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The device is intended for use by a qualified physician for use with GE Diagnostic Ultrasound Systems for ultrasound evaluation of Fetal; Abdominal; Pediatric; Peripheral Vascular; Urology (including prostate).

The C2-9-D is an ultrasound-imaging device that is attached to a GE ultrasound imaging system and used for diagnostic imaging. This device does not directly control energy delivered to the patient nor contain any software. The C2-9-D is primarily an abdominal transducer and its primary applications are pediatrics and obstetrics, however it may also be used for other applications as described in the indications for use.

The provided 510(k) Premarket Notification Submission for the GE Healthcare C2-9-D Ultrasound Transducer does not contain a study that proves the device meets acceptance criteria related to clinical performance or diagnostic accuracy.

This submission is for a transducer, which is a component of an ultrasound system, not a standalone diagnostic device with algorithms or AI. The substantial equivalence is based on technical, safety, and performance characteristics compared to a predicate device, rather than a clinical efficacy study typically seen for AI/diagnostic software.

Therefore, many of the requested details, such as sample sizes for test/training sets, expert qualifications, adjudication methods, MRMC studies, or ground truth types, are not applicable or not available in this document.

However, I can extract information related to the non-clinical acceptance criteria and the evaluation conducted:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Not applicable. This submission did not require clinical studies or a diagnostic test set for substantial equivalence. The "test sets" referred to were likely for engineering verification and validation against technical standards, not patient data.

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)

• Not applicable. No clinical ground truth was established as no clinical studies were performed.

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

• Not applicable. No clinical test set requiring adjudication of diagnostic outcomes.

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 is a hardware component (ultrasound transducer), not an AI/software device, and no MRMC study was conducted.

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

• Not applicable. This is a hardware component.

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

• Not applicable. No clinical ground truth was established for the device. The "truth" for this device's acceptance relied on meeting predefined physical, electrical, and safety standards.

8. The sample size for the training set

• Not applicable. This is a hardware component; there is no "training set" in the context of machine learning or algorithms.

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

• Not applicable. Same as above.

Study Proving Device Meets Acceptance Criteria:

The document states: "The subject of this premarket submission, C2-9-D Transducer, did not require clinical studies to support substantial equivalence."

Instead of a clinical study, the evidence for meeting acceptance criteria comes from non-clinical tests and conformance to recognized consensus standards:

• Summary of Non-Clinical Tests: "The device has been evaluated for acoustic output, biocompatibility, cleaning and disinfection effectiveness as well as thermal, electrical, electromagnetic and mechanical safety, and has been found to conform with applicable medical device safety standards."
• Compliance with Voluntary Standards: The document explicitly lists voluntary standards that the C2-9-D Transducer and its applications comply with:
  • IEC 60601-1 (General Safety)
  • IEC 60601-1-2 (Electromagnetic Compatibility)
  • IEC 60601-2-37 (Safety of Ultrasonic Medical Diagnostic Equipment)
  • NEMA UD 3 (Acoustic Output Display)
  • NEMA UD 2 (Acoustic Output Measurement)
  • ISO 10993-1 (Biocompatibility)
  • ISO 14971 (Risk Management)
• Quality Assurance Measures: The development process included risk analysis, requirements reviews, design reviews, unit-level testing (module verification), integration testing (system verification), performance testing (verification), safety testing (verification), and final acceptance testing (validation). These are the "studies" or processes by which the device's technical and safety acceptance criteria were met.

In summary, the "study" proving the device meets acceptance criteria is a series of non-clinical engineering verification and validation activities demonstrating compliance with established safety, performance, and international harmonized standards, rather than a clinical trial or AI performance study.

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