The Hitachi Aloka Medical. Ltd. AriettaS70 /AriettaV70 is intended for use by trained personnel (doctor, sonographer, etc.) for the diagnostic ultration of Abdominal. Cardiac. Intra-operative. I ctal. Pediative. Small Organ, Peripheral vessel, Biopsy, Trans-rectal, Trans-vaginal. Musculoskeletal. Neonatal Cephalic. Adult Cephalie, Endoscopy, Intra-luminal, Gynecology, Urology and Laparoscopic clinical applications.
The Modes of Operation are B mode. PW mode (Pulsed Wave Doppler). CW mode (Continuous Wave Doppler). Color Doppler. Amplitude Doppler (Color Flow Angiography), TDI (Tissue Doppler Imaging), 3D Imaging, 4D Imaging, Real Time Tissue Elastography, and Real Time Virtual Sonography.
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) O in various modes of operation
- o A computer system - to control the transducer and analyze the signals resulting from the reflected echocs
- O A video monitor with optional image recorder - to display the computed image or derived Doppler data
This document is a 510(k) Summary of Safety and Effectiveness for the Hitachi Aloka Medical, Ltd. Arietta70 / AriettaV70 Diagnostic Ultrasound System. It primarily focuses on demonstrating substantial equivalence to predicate devices and does not describe a study involving specific acceptance criteria and performance data for the device itself in terms of diagnostic accuracy or effectiveness measures.
Instead, the document details non-clinical testing to ensure the device's safety and technical performance against established standards, and then states that no clinical testing was required to prove substantial equivalence. Therefore, there is no study described here that directly "proves the device meets the acceptance criteria" in the sense of diagnostic performance or clinical outcomes.
However, based on the provided text, we can infer the "acceptance criteria" relate to safety, performance according to medical device standards, and substantial equivalence to legally marketed predicate devices.
Here's the breakdown of the information requested, based on what is available in the provided text:
1. A table of acceptance criteria and the reported device performance
Since no specific diagnostic performance metrics (e.g., sensitivity, specificity, accuracy) are reported for this device in comparison to acceptance criteria, the table will reflect the general safety and technical performance demonstrated through non-clinical testing and comparison to predicate devices.
| Acceptance Criteria Category | Reported Device Performance |
|---|---|
| Safety - General | No new hazards identified. |
| Safety - Acoustic Output | Evaluated; conforms to applicable medical device safety standards. Acoustic level below Track 3 FDA limits. |
| Safety - Biocompatibility | Evaluated; conforms to applicable medical device safety standards. Materials tested per ISO 10993-1; all biocompatibility testing conducted in accordance with component material characterization, type of body contact, and duration contact risk profile. |
| Safety - Cleaning & Disinfection Effectiveness | Evaluated; conforms to applicable medical device safety standards. Instructions for cleaning, disinfection, and sterilization provided in manuals. |
| Safety - Electromagnetic Compatibility (EMC) | Evaluated; conforms to applicable medical device safety standards. |
| Safety - Electrical Safety | Evaluated; conforms to applicable medical device safety standards. Designed and manufactured to the same electrical safety standards as predicate devices. |
| Safety - Mechanical Safety | Evaluated; conforms to applicable medical device safety standards. Designed and manufactured to the same physical safety standards as predicate devices. |
| Quality System Compliance | Manufactured in accordance with FDA 21 CFR 820 Quality System Regulations. |
| Technical Equivalence - Intended Use/Indications | Same intended use/indications for use as predicate devices. |
| Technical Equivalence - Gray Scale & Doppler Capabilities | Same gray scale and Doppler capabilities as predicate devices. |
| Technical Equivalence - Essential Technology | Same essential technology for imaging, Doppler functions, and signal processing as predicate devices. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Not applicable. No clinical test set data is described. The evaluation was based on non-clinical testing, engineering analysis, and bench testing, as well as comparison to predicate devices, rather than a clinical study with a patient test set.
3. 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)
Not applicable. No clinical test set with associated ground truth established by experts is described.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. No clinical test set requiring adjudication is described.
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 document is for a diagnostic ultrasound system and does not mention any AI components or MRMC comparative effectiveness studies.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. The document describes an ultrasound diagnostic system, not a standalone algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
Not applicable. No clinical ground truth was established as no clinical studies were performed or required for this 510(k) submission. For non-clinical testing, adherence to recognized standards and technical specifications served as the "ground truth" for performance.
8. The sample size for the training set
Not applicable. No training set is mentioned as this is not a machine learning or AI-based device submission requiring such data.
9. How the ground truth for the training set was established
Not applicable. There is no training set described.
§ 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.