(46 days)
The SmartLight Digital Film Viewer System is a radiographic film illuminator designed to automatically adapt film-viewing conditions to compensate for known physical and psychophysical limitations in human visual perception when reading radiographic films.
The Digital Film Viewer is a radiographic film illuminator with the following new indications for use:
- The Digital Film Viewer substantially improves the ability to detect and discern radiographic objects recorded on film compared to unmasked and masked light boxes.
- The Digital Film Viewer substantially improves the ability to detect and discern clinical information recorded on radiographic film compared to unmasked and masked light boxes.
- The Digital Film Viewer mitigates the age-dependent degradation in the ability to detect or discern radiographic objects recorded on film for readers over 30 years of age, as experienced on unmasked and masked light boxes.
The Digital Film Viewer is a radiographic film illuminator designed to automatically adapt film-viewing conditions to compensate for known physical and psychophysical limitations in human visual perception when reading radiographic films.
The device senses the size, location, and density of films mounted on its faceplate and automatically adapts film-viewing conditions, as described below:
- Adaptive Light Intensity The device automatically adapts the intensity of the back illumination system according to film density. Back light intensity ranges from 500-10,000 nits.
- Masking The device enables electro-optical collimation of the back illumination such that those parts of the faceplate covered by films are illuminated, while the rest of the faceplate remains dark, eliminating extraneous glare.
- Film Scatter Suppression The device incorporates an optical grid, which projects light in the forward direction to suppress optical scatter within the film (Callier effect).
- Ambient Light The device reduces the ambient light level when films are mounted on its faceplate.
- Pupil Diameter The device emits a dark blue light from its faceplate to control pupil dilation.
The provided text does not contain detailed information about specific acceptance criteria or a comprehensive study report with the requested metrics. It primarily focuses on the device description, intended use, and substantial equivalence determination for regulatory clearance.
However, based on the information available, I can extract and infer some points regarding the claims made about device performance, which would typically be linked to acceptance criteria in a detailed study.
Here's an attempt to answer your questions based on the provided text, acknowledging where information is missing:
1. Table of Acceptance Criteria and Reported Device Performance
The document doesn't provide a quantitative table of acceptance criteria. However, it states the "new indications for use" which implicitly serve as performance claims that a study would aim to prove. The reported performance is a qualitative statement of improvement.
| Acceptance Criteria (Implied from Intended Use) | Reported Device Performance |
|---|---|
| Substantially improve the ability to detect and discern radiographic objects recorded on film compared to unmasked and masked light boxes. | "The study data demonstrate substantial and significant improvement in observer ability to detect and discern radiographic information recorded on film, when using the Digital Film Viewer compared to either an unmasked or masked light box." |
| Substantially improve the ability to detect and discern clinical information recorded on radiographic film compared to unmasked and masked light boxes. | "The study data demonstrate substantial and significant improvement in observer ability to detect and discern radiographic information recorded on film, when using the Digital Film Viewer compared to either an unmasked or masked light box." (This statement consolidates both "radiographic objects" and "clinical information" as the text uses "radiographic information" to cover both.) |
| Mitigate age-dependent degradation in the ability to detect or discern radiographic objects recorded on film for readers over 30 years of age. | "The study data demonstrate substantial and significant improvement in observer ability to detect and discern radiographic information recorded on film, when using the Digital Film Viewer compared to either an unmasked or masked light box." (While the study is stated to show overall significant improvement, the specific mitigation of age-dependent degradation is claimed but not explicitly detailed as a separate outcome.) |
2. Sample Size Used for the Test Set and Data Provenance
- Sample size for test set: "a large number of observers" is mentioned. The exact number is not specified.
- Data provenance: Not specified (e.g., country of origin, retrospective or prospective). However, the study is described as a "controlled, statistical study," implying a prospective design for performance evaluation.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
This information is not provided in the text. The document refers to "observer ability to detect and discern radiographic information," which implies human observers were involved in the study itself, but it does not detail how the ground truth for the test cases was established (e.g., who determined the presence or absence of specific radiographic objects or clinical information that observers were asked to find).
4. Adjudication Method for the Test Set
This information is not provided in the text.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
Yes, a comparative effectiveness study involving multiple readers was performed. The text states:
- "The new indications for use relate to device performance and are based on data from a controlled, statistical study of a large number of observers."
- The study compared performance "when using the Digital Film Viewer compared to either an unmasked or masked light box."
Effect Size: The text states "substantial and significant improvement." However, specific quantitative effect sizes (e.g., AUC increase, sensitivity/specificity gains) or metrics on how much human readers improved with the AI (device) vs. without the AI are not provided.
6. Standalone (Algorithm Only Without Human-in-the-Loop) Performance
This device is a film illuminator designed to enhance human viewing of radiographic films. It "automatically adapts film-viewing conditions to compensate for known physical and psychophysical limitations in human visual perception when reading radiographic films."
Therefore, it is not a standalone AI algorithm. Its stated purpose is to improve human performance, meaning a "human-in-the-loop" is integral to its function and evaluation.
7. Type of Ground Truth Used
This information is not explicitly provided. Given the nature of a radiographic film illuminator improving "detection and discernment," the ground truth for cases in the study would likely involve:
- Expert consensus: Multiple radiologists or clinicians confirming the definitive presence or absence of specific objects/findings.
- Pathology or surgical correlation: For certain definitive findings.
