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The Eye Cubed V4 is indicated for use in ophthalmic imaging when the following conditions are present or suspected:

• Cataracts
• Retinal Detachments (a separation of the retina from the middle coat of the eyeball)
• Orbital Lesions
• Tumors
• Foreign bodies
• Inflammation
• Vascular Irregularities

Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
Ophthalmic: A, B, M, PWD, CWD, Colour Doppler, Amplitude Doppler, Colour Velocity Imaging, Combined (specify), Other (specify)

Specific transducer intended uses:
Ophthalmic 40 MHz Anterior Segment B-scan transducer: Anterior 40 MHz B-scan imaging of the eye
Ophthalmic 10 MHz Posterior Segment B-scan transducer: Posterior 10 MHz B-scan imaging of the eye
Ophthalmic 10 MHz Biometric A-scan transducer: 10 MHz Biometric A-scan imaging of the eye
Ophthalmic 8 MHz Diagnostic A-scan transducer: 8 MHz Diagnostic A-scan imaging of the eye
Ophthalmic 20 MHz Anterior Segment B-scan transducer: Anterior 20 MHz B-scan imaging of the eye

Not Found

The provided text is a 510(k) premarket notification letter from the FDA for a diagnostic ultrasound device, the "Eye Cubed Version 4," and its various transducers. It primarily focuses on the device's substantial equivalence to predicate devices and its intended uses.

Crucially, the document does not contain any information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, expert qualifications, adjudication methods, or comparative effectiveness studies. It is a regulatory approval letter, not a technical performance report.

Therefore, I cannot fulfill the request to provide:

1. A table of acceptance criteria and reported device performance.
2. Sample sizes for test sets or data provenance.
3. Number and qualifications of experts for ground truth.
4. Adjudication method.
5. MRMC comparative effectiveness study results or effect size.
6. Standalone algorithm performance.
7. Type of ground truth used.
8. Sample size for the training set.
9. How ground truth for the training set was established.

The document only states the device's intended uses for ophthalmic imaging when certain conditions are present or suspected: cataracts, retinal detachments, orbital lesions, tumors, foreign bodies, inflammation, and vascular irregularities. It also lists the specific transducers and their intended uses (e.g., "Anterior 40 MHz B-scan imaging of the eye").

Without additional information, these specific points cannot be addressed.

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Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Posterior 10MHz B-scan Imaging of the Eye; 10MHz Biometric A-scan Imaging of the Eye; 8MHz Diagnostic A-scan Imaging of the Eye; Anterior 20MHz B-scan Imaging of the Eye.

Not Found

The provided text contains an FDA 510(k) clearance letter for the Ellex I SYSTEM-ABD Ver.4.0 (Eye Cubed V4) ultrasonic pulsed echo imaging system and its associated transducers. This document describes the intended use and classification of the device, confirming its substantial equivalence to a legally marketed predicate device.

However, the letter does not contain any information regarding specific acceptance criteria, clinical studies, device performance metrics, sample sizes, ground truth establishment, or expert qualifications as requested in your prompt. The FDA 510(k) clearance process primarily focuses on demonstrating substantial equivalence to a predicate device, and the provided document is a notification of that clearance. It does not typically detail the specific testing and performance validation results that would be found in a comprehensive clinical study report.

Therefore, I cannot fulfill your request with the information provided. To generate the requested table and answer the study-specific questions, I would need a detailed clinical study report or a summary of performance data, which is not present in this 510(k) clearance letter.

Ask a specific question about this device