(549 days)
The ClearView™ System provides two sets of numbers under two different conditions, one with capacitive barrier to minimize the effect of variables such as oils and perspiration on the image and one without the capacitive barrier. The device provides numerical measures of electrophysiological signals emanating from the skin. The device is limited to use as a measurement tool and is not intended for diagnostic purposes or for influencing any clinical decisions. This device is only to be used to image and document electrophysiological signals emanating from the skin. Clinical management decisions should be made on the basis of routine clinical care and professional judgment in accordance with standard medical practice.
The ClearView System consists of the ClearView Device (hardware) attached to a computer/software system. The measurements are digital photographs acquired when placing a fingertip in contact with a glass electrode. A series of electrical impulses are applied to the glass electrode generating a localized electromagnetic field around the fingertip. Under the influence of this field, an image is generated. A software analysis of the images of the 10 fingers (including the thumbs) provides the inputs for an algorithm-driven Response Scale Report. The ClearView System provides numerical electrophysiological data to the healthcare professional. Any interpretation of this information is the responsibility of the healthcare professional; the device is limited to use as a measurement tool and is not intended for diagnostic purposes or for influencing any clinical decisions.
The ClearView™ System is intended as a non-invasive measurement tool for detecting electrophysiological signals from the skin. It is explicitly stated that the device is not intended for diagnostic purposes or for influencing any clinical decisions, and the reported numbers have no clinical context. Therefore, the acceptance criteria and study design focus on the repeatability and reproducibility of its measurements, rather than clinical efficacy.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Metric | Acceptance Threshold (Implicit) | Reported Device Performance |
|---|---|---|---|
| Reliability | Intraclass Correlation Coefficient (ICC) - Inter-Operator and Intra-Operator | "Good reliability" (ICC between 0.60 and 0.74) and "excellent reliability" (ICC above 0.75) based on Cicchetti (1994) and Cicchetti & Sparrow (1981) | Average Inter-Operator ICC: 0.74 (95%CI: 0.65, 0.83) |
| Average Intra-Operator ICC: 0.77 (95%CI: 0.68, 0.87) | |||
| Intraclass Correlation Coefficient (ICC) - Inter-Day and Intra-Day | "Good reliability" (ICC between 0.60 and 0.74) and "excellent reliability" (ICC above 0.75) | Average Inter-Day ICC: 0.72 (95%CI: 0.62, 0.82) | |
| Average Intra-Day ICC: 0.78 (95%CI: 0.71, 0.86) | |||
| Repeatability/Reproducibility | Coefficient of Variation (CV) | Relatively low coefficients of variation (implicitly indicating good repeatability and reproducibility) | Average CV by operator-scanner pair: 0.098 (95%CI: 0.061, 0.14) |
| Average CV by day: 0.096 (95%CI: 0.060, 0.13) |
Conclusion on Acceptance Criteria: The study results for ICCs generally fall within or exceed the "good reliability" and "excellent reliability" thresholds, and the coefficients of variation are reported as "relatively low," indicating the device meets its implicit acceptance criteria for repeatability and reproducibility.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: 18 subjects (9 males, 9 females).
- Data Provenance: Prospectively enrolled, single-center study. Subjects were recruited internally from the study site (family and friends of staff members, excluding employees directly involved with the study). This suggests a limited geographic origin, likely the country where EPIC™ Research & Diagnostics is located (Scottsdale, AZ, USA).
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not applicable as the study did not involve establishing a diagnostic ground truth or expert interpretation of the electrophysiological signals. The "ground truth" for this study was the raw measurement itself, and the goal was to assess its consistency.
