(89 days)
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.
| Metric | Reported Device Performance (Enfant™) |
|---|---|
| Sensitivity | 0.973 |
| Specificity | 0.808 |
| Positive Predictive Value | 0.706 |
| Negative Predictive Value | 0.984 |
| Test Completion Rate | 94% |
| Average Time to Complete Testing (both eyes) | < 10 minutes |
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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Summary of Safety and Effectiveness 510(k) K
1.0 Basic Information
Submitter
Name: Diopsys, Inc. Address: 16 Chapin Road Suite 911 P.O. Box 672 Pine Brook, NJ 07058
Contact Person:
Joseph Fontanetta Phone: 973-244-0622 973 244 0670 Fax: Email: JFontanetta@diopsys.com
Date Prepared: December 14 2004
Device Name: Enfant™M
Classification Name: Electroencephalograph, Evoked Response Classification Name: Electroencephalograph , Evoked Potential (VEP) System Regulatory Class: II Panels: Neurology
Number: 882.1400 Electroencephalograph
Electroencephalograph (EEG) Signal Spectrum Analyzer 882.1420 882.1890 Stimulator, Photic, Evoked Response
Product codes: GWE, GWQ,GWL
1.1 Identification of Legally Marked Device
The Enfant™ System is substantially equivalent to the Maculoscope and the Espion System(K863956) both manufactured by Doran (aka Diagnosys LLC) and the VERIS system(K983983) manufactured by Electro-Diagnostic Imaging, Inc. These are hardware and software products. The Enfant™ device is substantially equivalent to the predicate devices with regard to device features and specifications, as well as intended use. All devices are visual evoked response test systems with similar operating requirements that are based on standard clinical procedures. Devices consist of hardware and software to provide a photopic stimulus and EEG capture and analysis of the evoked response. Diopsys purchased the assets of NEUROSCIENTIFIC CORP. Registration number 2434082. The EEG amplifier is an updated version of the amplifier used on the Venus System (K880773). The updates include modification for EMC and obsolete parts.
1.2 Device Description
Horizontal Contrast Photopic stimuli are presented to the patient on a computer monitor at various numbers of elements in separately stimulated fields. The fields
Diopsys Inc. 16 Chapin Road Suite 911, P.O. Box 672 Pine Brook, NJ 07058
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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.
1.3 Intended Use
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.
| Feature | Enfant | RETIscanK023525 | VerisK983983 | DoranMaculoseopeK863956 | VenusSystemK880773 |
|---|---|---|---|---|---|
| Generate photic signalsand measure and displaythe electrical responsegenerated by the visualnervous system | YES | YES | YES | YES | Yes |
| Electrophysiological TestUnit for quantifying theresponse, measuring aparameter (VEP) relatedto the response | YES | YES | YES | YES | Yes |
| Intended PopulationsPatients with suspectedophthalmic conditions | YES | YES | YES | YES | Yes |
| Intended Use | YES | YES | YES | YES | Yes -ResearchUse Only |
| EnvironmentHospitals, clinics andphysician officies | YES | YES | YES | YES | Yes |
| Physiological DataCollected (VEP) | YES | YES | YES | YES | YES |
1.4 Comparison to Cleared Devices
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1.5 Performance Data
The Enfant system has been tested and reviewed to the following i standards listed below.
- EN 60601-1:2003 and CAN/CSA C22.2 No. 601.1 General Requirements 1.5.1 for Safetv.
- 101 Safety.
IEC 60601-1-2 :2001 Collateral Standard: Electromagnetic Compatibility 1.5.2 - IEC 60001-1-2 12001 Conaoleequipment incorporating programmable 1.5.3 electronic system
- IEC 60601-2-26:2002 Particular Requirements for Safety of 1.5.4 Electroencephalographs
- Electrochecphalographs
IEC 60601-2-40:1998 Particular Requirements for Safety -Specifications 1.5.5 for Electromyographs and Evoked Response Equipment.
1.6 Clinical performance data and support of effectiveness
1.0 Chilical performance and firmed the effectiveness of the Enfant system in An IND apploved childer stady common children's response to VEP. The study has been accepted for publication by the Journal of American Association for Pediatric accepted for publication by the ocument of the expected to be in the February 2005 issue.
