(18 days)
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:
- A table of acceptance criteria and reported device performance.
- Sample sizes for test sets or data provenance.
- Number and qualifications of experts for ground truth.
- Adjudication method.
- MRMC comparative effectiveness study results or effect size.
- Standalone algorithm performance.
- Type of ground truth used.
- Sample size for the training set.
- 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.
§ 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.