(246 days)
Diagnostic ultrasound imaging or Doppler analysis of the human body as follows: Fetal, Abdominal, Pediatric, Small Organs (Thyroid, Testicles, Breast), Neonatal Cephalic, Adult Cephalic, Cardiac, Transvaginal, Peripheral Vascular, Musculo-skeletal Superficial and Musculo-skeletal Conventional, Transrectal.
The SDU-1200Pro is a mobile diagnostic ultrasound system. This system has flat linear array, convex linear and sector probe with a frequency range of approximately 1.5 to 15 MHz. It has B mode, M mode, Pulsed Doppler mode, Continuous Doppler mode, Real time 3D mode, Color mode, or in a combination of modes.
The provided document is a 510(k) summary for the SHIMADZU MEDICAL SYSTEMS SDU-1200Pro Ultrasound Imaging System. It outlines the device's intended use and compliance with safety standards. However, it does not contain information about acceptance criteria or a study that proves the device meets specific performance criteria in terms of diagnostic accuracy or reader performance.
The document primarily focuses on:
- Device Description: A mobile diagnostic ultrasound system with various probes and imaging modes (B mode, M mode, Pulsed Doppler, Continuous Doppler, Real-time 3D, Color mode).
- Intended Use/Indications for Use: A list of clinical applications for which the device is intended (Fetal, Abdominal, Pediatric, Small Organs, Neonatal Cephalic, Adult Cephalic, Cardiac, Transvaginal, Peripheral Vascular, Musculo-skeletal Superficial, Musculo-skeletal Conventional, Transrectal). These are "previously cleared by FDA" (indicated by 'P' in the tables) or "new indication" (indicated by 'N').
- Safety Considerations: Compliance with international and national safety and acoustic output standards (IEC 60601-1, UL60601-1:2003, AIUM NEMA UD2, AIUM 1998, AIUM NEMA UD3).
- Substantial Equivalence: A claim that the device is substantially equivalent to a predicate device (Shimadzu SDU-1200Pro K061643), which is the basis for 510(k) clearance.
Therefore, I cannot provide the requested information regarding acceptance criteria and a study proving their fulfillment, as these details are not present in the provided text.
Specifically, the following information is missing from the document:
- A table of acceptance criteria and the reported device performance: The document only lists intended uses and safety standards. There are no quantitative performance metrics (e.g., sensitivity, specificity, accuracy for a particular clinical task) or acceptance criteria for such metrics.
- Sample size used for the test set and the data provenance: Not mentioned.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not mentioned.
- Adjudication method: Not mentioned.
- If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and the effect size of how much human readers improve with AI vs without AI assistance: This is an ultrasound imaging system, not an AI-assisted diagnostic device, and no such study is mentioned.
- If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable, as this is a medical imaging device, not an algorithm.
- The type of ground truth used: Not applicable, as no performance study is described.
- The sample size for the training set: Not applicable, as no algorithm training is mentioned.
- How the ground truth for the training set was established: Not applicable.
§ 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.