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The OTI-scan ultrasound system is a multi-purpose personal-computer-based ultrasonic diagnosis system for ophthalmic applications, intended to both visualize the interior of the eye by means of ultrasound and to make measurements inside the eye, including the measurement of axial length for determination of IOL power.

The OTI-scan is a compact Ultrasonic ophthalmic A-scan system and B-scan system that uses the principles of sonar (pulsed ultrasound) to measure the axial length of the eyes and to visualize the interior of the eye.

Here's a breakdown of the acceptance criteria and the study information based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size Used for the Test Set and Data Provenance

The document states:

• "Clinical tests: Not required."
• "Non-clinical tests: The A-B scan has had accuracy tests, ultrasonic emissions tests, electrical safety tests, and software validation tests."

Based on this, no clinical test set was used. The device's performance was established through non-clinical (laboratory/engineering) testing and comparison to an existing predicate device. Therefore, there's no information on sample size or data provenance (country of origin, retrospective/prospective) for a clinical test set.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

Since no clinical test set was required or performed, there's no information on experts used to establish ground truth. The acceptance was based on non-clinical testing and substantial equivalence to a predicate device.

4. Adjudication Method for the Test Set

As no clinical test set was required, there is no adjudication method described.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. The document explicitly states "Clinical tests: Not required."

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done

This refers to the device's inherent technical performance. The non-clinical tests (accuracy, ultrasonic emissions, electrical safety, and software validation) would fall under assessing the device's standalone performance. However, there's no detailed quantitative data provided from these tests, only that they were performed.

7. The Type of Ground Truth Used

For the non-clinical tests, the "ground truth" would likely be established by:

• Reference standards/phantoms for accuracy testing (e.g., measuring known distances or properties).
• Physics-based measurements for ultrasonic emissions and electrical safety (conformance to established standards).
• Software specifications and formal verification/validation procedures for software validation.

Since no clinical study was performed, there is no clinical ground truth (like expert consensus, pathology, or outcomes data) established.

8. The Sample Size for the Training Set

The document does not describe any training set because the submission is a Special 510(k) for a device that is functionally equivalent to an already marketed device (OTI i-scan, K960622). Machine learning or AI model training data is not mentioned or relevant to this submission. The device is an ultrasonic hardware and software system, not an AI diagnostic algorithm in the modern sense.

9. How the Ground Truth for the Training Set was Established

As no training set is mentioned or relevant to this type of device submission, this information is not applicable.

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