(49 days)
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:
| Acceptance Criteria Category | Reported Device Performance |
|---|---|
| Accuracy Tests | Passed (Details not specified in the provided text). |
| Ultrasonic Emissions Tests | Passed (Details not specified in the provided text). |
| Electrical Safety Tests | Passed (Details not specified in the provided text). |
| Software Validation Tests | Passed (Details not specified in the provided text). |
Details on Clinical Study (or lack thereof):
- Sample size used for the test set and the data provenance: Not applicable, as no clinical test set was required or reported.
- 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.
- Adjudication method for the test set: Not applicable, as no clinical test set was required or reported.
- 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.
- 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.
- 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.
- The sample size for the training set: Not applicable, as no clinical test or AI model training was reported.
- How the ground truth for the training set was established: Not applicable, as no clinical test or AI model training was reported.
§ 892.1560 Ultrasonic pulsed echo imaging system.
(a)
Identification. An ultrasonic pulsed echo imaging system is a device intended to project a pulsed sound beam into body tissue to determine the depth or location of the tissue interfaces and to measure the duration of an acoustic pulse from the transmitter to the tissue interface and back to the receiver. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II (special controls). A biopsy needle guide kit intended for use with an ultrasonic pulsed echo imaging system only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.