(99 days)
The OTI-Scan 3000 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 measurement of the axial length for determination of IOL power.
The OTI-Scan 3000 is an Ultrasonic ophthalmic A-Scan 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.
This document presents information about the OTI-Scan 3000, an ultrasonic ophthalmic A-Scan and B-Scan system. However, it does not contain explicit acceptance criteria or a detailed study description proving that the device meets specific performance criteria. The information provided primarily focuses on regulatory approval (510(k) summary) rather than a performance study.
Here's an analysis of the provided text with respect to your questions:
1. Table of Acceptance Criteria and Reported Device Performance
Based solely on the provided text, explicit quantitative acceptance criteria for device performance (e.g., accuracy thresholds, sensitivity, specificity) are not present. The document mentions "accuracy tests" were performed, but does not provide the results of these tests or the benchmarks they were measured against.
| Acceptance Criteria | Reported Device Performance |
|---|---|
| (No explicit quantitative acceptance criteria are provided in the document) | "Accuracy tests" were performed. No specific performance metrics or outcomes are reported in the furnished text. |
| Ultrasonic emissions teat compliance | Passed (implied by 510(k) clearance) |
| Electrical safety test compliance | Passed (implied by 510(k) clearance) |
| Software validation test compliance | Passed (implied by 510(k) clearance) |
2. Sample size used for the test set and the data provenance
The document mentions "Bench-top testing has been performed on the OTI-Scan 3000 including accuracy tests, ultrasonic emissions teats, electrical safety tests and software validation tests."
- Sample Size for Test Set: Not specified. The nature of "bench-top testing" often implies testing performed on the device itself or phantoms, rather than a clinical patient dataset.
- Data Provenance (e.g., country of origin of the data, retrospective or prospective): Not specified. Since this refers to bench-top testing, it's not a clinical data provenance.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not provided. Given that the listed tests are primarily technical bench-top tests (accuracy, emissions, electrical safety, software validation), the concept of "ground truth" established by clinical experts for a test set of images/data as one might find in an AI study for diagnostic performance is not applicable here. These tests would typically use known physical standards or calibrated equipment for "ground truth".
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
This information is not provided. Adjudication methods are typically used in studies involving human interpretation of clinical data, which is not described here.
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
No, a multi-reader multi-case (MRMC) comparative effectiveness study is not mentioned or implied in the provided text. This document describes the device itself and its 510(k) clearance, not research on AI assistance or human reader improvement.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
The OTI-Scan 3000 is an ultrasonic imaging system, not an AI algorithm. Therefore, the concept of a "standalone (algorithm only)" study is not applicable in this context. The device's performance is intrinsically tied to its hardware and integrated software for acquiring and processing ultrasound signals.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
For the bench-top tests described (accuracy, emissions, electrical safety, software validation), the "ground truth" would likely be:
- Accuracy tests: Calibrated physical standards or phantoms with known dimensions/properties.
- Ultrasonic emissions tests: Regulatory limits and measurements using specialized equipment.
- Electrical safety tests: Electrical safety standards and measurement equipment.
- Software validation tests: Software requirements specifications and expected outputs for given inputs.
Clinical "ground truth" (such as expert consensus or pathology) is not relevant for the tests described.
8. The sample size for the training set
This is not applicable. The OTI-Scan 3000 is a medical device, not an AI system that undergoes "training" in the machine learning sense. Its functionality is based on established physics principles of ultrasound.
9. How the ground truth for the training set was established
This is not applicable as the device is not an AI system.
§ 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.