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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; Abdominal; Pediatric; Small Organ (breast, testes, thyroid); Neonatal Cephalic; Cardiac (adult and pediatric); Peripheral Vascular; Musculo-skeletal Conventional and Superficial; Urology (including prostate); Transvaginal; and Intraoperative (abdominal, thoracic, vascular).

The LOGIQ P9 and LOGIQ P7 is a full featured, general purpose diagnostic ultrasound system which consists of a mobile console approximately 53 cm wide, 69 cm deep and 157 cm high that provides digital acquisition, processing and display capability. The user interface includes a computer keyboard, specialized controls, 10.4-inch LCD touch screen and color 21.5-inch LCD image display.

The provided text does not contain detailed acceptance criteria and a study proving the device meets those criteria in the traditional sense of a clinical performance study for an AI/ML device.

Instead, the document is a 510(k) premarket notification for a diagnostic ultrasound system (GE LOGIQ P9 and LOGIQ P7) and its various transducers. The "study" described is a non-clinical comparison to predicate devices to establish substantial equivalence, rather than a clinical trial demonstrating performance against specific metrics.

Here's a breakdown of the information that can be extracted, and where limitations exist based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not present a table of specific quantitative acceptance criteria or reported performance metrics in terms of accuracy, sensitivity, specificity, or other performance measures typically associated with AI/ML devices.

Instead, the "acceptance criteria" are implied by the comparison to legally marketed predicate devices and compliance with voluntary safety and performance standards. The "reported device performance" is framed as its "substantial equivalence" to these predicates.

Implied Acceptance Criteria (based on comparison to predicate and standards):

• Intended Use Equivalence: Same clinical intended uses as predicate devices.
• Imaging Capabilities Equivalence: Same imaging modes and similar capabilities (measurements, digital image capture, reviewing/reporting).
• Technological Equivalence: Employs the same fundamental scientific technology as predicate devices.
• Safety Standards Compliance: Acoustic output below FDA limits, compliance with AAMI/ANSI ES60601-1, IEC60601-1-2, IEC60601-2-37, NEMA UD 3, NEMA UD 2, ISO10993-1, ISO14971, and NEMA PS 3.1 3.20 (DICOM).
• Biocompatibility: Transducer materials and other patient contact materials are biocompatible.
• Quality Assurance: Adherence to risk analysis, requirements reviews, design reviews, unit testing, integration testing, performance testing, and safety testing.

Reported Device Performance (as stated in the document):

The LOGIQ P9 and P7 systems are "substantially equivalent to the predicate devices with regard to intended use, imaging capabilities, technological characteristics and safety and effectiveness."

Specific new features or transducers are noted to be "previously cleared by FDA" on other GE Healthcare devices, implicitly demonstrating their performance was already deemed acceptable.

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

The document explicitly states: "The subject of this premarket submission, LOGIO P9 and LOGIO P7, did not require clinical studies to support substantial equivalence."

Therefore, there is no test set of patient data of a specific sample size used for performance evaluation in the context of an AI/ML study, nor is there information on data provenance (country of origin, retrospective/prospective). The substantiation is primarily based on engineering and performance testing against standards, and comparison to already cleared predicate devices.

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

Since no clinical studies or test sets with patient data were required for this submission, there is no mention of experts used to establish ground truth for such a test set.

4. Adjudication Method for the Test Set

As no clinical test set was required, there is no adjudication method described.

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 done or reported in this document. The device is a diagnostic ultrasound system, not explicitly an AI-assisted diagnostic tool, and the submission focuses on substantial equivalence to existing ultrasound devices.

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

Not applicable. This submission is for an ultrasound imaging system. While it includes "software features" like STIC and OmniView, and a "general measurement tool" called Cardiac AFI, these are presented as capabilities of the ultrasound system itself, not as standalone AI algorithms whose performance is evaluated independently. The primary focus is the imaging hardware and its integrated software relative to predicate ultrasound devices.

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

For the new features or specific transducers mentioned as "previously cleared," their original submissions would have involved appropriate ground truth methods relevant to specific clinical applications (e.g., phantom studies for image quality, clinical data for specific measurements). However, for this specific 510(k) submission, since no new clinical studies were required, there is no ground truth established using patient data for the purpose of demonstrating performance of the LOGIQ P9/P7 as a complete system. The ground truth for proving safety and effectiveness here relies on compliance with engineering standards and demonstrated performance of predicate devices.

8. The Sample Size for the Training Set

Not applicable. This document describes a diagnostic ultrasound system, not an AI/ML algorithm that would undergo specific training on a data set.

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

Not applicable. As there is no AI/ML training set explicitly discussed, the establishment of ground truth for such a set is not detailed.

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