(142 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 (Spec.), Trans-esophageal (Cardiac, Non-Cardiac) - Adult/Pediatric, Wound (Cavernous), Fetal, Pediatric, Small Organ, Peripheral vessel, Biospy, Trans-rectal, Trans-vaginal, Musculoskeletal (Convent. / Superfic.), Neonatal Cephalic, Adult Cephalic, Endoscopy, Intraluminal, Gynecology, Urology, and Laparoscopic clinical applications.
The modes of operation of the Hitachi Noblus™ Ultrasound Diagnostic System are B mode, M mode, PW mode (Pulse Wave Doppler), CW mode (Continuous Wave 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 text describes a 510(k) premarket notification for the Hitachi Noblus™ Ultrasound Diagnostic System. This document asserts the substantial equivalence of the Noblus™ to legally marketed predicate devices, rather than detailing a specific study to prove acceptance criteria for novel functionalities.
Therefore, the acceptance criteria and details of a proving study as typically applied to new or significantly modified aspects requiring such validation are not fully present in the provided text. The document instead focuses on demonstrating that the new combined features and transducers of the Noblus™ are substantially equivalent to existing cleared devices, implying that the acceptance criteria for those existing devices are met.
However, I can extract the relevant information regarding the device's claimed performance based on its stated equivalence and the non-clinical testing performed.
Here's an interpretation based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance:
Since this is a 510(k) submission asserting substantial equivalence, formal acceptance criteria as a quantitative threshold for novel performance claims are not explicitly stated for new features. Instead, the "acceptance criteria" here implicitly refer to the device performing comparably to the predicate devices for their respective indications. The "reported device performance" is essentially that it functions in the specified modes and applications similar to the already cleared predicate devices.
| Acceptance Criteria (Implicit) | Reported Device Performance (Claimed Substantial Equivalence) |
|---|---|
| Diagnostic Ultrasound System functionality (general imaging, Doppler, signal processing) for indicated clinical applications. | The Noblus™ has the "same gray scale and Doppler capabilities" and "same essential technology for imaging, Doppler functions, and signal processing" as the predicate K130308. It is intended for a broad range of diagnostic ultrasound evaluations (Abdominal, Cardiac, Fetal, Small Organ, etc.). |
| Acoustic output within FDA limits. | Acoustic level is "below the Track 3 FDA limits." |
| Biocompatibility of materials. | Manufactured with materials "tested in accordance to ISO 10993-1" and all biocompatibility testing "conducted in accordance to each component material characterization, type of body contact, and duration contact risk profile." |
| Electrical and mechanical safety standards compliance. | Designed and manufactured to "the same electrical and physical safety standards." |
| Cleaning and disinfection effectiveness for re-usable components. | Designed to be re-usable and "provide instructions for cleaning, disinfection, and sterilization in the Ultrasound system and transducer manuals." |
| Effective wound scanning capabilities. | Capable of scanning wounds "in the same manner as the predicate Hudson 2020/2040/2060 scanner [K022928]" without additional risk. |
| Effective free-hand scanning for 3D visualization. | Employs free-hand scanning for 3D visualization "the same as the Hitachi HI VISION ASCENDUS Diagnostic Ultrasound Scanner cleared via K110673." |
| Effective Real Time Tissue Elastography (RTTE) with Strain Ratio for tissue characterization comparable to predicate elastography features. | The RTTE feature incorporates a Strain Ratio, which is "substantially equivalent to the Siemen Acuson S2000 [K130881] Supersonic Image Shearwave Elastography feature." It provides a color graph of tissue strain to assist in visualization and perimeter of a tumor, lump or mass, without additional risk. |
2. Sample Size Used for the Test Set and Data Provenance:
The document explicitly states "Non-clinical Testing" and "Clinical testing: None required." This indicates that no new clinical test set with a specific sample size was collected or analyzed for the purpose of this specific 510(k) submission to prove the device meets acceptance criteria for novel claims. The primary basis for equivalence is comparison to previously cleared devices. If any non-clinical testing involved datasets (e.g., for algorithm validation if there were any, which isn't explicitly detailed as a novel algorithm here), the details are not provided in this summary.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications:
Given that "Clinical testing: None required" and the submission relies on substantial equivalence to existing devices, there is no mention of a new test set requiring new ground truth established by experts specifically for this submission. The ground truth for the predicate devices would have been established during their respective clearance processes.
4. Adjudication Method for the Test Set:
Not applicable, as no new clinical test set (with specific ground truth requiring adjudication) was explicitly described for this submission.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:
No, an MRMC comparative effectiveness study is not mentioned as having been done for this submission. The submission is based on substantial equivalence, comparing the device to existing cleared devices rather than assessing performance improvement with or without AI assistance.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done:
The document describes an ultrasound system with various imaging modes and features, including "Real Time Tissue Elastography" with a "strain ratio feature." While Elastography involves algorithms, the submission doesn't detail a standalone algorithmic performance study independent of human interpretation. The claim is that the feature itself is substantially equivalent to a predicate device's feature, implying that its standalone performance would be comparable, but no specific study is described.
7. The Type of Ground Truth Used:
For the features deemed substantially equivalent to predicate devices, the presumed "ground truth" would have been established during the clearance of those predicate devices. This could include various types of clinical data, expert consensus, and in some cases, pathology or outcome data, depending on the specific application addressed by each predicate. For the Real Time Tissue Elastography, the comparison is functionally qualitative ("provides color graph of tissue strain... to assist in visualization and perimeter of a tumor, lump or mass in liver, breast, thyroid, etc. for biopsy purposes") rather than being tied to definitive pathology for this specific submission's evaluation.
8. The Sample Size for the Training Set:
Not applicable. This is a 510(k) demonstrating substantial equivalence for an ultrasound system, not a submission for a de novo AI/ML algorithm that would undergo specific training and validation studies with disclosed training set sizes. The "training" for the device's various imaging modes is inherent in its engineering and design based on established ultrasound physics and technologies, and comparison to predicate devices, not typically in the sense of an AI/ML training dataset.
9. How the Ground Truth for the Training Set Was Established:
Not applicable, as there's no mention of an AI/ML training set in the context of this 510(k) summary. The development of the Noblus™ system relies on established medical device development practices and comparisons to already cleared technologies.
§ 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.