(90 days)
The OTI i+tech "i-scan" ultrasound system is 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 i+tech "i-scan" ultrasound system is a multipurpose personal-computer-based ultrasonic diagnosis system for ophthalmic applications. It includes three separate transducers which provide: 1. A Biometry X-mode for measurement of axial length, using a focused probe which can be hand-held or placed in a tonometer-holder. The operator has a choice of automatic measurement (in which the system automatically finds the critical structures in the eye and makes the measurements) or manual (in which the A-scan is presented on screen and the operator selects the points for a the measurements). 2. An A-scan mode for observation and measurement of the internal structures in the eye, with its own handheld probe. 3. A B-scan mode, usinç a hand-held motor-driven transducer, permitting visualization of internal structures in the eye. In X-mode, the system also performs IOL calculations with a choice of several algorithms.
The provided K960622 document describes the "i-scan" Ophthalmic Ultrasound System. However, it does not contain specific acceptance criteria, detailed study results, or the structured information requested in the prompt's numbered list. The document states that the device was compared to a predicate device on ten eyes and found to have "equivalent accuracy," but provides no quantifiable metrics or details about this comparison.
Therefore, many of the requested fields cannot be filled based on the provided text.
Here's a summary based on the available information, with clear indications where the information is not provided in the document:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Not Specified) | Reported Device Performance (Implied) |
|---|---|
| No specific numeric acceptance criteria (e.g., accuracy, precision thresholds) are defined in the document. The document only states that the device's accuracy should be "equivalent" to the predicate device. | "accuracy is equivalent to that of the predicate device" (Sonomed Model A2500) based on a clinical comparison of 10 eyes. Bench tests on a phantom were also conducted. |
2. Sample size used for the test set and the data provenance
- Sample Size (Test Set): 10 eyes
- Data Provenance: Clinical tests comparing the i-scan with a predicate device. The country of origin is not specified, but the submitter is in Canada. It's a prospective clinical test to compare the new device to an existing one.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not Provided. The document does not mention the number or qualifications of experts involved in establishing ground truth for the clinical comparison.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Provided. The document does not describe any adjudication method for the clinical test set.
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 an ophthalmic ultrasound system for visualization and measurement, not an AI-assisted diagnostic tool for interpretation by human readers in the context of an MRMC study. The "AI" component would be referring to the "automatic measurement" function, but the document does not describe an MRMC study related to its effectiveness in improving human reader performance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Partially Addressed - "Automatic Mode": The device has an "automatic measurement" option for IOL measurement where the "system automatically finds the critical structures in the eye and makes the measurements." Bench tests were performed on a phantom in this "automatic mode." However, details on the specific performance metrics or a comparison to human performance in standalone mode are not provided.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Not Explicitly Stated for Clinical Tests. For the clinical tests, the ground truth is implied to be the measurements obtained from the predicate device (Sonomed Model A2500), as the new device's accuracy was compared to it.
- Phantom Measurements: For bench tests, a phantom was used, implying the "truth" was the known measurements of the phantom.
8. The sample size for the training set
- Not Applicable / Not Provided. The document does not mention a "training set" in the context of machine learning or AI model development. The automatic measurement function's development process (if it involved machine learning) is not described.
9. How the ground truth for the training set was established
- Not Applicable / Not Provided. No training set is mentioned in the document.
§ 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.