(57 days)
The Hitachi Noblus™ Ultrasound Diagnostic System is intended for use by trained personnel (doctor, sonographer, 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 Hitachi Noblus™ Ultrasound Diagnostic System are B mode, PW mode (Pulse Wave Doppler), CW mode (Continuous Wave Doppler), Color Doppler, Amplitude Doppler (Color Flow Angiography), TDI (Tissue Doppler Imaging), 3D Imaging, and Real Time Tissue Elastography.
An ultrasound diagnostic system with the following features:
- Ultrasound transducer(s) to generate the transmitted ultrasound energy and detect the reflected echoes
- Ultrasound transducer accessories (standard and optional) to maximize functional usage of transducer(s) in various modes of operation
- A computer system to control the transducer and analyze the signals resulting from the reflected echoes
- A standard Lithium ion computer battery to allow for system portability
- A video monitor with optional image recorder to display the computed image or derived Doppler data
The provided document is a 510(k) summary for the Hitachi Noblus™ Diagnostic Ultrasound System. This type of submission focuses on demonstrating substantial equivalence to a predicate device rather than novel performance claims requiring extensive clinical studies with specific acceptance criteria.
The document explicitly states: "Clinical testing: None required" [Section 1.1b, Page 1]. This indicates that the device's performance was not evaluated against specific acceptance criteria in a dedicated clinical study for this 510(k) submission. Instead, substantial equivalence was demonstrated through non-clinical testing and comparison to a predicate device already cleared by the FDA.
Therefore, many of the requested details about acceptance criteria and clinical study methodology are not applicable or available in this document.
Here's a breakdown of the available information based on your request:
1. Table of Acceptance Criteria and Reported Device Performance
Not applicable/available. This submission does not provide specific performance metrics or acceptance criteria for a new clinical study. The device's performance is implicitly accepted as equivalent to the predicate device (Hitachi HI VISION Avius Diagnostic Ultrasound Scanner [K102901]) based on technical comparisons and adherence to safety standards.
2. Sample Size Used for the Test Set and Data Provenance
Not applicable/available. As no clinical testing was required or conducted for this 510(k) submission to establish acceptance criteria, there is no test set sample size or data provenance to report. The evaluation was based on non-clinical testing and comparison to a predicate device.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
Not applicable/available. Since no new clinical testing was performed to establish performance against acceptance criteria, there was no need for experts to establish ground truth for a test set in this submission.
4. Adjudication Method for the Test Set
Not applicable/available. No clinical test set was used to assess performance against acceptance criteria.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
No. A Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done, as explicitly stated "Clinical testing: None required." The submission focuses on demonstrating substantial equivalence.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done
Not applicable/available. This device is an ultrasound system with various imaging modes, not an AI algorithm. Therefore, the concept of "standalone (algorithm only without human-in-the-loop performance)" does not apply in this context. The operational modes (B mode, PW mode, CW mode, Color Doppler, etc.) are integrated features of the ultrasound system and are inherently used with human operators.
7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)
Not applicable/available. No new clinical data requiring ground truth establishment was generated for this 510(k) submission.
8. The Sample Size for the Training Set
Not applicable/available. The Hitachi Noblus™ Diagnostic Ultrasound System is a medical imaging device, not an AI/ML model that requires a training set in the conventional sense. The "training" for such devices typically involves engineering and optimizing hardware and software components based on known physics, signal processing principles, and image quality standards, rather than specific clinical image datasets.
9. How the Ground Truth for the Training Set Was Established
Not applicable/available. As the device is not an AI/ML model requiring a training set, the concept of establishing ground truth for a training set does not apply.
Summary of Device Substantiation:
The Hitachi Noblus™ Diagnostic Ultrasound System gained FDA clearance (K130308) by demonstrating substantial equivalence to an existing legally marketed predicate device, the Hitachi HI VISION Avius Diagnostic Ultrasound Scanner [K102901].
The substantiation was based on:
- Non-clinical Testing: The device and its transducers were evaluated for acoustic output, biocompatibility, cleaning & disinfection effectiveness, electromagnetic compatibility, electrical safety, and mechanical safety, conforming to applicable medical device safety standards [Section 1.1b, Page 1].
- Technical Comparison: The subject device was shown to be technically comparable to the predicate device, sharing the same fundamental and scientific technologies, intended use, indications for use, gray scale and Doppler capabilities, essential technology for imaging, Doppler functions, signal processing, and acoustic levels below FDA limits [Section 1.1b, Page 1].
- Quality System Compliance: Both subject and predicate devices are manufactured in accordance with FDA 21 CFR 820 Quality System Regulations and designed/manufactured to the same electrical and physical safety standards [Section 1.1b, Page 1].
- Biocompatibility: Materials used were tested according to tripartite biocompatibility guidance and ISO 10993-1 [Section 1.1b, Page 1].
- Cleaning and Disinfection: Instructions for cleaning, disinfection, and sterilization are provided [Section 1.1b, Page 1].
The clearance process for such a device relies on these comparisons to ensure the new device is as safe and effective as a previously cleared device, without the need for new clinical trials if substantial equivalence can be adequately demonstrated through other means.
§ 892.1550 Ultrasonic pulsed doppler imaging system.
(a)
Identification. An ultrasonic pulsed doppler imaging system is a device that combines the features of continuous wave doppler-effect technology with pulsed-echo effect technology and is intended to determine stationary body tissue characteristics, such as depth or location of tissue interfaces or dynamic tissue characteristics such as velocity of blood or tissue motion. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II.