Search Results

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:

1. 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.
2. Sample size used for the test set and the data provenance: Not mentioned.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not mentioned.
4. Adjudication method: Not mentioned.
5. 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.
6. 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.
7. The type of ground truth used: Not applicable, as no performance study is described.
8. The sample size for the training set: Not applicable, as no algorithm training is mentioned.
9. How the ground truth for the training set was established: Not applicable.

Ask a specific question about this device