(34 days)
The General Scanning model LD2000 SERIES laser film digitizer is intended to convert medical images stored on film to digital data for copying, storage, and transmission. It is intended for use to digitize copies of conventional x-rays and films produced by imagers that fall in the ranges for size and optical density range detailed in the specifications.
The General Scanning model LD2000 SERIES laser film digitizer is intended to convert medical images stored on film to digital data for copying, storage, and transmission. It is intended for use to digitize copies of conventional x-rays and films produced by imagers that fall in the ranges for size and optical density range detailed in the specifications.
The digitizer utilizes laser light to scan the film, extracts the image data by measuring the transmitted light, converts it into digital form, and transmits the data over a digital link. The digitized information may then be transmitted to a Laser Imager for printed hardcopy or to a Work Station for use in Teleradiology (transmission of images) or PACS (Picture Archiving Communication Systems).
The LD2000 SERIES contains the scanning laser and detection module, a film transport, and electronics to convert and transmit the image data and provide control and calibration.
The digitizer is a system for converting images on x-ray and films into digital data. It accomplishes this by scanning a focused laser beam across the film as the film itself is moved by means of motor-operated rollers. Solid state photo diodes are used to detect the amount of laser light which passes through the film at each pixel. This provides a measure of optical density at each pixel, and this measurement becomes the digital value for that pixel. The aggregate of the digital values for all the pixels on the film being digitized is thus a digital representation of the film's image. The digitizer sends this digital version of the image via an electronic interface.
LD2000 SERIES Laser Film Digitizer Acceptance Criteria and Study Details
1. Acceptance Criteria and Reported Device Performance
The document describes several specifications for the LD2000 SERIES laser film digitizer. These essentially serve as the acceptance criteria against which the device's performance is measured. The study described focuses on demonstrating "substantial equivalence" to predicate devices, implying that the LD2000 SERIES meets or exceeds the critical performance characteristics of those predicate devices.
| Acceptance Criteria (Specification) | Reported Device Performance (LD2000 SERIES) |
|---|---|
| Light source | Visible semiconductor diode |
| Spot size | 85 - 170 µm |
| Image Detectors Type | Solid State |
| Image Detectors Quantity | Nine |
| Film Size | 8" to 14" wide |
| Scan Size | 14.0" x 17.0" min |
| Pixels Not On Film | Set to Max OD value |
| Scan time (14" x 17") | 12 seconds typical for 2K resolution |
| Spatial Resolution - Number of pixels | 2048 x 2480, 1024 x 1240 (configurable up to 4096 x 4974) |
| Spatial Resolution - Pixel Size | ~170 µm @ 2048 pixels on 14", ~85 µm @ 4096 pixels on 14" |
| MTF @ 6 lp/mm | 0.4 (85 µm pixel at 4096 pixels on 14") |
| Optical Density Range | 0.03 to 3.5 OD |
| Optical Density Resolution | OD .03 - 2.5: .01 OD; OD 2.5 - 3.0: .02 OD; OD 3.0 - 3.5: .05 OD |
| Interface | SCSI (Custom Configurations available) |
| Grey scale resolution | 12 bits (4096) |
| Power requirements (Voltage) | 87 - 132 / 200 - 264; 4 position user selected |
| Power requirements (Frequency) | 47 - 63 Hz Single Phase |
| Power requirements (Current Rating) | 650 mA |
| Temperature (operating) | 15C to 40C |
| Temperature (non-operating) | -40C to 60C |
| Relative Humidity (operating) | 25-70% non-condensing |
| Relative Humidity (non-operating) | 10-90% |
| Dimensions (with pedestal) | 11"D x 22.25"W x 40" H |
| Weight (with pedestal) | 60 - 77 lbs. |
2. Sample Size for Test Set and Data Provenance
The document does not detail a specific test set or studies involving patient data or clinical images that would typically have a specific sample size. Instead, the "study" described is a Section 510(k) comparison for substantial equivalence to previously cleared predicate devices. The performance data presented (e.g., OD range, spot size, resolution) are product specifications, which would have been validated during the device's development and engineering testing, rather than through a dedicated clinical test set as commonly understood in AI/software medical device submissions.
