(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.
§ 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.