(11 days)
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 C1-6-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 CI-6-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 document is a 510(k) Premarket Notification Submission for the GE Healthcare C1-6-D Ultrasound Transducer. It focuses on demonstrating substantial equivalence to a predicate device based on non-clinical tests and technology.
Therefore, the following information cannot be extracted from the document:
- A table of acceptance criteria and the reported device performance: The document states that "The subject of this premarket submission, C1-6-D Transducer, did not require clinical studies to support substantial equivalence." This means there are no clinical acceptance criteria or reported device performance metrics related to a clinical study provided.
- Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): No clinical test set was used.
- 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): No clinical test set required ground truth establishment.
- Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable as no clinical test set was used.
- 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 device is an ultrasound transducer, not an AI-powered diagnostic tool, and no MRMC study was conducted.
- If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable. This is a hardware transducer, not an algorithm.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable as no clinical ground truth was established for this submission.
- The sample size for the training set: Not applicable as there is no training set mentioned for this device.
- How the ground truth for the training set was established: Not applicable as there is no training set.
Conclusion from document:
The GE Healthcare C1-6-D Ultrasound Transducer did not require clinical studies to support substantial equivalence. The submission focused on demonstrating substantial equivalence through non-clinical tests, including acoustic output, biocompatibility, cleaning and disinfection effectiveness, and thermal, electrical, electromagnetic, and mechanical safety. The device's technology is stated to be the same as its predicate device.
§ 892.1570 Diagnostic ultrasonic transducer.
(a)
Identification. A diagnostic ultrasonic transducer is a device made of a piezoelectric material that converts electrical signals into acoustic signals and acoustic signals into electrical signals and intended for use in diagnostic ultrasonic medical devices. Accessories of this generic type of device may include transmission media for acoustically coupling the transducer to the body surface, such as acoustic gel, paste, or a flexible fluid container.(b)
Classification. Class II.