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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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