Therefore, information on data provenance (country of origin, retrospective/prospective) and specific sample sizes for a clinical test set is not applicable in this document as it pertains to engineering specifications and comparison to predicate devices, not evaluation with a clinical dataset.
3. Number of Experts and Qualifications for Ground Truth
Given this is a 510(k) for a laser film digitizer (a hardware device for converting analog images to digital), and not an AI or diagnostic imaging algorithm, the concept of "ground truth" established by experts for a test set (e.g., radiologists interpreting images) is not applicable. The "ground truth" for this device's performance would relate to physical measurements and engineering standards (e.g., accuracy of optical density measurement, spatial resolution measurement against known reference standards).
4. Adjudication Method
As there is no clinical test set requiring expert interpretation or labeling, an adjudication method for ground truth is not applicable.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No MRMC study was conducted or described. This type of study is relevant for evaluating the impact of an AI algorithm on human reader performance, which is not the purpose of this device submission.
6. Standalone Performance Study
The document outlines the specifications and functionality of the LD2000 SERIES as a standalone device for digitizing medical films. The described performance aspects (e.g., optical density range, spatial resolution) are inherent to the algorithm and hardware. While not termed a "standalone performance study" in the modern sense (which often implies a clinical accuracy study), the reported specifications are indeed indicative of the device's standalone capability. The entire submission generally serves to demonstrate that the device, used in a standalone manner, meets its intended technical specifications and is equivalent to other standalone digitizers.
7. Type of Ground Truth Used
The "ground truth" for this device's acceptance is based on engineering specifications and measurements against established technical standards, rather than clinical outcomes, pathology, or expert consensus on image findings. For example, the OD range and resolution would be verified using calibrated optical density step wedges, and spatial resolution using resolution test patterns.
8. Sample Size for the Training Set
As this is a hardware device (film digitizer) and not an AI/ML algorithm, the concept of a "training set" for model development is not applicable. The device's parameters are physically designed and calibrated, not learned from a dataset.
9. How Ground Truth for the Training Set Was Established
Since there is no training set for an AI/ML algorithm, this question is not applicable. The "ground truth" for the device's design and calibration would involve established physics principles, optical engineering standards, and precise measurement tools.
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MAR 1 9 1998
510(k) SUMMARY 2.
| 2.1 | Company Name | General Scanning Inc. (GSI)500 Arsenal StreetWatertown, MA 02172 USA |
|---|---|---|
| 2.2 | Contact Person | Steven P. ZisPhone # (617) 924-1010 x181Fax # (617) 923-1877 |
| 2.3 | Date | February 12, 1998 |
| 2.4 | Device Name | |
| Classification Name | Medical Image Digitizer | |
| Classification Number | 90LMA - Radiology Device | |
| Common Name | Laser Film Digitizer | |
| Trade/Proprietary Name | LD2000 SERIES (Marketing Name) | |
| 2.5 | Substantial Equivalence - Predicate Devices | |
| General Scanning LD2800 | K973411 | |
| Lumiscan 85LF | ||
| Lumiscan 100 | K901423 | |
| Konica | K9333830 | |
| Nishimoto Sangyo ED-2000 | ||
| Nishimoto Sangyo ED-3500 | ||
| 2.6 | Device Description and "Statement of Indications For Use"The General Scanning model LD2000 SERIES laser film digitizer isintended to convert medical images stored on film to digital data forcopying, storage, and transmission. It is intended for use to digitize copiesof conventional x-rays and films produced by imagers that fall in theranges for size and optical density range detailed in the specifications.The digitizer utilizes laser light to scan the film, extracts the image data bymeasuring the transmitted light, converts it into digital form, and transmitsthe data over a digital link. The digitized information may then be |
transmitted to a Laser Imager for printed hardcopy or to a Work Station for use in Teleradiology (transmission of images) or PACS (Picture Archiving Communication Systems).
