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LOGIQ Fortis is intended for use by a qualified physician for ultrasound evaluation of Fetal/Obstetrics; Abdominal (including Renal, Gynecology/Pelvic); 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 and Vascular).

Modes of operation include: B, M, PW Doppler, CW Doppler, Color Doppler, Color M Doppler, Power Doppler, Harmonic Imaging, Coded Pulse, 3D/4D Imaging mode, Elastography, Shear Wave Elastography, Attenuation Imaging and Combined modes: B/M, B/Color, B/PWD, B/Color/PWD, B/Power/PWD.

The LOGIQ Fortis is intended to be used in a hospital or medical clinic.

The LOGIQ Fortis is a full featured, Track 3, general purpose diagnostic ultrasound system which consists of a mobile console approximately 575 mm wide (keyboard), 925 mm deep and 1300 mm high that provides digital acquisition, processing and display capability. The user interface includes a digital keyboard (physical keyboard as an option), specialized controls, 12-inch high-resolution color touch screen and 23.8-inch High Contrast LED LCD monitor (or 23.8-inch High Resolution LED LCD monitor as an option).

Here's a breakdown of the acceptance criteria and study details for the AI features of the LOGIQ Fortis Ultrasound System, based on the provided FDA 510(k) clearance letter:

AI Features Analyzed:

1. Auto Abdominal Color Assistant 2.0
2. Auto Aorta Measure Assistant
3. Auto Common Bile Duct (CBD) Measure Assistant
4. Ultrasound Guided Fat Fraction (UGFF)

1. Auto Abdominal Color Assistant 2.0

1.1. Acceptance Criteria and Reported Device Performance:

1.2. Sample Size and Data Provenance (Test Set):

• Number of individual subjects: 49
• Number of annotation images: 1186
• Country: USA (100%)
• Retrospective/Prospective: Not explicitly stated, but the description "Before the process of data annotation, all information displayed on the device is removed and performed on information extracted purely from Ultrasound B-mode images" and "Readers to ground truth the 'anatomy' visible in static B-Mode image" suggests retrospective analysis of collected images.

1.3. Number and Qualifications of Experts for Ground Truth (Test Set):

• Number of Experts: Not specified ("Readers to ground truth the 'anatomy'").
• Qualifications: Not specified (generally, these would be qualified ultrasonographers or radiologists).

1.4. Adjudication Method (Test Set): Not specified.

1.5. MRMC Comparative Effectiveness Study: No, this study evaluates the standalone performance of the AI model.

1.6. Standalone Performance: Yes, this study was done to evaluate the algorithm's performance in detecting abdominal structures.

1.7. Type of Ground Truth Used: Expert consensus on "anatomy" visible in static B-Mode images.

1.8. Sample Size for Training Set: Not explicitly stated, but implied to be separate from the test set.

1.9. How Ground Truth for Training Set Was Established: Not explicitly stated, but implied to be similar to the test set, with experts annotating B-mode images.

2. Auto Aorta Measure Assistant

2.1. Acceptance Criteria and Reported Device Performance:

2.2. Sample Size and Data Provenance (Test Set):

• Long View Aorta:
  • Subjects: 36 (11 Male, 25 Female)
  • Country: 16 Japan, 20 USA
• Short View Aorta:
  • Subjects: 35 (11 Male, 24 Female)
  • Country: 15 Japan, 20 USA
• Retrospective/Prospective: Not explicitly stated, but "Validation images were collected on LOGIQ Fortis" and the truthing process suggests retrospective analysis of collected images.

2.3. Number and Qualifications of Experts for Ground Truth (Test Set):

• Number of Experts: Not specified ("Readers to ground truth...").
• Qualifications: Not specified.

2.4. Adjudication Method (Test Set): An "arbitrator to select most accurate measurement among all readers" was used. This suggests a form of adjudication, possibly 2+1 or similar, where the arbitrator acts as the tie-breaker/final decision-maker.

2.5. MRMC Comparative Effectiveness Study: Yes, this study directly compares human performance with and without AI assistance by measuring keystrokes and accuracy.

• Effect Size (Keystrokes):
  • Long View Aorta: Reduction of ~2.896 keystrokes (4.132 - 1.236)
  • Short View Aorta: Reduction of ~4.743 keystrokes (7.05 - 2.307)
    (While not a traditional effect size like AUC improvement, this quantifies human workflow improvement).