Methods: A new, "child-friendly" visual evoked potential (VEP) system (Enfant™ Methous. A new, "child Thenary" "ise in screening. 122 children, aged 6 months to 5 Diopsys, me., I me Droom in , results in masked fashion to results of standard
years, were tested, comparing test results in masked fashion to results of standard years, were tested, comparing test rostical program analyzed VEP differences between opinnamologio enamine a "pass" or "fail" for each child. For verbal patients, clinical amblyopia was defined as an interocular difference of two or more lines in best corrected amblyopla was defined as an mients, clinical amblyopia was defined by the clinician's vious dout). It is the occlusion or atropine penalization. Preverbal children with decision to treat with occrasion of anyopical eye pathology were also considered clinical positives.
positives.
Results: The test was completed by 94% of the test sample, each child requiring an Results. The test was to complete testing of both eyes. The sensitivity was 0.973, specificity 0.808, positive predictive value 0.706, and the negative predictive value 0.984
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Image /page/3/Picture/1 description: The image shows the seal for the Department of Health & Human Services - USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract image of an eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR 16 2005
Mr. Joseph Fontanetta President Diopsys, Inc. 16 Chapin Road, Suite 911 P.O. Box 672 Pine Brook, New Jersey 07058
Re: K043491
Trade/Device Name: Enfant™ Regulation Number: 21 CFR 882.1890 Regulation Name: Evoked response photic stimulator Regulatory Class: II Product Code: GWE Dated: February 17, 2005 Received: February 18, 2005
Dear Mr. Fontanetta:
We have reviewed your Section 510(k) premarket notification of intent to market the device we have reviewed your Section 910(t) premained is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encrosure) to regard management date of the Medical Device Amendments, or to commerce prior to May 28, 1770, the enactified in accordance with the Federal Food. Drug. devices that have been recuire approval of a premarket approval application (PMA). and Cosmetic Act (Act) that do not require approvisions of the general controls provisions of the Act. The You may, therefore, market the act include requirements for annual registration, listing of general controls provisions of the tice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it If your device is classified (500 above) ins. Existing major regulations affecting your device can thay be subject to such additions, Title 21, Parts 800 to 898. In addition, FIDA may be found interest announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination docs not mean r lease be advised that i Dr Brissian that your device complies with other requirements of the Act that I DA has made a cound regulations administered by other Federal agencies. You must of any I cach statutes and regaranents, including, but not limited to: registration and listing (21 Comply with an the 11et 51e 31equirements)
CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set CITY art 607), adomig (21 OFF Septation (21 CFR Part 820); and if applicable, the electronic forth in the quant) bystems (Sections 531-542 of the Act); 21 CFR 1000-1050.
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Page 2 - Mr. Joseph Fontanetta
This letter will allow you to begin marketing your device as described in your Section 5 0(k) This letter will allow you to begin marketing your artial equivalence of your device to a legally premarket notification. The FDA midnig of substanted on the some of thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please
ntiled If you desire specific advice for your device of 10-Also, please note the regulation entitled.
contact the Office of Compliance at (240) 276-0115. Also, please note them of contact the Office of Complanee at (216) 217 or (21CFR Part 807.97). You may obtain
"Misbranding by reference to premarket notification" (21CFR the Division of Small "Misbranding by reference to premance notified.org.in the Act from the Division of Small
on of Small information on your responsibilities under the Act from the (900) 638, 10 other general information on your responsion its toll-free number (800) 638-2041 or 1941)
Manufacturers, International and Consumer Assistance at its for himl Manufacturers, International and Consumer Abolskaree arov/cdrh/industry/support/index.html.
Sincerely yours,
Euch
Miriam C. Provost, Ph Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known): K043491
Device Name: Enfant
Indications For Use: The Enfant is a non-invasive medical device to screen, without Indications For USe: The Entailt is a nori-infants and pe-school children. The system
dilation or sedation, for visual disorders in infants and press may function dilation or sedation, for visual ulsolucis in this in a pro other visual pathway function
uses Visual Evoked potentials to provide information about the visual pathway functi uses Visual Evoked potontials to promise to vision.
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use _ (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Emile Thoms, M
Intsion Sign-Off) Pivision of General, Restorative nd Neurological Devices
§ 882.1890 Evoked response photic stimulator.
(a)
Identification. An evoked response photic stimulator is a device used to generate and display a shifting pattern or to apply a brief light stimulus to a patient's eye for use in evoked response measurements or for electroencephalogram (EEG) activation.(b)
Classification. Class II (performance standards).