4. Adjudication Method (for the test set)
This information is not applicable. The study focused on the technical performance (repeatability and reproducibility) of the device's measurements, not on clinical interpretations that would require adjudication.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done
No, a Multi Reader Multi Case (MRMC) comparative effectiveness study was not done. The study design involved three trained and certified operators using three different ClearView Scanners to assess the consistency of the device's measurements, not to compare human reader performance with and without AI assistance. The device is explicitly not intended for diagnostic purposes or for influencing clinical decisions.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
The study primarily assessed the system's standalone performance in terms of repeatability and reproducibility. While operators initiated scans, the analysis and generation of "numerical measures of electrophysiological signals" are done by the device's software. The study's focus on Coefficient of Variation and ICCs for these numerical outputs directly evaluates the consistency of the algorithm's output under different operators, scanners, and days. The "device is limited to use as a measurement tool and is not intended for diagnostic purposes or for influencing any clinical decisions," implying its output stands on its own as a measurement.
7. The Type of Ground Truth Used
The "ground truth" for this study was the device's own measurements of electrophysiological signals. The study aimed to assess the consistency and reliability of these measurements across different variables (operators, scanners, days), rather than comparing them to an external, independently established clinical ground truth (e.g., pathology, clinical outcome, or expert consensus on diagnosis).
8. The Sample Size for the Training Set
This information is not provided in the document. The document describes a clinical study to assess the performance of the device, but it does not detail any internal training data used for the device's software algorithm development.
9. How the Ground Truth for the Training Set Was Established
This information is not provided in the document. As this document describes the regulatory submission for the device and a study on its reliability, details about the development and training of the internal algorithm are not included.
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DE NOVO CLASSIFICATION REQUEST FOR CLEARVIEW™ SYSTEM
REGULATORY INFORMATION
FDA identifies this generic type of device as:
Evoked Photon Image Capture Device. An evoked photon image capture device is a prescription, electrically powered device intended for use as a non-invasive measurement tool that applies electricity to detect electrophysiological signals emanating from the skin, which are reported numerically and as images without clinical interpretation. The device is not intended for diagnostic purposes.
NEW REGULATION NUMBER: 882.1561
CLASSIFICATION: CLASS I, (Exempt from premarket notification review, subject to limitations in 21 CFR 882.9)
PRODUCT CODE: PNA
BACKGROUND
DEVICE NAME: CLEARVIEW™ SYSTEM
SUBMISSION NUMBER: DEN150004
DATE OF DE NOVO: JANUARY 13, 2015
CONTACT: NANCY RIZZO, PH.D. EPICTM RESEARCH & DIAGNOSTICS 7659 E. PINNACLE PEAK ROAD SUITE 115 SCOTTSDALE, AZ 85255
REQUESTER'S RECOMMENDED CLASSIFICATION: CLASS I, EXEMPT
INDICATIONS FOR USE
The ClearView™ System provides two sets of numbers under two different conditions, one with capacitive barrier to minimize the effect of variables such as oils and perspiration on the image and one without the capacitive barrier. The device provides numerical measures of electrophysiological signals emanating from the skin. The device is limited to use as a measurement tool and is not intended for diagnostic purposes or for influencing any clinical decisions. This device is only to be used to image and document electrophysiological signals emanating from the skin. Clinical management decisions should be made on the basis of routine clinical care and professional judgment in accordance with standard medical practice.
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LIMITATIONS
The sale, distribution, and use of the device are restricted to prescription use in accordance with 21 CFR 801.109.
The device is not intended for diagnostic purposes or for influencing any clinical decisions. The reported numbers have no clinical context. Clinical management decisions are not to be made on the basis of the ClearView System, but rather on the basis of routine clinical care and professional judgment.
PLEASE REFER TO THE LABELING FOR A MORE COMPLETE LIST OF WARNINGS. PRECAUTIONS AND CONTRAINDICATIONS
RATIONALE FOR EXEMPTION
Section 510(1) of the FD&C Act (21 U.S.C. 360(1)) provides that a class I device is not subject to the premarket notification requirements under section 510(k) of the FD&C Act unless the device is of substantial importance in preventing impairment of human health or presents a potential unreasonable risk of illness or injury. FDA has determined that the device does meet these criteria and, therefore, premarket notification is not required for the device.
General controls provide reasonable assurance of safety and effectiveness if device manufacturers comply with such requirements, which includes current good manufacturing practice requirements (21 CFR part 820), including design controls (820.30) due to the inclusion of software, and general labeling (21 CFR part 801). Examples exceeding the limitations of exemption could include indications for diagnostic purposes, clinical decision making, or a significant change in the technological characteristics.
