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The OTI-scan HF module is an option for the OTI-scan (K030770), a multi-purpose personal-computer-based ultrasonic B-scan diagnostic system for ophthalmic applications.

Transducer for B-scans with OTI-Scan HF Module

The OTI-scan HF module is an ultrasonic ophthalmic B-scan system that uses the principles of sonar (pulsed ultrasound) to visualize and measure the interior of the eye with high-frequency transducers to obtain better accuracy.

The OTI-Scan HF Module did not report any clinical study to prove the device met acceptance criteria. The submission states "Not required" for clinical tests. The device's equivalency was based on non-clinical tests including accuracy tests, ultrasonic emissions tests, electrical safety tests, and software validation tests, concluding it is equivalent in safety and efficacy to a legally-marketed predicate device.

Table of Acceptance Criteria and Device Performance:

Since no clinical study was conducted or required, no specific acceptance criteria or reported device performance for clinical outcomes were provided in the document. The general acceptance criteria focused on non-clinical aspects:

Details on Clinical Study (or lack thereof):

1. Sample size used for the test set and the data provenance: Not applicable, as no clinical test set was required or reported.
2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable, as no clinical test set was required or reported.
3. Adjudication method for the test set: Not applicable, as no clinical test set was required or reported.
4. 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, as no clinical study involving human readers or AI assistance was conducted or reported.
5. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable, as the device is an ultrasonic B-scan system and not an AI algorithm. Its performance is tied to its physical and software functionality rather than an AI's standalone diagnostic capability.
6. The type of ground truth used: For the non-clinical tests, the ground truth would have been established by engineering specifications, regulatory standards, and established testing protocols for ultrasonic devices and software.
7. The sample size for the training set: Not applicable, as no clinical test or AI model training was reported.
8. How the ground truth for the training set was established: Not applicable, as no clinical test or AI model training was reported.

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