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The Enfant is a non-invasive medical device to screen, without dilation or sedation, for visual disorders in infants and pre-school children. The system uses Visual Evoked potentials to provide information about the visual pathway function and about optical or neural abnormalities related to vision.

Horizontal Contrast Photopic stimuli are presented to the patient on a computer monitor at various numbers of elements in separately stimulated fields. The fields are varied in spatial size over a number of cycles. The signals are analyzed by the software using algorithms for spatial filtering and artifact rejection. Data may be presented in number form and on a graph. The device also adds some attention features specifically for children. In particular, a cartoon is presented prior to the VEP pattern. During the Cartoon presentation no data is collected. Age appropriate music is also presented to patient as well. The music is only intended as an attention facilitator.

The Enfant™ System is a non-invasive medical device designed to screen for visual disorders in infants and pre-school children without requiring dilation or sedation. It uses Visual Evoked Potentials (VEP) to assess visual pathway function and identify optical or neural abnormalities related to vision.

Here's an analysis of its acceptance criteria and the supporting study:

1. Acceptance Criteria and Reported Device Performance

The provided document does not explicitly state pre-defined acceptance criteria in terms of specific performance metrics (like minimum sensitivity, specificity, etc.) for marketing authorization. However, the clinical performance study itself establishes the device's measured effectiveness, which implicitly served as the basis for substantial equivalence with predicate devices.

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size for Test Set: 122 children
• Ages: 6 months to 5 years
• Data Provenance: The study was an investigational new drug (IND) approved study conducted in children. The specific country of origin is not explicitly stated, but Diopsys, Inc. is located in Pine Brook, NJ, USA, and the FDA letter indicates a US regulatory context. The study design implies prospective data collection as it involved intentionally testing children with the Enfant™ system and comparing results masked to a gold standard.

3. Number of Experts Used to Establish Ground Truth and Qualifications

• Number of Experts: Not explicitly stated as a number of individual experts. The "results of standard ophthalmlogic examination" was used as the reference. This implies multiple ophthalmologists were involved in the standard clinical diagnoses.
• Qualifications of Experts: The ground truth was established by "standard ophthalmologic examination." For verbal patients, clinical amblyopia was defined by an interocular difference of two or more lines in best-corrected visual acuity. For preverbal children, ground truth was based on the clinician's decision to treat with occlusion or atropine penalization, or the presence of any other typical eye pathology. This indicates that board-certified ophthalmologists were the experts, providing clinical diagnoses typical of their practice.

4. Adjudication Method for the Test Set

The study describes "comparing test results in masked fashion to results of standard ophthalmologic examination." This implies that the Enfant™ system's results were interpreted independently (masked) from the ophthalmologic examination results. A "statistical program" then analyzed VEP differences and assigned a "pass" or "fail" for each child. While not explicitly specifying an adjudication method for conflicting results between experts, the structure suggests the "standard ophthalmologic examination" served as the definitive ground truth against which the device's output was compared. No specific 2+1 or 3+1 type of expert adjudication is mentioned for establishing the ground truth itself; rather, the clinical diagnosis by an ophthalmologist was the gold standard.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No, a multi-reader, multi-case (MRMC) comparative effectiveness study was not performed as described in this document. The study focused on the standalone performance of the Enfant™ system compared to clinical diagnosis, rather than comparing human readers with and without AI assistance.

6. Standalone Performance Study

Yes, a standalone performance study was performed. The study aimed to evaluate the Enfant™ system's ability to screen for visual disorders by comparing its "pass" or "fail" results directly against the gold standard of "standard ophthalmologic examination." The reported sensitivity, specificity, PPV, and NPV are all measures of this standalone algorithm's performance.

7. Type of Ground Truth Used

The type of ground truth used was expert clinical diagnosis/examination (ophthalmology).

• For verbal patients: Clinical amblyopia was defined as an interocular difference of two or more lines in best-corrected visual acuity.
• For preverbal children: Clinical amblyopia was defined by the clinician's decision to treat with occlusion or atropine penalization, or the presence of any other typical eye pathology.

8. Sample Size for the Training Set

The document does not provide information regarding a distinct training set sample size. The study described is a clinical validation study, likely assessing the performance of a system that was developed and potentially trained on other data not detailed here.

9. How the Ground Truth for the Training Set Was Established

As no information is provided about a specific training set or its sample size, an explanation of how its ground truth was established cannot be given based on the provided text.

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