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510(k) Data Aggregation
(383 days)
UST-5550-R; UST-5536-R; L43K
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:
| Test Criteria | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Grasp and Release Test with da Vinci 8 mm ProGrasp robotic arm | Grasp and release with UST-5550-R/L43K the 8mm ProGrasp robotic arm starting straight, 180° and straight and releasing 100/500 times. The L43K must complete the testing without loss of imaging performance or broken and/or loose components. | Pass – after completing 100 and 500 grasp and release movements there is no signs of physical damage and no changes in imaging performance. |
| Bend and Flexibility Test with da Vinci 8 mm ProGrasp robotic arm | Bend and Release with UST-5550-R/L43K with da Vinci S and Prograsp 8mm Forceps. All Robotic Ultrasound Probe samples must complete 500/1000 random articulations in a north, south, east and west direction without loss of imaging performance, broken and/or loose components. | Pass - after completing 500 and 1000 random articulations in a north, south, east and west direction there were no broken and/or loose components and no loss of imaging 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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