(85 days)
The Ophthalmic Technologies Inc. (OTI) 3D i-scan is intended to be used as an accessory with the OTI i-scan Ophthalmic B-scan Ultrasound system (K960622) to provide a three-dimensional visualization of the interior of the globe. The device is indicated when it is desirable to have a three-dimensional depiction (perspective rendering) of the interior of the globe for diagnostic purposes.
The 3D i-scan works in conjunction with the Ophthalmic Technologies Inc. (OTI) i-scan ophthalmic B-scan system. It automatically makes a series of 201 B-scans at different angles, and then combines them to produce a perspective image, called the "3D image." Scanning is done through a closed eye-lid. The 3D i-scan consists of a computer and computer monitor, and a mechanical scan assembly which holds the B-scan ultrasonic scanner and rotates it at a speed synchronized with the lateral scanning rate of the probe. Ultrasonic gel is used as a coupling medium between the transducer and the surface of the eye-lid. The computer system assembles the multiple images of the interior of the eye, all taken at a slightly different angle, and produces a three-dimensional representation of the interior of the eye on the computer monitor screen. Software facilities are included for a number of types of image manipulation, such as slicing, changing perspective or line, and measurement of distances, areas, and volumes.
The provided text describes a 510(k) submission for the Ophthalmic Technologies 3D i-scan, a program designed to convert ultrasound scans into perspective images for ophthalmic diagnosis. However, the document does not contain detailed acceptance criteria or a comprehensive study plan with explicit performance metrics.
Here's an analysis of the information available based on your request, with significant gaps noted:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Explicitly Stated in Document) | Reported Device Performance (Explicitly Stated in Document) |
|---|---|
| None explicitly stated as quantifiable acceptance criteria. The document generally refers to "measurement accuracy" and "imaging capabilities" without defining success thresholds. | - "A test of the measurement accuracy of the system, done by outside experts, is included." (No specific results provided) |
| - "validation test of the imaging capabilities is included, as is the software validation test." (No specific results provided) | |
| Implicit Acceptance: Substantial equivalence to predicate device. | "The OTI 3D i-scan is equivalent in safety and efficacy to the legally-marketed predicate devices." |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not specified.
- Data Provenance: Not specified. It's implied that "outside experts" conducted the tests, but no geographical origin or retrospective/prospective nature of the data is mentioned.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts
- Number of Experts: Not specified. The document states "A test of the measurement accuracy of the system, done by outside experts, is included."
- Qualifications of Experts: Not specified.
4. Adjudication Method for the Test Set
- Not specified.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size
- No MRMC study is mentioned or described. The document focuses on the device's standalone capabilities and its equivalence to a predicate device.
6. If a Standalone (Algorithm-Only Without Human-in-the-Loop Performance) Was Done
- Yes, a standalone performance assessment was done. The described tests for "measurement accuracy" and "imaging capabilities" relate to the device's inherent ability to convert B-scans into 3D images and perform measurements, which are standalone functionalities. The 3D i-scan is described as a "Program to convert Ultrasound scans to perspective images," implying an algorithm-only function in generating the 3D view.
7. The Type of Ground Truth Used
- Implied Ground Truth: For the "measurement accuracy" test, the ground truth would likely be physical measurements or known geometric properties of the objects or phantoms being scanned.
- For the "imaging capabilities" validation, the ground truth would likely be established 2D ultrasound images (B-scans) or known anatomical structures, against which the generated 3D images are compared for fidelity and correct representation. The document does not explicitly state the source (e.g., pathology, clinical outcomes, or expert consensus on a different imaging modality).
8. The Sample Size for the Training Set
- Not specified. The document describes the device as almost entirely a software system but does not detail its development process, including training data.
9. How the Ground Truth for the Training Set Was Established
- Not specified. Due to the lack of information on a training set or machine learning aspects, this detail is absent. The device acts more as an image processing and visualization tool rather than a diagnostic AI that learns from labeled data in the way modern AI models do.
Summary of Device and Study:
The Ophthalmic Technologies 3D i-scan is a software accessory that works with an existing Ophthalmic B-scan Ultrasound system (OTI i-scan) to create 3D visualizations of the eye's interior. It achieves this by automatically taking a series of 201 B-scans at different angles and combining them. The 510(k) submission highlights its "measurement accuracy" and "imaging capabilities" validation through tests conducted by "outside experts." The core argument for substantial equivalence is based on its similarity to the predicate device (Life Imaging Systems Sirus, K961403) and the fact that it is primarily a software addition.
Key Gaps in Information from the Document:
The provided document is a 510(k) summary, which often provides a high-level overview. It lacks the granular detail of a full study report, specifically:
- Quantifiable acceptance criteria (e.g., "accuracy must be within X mm").
- Specific numerical results of the performance tests (accuracy values, image quality metrics).
- Details about the test cases (number, characteristics).
- Specifics about the "outside experts."
- Any mention of AI/ML, training data, or human-in-the-loop performance studies, which are common in more recent device submissions. This device predates the widespread use of deep learning in medical imaging.
§ 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.