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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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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.

• 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.

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