The LD2000 SERIES contains the scanning laser and detection module, a film transport, and electronics to convert and transmit the image data and provide control and calibration.
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Principle of Operation - Overview 2.6.1
The digitizer is a system for converting images on x-ray and films into digital data. It accomplishes this by scanning a focused laser beam across the film as the film itself is moved by means of motor-operated rollers. Solid state photo diodes are used to detect the amount of laser light which passes through the film at each pixel. This provides a measure of optical density at each pixel, and this measurement becomes the digital value for that pixel. The aggregate of the digital values for all the pixels on the film being digitized is thus a digital representation of the film's image. The digitizer sends this digital version of the image via an electronic interface.
| MODULE | DESCRIPTION | MAIN COMPONENTS |
|---|---|---|
| Laser | Supplies light beam ofappropriate size,wavelength, and power tothe Scan. | Laser diodeDiode modulator board |
| Scan | Takes light beam fromLaser and scans it acrossfilm in x-direction. | Spinning polygon w/built-in controllerLenses, mirrors |
| Transport | Detects and aligns film;moves film through system. | Film sensorFilm rollersStepper motor |
| LightCollection | Detects transmitted light;performs A/D conversion. | PhotodiodesDiffusion screenADC board |
| Controller | Provides image data path;generates pixel clock forLight Collection; drivesstepper motor for Transport;monitors sensors; controlsinterface I/O. | Controller board |
| Software | Code for all Controllerfunctions. | PROM-based firmware |
| Power Supply | Provides electrical powerfor all modules. +5 VDC fordigital circuits. ±5 and +24VDC for analog circuits. | 5/24V linear supply(2) 5V linear supplies |
| Enclosure | Provides light-tight, EMI-ontrolled, cleannvironment with reasonableser and service access. | SkinsFilm input slotFilm exit binUser interfaceAC and data cables |
The table below describes and identifies the main components of the modules that make up the LD2000 SERIES digitizer.
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2.7
LD2000 SERIES Specifications
| Light source | Visible semiconductor diode |
|---|---|
| Spot size | 85 - 170 µm |
| Image Detectors | |
| Type | Solid State |
| Quantity | Nine |
| Image Size | |
| Film Size: | 8" to 14" wide |
| Scan Size: | 14.0" x 17.0" min |
| Pixels Not On Film: | Set to Max OD value |
| Scan time (14" x 17") | 12 seconds typical for 2K resolution |
| Spatial Resolution | |
| Number of pixels: | 2048 x 24801024 x 1240other pixel resolutions configurable up to4096 x 4974 on a 14" x 17" film |
| Pixel Size: | ~170 µm @ 2048 pixels on 14"~85 µm @ 4096 pixels on 14" |
| MTF @ 6 lp/mm: | 0.4 (85 µm pixel at 4096 pixels on 14") |
| Optical Density | |
| OD Range: | 0.03 to 3.5 |
| OD Resolution | OD .03 - 2.5: .01 ODOD 2.5 - 3.0: .02 ODOD 3.0 - 3.5: .05 OD |
| Interface | SCSI(Custom Configurations available per Customer Specifications) |
| Grey scale resolution | 12 bits (4096) |
| Power requirements | |
| Voltage: | 87 - 132 / 200 - 264; 4 position user selected |
| Frequency: | 47 - 63 Hz Single Phase |
| Current Rating: | 650 mA |
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Temperature
operating non-operating 15C to 40C -40C to 60C
Relative Humidity operating non-operating
25-70% non-condensing 10-90%
Dimensions with pedestal wall mount
11"D x 22.25"W x 40" H 60 - 77 lbs. (with pedestal)
11"D x 22.25"W x 48.5" H
Weight
2.7
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| 2.8 | Substantial Equivalence Comparison and ChartThe General Scanning LD2000 SERIES is substantially equivalent to allof the Lumisys, Nishimoto Sangyo and Konica digitizers listed.Specifically, |
|---|---|
| Size: | The General Scanning model LD2000 SERIES is slightly largerin size than the other products listed. This is primarily due to astand which is offered with the product. |
| Weight: | General Scanning's product weight is 60 - 77 lbs. similar to theLumisys 85LF at 75 lbs. |
| Power: | All units offer dual voltage (120/240 VAC). |