DEVICE DESCRIPTION
The ClearView System consists of the ClearView Device (hardware) attached to a computer/software system. The measurements are digital photographs acquired when placing a fingertip in contact with a glass electrode. A series of electrical impulses are applied to the glass electrode generating a localized electromagnetic field around the fingertip. Under the influence of this field, an image is generated. A software analysis of the images of the 10 fingers (including the thumbs) provides the inputs for an algorithm-driven Response Scale Report. The ClearView System provides numerical electrophysiological data to the healthcare professional. Any interpretation of this information is the responsibility of the healthcare professional; the device is limited to use as a measurement tool and is not intended for diagnostic purposes or for influencing any clinical decisions.
The ClearView System includes the following components: (1) ClearView Device, (2) Power cord, (3) USB external cable, (4) Electrode cover, (5) Finger shroud, (6) Reference probe, (7) Reference probe cable, (8) Reference probe shroud, (9) Instructions for Use, (10) Computer All-In-One System or Laptop with ClearView Software installed, (11) Keyboard and mouse, (12) USB hardware key, (13) Capacitive barriers, (14) Cleaning cloths, and (15) Alcohol swabs. Figure 1 below depicts the ClearView Device.
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Image /page/2/Picture/0 description: The image shows a gray EPIC device sitting on a desk next to a computer keyboard and monitor. The device has a black top with a small, rectangular opening. The word "EPIC" is printed in white on the side of the device. There are several cables plugged into the back of the device.
Figure 1: The ClearView Device as it is connected to the Clear View System.
The ClearView Device, All-In-One System or Laptop, and EPIC ClearView Software are intended to work only as part of the system, and not with any third-party hardware or software.
The electrode consists of a glass disc that electrically isolates the patient's finger from the voltage that is generated on the conductive bottom surface of the glass. The conductive surface is connected to a printed wiring board (PWB). The conductive glass assembly and the printed wiring board together form the electrode that is used in the creation of the electric field.
When a finger is applied to the glass, the operator initiates image capture through the Clear View Software. The ClearView Device initiates a pulsed voltage to the bottom of the glass generating a localized electromagnetic field around the finger. b(4)
This light (signal) is captured by a camera. A software analysis provides the inputs for the measurement.
Two complete sets of images are generated for each patient:
- . The first sequence is captured and recorded using all ten fingers, individually placed directly on the glass.
- . The second set is captured and recorded using all ten fingers, individually placed with a capacitive barrier between the finger and the glass. The capacitive barrier is designed to eliminate the body's response (perspiration and oil) from the data analysis.
The ClearView Software is designed to analyze the images collected. Each image is assigned a number of partitions and then translated into a linear waveform and the characterization data is presented through the pixel distribution and the respective correlations as it relates to each partition. Mathematical calculations are used to generate values for area and intensity of the lighted pixels. The images are further characterized through five additional mathematical coefficients, which each use area and intensity as their base. To generate the individual measurements the data is analyzed, and translated to a normalized scale (the normalized scale
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does not have units associated). The data is analyzed by the ClearView Software and a report is generated.
The ClearView Report, generated by the ClearView Software, is intended to report electrophysiological scores associated with five different measurements. An example report is shown in Figure 2 below:
| ClearView ReportPrepared for: First Subject | ||||||
|---|---|---|---|---|---|---|
| Visit Date: 10/13/2015 | Age: 53 | Gender: Male | ||||
| The ClearView System is a non-invasive measurement tool for the detection of electrophysiologicalsignals emanating from the skin. The device is not intended for diagnostics purposes.The table below provides the ClearView Response Scale results. | ||||||
| Output System | Without | With | ||||
| Measurement #1 | Capacitive Barrier1.1 | Capacitive Barrier2.1 | ||||
| Measurement #2 | 0.7 | 1.3 | ||||
| Measurement #3 | 1.3 | 1.4 | ||||
| Measurement #4 | 0.1 | 0.6 |
Figure 2: Example of a ClearView Report
SUMMARY OF NONCLINICAL/BENCH STUDIES
Nonclinical performance data were provided related to the following areas: biocompatibility, electrical safety, electromagnetic compatibility (EMC), and software.
