(131 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 sarano is a mobile diagnostic ultrasound system. This system has flat linear array, convex and with a frequency range of approximately 2 to 15 MHz. It has B mode, M mode, or in a combination of modes. Also the sarano has two kinds of monitor; CRT and LCD. The former is standard model and latter is optional model.
This is a 510(k) Premarket Notification for a diagnostic ultrasound system (sarano) and its associated transducers. The document describes the device, its intended use, and conformance to safety standards. However, it does not contain any information about clinical performance studies, acceptance criteria for device accuracy, or expert evaluations of image quality or diagnostic capability.
Therefore, I cannot provide the requested information regarding acceptance criteria and the study that proves the device meets them from the provided text.
Specifically:
- A table of acceptance criteria and the reported device performance: This information is not present in the document. The document primarily focuses on the device's technical specifications, intended uses, and compliance with safety and measurement standards.
- Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): No test set, sample size, or data provenance information is provided as there are no clinical performance studies described.
- 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 ground truth establishment information is provided as there are no clinical performance studies described.
- Adjudication method (e.g. 2+1, 3+1, none) for the test set: No adjudication method is described.
- 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: No MRMC study is mentioned, nor is any AI component.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: No standalone algorithm performance is mentioned, nor is any AI component.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc): No ground truth type is specified.
- The sample size for the training set: No training set information is provided, as there is no mention of a machine learning or AI component.
- How the ground truth for the training set was established: No ground truth establishment for a training set is provided.
The document discusses the device's adherence to voluntary and measurement standards like IEC 60601-1 (safety), UL60601-1 (safety), AIUM NEMA UD2 (acoustic output measurement), and AIUM NEMA UD3 (real-time display of thermal and mechanical acoustic output indices). These are safety and performance standards for the physical device and its acoustic output, not clinical performance or diagnostic accuracy.
The FDA's letter of substantial equivalence (K082224) is based on the device being substantially equivalent to a predicate device (Shimadzu Corporation sarano K061641), implying that its performance characteristics are similar to a previously cleared device, rather than requiring new clinical performance studies for diagnostic accuracy for this specific submission.
§ 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.