(223 days)
The HI VISION Preirus is intended for use by trained personnel (doctor, songrapher, etc.) for the diagnostic ultrasound evaluation of Abdominal, Cardiac. Intra-operative. Fetal. Pediatric. Small Organ, Peripheral vessel, Biopsy, Trans-rectal, Trans-vaginal, Musculoskeletal, Neonatal Cephalic, Adult Cephalic, Endoscopy, Intra-luminal, Gynecology, Urology and Laparoscopic clinical applications.
The Modes of Operation of the HI VISION Preirus are B mode, M mode, PW mode (Pulsed Wave Doppler), CW mode (Continuous Wave Doppler), Color Doppler, Amplitude Doppler (Color Flow Angiography), TDI (Tissue Doppler Imaging), 3D Imaging, Real Time Tissue Elastography, and Real Time Virtual Sonography.
An ultrasound system consists of the following:
- Ultrasound transducer(s) to generate the transmitted ultrasound energy and detect the . reflected echoes
- . A computer system to control the transducer and analyze the signals resulting from the reflected echoes
- A video monitor with optional image recorder to display the computed image or derived . Doppler data
The provided document is a 510(k) Premarket Notification for the Hitachi HI VISION Preirus Diagnostic Ultrasound Scanner. It details the device's intended use and claims substantial equivalence to predicate devices, but does not contain a study that proves the device meets specific acceptance criteria for diagnostic performance.
The "Summary of Design Control Activities" section mentions "Verification Activities" and states that "the results demonstrated that the predetermined acceptance criteria were met." However, it only lists general categories of tests performed (Electrical, Mechanical safety; Acoustic output safety; Software; Probe patient contact materials) and refers to external standards (IEC60601-1, FDA Guidance, IEC60601-2-37, ISO10993). It does not provide specific acceptance criteria values or the results of these tests.
Therefore, I cannot populate the table or provide detailed answers to most of your questions as the document does not contain the requested information regarding a diagnostic performance study.
Here's an assessment based on the available information:
1. Table of Acceptance Criteria and Reported Device Performance
Not available in the provided document. The document states that verification activities were performed and met "predetermined acceptance criteria," but it does not specify what those criteria were in quantitative or qualitative terms for diagnostic performance. It lists general safety and performance characteristics that were verified against standards, but not criteria for clinical efficacy or diagnostic accuracy.
2. Sample Size Used for the Test Set and Data Provenance
Not available in the provided document. No diagnostic performance study is detailed, therefore no information on test set sample size or data provenance is present.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
Not available in the provided document. No diagnostic performance study is detailed, therefore no information on ground truth experts or their qualifications is present.
4. Adjudication Method for the Test Set
Not available in the provided document. No diagnostic performance study is detailed, therefore no information on adjudication methods is present.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and its effect size
No. The document does not mention an MRMC comparative effectiveness study involving human readers with or without AI assistance. The device is a diagnostic ultrasound scanner, and its submission focuses on substantial equivalence based on its technological characteristics and intended uses being similar to existing cleared devices, rather than a direct comparison of diagnostic performance with human readers.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. The device is a diagnostic ultrasound scanner, an imaging system that requires human operation and interpretation. It is not an AI algorithm designed for standalone performance without human input. While it includes "Real Time Tissue Elastography" and "Real Time Virtual Sonography" modes, the document does not describe them as standalone diagnostic algorithms.
7. The Type of Ground Truth Used
Not available in the provided document. No diagnostic performance study is detailed, therefore no information on the type of ground truth used is present. The submission focuses on validating the technical performance and safety of the ultrasound system itself against established standards.
8. The Sample Size for the Training Set
Not applicable/Not available. As there is no mention of a diagnostic performance study for an AI-driven component that would require a "training set" for an algorithm, this information is not relevant or provided. The document describes a medical imaging device, not an AI model that undergoes training on data.
9. How the Ground Truth for the Training Set Was Established
Not applicable/Not available. Similar to point 8, this is not relevant to the content provided in the document.
§ 892.1560 Ultrasonic pulsed echo imaging system.
(a)
Identification. An ultrasonic pulsed echo imaging system is a device intended to project a pulsed sound beam into body tissue to determine the depth or location of the tissue interfaces and to measure the duration of an acoustic pulse from the transmitter to the tissue interface and back to the receiver. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II (special controls). A biopsy needle guide kit intended for use with an ultrasonic pulsed echo imaging system only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.