BIOCOMPATIBILITY/MATERIALS
The ClearView System is a non-invasive device with limited (≤ 24 hours) contact (per ISO 10993-1 definitions); the only contact is by the intact skin on the fingertips. Several portions of the device will come into contact with the patient's intact skin for approximately five minutes for each scan session. The contacting materials are commonly found in daily use including glass, silicone, and PVC. Table 1 shows the patient's potential for contacting materials, materials of construction, and common use of the material. Because of the non-invasive contact and the everyday use of these materials. no biocompatibility testing was conducted.
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| Contacting SurfaceComponent | Material of Construction |
|---|---|
| Outer plastic housing | ABS/PC, Natural b(4) |
| Capacitive barrier | Specification plastic with anti-static characteristics |
| Electrode cover andfinger shroud | URETHANE b(4) |
| Glass lens | Glass |
| Finger shroud curtains | Neoprene |
Table 1: Materials Used in ClearView System
ELECTROMAGNETIC COMPATIBILITY (EMC)
EMC testing was performed on the ClearView System in accordance with IEC 60601-1-2: 2007, EN 61000-4-2:2008 Electrostatic Discharge (ESD), EN 61000-4-3:2008 Radiated, Radio Frequency, Electromagnetic Field Immunity Test, EN 61000-4-4:2004 Electrical Fast Transient/Burst Immunity Test (EFT), EN 61000-4-5:2005 Surge Immunity Test (Mains), EN 61000-4-6:2008 Immunity to Conducted Disturbances, Induced by Radio Frequency Fields, EN 61000-4-8:2009: Power Frequency Magnetic Field Immunity, and EN 61000-4-11:2004 Voltage Dips, Short Interruptions and Voltage Variations Immunity. It was also tested to the following emissions standards: EN 55011-2007 (CISPR-11) Radiated Emission, EN 55011-2007 (CISPR-11) Conducted Emission, EN 61000-3-2:2009 Limits for Harmonic Current Emission <16A , EN 61000-3-3:2008, and Limitations of Voltage Fluctuations and Flicker in Low-Voltage Supply Systems >16A.
ELECTRICAL SAFETY
Electrical safety testing was performed on the ClearView System in accordance with: IEC 60601-1: 1988, IEC 60601-1: Amendment 1 (1991), and IEC 60601-1: Amendment 2 (1995). Note that testing from the most recent third addition of IEC 60601-1 (Design Reviews and Risk Analysis) was deemed unnecessary because the physical testing of the device according to the version standard to which the device was tested is adequate to ensure safety for this device and because of the low risk of the device.
SOFTWARE
The software for the ClearView System presents a "minor" level of concern based on answers to questions listed in FDA's Guidance for the Content of Premarket Submission for Software Contained in Medical Devices (May 11, 2005). Adequate documentation has been provided.
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SUMMARY OF CLINICAL INFORMATION
A prospectively enrolled, single center, randomized study was performed to assess the repeatability and reproducibility of the ClearView Scanner to demonstrate the reliability of the ClearView System measurements.
Eligibility Criteria
Subjects were recruited internally from the study site. Family and friends of staff members were screened and enrolled as long as they met all inclusionary and no exclusionary criteria. Site employees directly involved with the study and their family members were ineligible. Potential subjects were screened for age and availability. Pregnant or potentially pregnant women, anyone with implanted cardiac or electrical scanners or loss of part of any finger were excluded.
