(267 days)
The EYEPORT is indicated for the treatment of poor accommodative and vergence facility, convergence insufficiency and large accommodative lag (in non-presbyopic subjects).
Plastic bar with alternating red and blue lights. Individual light sources turn on and off to create visual stimuli.
The provided 510(k) summary for the EYEPORT Vision Training System (K051684) does not contain any information about acceptance criteria or a study that proves the device meets such criteria.
The document primarily focuses on establishing substantial equivalence to predicate devices based on design and intended use, rather than presenting performance data from clinical or technical studies.
Therefore, for your request, the following information cannot be extracted from the provided text:
- A table of acceptance criteria and the reported device performance: Not available.
- Sample sized used for the test set and the data provenance: Not available.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not available.
- Adjudication method for the test set: Not available.
- 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. This device is a training system, not an AI diagnostic tool involving human readers.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not available.
- The type of ground truth used: Not available.
- The sample size for the training set: Not available.
- How the ground truth for the training set was established: Not available.
The document is a 510(k) summary for a Class I device (Fixation Device), which typically requires less robust clinical evidence for clearance compared to higher-risk devices. The submission focuses on demonstrating that the device is substantially equivalent to legally marketed predicate devices (Gruss Electro Wand and Vis-Flex) based on indications for use, target population, design, anatomical sites, fundamental technology, energy source, and where used. The key differences highlighted are minor (length of the light bar and color of the light sources, with the EYEPORT's red and blue lights utilizing chromatic aberration) and are presented as design choices rather than requiring extensive performance validation.
§ 886.1290 Fixation device.
(a)
Identification. A fixation device is an AC-powered device intended for use as a fixation target for the patient during ophthalmological examination. The patient directs his or her gaze so that the visual image of the object falls on the fovea centralis (the center of the macular retina of the eye.)(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 886.9.