- Clinical outcomes data: Though less likely for immediate detection tasks on an illuminator, it could be used for confirming clinical significance.
The document states "observer ability to detect and discern radiographic information," which suggests a 'reference standard' was used to determine what was truly present or absent on the films.
8. Sample Size for the Training Set
The device is described as a "Digital Film Viewer" that uses electro-optical and physical mechanisms to adapt viewing conditions. It's not a machine learning model in the modern sense that typically has a "training set" to learn from data. The device's adaptive mechanisms (e.g., adaptive light intensity, masking, film scatter suppression) are based on pre-programmed rules and optical principles, not on being "trained" on a dataset.
Therefore, the concept of a "training set" for this device is not applicable.
9. How the Ground Truth for the Training Set Was Established
As explained in point 8, there is no "training set" for this type of device. Its functionalities are engineered and implemented based on known principles of human visual perception and physics, not through machine learning.
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510(k) Summary for SmartLight Digital Film Viewer Appendix D
1. Sponsor
Contact:
SmartLight Inc. 241 Main Street Hackensack, NJ 07601 201-487-4544 (T) 201-487-4746 (F)
A. Robert Sohval, PhD
Date Prepared:
April 15, 1999
2. Device Name
SmartLight Digital Film Viewer System Proprietary Name: Common or Usual Name: Radiographic Film Illuminator Radiographic Film Illuminator Classification Name:
3. Predicate Device
Product: ADViewer Company: ADP Ltd. K952188
4. Device Description
The Digital Film Viewer is a radiographic film illuminator designed to automatically adapt film-viewing conditions to compensate for known physical and psychophysical limitations in human visual perception when reading radiographic films.
The device senses the size, location, and density of films mounted on its faceplate and automatically adapts film-viewing conditions, as described below:
- Adaptive Light Intensity The device automatically adapts the intensity of the (a) back illumination system according to film density. Back light intensity ranges from 500-10,000 nits.
- Masking The device enables electro-optical collimation of the back illumination (b) such that those parts of the faceplate covered by films are illuminated, while the rest of the faceplate remains dark, eliminating extraneous glare.
- Film Scatter Suppression The device incorporates an optical grid, which (c) projects light in the forward direction to suppress optical scatter within the film (Callier effect).
- Ambient Light The device reduces the ambient light level when films are (d) mounted on its faceplate.
- Pupil Diameter The device emits a dark blue light from its faceplate to control (e) pupil dilation.
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5. Intended Use
The Digital Film Viewer is a radiographic film illuminator with the following new indications for use:
- The Digital Film Viewer substantially improves the ability to detect and discern (a) radiographic objects recorded on film compared to unmasked and masked light boxes.
- The Digital Film Viewer substantially improves the ability to detect and discern (b) clinical information recorded on radiographic film compared to unmasked and masked light boxes.
- The Digital Film Viewer mitigates the age-dependent degradation in the ability to (c) detect or discern radiographic objects recorded on film for readers over 30 years of age, as experienced on unmasked and masked light boxes.
6. Technological Characteristics and Substantial Equivalence
There are no significant differences in the technological characteristics of the Digital Film Viewer with the new indications for use and the predicate devices have the same overall intended use and function for the illumination and viewing of radiographic films.
7. Performance Characteristics
The new indications for use relate to device performance and are based on data from a controlled, statistical study of a large number of observers.
The study data demonstrate substantial and significant improvement in observer ability to detect and discern radiographic information recorded on film, when using the Digital Film Viewer compared to either an unmasked or masked light box.
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Image /page/2/Picture/1 description: The image is a black and white logo for the Department of Health & Human Services - USA. The logo is circular in shape, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter of the circle. In the center of the circle is a stylized image of three human figures, one behind the other, with their heads tilted upwards.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
1999 JUN
A. Robert Sohval. Ph.D. Chief Executive Officer SmartLight, Incorporated 241 Main Street Hackensack, New Jersey 07601 Re:
K991302 SmartLight Digital Film Viewer, Models SL 4000Plus and SL 2000 Plus Dated: April 15, 1999 Received: April 16, 1999 Regulatory Class: I 21 CFR 892.1890/Procode: 90 IXC
Dear Dr. Sohval:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls of the Act include requirements for annual registration. Iisting of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class III (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling requlation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4613. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification"(21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597, or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".
Sincerely yours,
CAPT Daniel C. Schultz, M.D.
APT Daniel G. Schultz, M.D. Acting Director, Division of Reproductive. Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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2. INDICATIONS FOR USE STATEMENT
| 510(k) Number: | K991302 |
|---|---|
| Device Name: | SmartLight Digital Film Viewer System |
| Indications for Use: | The SmartLight Digital Film Viewer System is aradiographic film illuminator designed to automaticallyadapt film-viewing conditions to compensate for knownphysical and psychophysical limitations in human visualperception when reading radiographic films. |
(PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NECESSARY)
Concurrence of CDRH, Office of Device Evaluation (ODE)
David A. Degnan
(Division Sign-Off)
(Division of Reproductive, Abdominal, ENT, and Radiological Deyic 510(k) Number .
Prescription Use
(Per 21 CFR 801.109)
§ 892.1890 Radiographic film illuminator.
(a)
Identification. A radiographic film illuminator is a device containing a visible light source covered with a translucent front that is intended to be used to view medical radiographs.(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 § 892.9.