| Scan size: | Maximum scan size for all listed digitizers is 14" x 17". |
| Spot size: | General Scanning's product has an 85um spot which fallswithin the 50 - 420um spot offered by the Lumisys 100. |
| Density range: | Our density range of 0.03 - 3.5 OD is within the range offeredby all products listed. |
| Grey Scale: | All products listed except Konica offer 12 bit grey scale. |
| Laser source: | Konica and both Nishimoto Sangyo products use semi-conductor laser sources. |
| Beam scan: | Konica and both Nishimoto Sangyo products use a polygonscanner for scanning the x-axis of the image. |
| Maximum resolution: | General Scanning's product is exactly equal to the NishimotoSangyo ED-3500, and is within the range offered in theLumisys 85LF. |
| Interface: | General Scanning is offering a standard SCSI or custominterface. This is equivalent to the products listed. |
The following page show a chart highlighting the substantial equivalence of the LD2000 SERIES to the Lumiscan 85LF, Lumiscan100, Konica, Nishimoto Sangyo ED-2000 and ED-3500 Film Digitizer models.
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Image /page/5/Picture/0 description: The image shows the text "DEPARTMENT OF HEALTH & HUMAN SERVICES". The text is in all caps and is in a bold, serif font. The text is centered on the image and is the only element present.
MAR 19 1998
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Steven Zis Quality Systems Manager General Scanning, Inc. (GSI) Optical Scanning Products Division 500 Arsenal Street Watertown, MA 02172
Re:
K980565 LD2000 Series Dated: February 12, 1998 Received: February 13, 1998 Regulatory class: Unclassified Procode: 90 LMA
Dear Mr. Zis:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we bare 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 Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drue, 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 problibitions 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 Felecal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Proctice requirements, as set forth in the Quality System Regulation (OS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic OS 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 predication for your device and 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 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/dsmaldsmamain.html".
Sincerely yours,
Lillian Yin, Ph.D.
Lillian Yin, Ph.D. Director, Division of Reproductive Abdominal, Ear, Nose and Throa and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Statement of Indications for Use 1.1
The General Scanning model LD2000 SERIES laser film digitizer is intended to convert medical images stored on film to digital data for copying, storage, and transmission. It is intended for use to digitize copies of conventional x-rays and films produced by imagers that fall in the ranges for size and optical density range detailed in the specifications.
The digitizer utilizes laser light to scan the film, extracts the image data by measuring the transmitted light, converts it into digital form, and transmits the data over a digital link. The digitized information may then be transmitted to a Laser Imager for printed hardcopy or to a Work Station for use in Teleradiology (transmission of images) or PACS (Picture Archiving Communication Systems).
The LD2000 SERIES contains the scanning laser and detection module, a film transport, and electronics to convert and transmit the image data and provide control and calibration.
David A. Seymour
(Division Sign-Off)
Division of Reproductive, Abdominal, EN and Radiological De 510(k) Number
Prescription Use
(Per 21 CFR 801.109) ✓
§ 892.2030 Medical image digitizer.
(a)
Identification. A medical image digitizer is a device intended to convert an analog medical image into a digital format. Examples include Iystems employing video frame grabbers, and scanners which use lasers or charge-coupled devices.(b)
Classification. Class II (special controls; voluntary standards—Digital Imaging and Communications in Medicine (DICOM) Std., Joint Photographic Experts Group (JPEG) Std.). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.