Search Results

The iScreen Vision Screener 3000 is a vision screening tool intended to capture and record red reflex images which contain information on ocular status to aid in eye examination.

The iScreen Vision Screener 3000 is intended for use solely for a pediatric population by trained professionals.

Device Description

The device consists of an illumination source and camera to record and measure the retinal reflex and ocular status for later analysis by an appropriate expert. Certain features of the device have been modified from the predicate design to enhance ease of use and in response to user feedback, e.g., the patient positioning system has been modifications include the addition of a second flash, a smaller form factor, and integration of the previously separate PC screen and keyboard into the device casing.

AI/ML Overview

Based on the provided text, the iScreen Vision Screener 3000 is a modification of a previously cleared device (iScreen Vision Screener, K010315). The submission is a Special 510(k), which typically means that the modifications do not raise new or different questions of safety or effectiveness. Therefore, the "acceptance criteria" and "study" described are primarily focused on demonstrating that the modifications do not negatively impact the device's safety and effectiveness compared to the predicate, rather than establishing de novo performance metrics with a new clinical study.

Here's the breakdown of the information requested, based on the provided text:

1. A table of acceptance criteria and the reported device performance

The provided text does not specify quantitative acceptance criteria or a direct performance study comparing the iScreen Vision Screener 3000's diagnostic accuracy or other performance metrics against a gold standard.

Instead, the documentation focuses on demonstrating that the modifications (e.g., addition of a second flash, smaller form factor, integrated PC screen) do not adversely affect safety or effectiveness. The performance data section states:

Criterion Type	Details
Risk Assessment	Acceptance Criteria: Residual risks of the device (after modifications) are deemed acceptable in relation to device benefits.
Reported Performance: A Failure Mode and Effects Analysis (FMEA) was used, and residual risks were found acceptable.
Design Verification	Acceptance Criteria: Device design controls are met, and verification activities confirm the modified design functions as intended.
Reported Performance: Design verification activities were performed.
Design Validation	Acceptance Criteria: Device design controls are met, and validation activities confirm the modified device meets user needs and intended use.
Reported Performance: Design validation activities were performed.
Substantial Equiv.	Acceptance Criteria: The modified device has the "same intended use and principle of operation" as the predicate, and modifications "do not raise new or different questions of safety or effectiveness."
Reported Performance: This was affirmed, leading to a Substantial Equivalence determination.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The provided documentation does not mention a specific "test set" or clinical study with a sample size for evaluating the diagnostic performance of the iScreen Vision Screener 3000. For a Special 510(k) for device modifications, clinical data is often not required if engineering and bench testing can demonstrate that the changes do not affect the device's fundamental performance. The focus here is on design verification and validation activities, which typically involve engineering tests and user evaluations rather than large-scale clinical trials.

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 applicable, as a clinical "test set" with ground truth established by experts is not described in the provided special 510(k) summary.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable, as a clinical "test set" is not described.

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 applicable. The iScreen Vision Screener 3000 is an "Ophthalmic Camera" that "capture[s] and record[s] red reflex images which contain information on ocular status to aid in eye examination." It is not described as an AI-powered diagnostic device, and therefore, an MRMC study comparing human readers with and without AI assistance would not be relevant to this submission. The device is intended to be used by "trained professionals" who then analyze the captured images.

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

Not applicable. The device's description indicates it captures images for later analysis by an appropriate expert, implying human-in-the-loop performance. It is not presented as an AI algorithm that provides a standalone diagnosis.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

Not applicable, as a clinical performance study requiring ground truth is not described in the provided text.

8. The sample size for the training set

Not applicable. The device is not described as an AI/ML algorithm that would require a "training set." It is an imaging device.

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

Not applicable, as a "training set" for an AI/ML algorithm is not relevant to this device description.

Ask a Question

Ask a specific question about this device

K Number

K010315

Device Name

ISCREEN VISION SCREENER