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The ISEN-Goggles with Data Viewer are used in the assessment of nystagmus by measuring, displaying, and analyzing eye movements.

This device consists of patient eye goggles ("ISEN-Goggles"), previously cleared under K152727, and a software application for data visualization and analysis ("Data Viewer").

The ISEN-Goggles have an adjustable, elastic headband, an LCD display, two green LED lights to provide optional focal points, eight infrared LED lights to provide illumination for the internal cameras, an internal SD-type memory, and buttons to operate the device's function. There is also a micro-USB port to facilitate transfer of data captured and stored in the device's SD-type memory.

The patient eye goggles are an opaque, facially worn device fitted with two small video cameras, and two wavelengths of light emitting diodes (LEDs). One set of lights provides illumination for the cameras. The other allows the user to provide a focus point for the patient, if this is desired. These signals are processed by the image processor that allows for nearsimultaneous viewing of the video images from both eyes on the attached LCD screen.

The Data Viewer software retrieves data from the goggles, displays it, performs analysis functions, and exports customizable reports. It includes a patient database.

The provided text from the 510(k) notification for the ISEN-Goggles with Data Viewer (K163270) specifically states:

"No clinical testing is included in this 510(k)."

Therefore, based on the provided document, the following points cannot be addressed as no study was presented to prove the device meets acceptance criteria.

1. A table of acceptance criteria and the reported device performance: Not available.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): Not available.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience): Not available.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not available.
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 available.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable, as no clinical testing was performed for the algorithm component.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not available.
8. The sample size for the training set: Not applicable, as no clinical testing was performed for the algorithm component.
9. How the ground truth for the training set was established: Not applicable, as no clinical testing was performed for the algorithm component.

The 510(k) submission primarily relies on non-clinical testing and substantial equivalence to a predicate device (ICS Impulse System Model 1085, K151504). The non-clinical testing included:

• Electrical safety testing: IEC 60601-1
• Electromagnetic compatibility testing: IEC 60601-1-2
• Lamp safety: IEC 62471
• FCC regulations: 47 CFR Part 15
• Battery testing: IEC 62133
• Biocompatibility testing: ISO 10993
• Hardware and software verification and validation.

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