(69 days)
The Hitachi Aloka Medical. Ltd. UST-5310 / UST-5311 transducers for use with the PROSOUND ALPHA6 Diagnostic Citrasound scanner are intended for use by trained personnel (doctor, sonographer, etc.) for the diagnostic ultrassund evaluation during Intra-operative and Intra-operative (neurosurgery) procedures.
The device is not indicated for Ophthalmic applications.
Linear Array transducer
The provided text describes a 510(k) premarket notification for diagnostic ultrasound transducers (Hitachi Aloka Medical, Ltd. UST-5310 and UST-5311). This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than conducting extensive clinical studies to prove novel performance benefits.
Here's an analysis of the acceptance criteria and study information based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not present explicit acceptance criteria in terms of specific performance metrics (e.g., sensitivity, specificity, accuracy) that the device must meet, as would be common for AI/ML-based diagnostic devices. Instead, the acceptance criteria for this 510(k) submission are based on demonstrating substantial equivalence to existing predicate devices.
The "performance" of the device is assessed by its technical comparability and safety.
| Acceptance Criteria Category | Reported Device Performance (Summary from 510(k)) |
|---|---|
| Substantial Equivalence to Predicate Device | The UST-5310 and UST-5311 are technically comparable and substantially equivalent to the currently marketed UST-534 & UST-536 Intraoperative transducers. Both are track 3 systems with the same fundamental and scientific technologies. |
| Safety | - Evaluated for acoustic output, biocompatibility, cleaning & disinfection effectiveness, electromagnetic compatibility, electrical, and mechanical safety. |
- Found to conform to applicable medical device safety standards.
- Biocompatibility testing conducted in accordance with ISO 10993-1.
- Acoustic level below Track 3 FDA limits. |
| Manufacturing | Manufactured in accordance with FDA 21 CFR 820 Quality System Regulations. |
| Technology | Same essential technology for imaging, Doppler functions, and signal processing as predicate devices. |
| Modes of Operation | Same modes of operation (B, M, PWD, CD, PowerFlow, and combinations). |
| Intended Use/Indications | Indicated for diagnostic ultrasound imaging during Intra-operative and Intra-operative (neurosurgery) procedures, similar to predicate but with a difference in sterilization methodology (single-use sterile vs. reusable). |
| Sterilization | Designed to be sterilized via EtO. The subject device is supplied sterile, while the predicate is supplied non-sterile with instructions for cleaning, disinfection, and sterilization. |
| Materials | New material: Ethylene Vinyl Acetate, but all other materials previously cleared by FDA. |
2. Sample size used for the test set and the data provenance
No clinical test set or data provenance is mentioned. The submission explicitly states "Clinical testing: None required." This indicates that the regulatory pathway for these transducers did not require a clinical study with a test set of patient data, as the device is deemed substantially equivalent based on technical specifications and non-clinical testing.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable, as no clinical testing with a test set was required or performed for this submission.
4. Adjudication method for the test set
Not applicable, as no clinical testing with a test set was required or performed.
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 device is a diagnostic ultrasound transducer, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is a hardware component (ultrasound transducer), not a standalone algorithm.
7. The type of ground truth used
Not applicable in the context of clinical performance. The "ground truth" for this submission revolves around technical and safety standards compliance and substantial equivalence to a legally marketed predicate device. This is demonstrated through non-clinical testing (acoustic output, biocompatibility, electrical safety, etc.) as opposed to clinical outcomes or expert consensus on image interpretation.
8. The sample size for the training set
Not applicable. This is a hardware device (ultrasound transducer), not an AI/ML system requiring a training set.
9. How the ground truth for the training set was established
Not applicable. No training set or associated ground truth establishment is mentioned or relevant for this type of device.
§ 892.1570 Diagnostic ultrasonic transducer.
(a)
Identification. A diagnostic ultrasonic transducer is a device made of a piezoelectric material that converts electrical signals into acoustic signals and acoustic signals into electrical signals and intended for use in diagnostic ultrasonic medical devices. Accessories of this generic type of device may include transmission media for acoustically coupling the transducer to the body surface, such as acoustic gel, paste, or a flexible fluid container.(b)
Classification. Class II.