Search Results

i-Scan Imaging Plate Scanner is intended to be used for scanning and processing digital images exposed on IP Imaging Plate in dental applications.

i-Scan Imaging Plate Scanner is a dental device that scans IP imaging plates that have been exposed in place of dental X-ray film and allows the resulting images to be displayed on a personal computer and stored for later recovery. It will be used by licensed clinicians and authorized technicians for this purpose. The device is an intraoral Plate Scanner, which is designed to read out intraoral Plates of the size 0, 1, 2 and 3. Intraoral plate scanners are state of the art since 2002 and are available in various designs from many companies around the world. The intraoral plates are put into the mouth of the patient, exposed to Xrays and then are read out with the device. The read-out-process is carried out with 651-665 nm laser. The laser beam is moved across the plate by an oscillating MEMS mirror. The laser beam stimulates the top coating of the plates, which consists of Xray sensitive material. Depending on the exposed dose, the coating emits different levels of light. These light particles are then requisitioned by an optical sensor (Photo Multiplier Tube/ PMT) and transferred into an electrical output signal is digitalized and is the data for the digital X-ray image. The data is transmitted via WIFI to a computer. Before the plate is discharged, the remaining data is erased by a LED-PCB. The user chooses which size of plate he must use and prepares the device by inserting the appropriate plate insert into the device. He then exposes the plate and then puts the plate directly into the insert by pushing it out of the light protection envelope. The user closes the light protection over and starts the read-out process. After the read out process the picture is transmitted to the connected computer, the picture can be viewed, and the IP is erased and ready to use for the next acquisition.

The provided document, a 510(k) summary for the i-Scan Imaging Plate Scanner, does not contain information about acceptance criteria or a study proving the device meets specific performance metrics in the way typically expected for an AI/ML medical device. This device is an X-ray imaging plate scanner, not an AI-powered diagnostic or assistive tool.

Therefore, many of the requested sections (e.g., sample size for test set, data provenance, number of experts, adjudication method, MRMC study, standalone performance, training set details) are not applicable to the information provided in this document.

However, I can extract information related to performance testing and comparison with a predicate device, which are relevant to the device's substantial equivalence determination.

Here's a breakdown of the available information based on your request, with "Not Applicable (N/A)" for criteria not found or relevant to this type of device:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state "acceptance criteria" for clinical performance. Instead, it compares the subject device's technical specifications to those of a predicate device (Duerr Dental AG ScanX Intraoral View). The performance testing conducted was against international standards for X-ray imaging devices.

Ask a specific question about this device

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

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.

Ask a specific question about this device

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

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.

Ask a specific question about this device