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The GE Diasonics Gateway & Gateway FX with Harmonic Imaging are general purpose ultrasound imaging systems 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: Ophthalmic, Fetal, Abdominal, Intraoperative, Small Organ, Neonatal Cephalic, Adult Cephalic, Cardiac, TR, TV, PV, and Musculo-skeletal Conventional & Superficial.

The GE Diasonics Gateway FX with Harmonic Imaging are mobile consoles approximately 69 cm wide, 107 cm deep and 132 cm high equipped with a keyboard control panel, black and white video display monitor, color video display monitor, assorted transducers and optional image storage or hard-copy devices. Harmonic imaging enhances or highlights the imaging of nonlinear tissue characteristics and contrast media.

The provided document (K993069) describes a special 510(k) premarket notification for a modification to the GE Diasonics Gateway and Gateway FX Diagnostic Ultrasound System to include Harmonic Imaging.

Based on the document, here's a breakdown of the acceptance criteria and study information:

1. Table of Acceptance Criteria and Reported Device Performance:

The document states that the Harmonic Imaging modification is substantially equivalent to the currently marketed Gateway FX. The "acceptance criteria" here are based on the device conforming to safety standards and demonstrating equivalence to a predicate device, rather than specific performance metrics like sensitivity or specificity.

• Acoustic output
• Biocompatibility
• Thermal safety
• Electrical safety
• Mechanical safety
  Conformance with 21 CFR 820 (GMP) and ISO 9001/EN 46001 quality system standards | "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."
  "The design and development process of the manufacturer conforms with 21 CFR 820 and ISO 9001/EN 46001 quality system standards."
  "Compliance is verified through independent evaluation with ongoing factory surveillance." |
  | Effectiveness/ Equivalence| Same technological characteristics, design, construction, materials as predicate device.
  Comparable in key safety and effectiveness features as predicate device.
  Same intended uses, operating modes, and transducers as predicate device.
  Consistency with traditional clinical practice, FDA guidelines, and established methods of patient examination. | "The GE Diasonics Gateway FX with Harmonic Imaging are of a comparable type and substantially equivalent to the currently marketed Gateway FX. They have the same technological characteristics, use the same design, construction and materials, are comparable in key safety and effectiveness features, and have the same intended uses, operating modes and transducers as the predicate device."
  "Intended uses and other key features are consistent with traditional clinical practice, FDA guidelines, and established methods of patient examination." |
  | Intended Use | The GE Diasonics Gateway & Gateway FX with Harmonic Imaging are general purpose ultrasound imaging systems 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: Ophthalmic, Fetal, Abdominal, Intraoperative, Small Organ, Neonatal Cephalic, Adult Cephalic, Cardiac, TR, TV, PV, and Musculo-skeletal Conventional & Superficial. | The Harmonic Imaging modification is specifically applied to B mode for the CLA/3.5MI/50-2D probes for the Gateway FX system and to B mode for the CLA/3.5MI/40 probe for the Gateway system, supporting the stated general purpose ultrasound imaging indications. |

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

• No clinical test set was required or performed for this specific 510(k) modification. The submission states: "Clinical Tests: None required."
• The data provenance would therefore be internal engineering evaluations and comparisons to the predicate device, rather than patient data.

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

• Not applicable. No clinical test set with a ground truth established by experts was used for this modification. The assessment focused on technical equivalence and compliance with engineering and safety standards.

4. Adjudication Method for the Test Set:

• Not applicable. No clinical test set requiring adjudication was performed.

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 study was done. This device predates widespread "AI" in medical imaging as we understand it today (1999). Harmonic imaging is a signal processing technique, not an AI-driven interpretive tool. The submission refers to it as "conventional digital image processing technology."

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

• Not applicable in the context of an "algorithm only" performance study. The device itself is an ultrasound system that produces images for human interpretation. The "Harmonic Imaging" feature is an image enhancement, not a diagnostic algorithm that provides a standalone output. Its performance is intrinsically tied to the system's overall image quality and safety, which was assessed through non-clinical tests.

7. The Type of Ground Truth Used:

• For the non-clinical tests, the "ground truth" was established by medical device safety standards and the performance characteristics of the predicate device. For example, acoustic output limits would be a "ground truth" for safety, and the image quality and functionality of the established predicate device served as the benchmark for equivalence.

8. The Sample Size for the Training Set:

• Not applicable. There is no "training set" in the context of a machine learning or AI algorithm for this device. Harmonic imaging is a physics- and signal-processing-based technique.

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

• Not applicable. As there was no training set, there was no ground truth for a training set to be established.

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