasound system that does not appear to incorporate AI functionality for interpretation or diagnostic assistance to human readers. Therefore, an MRMC study on AI assistance is not relevant to this submission.

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

Not applicable. The LOGIQ S8 is a diagnostic ultrasound system, not a standalone algorithm. Its performance is intrinsically tied to human operation and interpretation.

7. The Type of Ground Truth Used:

For the non-clinical tests, the "ground truth" would be established by the specifications and benchmarks defined within the cited industry standards (e.g., NEMA UD 2 for acoustic output, IEC 60601 series for safety). For the substantial equivalence claim, the "ground truth" is the established safety and effectiveness of the predicate devices.

8. The Sample Size for the Training Set:

Not applicable, as this submission does not describe a machine learning or AI-based device that would require a training set.

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

Not applicable, as there is no training set for this device.

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The device is intended for use by a qualified physician for ultrasound evaluation of Fetal; Abdominal; Pediatric; Small Organ (breast, testes, thyroid); Neonatal Cephalic; Adult Cephalic; Cardiac (adult and pediatric); Peripheral Vascular; Musculo-skeletal Conventional and Superficial; Urology (including prostate); Transrectal; Transvaginal and Intraoperative (abdominal, thoracic, vascular and neurosurgical).

The LOGIQ S8 is a full featured, general purpose diagnostic ultrasound system which consists of a mobile console approximately 62 cm wide, 88 cm deep and 175 cm high that provides digital acquisition, processing and display capability. The user interface includes a computer keyboard, specialized controls, 9-inch LCD touch screen and color 19-inch LCD image display.

The GE Logiq S8 Ultrasound System did not require clinical studies. The submissions focused on non-clinical testing to demonstrate substantial equivalence to predicate devices (K092271 Logiq E9 Diagnostic Ultrasound System and K052441 Logiq 7 Diagnostic Ultrasound System). Therefore, there are no specific acceptance criteria or details of a study proving device performance on human test sets as typically found for algorithms.

Here's a breakdown of the requested information based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance: This information is not available in the provided document as clinical studies were not deemed necessary. The device was evaluated against safety standards.

2. Sample sized used for the test set and the data provenance: Not applicable, as no clinical test set was used. The evaluation was based on non-clinical tests.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable, as no clinical test set was used and thus no ground truth established by experts was required for this submission.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable, as no clinical test set was used.

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, as this is a diagnostic ultrasound system, not an AI-assisted interpretation device. No MRMC study was performed.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable, as this is a diagnostic ultrasound system, not an algorithm.

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc): Not applicable, as no clinical studies requiring ground truth were performed. The equivalence was based on meeting safety and performance standards for an ultrasound machine.

8. The sample size for the training set: Not applicable, as this is a diagnostic ultrasound system and not an AI/ML algorithm that requires a training set.

9. How the ground truth for the training set was established: Not applicable, as this is a diagnostic ultrasound system and not an AI/ML algorithm.

Summary of Non-Clinical Tests (from Section 1 of the Input):

The device underwent the following non-clinical evaluations to ensure safety and effectiveness:

• Acoustic output
• Biocompatibility
• Cleaning and disinfection effectiveness
• Thermal safety
• Electrical safety
• Electromagnetic safety
• Mechanical safety

These evaluations confirmed conformity to applicable medical device safety standards and voluntary standards detailed in Sections 9, 11, and 17 of the premarket submission. Quality assurance measures included:

• 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)

Conclusion regarding substantial equivalence:

GE Healthcare considered the Logiq S8 to be as safe, as effective, and its performance substantially equivalent to the predicate devices (K092271 Logiq E9 Diagnostic Ultrasound System and K052441 Logiq 7 Diagnostic Ultrasound System) based on these non-clinical tests. Clinical studies were not required for this determination.

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