Search Results

The SightSaver™ is an evoked response photic stimulator that is used to apply a visible light stimulus to a patient's eyes for use in evoked response measurements or for electroencephalogram (EEG) activation.

The SightSaver™ Visual Stimulator is designed to be used in hospital and clinical settings by trained medical personnel and is for prescription use only.

The SightSaver™ Visual Stimulator is used to expose the eyes to light in order to elicit a physiological response. LEDs inside the device flash light at the eye. The SightSaver™ Visual Stimulator is disposable and made with specifically shaped self-sticking adhesive foam padding which conforms to the periocular region of the patient's face.

The SightSaver™ is designed to be connected to a triggering and acquisition system which records, analyzes, or processes the patient's responses.

The triggering and acquisition system is not included as part of the 510(k).

Here's a breakdown of the acceptance criteria and study information based on the provided text, focusing on what is explicitly stated:

1. Table of Acceptance Criteria and Reported Device Performance

The provided text does not explicitly detail a table of acceptance criteria with corresponding device performance for the SightSaver™ Visual Stimulator. The submission focuses on demonstrating substantial equivalence to predicate devices, rather than meeting specific performance metrics against predefined criteria.

However, it does implicitly suggest one key performance/safety criterion that the device meets or exceeds:

The document states: "The SightSaver™ Visual Stimulator has been tested to higher safety performance standards compared with the predicate devices but is the same as the predicate devices in: Intended use, Overall design and form factor, Technological characteristics." This implies that while specific performance metrics aren't listed, the device met or exceeded relevant safety and performance standards, notably ISO 15004-2, which the predicates did not.

2. Sample size used for the test set and the data provenance

The provided 510(k) summary does not contain any information about a test set sample size or data provenance (e.g., country of origin, retrospective/prospective) for a clinical study evaluating the SightSaver™ Visual Stimulator's performance. The submission primarily relies on a comparison to predicate devices and adherence to standards.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

As there is no mention of a test set or clinical study in the provided text, there is no information regarding the number or qualifications of experts used to establish ground truth.

4. Adjudication method for the test set

Similarly, due to the absence of a described test set or clinical study, there is no information about an adjudication method.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and if so, what was the effect size of how much human readers improve with AI vs without AI assistance

The SightSaver™ Visual Stimulator is described as an "evoked response photic stimulator" and not an AI-powered diagnostic device designed to assist human readers. Therefore, no MRMC comparative effectiveness study involving AI assistance for human readers was done or is relevant to this device.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done

The device is a hardware stimulator and not an algorithm. Therefore, no standalone algorithm performance study was done or is relevant. The device functions by exposing eyes to light for evoked response measurements, and its performance would be assessed through its electrical and optical characteristics, not as a standalone diagnostic algorithm.

7. The type of ground truth used

Since no clinical study evaluating diagnostic accuracy or a similar measure is described, no specific type of ground truth (e.g., expert consensus, pathology, outcomes data) for such a study is mentioned. The "ground truth" for the device's function is its ability to produce a visible light stimulus according to specifications for evoked response measurements or EEG activation.

8. The sample size for the training set

The provided text does not contain any information about a training set since the device is a hardware stimulator and not a machine learning algorithm.

9. How the ground truth for the training set was established

As there is no mention of a training set, there is no information on how ground truth for a training set was established.

Ask a specific question about this device