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510(k) Data Aggregation
(232 days)
HITACHI MEDICAL CORPORATION
The 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.), Intra-operative (Neuro.), Transesophageal (Cardiac) - Adult/Pediatric, Wound (Cavernous/Non-Cavernous), Fetal, Pediatric, Small Organ, Peripheral vessel, Biopsy, Trans-rectal, Musculoskeletal (Convent. / Superfic.), 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, M mode (Pulse Wave Doppler), CW mode (Continuous Wave Doppler), Color Doppler (Color Flow Angiography), TDI (Tissue Doppler Imaging), 3D Imaging, 4D 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 O
- Ultrasound transducer accessories (standard and optional) to maximize functional usage of transducer(s) O in various modes of operation
- A computer system to control the transducer and analyze the signals resulting from the reflected echoes O
- A video monitor with optional image recorder to display the computed image or derived Doppler data O
The provided text is related to a 510(k) premarket notification for the NOBLUS™ Ultrasound Diagnostic System. It primarily focuses on the device's intended use and comparison to a predicate device, rather than detailed acceptance criteria and study results for device performance. Therefore, I can only extract limited information relevant to your request.
Here's what can be gathered:
1. Table of Acceptance Criteria and Reported Device Performance:
The document lists "FDA Track" and "Transmit Channel" as comparative characteristics, implying these were evaluated, though specific acceptance criteria values or performance metrics are not explicitly stated in a tabular format as you requested. The comparison indicates the devices performed equivalently.
| Characteristic | Acceptance Criteria (Implied) | Reported Device Performance (Subject Device) |
|---|---|---|
| FDA Track | Within FDA limits | 1 probe / 3 probes (with Probe extension unit) |
| Transmit Channel | Sufficient for operation | 64 |
| Acoustic Level | Below Track 3 FDA limits | Below Track 3 FDA limits |
| Biocompatibility | Conforms to ISO 10993-1 | Conforms to ISO 10993-1 |
| Cleaning & Disinfection | Effectiveness demonstrated | Effectiveness demonstrated |
| Electromagnetic Compatibility | Conforms to applicable standards | Conforms to applicable standards |
| Electrical & Mechanical Safety | Conforms to applicable standards | Conforms to applicable standards |
| Quality System Compliance | Conforms to FDA 21 CFR 820 | Conforms to FDA 21 CFR 820 |
2. Sample size used for the test set and the data provenance:
The document states "No new hazards were identified with the subject device and its transducers have been evaluated..." and "No new safety or effectiveness questions are raised related to these changes." This phrasing indicates that evaluations were performed, but no specific sample size for a test set or data provenance (e.g., country of origin, retrospective/prospective) is provided. The evaluation appears to be based on design, materials, and compliance with standards rather than clinical data from a test set.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
Since no clinical testing necessitating a test set and ground truth establishment is mentioned, this information is not available in the provided text. The evaluation method described focuses on engineering and regulatory compliance.
4. Adjudication method for the test set:
Not applicable, as no clinical test set requiring adjudication is mentioned.
5. 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:
Not applicable. The device is an ultrasound diagnostic system, not an AI-assisted diagnostic tool for human readers. The document does not mention any AI capabilities or comparative effectiveness studies of this nature.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. The device is an ultrasound diagnostic system, which inherently involves human operation and interpretation. The document does not describe any standalone algorithm performance testing.
7. The type of ground truth used:
Not explicitly stated for performance evaluation as the evaluation methods lean towards engineering and regulatory compliance. For the broader context of diagnostic ultrasound, the "ground truth" would generally be established by definitive diagnostic methods (e.g., pathology, surgical findings, clinical follow-up) for the conditions being diagnosed. However, these are not directly referenced as part of this device's "study" for acceptance criteria.
8. The sample size for the training set:
Not applicable. This is a medical device submission for an ultrasound system, not an AI/machine learning model that typically requires a training set.
9. How the ground truth for the training set was established:
Not applicable, as there is no training set mentioned for an AI/machine learning model.
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