(56 days)
Radiographic Film Reading
The SL800001 is a motorized radiographic film illuminator which enables electro-optical masking of the back illumination in such a way that those parts of the face plate which are covered by films are illuminated, and exposed parts of the face plate are masked (dark). The SL80000 is designed to minimize problems which are associated with glare induced degradation of visual perception capacity and fatigue of film readers. The SL800000 is is comprised of a motorized belt assembly, fluorescent backlight assembly, electro-optical shutter asembly, CCD based film detection assembly and PC-based control hardware and software.
The provided text describes the Smart Motorized Viewer SL8000DLX, a device designed to improve radiographic film reading by electro-optical masking of back illumination. However, the document does not contain information about specific acceptance criteria, a formal study design with performance metrics, sample sizes for test or training sets, details on expert readers, adjudication methods, or MRMC study results.
The 510(k) summary only states that the device is designed to minimize problems associated with glare-induced degradation of visual perception and fatigue. It also mentions compliance with MDD93/42/EEC standards for electrical and mechanical safety.
The summary concludes by stating, "Based on the above, it is SmartLight's opinion that the SL80000445 is substantially equivalent to the predicate devices." This implies that the device's acceptance criteria are implicitly met by demonstrating substantial equivalence to its predicate devices, which are AMS/Planilux Rotolux and Mammolux (K922079), S&S/RADX MV220/MV400, and SmartLight's Digital Film Viewer SL4000°LCS (K952188). The key difference highlighted is the method of restricting back illumination (electro-optical shutters vs. manual mechanical shutters).
Therefore, a table of acceptance criteria and a detailed study proving the device meets those criteria, as typically found in modern medical device submissions with quantitative performance claims, cannot be extracted from this document. The submission focuses on demonstrating substantial equivalence primarily through a qualitative comparison of design and intended use with predicate devices.
Summary of available information regarding acceptance criteria and study data:
- Acceptance Criteria/Performance Goal: Not explicitly stated as quantitative metrics. The implicit goal is to provide a radiographic film reading experience that minimizes glare-induced degradation of visual perception and fatigue, similar to or better than predicate devices, and to comply with electrical and mechanical safety standards.
- Reported Device Performance:
- Functionality: Restricts back illumination to film areas by electro-optical shutters.
- Benefit: Designed to minimize glare-induced degradation of visual perception capacity and fatigue of film readers.
- Safety: Designed to comply with MDD93/42/EEC standards of electrical and mechanical safety.
- Hazard Mitigation: Failure in electro-optical masking is immediately observed by the operator, who can reset the device.
- Study Details (Not explicitly present in the document):
- Sample size for the test set and data provenance: No information.
- Number of experts used to establish the ground truth for the test set and their qualifications: No information.
- Adjudication method for the test set: No information.
- MRMC comparative effectiveness study: No information on such a study or effect size.
- Standalone (algorithm only without human-in-the-loop) performance: Not applicable, as this is an illuminator, not an AI algorithm. Its performance is inherent in its design and operation for human readers.
- Type of ground truth used: Not applicable, as no diagnostic study with "ground truth" is described.
- Sample size for the training set: Not applicable, as no AI model requiring a training set is described.
- How the ground truth for the training set was established: Not applicable.
In essence, the 510(k) relies on a qualitative argument for substantial equivalence rather than a quantitative performance study with explicit acceptance criteria.
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Image /page/0/Picture/1 description: The image shows the word "SMARTLIGHT" in bold, black letters. The letters "SMART" are larger and not enclosed, while "LIGHT" is smaller and enclosed in a black rectangle. There is a black line underneath the word "SMART".
October 12, 1997
510(k) Summary
DEC 1 2 1997
Classification Name: Radiographic film illuminator Smart Motorized Viewer SL8000DLX Model name:
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.
The SL800001 is a motorized radiographic film illuminator which enables electro-optical masking of the back illumination in such a way that those parts of the face plate which are covered by films are illuminated, and exposed parts of the face plate are masked (dark). The SL80000 is designed to minimize problems which are associated with glare induced degradation of visual perception capacity and fatigue of film readers.
The SL800000 is is comprised of a motorized belt assembly, fluorescent backlight assembly, electro-optical shutter asembly, CCD based film detection assembly and PC-based control hardware and software.
Predicate devices include AMS/Planilux Rotolux and Mammolux (K922079), S&S/RADX MV220/MV400 and SmartLight's Digital Film Viewer SL4000"LCS (K952188). The indication for use of the predicate devices and the SL8000 04x is radiographic film reading.
The SL800000 restricts the back illumination to film areas by electro-optical shutters in a 110 DE000 - Tostrely the Oasignal Film Viewer SL4000°LUS (K952188). AMS/Planilux Rotolux and Mammolux (K922079) and S&S/RADX MV220/MV400 restrict the back illumination by manual adjustment of mechanical shutters.
The SL8000 "In is designed to comply with MDD93/42/EEC standards of electrical and mechanical safety.
The only identified specific modality hazard is a failure in the electro-optical masking, which might degrade the quality of the film reading. Such failure is, however, immediately observed by the operator of the device, who should take the necessary steps (such as pressing the RESET key) to correct the problem.
Based on the above, it is SmartLight's opinion that the SL8000445 is substantially equivalent to the predicate devices.
Dan Ben-Zeev
President
:
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Image /page/1/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus, which is a symbol of medicine, with three lines representing the branches of government. The text "DEPARTMENT OF HEALTH & HUMAN" is arranged in a circular fashion around the caduceus.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC 1 2 1997
Re: K973965
Dan Ben-Zeev President SMARTLIGHT, Ltd. 47 Hataasiya St. P.O. Box 356 Nesher 36602 ISRAEL
Smart Motorized Viewer SL8000DLX Dated: October 12, 1997 Received: October 17, 1997 Regulatory Class: I 21 CFR 892.1890/Procode: 90 IXC
Dear Mr. Ben-Zeev:
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 devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical 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 provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either 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 requirement, 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 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.dexice.on.our.labeling.regulation (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/dsmamain.html".
Sincerely yours.
h.7liau Yu
Lillian Yin, Ph.D.
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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510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
Device Name: _________________________________________________________________________________________________________________________________________________________________
Indications For Use:
.
:
Radiographic Film Reading
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Wiliam Yri
(Division Sign-Off) (Division of Reproductive, Abdominal, ENT, and Radiological Dey 510(k) Number
OR
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.