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The UST-5550-R and UST-5536-R transducer is intended for use with the PROSOUND ALPHA 7 Diagnostic Ultrasound Systems by trained personnel (doctor, sonography, etc.) for the diagnostic ultrasound evaluation during robotic* and non-robotic** intra-operative and laparoscopic procedures.
The L43K transducer is intended for use with the ARIETTA60, ARIETTA 70 and NOBLUS Diagnostic Ultrasound Systems by trained personnel (doctor, sonography, etc.) for diagnostic ultrasound evaluation during robotic* and non-robotic** intra-operative and laparoscopic procedures.
This device is not indicated for Ophthalmic applications.
*For robotic use, these devices can only be used with the da Vinci™ Surgical System and da Vinci™ 8 mm ProGrasp Forceps.
**For non-robotic use, these devices can only be used with the Covidien SILST™ Clinch

Linear Array transducer

The provided text describes a 510(k) premarket notification for diagnostic ultrasonic transducers (UST-5550-R, UST-5536-R, L43K). The submission focuses on demonstrating substantial equivalence to predicate devices, primarily through non-clinical testing related to material and design changes.

The document does not describe a study involving an AI/Machine Learning device that aids human readers or a standalone AI algorithm. Instead, it concerns the physical and performance attributes of an ultrasonic transducer. Therefore, many of the requested points regarding AI model development, ground truth establishment, expert adjudication, and MRMC studies are not applicable to this submission.

Here is the information that can be extracted from the provided text, primarily related to the non-clinical testing performed to support the device's acceptance:

Device: UST-5550-R, UST-5536-R, L43K Diagnostic Ultrasonic Transducers

1. Table of Acceptance Criteria and Reported Device Performance:

2. Sample size used for the test set and the data provenance:

• Sample Size: Not explicitly stated as a number of devices, but the tests were performed on "the Robotic Ultrasound Probe samples" which underwent 100/500 (Grasp and Release) and 500/1000 (Bend and Flexibility) cycles. The "L43K" is specifically mentioned for both tests, and "UST-5550-R" for the grasp and release test.
• Data Provenance: The tests are non-clinical, hardware performance tests. The devices are manufactured in the U.S.A. (UST-5550-R and UST-5536-R by SOMA Manufacturing, LLC for Hitachi Aloka Medical, Ltd.) and Japan (L43K by Hitachi, Ltd.). The testing itself would likely have been conducted at the manufacturer's R&D facilities. This is prospective testing, specifically designed to demonstrate the safety and effectiveness of the modified device.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• Not applicable as this is a non-clinical, performance-based validation of a medical device (ultrasound transducer), not an AI/ML study involving human interpretation of medical images. "Ground truth" in this context refers to the engineering specifications and expected physical performance.

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

• Not applicable. This is a non-clinical, objective performance test. The criteria are met or not met based on direct observation and measurement of physical damage and imaging performance characteristics.

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. This submission is for an ultrasonic transducer, not an AI-powered diagnostic tool. The "effect size" mentioned pertains to AI-assisted human reader performance, which is outside the scope of this device's validation.

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

• Not applicable. This is not an AI algorithm.

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

• For this device, the "ground truth" relates to the functional integrity and imaging performance of the transducer after mechanical stress. This is established through predefined engineering specifications and validated test methods (e.g., visual inspection for physical damage, evaluation of imaging performance using phantoms or established quality control procedures). It is not based on expert consensus, pathology, or outcomes data in the sense of a diagnostic interpretation study.

8. The sample size for the training set:

• Not applicable. This is not an AI/ML device that requires a training set.

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

• Not applicable. No training set is involved for this type of device.

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HI VISION Ascendus is intended for use by trained personnel (doctor, sonographer, etc.) for the diagnostic ultrasound evaluation of Abdominal, Cardiac, Intra-operative, Trans-esophageal (Cardiac) - Adult/Pediatric, Fetal, Pediatric, Small Organ, Peripheral vessel, Biopsy, Trans-rectal, Trans-vaginal, Musculoskeletal (Convent. / Superfic.), Neonatal Cephalic, Adult Cephalic, Endoscopy, Intra-luminal, Gynecology, Urology and Laparoscopic clinical applications.

The modes of operation of the HI VISION Ascendus are B mode, M mode (Pulsed Wave Doppler), CW mode (Continuous Wave Doppler), Dual Doppler mode, CFI mode (Color Flow Image), Amplitude Dopper (Color Flow Angiography), TDI (Tissue Doppler Imaging), 3D Imaging, Real-time Virtual Sonography, Real-time Tissue Elastography and Shear Wave Measurement.

