(246 days)
Diagnostic ultrasound imaging or Doppler analysis of the human body as follows: Fetal, Abdominal, Pediatric, Small Organs (Specify), Neonatal Cephalic, Adult Cephalic, Cardiac, Transvaginal, Peripheral Vascular, Musculo-skeletal Superficial and Musculo-skeletal Conventional.
Small Organ (Specify): Thyroid, Testicles, Breast.
The SDU-2200Pro is a mobile diagnostic ultrasound system. This system has flat linear array, convex linear and sector probe with a frequency range of approximately 2 to 15 MHz. It has B mode, M mode, Pulsed Doppler mode, Continuous Doppler mode, Color mode, Real time 3D mode, or in a combination of modes.
The provided document is a 510(k) summary for the Shimadzu SDU-2200Pro Diagnostic Ultrasound System. This type of submission is for demonstrating substantial equivalence to a predicate device, not for proving the device meets specific performance acceptance criteria through clinical studies in the way you've outlined for AI/ML devices.
Therefore, the document does not contain information about:
- Acceptance criteria in terms of measurable performance metrics (e.g., sensitivity, specificity, accuracy) for a specific diagnostic task.
- A study conducted to prove the device meets acceptance criteria, as would be done for an AI/ML device.
- Sample sizes used for test sets.
- Data provenance (country of origin, retrospective/prospective).
- Number of experts or their qualifications to establish ground truth for a test set.
- Adjudication methods.
- Multi-reader multi-case (MRMC) comparative effectiveness studies or effect sizes for human reader improvement with AI.
- Standalone (algorithm only) performance studies.
- The type of ground truth used (e.g., pathology, outcomes data).
- Sample size for training sets.
- How ground truth for training sets was established.
Instead, this document focuses on:
- Device Description: A mobile diagnostic ultrasound system with various probes and imaging modes (B mode, M mode, Pulsed Doppler, Continuous Doppler, Color mode, Real-time 3D mode, or combinations).
- Intended Use: Broad diagnostic ultrasound imaging and Doppler analysis for various clinical applications (Fetal, Abdominal, Pediatric, Small Organs, Neonatal Cephalic, Adult Cephalic, Cardiac, Transvaginal, Peripheral Vascular, Musculo-skeletal Superficial, Musculo-skeletal Conventional).
- Safety Considerations: Compliance with international safety and acoustic output standards (IEC 60601-1, UL60601-1:2003, AIUM NEMA UD2, AIUM NEMA UD3).
- Substantial Equivalence: The device is deemed substantially equivalent to a previously cleared predicate device (Shimadzu SDU-2200Pro, K061637). This typically means that the new device has the same intended use, technological characteristics, and safety and effectiveness profile as the predicate, or if it has different technological characteristics, these do not raise new questions of safety and effectiveness and the device is as safe and effective as the predicate.
- Transducer Configurations: A list of various transducers and their specific cleared indications for use (marked 'P' for previously cleared or 'N' for new indications for that specific transducer model/application combination).
In summary, the provided text does not contain the information requested in your prompt regarding acceptance criteria and performance studies for an AI/ML device. It is a regulatory submission for a conventional ultrasound system demonstrating substantial equivalence based on its physical and functional characteristics and compliance with recognized standards.
§ 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.