Search Results

The ArcScan Insight 100 is indicated for use in adults to measure dimensions of the human eye. To provide tomographic, high-resolution ultrasound images of the eye. It is also designed to measure these tissues and structures, such as anterior chamber depth, angle-to-angle width and sulcus-to-sulcus width. Measurements can be made of the cornea and its individual layers including the epithelium, stroma, and surgically induced surfaces. Measurement also may be made of pathological structures such as solid masses or cysts and it is therefore useful in evaluation and/or planning of refractive surgery and evaluation of pathologies of the anterior segment such as trauma, tumors, cysts, glaucoma and hypotony.

ArcScan Insight 100 is a precision ultrasound device for imaging and biometry of the eye. It uses a 20-60 MHz transducer that scans the eye in an arc whose curvature approximates the anterior ocular surfaces. Specifically, the ArcScan Insight 100 can measure the thickness of the cornea and its individual layers, the epithelium, stroma, and surgically induced surfaces. Measurements can also be made of the anatomic structures comprising the anterior of the eye such as anterior chamber depth, angle-to-angle width, and sulcus-to-sulcus width. Measurements can be made of pathologic structures such as solid masses and cysts.

Here's a breakdown of the acceptance criteria and study information for the ArcScan Insight 100 device, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

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

The provided document does not specify the sample size used for the test set or the data provenance (e.g., country of origin, retrospective/prospective). It only states that the device's measurement performance capability was "demonstrated to meet specifications."

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

The document does not provide any information regarding the number of experts used or their qualifications for establishing ground truth for the test set.

4. Adjudication Method for the Test Set:

The document does not specify any adjudication method (e.g., 2+1, 3+1, none) for the test set.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

The document does not indicate that a multi-reader multi-case (MRMC) comparative effectiveness study was done, nor does it mention any effect size for human readers improving with or without AI assistance. The device appears to be a diagnostic imaging and measurement device, not an AI-assisted diagnostic tool in the sense of comparing human reader performance.

6. Standalone (Algorithm Only) Performance Study:

The document describes the performance of the device itself in its ability to take measurements and produce images. This implies a standalone evaluation of the algorithm's performance in generating these outputs against its specifications. However, it doesn't explicitly frame it as an "algorithm-only" study in the modern sense of comparing it against human performance or other algorithms. It verifies that the device, as an integrated system, performs as specified.

7. Type of Ground Truth Used:

The document does not explicitly state the type of ground truth used. Given the nature of the device (precision measurement of ocular structures), the ground truth for "meeting specifications" would likely involve:

• Physical Phantoms or Standards: For validating axial and lateral resolution, and the accuracy of physical measurements (thickness, lateral dimensions).
• Known Anatomical Dimensions: For validating measurements against established anatomical norms or surgically confirmed dimensions, if human subjects were used.

8. Sample Size for the Training Set:

The document does not mention a training set sample size. This is consistent with the device being a precision ultrasound measurement system rather than a machine learning or AI-driven diagnostic algorithm that typically relies on extensive training data.

9. How the Ground Truth for the Training Set Was Established:

As no training set is mentioned in the context of machine learning or AI, the document does not provide information on how ground truth for a training set was established. The "ground truth" implicitly referred to is the accuracy of the device's measurements against objective physical standards or precise reference measurements.

Ask a specific question about this device