Search Results

Ask a specific question about this device

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.

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.

Ask a specific question about this device

The device is intended for use by a qualified physician for ultrasound evaluation of Fetal, Abdominal, Intra-operative, Intra-operative (Neuro), Laparoscopic, Pediatric, Neonatal Cephalic, Trans-rectal & vaginal, Musculo-skeletal, Gynecological, Cardiac-(Adult, Neonatal, Pediatric), TEE & Peripheral Vascular.
The device is not indicated for Ophthalmic applications.

The Prosound Alpha 7 Ver. 6.0 Diagnostic Ultrasound System is a full feature imaging and analysis system. It consist of a mobile console that provides acquisition, processing and display capability. The user interface includes a computer type keyboard, specialized controls and a display.

The provided document is a 510(k) summary for the Hitachi Aloka Medical Prosound Alpha 7 Ver. 6.0 Diagnostic Ultrasound System. It primarily focuses on demonstrating substantial equivalence to a predicate device and specifying the intended uses for various transducers. It does not contain acceptance criteria for device performance or a study demonstrating that the device meets such criteria.

The document states:

• "I. Non-clinical Tests: The device and its transducers have been evaluated for acoustic output, biocompatibility, cleaning & disinfection effectiveness, electromagnetic compatibility, as well as electrical and mechanical safety, and have been found to conform with applicable medical device safety standards."
• "2. Clinical Tests: None Required."

Given this, I cannot extract specific acceptance criteria related to clinical performance or a study proving the device meets those criteria from the provided text.

Therefore, the requested table and information cannot be fully populated as the core information (acceptance criteria and a study demonstrating meeting them) is not present in the provided 510(k) summary for clinical performance.

However, I can provide the non-clinical acceptance criteria that were met.

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• The document states "Clinical Tests: None Required." Therefore, there is no information on a sample size for a clinical test set or data provenance from such a study. For non-clinical tests, specific sample sizes (e.g., number of units tested for acoustic output) are not detailed in this summary, but implied to be sufficient to demonstrate conformity to standards.

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)

• No clinical test set was used, so no experts were involved in establishing ground truth for a test set in the context of clinical performance.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

• No clinical test set was used, so no adjudication method is applicable.

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

• No MRMC study was mentioned, nor is this device described as having AI capabilities.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

• This device is a Diagnostic Ultrasound System; it does not appear to be an algorithm-only device, and no standalone performance study in that context is mentioned.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

• No clinical ground truth was established as clinical tests were not required. The "ground truth" for non-clinical aspects was defined by applicable safety and performance standards.

8. The sample size for the training set

• Not applicable. This document pertains to regulatory submission for a diagnostic ultrasound system, not typically an AI-based system that requires a training set in the machine learning sense.

9. How the ground truth for the training set was established

• Not applicable. (See point 8)

Ask a specific question about this device