2.6. Standalone Performance: Partially. The accuracy measurements compare AI baseline against an arbitrator's selected measurement, indicating standalone algorithm accuracy, but the primary focus is on human-in-the-loop efficiency.

2.7. Type of Ground Truth Used: Expert consensus on measurements, with an arbitrator for final selection.

2.8. Sample Size for Training Set: Not explicitly stated, but independence from the test set is ensured by "exam site origin."

2.9. How Ground Truth for Training Set Was Established: Not explicitly stated, but implied to be similar to the test set, with experts performing measurements.

3. Auto Common Bile Duct (CBD) Measure Assistant

3.1. Acceptance Criteria and Reported Device Performance:

3.2. Sample Size and Data Provenance (Test Set):

• Subjects: 25 (11 Male, 14 Female)
• Countries: USA (40%), Japan (60%)
• Retrospective/Prospective: Not explicitly stated, but "Validation images were collected on LOGIQ Fortis" and the truthing process suggests retrospective analysis of collected images.

3.3. Number and Qualifications of Experts for Ground Truth (Test Set):

• Number of Experts: Not specified ("Readers to ground truth...").
• Qualifications: Not specified.

3.4. Adjudication Method (Test Set): An "arbitrator to select most accurate measurement among all readers" was used.

3.5. MRMC Comparative Effectiveness Study: Yes, this study directly compares human performance with and without AI assistance by measuring keystrokes and accuracy (specifically, accuracy with and without segmentation scroll edit, which implies human interaction with AI).

• Effect Size (Keystrokes): Average reduction of 1.62 keystrokes.

3.6. Standalone Performance: Partially. The measurement accuracy with and without segmentation scroll edit provides insight into the algorithm's performance and the benefit of human refinement, but the primary focus is on human-in-the-loop efficiency and accuracy.

3.7. Type of Ground Truth Used: Expert consensus on measurements, with an arbitrator for final selection.

3.8. Sample Size for Training Set: Not explicitly stated, but independence from the test set is ensured by "exam site origin."

3.9. How Ground Truth for Training Set Was Established: Not explicitly stated, but implied to be similar to the test set, with experts performing measurements.

4. Ultrasound Guided Fat Fraction (UGFF)

4.1. Acceptance Criteria and Reported Device Performance:

4.2. Sample Size and Data Provenance (Test Set): This section describes the clinical studies used for validation of the UGFF index, rather than a traditional AI test set.

• Primary Study (Development/Validation of UGFF Index):

  • Subjects: 582 participants
  • Country: Japan
  • Retrospective/Prospective: "external clinical study in Japan" implies prospective data collection, with subsequent analysis.

• Second Confirmatory Study:

  • Subjects: 15 US patients, 5 EU patients (Total 20)
  • Country: US and EU
  • Retrospective/Prospective: Not specified.

• Third Confirmatory Study (Comparison with Predicate):

  • Subjects: 24 EU patients
  • Country: EU
  • Retrospective/Prospective: Not specified.

4.3. Number and Qualifications of Experts for Ground Truth (Test Set):

• UGFF Study: The ground truth is established by a reference imaging modality (MRI-PDFF) and a comparison device (UDFF), not directly by human experts interpreting ultrasound images for the purpose of the study. The study involves acoustic property measurements.

4.4. Adjudication Method (Test Set): Not applicable, as the ground truth is based on MRI-PDFF and UDFF, not human interpretation requiring adjudication.

4.5. MRMC Comparative Effectiveness Study: No, this is a clinical validation against a reference standard and a comparative study against a predicate device.

4.6. Standalone Performance: Yes, the UGFF index is an algorithm-generated value based on acoustic properties, and its performance is evaluated in a standalone manner against established reference methods (MRI-PDFF) and a legally marketed predicate (UDFF).

4.7. Type of Ground Truth Used: Quantitative measurements from a reference imaging modality (MRI Proton Density Fat Fraction - MRI-PDFF %) and a comparative device (Ultrasound-Derived Fat Fraction (UDFF, Siemens)).

4.8. Sample Size for Training Set: The UGFF index is based on a least squares fit (estimation) between acoustic property measurements and MRI-PDFF measurements from the primary 582-subject study. This study effectively serves as the "training" dataset for establishing the correlation and the estimation model.

4.9. How Ground Truth for Training Set Was Established: MRI-PDFF measurements were obtained from the liver of these 582 participants.

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