Protocol
Three trained and certified EPIC employees were designated Clear View Scanning operators. These operators were assigned a Clear View Scanner and were considered an operator-scanner pair for statistical analysis. Subjects were screened for eligibility and enrolled if criteria were met. All subjects were consented in accordance with the Declaration of Helinski, ICH GCP, US Code of Regulations for Protection of Human Subjects (21 CFR 50.25, CFR 50. 27, and CFR Part 56 Subpart A), the Health Insurance Portability and Accountability Act (HIPAA), and local regulations. Subjects were randomly scanned consecutively on three different ClearView Scanners (Scanners 100, 102, 10E) with three different operators (operator-scanner pair #1, #2, #3). Each subject was scanned twice on all three ClearView Scanners on both Day 1 and Day 2 of the study. Between scans on the same operator-scanner, each subject stepped away from the scanner for at least 20 seconds, than were repositioned for a subsequent scan. Subjects had 10 fingers measured; twice with a capacitive (filter) barrier and twice without a capacitive barrier, for a total of 40 images at each operator-scanner. This procedure was completed by all subjects on all three operator-scanners. On Day 2 all subjects followed the same procedure. The order in which subjects were scanned and order of operatorscanner scanning was randomized and documented for both Day 1 and Day 2.
Sample Size/Test Frequency Determination
The sample size calculation to assess the repeatability and reproducibility of ClearView Response Scale was based on Intraclass Correlation Coefficient (ICC). A sample size of 18 subjects with 2 repeated scans per subject achieves 80% power to detect an expected ICC of 0.80 or greater when the null ICC is 0.50 with sigmificance level of 0.05 (Walter et al, 1998). This sample size of 18 subjects was calculated to evaluate the reliability of 3 operators-scanner pairs, and across 2 days.
Results
Nine (9) males and nine (9) females were screened and enrolled. Ages ranged from 23 to 77 years of age for females and 32 to 65 years of age for males, and were ethnically diverse. All 18 subjects completed all required 12 scans across two days, giving a total of 216 scans in this study.
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There were no known or reported Adverse Events (AE) that occurred during the study and no occurrence of any unanticipated or anticipated adverse scanner effects.
Reliability of measurement scores was assessed by Coefficient of Variation and Intraclass (Interclass) Correlation Coefficients (ICC). The coefficient of variation was calculated as the residual standard deviation from the repeated measures ANOVA fitted with subject and each factor (operator-scanner pair and day) as random effects and divided by the mean of each measurement score, with and without barrier. The ICCs were calculated from repeated measures analysis of variance (ANOVA) with subject and each factor (operator-scanner pair and day) as random effects. Inter-factor and intra-factor ICCs were derived for each measurement score, with and without barrier. Coefficients of variations were summarized in Table 2 and Table 3 for reliability by operator-scanner pair and by day, respectively.
| 3 Operators | System Names | OverallMean | ResidualVariance | CoefficientofVariation |
|---|---|---|---|---|
| Without Barrier | Measurement 1 | 2.390 | 0.0996 | 0.132 |
| Measurement 2 | 2.644 | 0.0986 | 0.119 | |
| Measurement 3 | 1.871 | 0.0012 | 0.019 | |
| Measurement 4 | 1.330 | 0.0369 | 0.144 | |
| Measurement 5 | 1.484 | 0.0458 | 0.144 | |
| With Barrier | Measurement 1 | 2.235 | 0.0977 | 0.140 |
| Measurement 2 | 2.093 | 0.0382 | 0.093 | |
| Measurement 3 | 1.743 | 0.0024 | 0.028 | |
| Measurement 4 | 1.945 | 0.0039 | 0.032 | |
| Measurement 5 | 1.929 | 0.0659 | 0.133 |
Table 2: Reliability by Operator/Scanner
Table 3: Reliability by Day
| 2 days | System Names | OverallMean | Residualvariance | CoefficientofVariation |
|---|---|---|---|---|
| WithoutBarrier | Measurement 1 | 2.390 | 0.0688 | 0.110 |
| Measurement 2 | 2.644 | 0.0898 | 0.113 | |
| Measurement 3 | 1.871 | 0.0011 | 0.017 | |
| Measurement 4 | 1.330 | 0.0334 | 0.137 | |
| Measurement 5 | 1.484 | 0.0327 | 0.122 | |
| WithBarrier | Measurement 1 | 2.235 | 0.1068 | 0.146 |
| Measurement 2 | 2.093 | 0.0458 | 0.102 | |
| Measurement 3 | 1.743 | 0.0024 | 0.028 | |
| Measurement 4 | 1.945 | 0.0046 | 0.035 | |
| Measurement 5 | 1.929 | 0.0822 | 0.149 |
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The average coefficient of variation by operator-scanner pair was 0.098 (95%C1: 0.061, 0.14) and the average coefficient of variation by day was 0.096 (95%CI: 0.060, 0.13). The average Inter-Operator ICC was 0.74 (95%C1: 0.65, 0.83) and the average Intra-Operator ICC was 0.77 (95%CI: 0.68, 0.87). The average Inter-Day ICC was 0.72 (95%CI: 0.62, 0.82) and the average Intra-Day ICC was 0.78 (95%CI: 0.71, 0.86),
Based on the literature, ICC between 0.4 and 0.59 is considered fair reliability; ICC between 60 and 0.74 is considered good reliability; and ICC above 0.75 is considered excellent reliability (Cicchetti, 1994 and Cicchetti and Sparrow, 1981). The ICC values in this study demonstrated good reliability of the measurement scores from ClearView. The Clear View Scanner demonstrated high repeatability and reproducibility across operators, days, and scanners, as evidenced by relatively low coefficients of variation.