An ultrasound diagnostic system with the following features:

• Ultrasound transducer(s) = to generate the transmitted ultrasound energy and detect the reflected echoes O
• O Ultrasound transducer accessories (standard and optional) - to maximize functional usage of transducer(s) in various modes of operation
• O 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

The provided document is a 510(k) premarket notification for the Hitachi HI VISION Ascendus ultrasonic pulsed doppler imaging system. It establishes substantial equivalence to legally marketed predicate devices. The document does not contain acceptance criteria or a study proving the device meets acceptance criteria in the typical sense of a clinical trial evaluating performance against a predefined metric. Instead, it demonstrates substantial equivalence by comparing the device's features, intended use, and adherence to safety standards with those of predicate devices.

Here's a breakdown of the requested information based on the provided text:

1. A table of acceptance criteria and the reported device performance

The document does not specify quantitative acceptance criteria or a "reported device performance" in terms of clinical accuracy metrics (e.g., sensitivity, specificity, AUC) for the HI VISION Ascendus itself. Instead, the "performance" described is the system's array of features and its substantial equivalence to previously cleared devices.

Here’s a table summarizing the comparison to predicate devices, which serves as the basis for asserting safety and effectiveness:

The acceptance criteria for substantial equivalence are implied through the comparison: the subject device must demonstrate equivalent intended use, technological characteristics, safety, and effectiveness to its predicate devices. The document asserts that "The subject and predicate device(s) are both indicated for diagnostic ultrasound imaging and fluid flow analysis" and "The subject and predicate device(s) have the same gray scale and Doppler capabilities."

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 explicitly states: "Clinical testing: None required". This indicates that no clinical "test set" in the sense of patient data was used to prove performance against acceptance criteria for this 510(k) submission. The submission relies on non-clinical testing and substantial equivalence to predicate devices already on the market.

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)

Since no clinical testing was performed for this submission, there is no information provided regarding experts establishing ground truth for a test set.

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

As no clinical testing was performed, there is no adjudication method described for a test set.

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

The document does not mention any MRMC comparative effectiveness studies or any AI assistance. The device in question is an ultrasound imaging system, not an AI-based diagnostic tool.

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

This pertains to AI-based algorithms. The document does not describe the device as an AI-based algorithm, but rather an ultrasound imaging system. Therefore, no standalone algorithm performance study was reported.

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

Since no clinical testing data was reported as part of this submission, no type of ground truth for a test set is specified.

8. The sample size for the training set

This is relevant for machine learning models. The document does not indicate the use of such models or discuss a training set.

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

As no training set is discussed, the method for establishing its ground truth is not mentioned.

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The Hitachi Aloka Medical, Ltd UST-5310 or UST-5311 or UST-5311-TIP transducers are intended for use with the PROSOUND ALPHA 6, PROSOUND ALPHA 7 and ARIETTA70 Diagnostic Ultrasound systems by trained personnel (doctor, sonographer, etc.) for the diagnostic ultrasound evaluation during intraoperative and Intra-operative (neurosurgery) procedures.

This device is not indicated for Ophthalmic applications.

Linear Array transducer

The provided text is a 510(k) summary for a medical device (ultrasound transducers). It describes the device, its intended use, and compares it to a predicate device to establish substantial equivalence. However, it does not contain information about acceptance criteria or a study that specifically proves the device meets those criteria in the way you've outlined.

The document states:

• "No new hazards were identified with the addition of the UST-5311 transducers to the PROSOUND ALPHA7 & ARIETTA70."
• "The subject systems and the transducers have been evaluated for acoustic output, biocompatibility, electromagnetic compatibility, as well as electrical and mechanical safety, and have been found to conform to applicable medical device safety standards."
• "Clinical testing: None required"

This means the submission relies on demonstrating that the new application (using existing transducers with new ultrasound systems) does not introduce new risks and that the components (transducers and systems) individually meet safety and performance standards. It does not describe a performance study with acceptance criteria in the context of diagnostic accuracy, sensitivity, specificity, etc., which would typically be included for devices that provide diagnostic insights.

Therefore, I cannot provide the answer in the requested format because the necessary information is not present in the provided text. The document is essentially declaring that the existing transducers, when used with modified systems, are still safe and effective as previously determined, without the need for a new study to assess their diagnostic performance against specific acceptance criteria.

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