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The Laser Speckle Flowgraphy LSFG-NAVI system is intended to capture and display the blood flow distribution in the human retina in real time, and to monitor the blood flow in retinal vessels for their quantitative evaluation.

The LSFG-NAVI can visualize and measure the distribution of blood flow in the human retina in a broad area from macular to the optic nerve head. The most useful feature of the instrument is the ability to non-invasively observe varying blood flow synchronized with the heartbeat as a series of 2D blood flow maps.

The LSFG-NAVI consists of following major units:

• (1) LSFG-NAVI Camera Unit: including an emitter of a diode laser, retinal camera imaging system, imager, CCD camera (video capturing)
• (2) Personal Computer (PC): including LSGF-NAVI System Software (Measurement Software and Analysis Software
• (3) 3D-Stage Unit: The LSFG-NAVI Camera Unit is attached to the 3D-Stage unit and a patient places his/her head and face at Chin Rest and Head Rest of the 3D-Stage Unit.
• (4) Electronic Unit: including the AC Adapter and Isolation Transformer.

I am sorry, but the provided text does not contain the detailed information necessary to answer your request about acceptance criteria and the study that proves the device meets them. The document is an FDA 510(k) premarket notification letter and summary for the LSFG-NAVI device, which focuses on establishing substantial equivalence to a predicate device.

Specifically, the document states:

• "Non clinical performance data: LSFG-NAVI has been tested and met the standards for Electrical safety testing of IEC 60601-1, electromagnetic compatibility testing of IEC 60601-1-2, laser safety testing of IEC 60825-1, optical radiation levels of ISO 15004. The LSFG-NAVI software was also verified and validated according the 'Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices' issued by FDA in 2005. Risk mitigation of LSFG-NAVI software was also carried out based on ISO 14971. Furthermore, the 3 non-clinical testing were performed to establish its effectiveness and performance, namely, Validation of blood flow index measurement, validation of time variation of blood flow index measurement, and validation of perfusion map of retina."
• "It is of importance to note that the LSFG-NAVI has not been tested clinically where this statement is included in the User Manual to inform the end user."

Therefore, I cannot provide:

1. A table of acceptance criteria and reported device performance for clinical effectiveness, as no clinical study is mentioned. The non-clinical tests relate to safety and basic functional validation, not clinical performance metrics.
2. Sample sizes or data provenance for a test set proving clinical effectiveness.
3. Number or qualifications of experts, or adjudication methods for ground truth, as no clinical ground truth assessment is described.
4. Information on a multi-reader multi-case (MRMC) comparative effectiveness study or human reader improvement, as the device was not clinically tested.
5. Standalone algorithm performance, as the document focuses on the integrated device.
6. The type of ground truth used (expert consensus, pathology, outcomes data) for clinical effectiveness.
7. Sample size for the training set.
8. How the ground truth for the training set was established.

The document emphasizes that substantial equivalence was demonstrated through non-clinical testing and comparison of technological characteristics with a predicate device, and explicitly states that clinical testing was not performed.

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