LABELING
The labeling meets the requirements of 21 CFR §801.109 for prescription devices.
The following information is included in the labeling for the ClearView System: contraindications, warnings, and precautions, system description, indications for use, system set up, device calibration, how to enter patient information, how to capture images, how to generate reports, and general device care, storage, and disposal instructions.
BENEFIT/RISK DETERMINATION
The risks associated with the evoked photon image capture device are adverse tissue reaction, electromagnetic incompatibility, and electromagnetic malfunction (e.g., shock). The severity and incidence of these risks to health are relatively low due to the very limited patient contact with the device. As such, general controls are sufficient to mitigate these risks and reasonably assure safety and effectiveness. General controls include but are not limited to good manufacturing practice requirements (21 CFR part 820), including design controls (820.30) due to the inclusion of software, and general labeling (21 CFR part 801).
The probable benefits of the device are based on the ClearView™ System being a tool that provides physicians with quantified measurements of electrophysiological response associated with individual patients. The measurements reported by the ClearView Scanner demonstrated high repeatability and reproducibility. The inherent benefit associated with ClearView™ System relates to the device's ability to provide physicians immediate access to electrophysiological information on patients in a safe and noninvasive manner.
Additional factors considered in determining probable risks and benefits for the device is that it is not intended for diagnostic purposes or for influencing any clinical decisions. The reported numbers have no clinical context.
Patient Perspectives
This submission did not include specific information on patient perspectives for this device.
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Benefit/Risk Conclusion
In conclusion, given the available information above, the data support that for use as a non-invasive measurement tool that detects and records electrophysiological signals, the probable benefits outweigh the probable risks for the ClearView™ System.
CONCLUSION
The de novo request for the ClearView™ System is granted and the device is classified under the following:
Product Code: PNA Device Type: Evoked Photon Image Capture Device Class: Class I, (Exempt from premarket notification, subject to limitations in 21 CFR 882.9) Regulation: 21 CFR 882.1561
REFERENCES
Cicchetti D.V. (1994) "Guidelines, Criteria, and Rules of Thumb for Evaluating Normed and Standardized Assessment Instruments in Psychology." Psychological Assessment. Vol. 6, No.4, 284-90.
Cicchetti, DV and Sparrow, SS (1981) "Developing criteria for establishing interrater reliability of specific items: Applications to assessment of adaptive behavior." American Journal of Mental Deficiency, 86, 127-137.
Walter, S.D., Eliasziw, M. Donner, A (1998) "Sample size and optimal designs for reliability studies." Statistics in Medicine. 17, 101-110.
§ 882.1561 Evoked photon image capture device.
(a)
Identification. An evoked photon image capture device is a prescription, electrically powered device intended for use as a noninvasive measurement tool that applies electricity to detect electrophysiological signals emanating from the skin, which are reported numerically and as images without clinical interpretation. The device is not intended for diagnostic purposes.(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 § 882.9.