(89 days)
The CE-3000 Contrast Enhancer like the FluoroVision, may be used in any application where a viewing device (fluoroscope, endoscope, laparoscope, etc.) and monitor is incorporated to aid in diagnosis and treatment of a disease such as an arthroscopy or cholecystectomy. Despite the different indication statements, both devices have the same function and purpose and the differences in intended use does not create new safety or effectiveness issues.
The CE-3000 takes a video signal in and allows an operator to control, via three knobs on the front panel, the local gain of spatial frequencies, through high specd signal processing, to generate video optimized for specific functions in real time. The three knohs on the front of the device, DETAIL (kernel size), CONTRAST and BACKGROUND, allow the operator to "dial-in" the picture to his preference or he may press the PRESET button to set the cnhancement to predetermined factory settings. A SPLIT screen button is available to help the user to set the optimum enhancement. Selecting the BYPASS switch displays original unprocessed video.
The CE-3000 has a main processor circuit board (core board) which incorporates DigiVision. Inc.'s patented V-Lace technology (for video locally adaptive contrast enhancement) can be adjusted to give the appropriate enhancement to any video scene. The image processing algorithm is expressed as:
Y = c(X · X_bar(d)) + (l · b)X_bar(d) + bM.
The CE-3000 incorporates software as embedded software in the micro controller which is used, in turn to program an EEPROM. There exists no user changeable software.
The enclosure for the CE-3000 is metal (aluminum). The other components are commercially available hardware and electronic components and printed circuit cards manufactured to DigiVision, Inc. specifications.
The provided text primarily describes a device called the CE-3000 Contrast Enhancer and claims its substantial equivalence to an older device, the FluoroVision. It discusses the device's technical characteristics, operation, and safety standards, but does not include a formal study comparing the device's performance against specific acceptance criteria, nor does it provide quantitative performance metrics.
Therefore, I cannot populate the table or answer most of the questions as the information is not present in the provided text.
Here's a breakdown of what can and cannot be answered based on the input:
Acceptance Criteria and Study Information:
| Feature | Description / Information from Text |
|---|---|
| 1. Acceptance Criteria and Reported Device Performance | Not provided in the text. The document states: "Since these two devices use the same algorithm, the output and performance is identical. We have included some pictures of examples of processing (see Pictures of Processing)." This is a claim of equivalence, not a demonstration of meeting specific performance criteria. |
| 2. Sample size and data provenance (test set) | Not applicable. No formal test set or performance study is described. |
| 3. Number and qualifications of experts (test set) | Not applicable. No formal test set or ground truth establishment by experts is described. |
| 4. Adjudication method (test set) | Not applicable. No formal test set or ground truth establishment by experts is described. |
| 5. Multi-reader multi-case (MRMC) study | No. The text does not mention an MRMC comparative effectiveness study. |
| 6. Standalone performance study | No. The text does not describe a standalone performance study with quantitative metrics. It claims identical performance to a predicate device. |
| 7. Type of ground truth used | Not applicable. No formal study requiring ground truth is described. |
| 8. Sample size for training set | Not applicable. The device uses a pre-existing algorithm (V-Lace technology) and is primarily an analog-like signal processor with real-time adjustments via knobs. There's no mention of a machine learning model that would require a "training set" in the typical sense. |
| 9. How training set ground truth was established | Not applicable. See point 8. |
Summary of what can be inferred from the document:
- Device Name: CE-3000 Contrast Enhancer
- Manufacturer: DigiVision, Inc.
- Intended Use: "May be used in any application where a viewing device (fluoroscope, endoscope, laparoscope, etc.) and monitor is incorporated to aid in diagnosis and treatment of a disease such as an arthroscopy or cholecystectomy."
- Algorithm: Uses DigiVision's patented V-Lace technology. The image processing algorithm is expressed as: $$\mathbf{Y} = \mathbf{c}(\mathbf{X} \cdot \bar{\mathbf{X}}(\mathbf{d})) + (\mathbf{l} \cdot \mathbf{b})\bar{\mathbf{X}}(\mathbf{d}) + \mathbf{b}\mathbf{M}.$$
- Claim of Performance: "Since these two devices [CE-3000 and FluoroVision] use the same algorithm, the output and performance is identical." (This is a claim of equivalence, not a direct performance measurement of the CE-3000 against set criteria).
- Safety Standards Met: UL 544, IEC 601-1, EN60601-1-2: 1993.
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K9622660
Image /page/0/Picture/1 description: The image shows the logo for DigiVision. The logo consists of a stylized, three-dimensional shape on the left, resembling three interconnected cubes. To the right of the shape is the word "DigiVision" in a bold, sans-serif font. The overall design is simple and modern.
SEP - 9 COS
DigiVision, Inc.
5626 Oberlin Drive
San Diego, CA 92121
(619) 458-1111
FAX (619) 458-0652
510K SUMMARY
For
DEVICE TRADE NAME: CE-3000 CONTRAST ENHANCER
COMMON NAME: VIDEO CONTRAST ENHANCER
CLASSIFICATION NAME: ENDOSCOPE AND ACCESSORIES ( 876.1500)
SUBMITTED BY: CHARLES A. BRASS - ADMINISTRATOR, QA/QC
DIGIVISION, INC.
5626 OBERLIN DRIVE
SAN DIEGO, CA 92121
CONTACT PERSON: CHARLES A. BRASS
CLAIMING SUBSTANTIAL EQUIVALENCE TO:
DIGIVISION - FLUOROVISION
COMMON NAME: VIDEO CONTRAST ENHANCER
CLASSIFICATION NAME: IMAGE-INTENSIFIED FLUOROSCOPIC X-RAY SYSTEM
(ACCESSORY) (PER 21 CFR 892.1650)
510K NUMBER K864584
PREPARED June 7, 1996
DATE
{1}------------------------------------------------
510K SUMMARY
Description
The CE-3000 takes a video signal in and allows an operator to control, via three knobs on the front panel, the local gain of spatial frequencies, through high specd signal processing, to generate video optimized for specific functions in real time. The three knohs on the front of the device, DETAIL (kernel size), CONTRAST and BACKGROUND, allow the operator to "dial-in" the picture to his preference or he may press the PRESET button to set the cnhancement to predetermined factory settings. A SPLIT screen button is available to help the user to set the optimum enhancement. Selecting the BYPASS switch displays original unprocessed video.
The CE-3000 has a main processor circuit board (core board) which incorporates DigiVision. Inc.'s patented V-Lace technology (for video locally adaptive contrast enhancement) can be adjusted to give the appropriate enhancement to any video scene. The image processing algorithm is expressed as:
$$\mathbf{Y} = \mathbf{c}(\mathbf{X} \cdot \bar{\mathbf{X}}(\mathbf{d})) + (\mathbf{l} \cdot \mathbf{b})\bar{\mathbf{X}}(\mathbf{d}) + \mathbf{b}\mathbf{M}.$$
The CE-3000 incorporates software as embedded software in the micro controller which is used, in turn to program an EEPROM. There exists no user changeable software.
The enclosure for the CE-3000 is metal (aluminum). The other components are commercially available hardware and electronic components and printed circuit cards manufactured to DigiVision, Inc. specifications.
Intended use
The CE-3000 Contrast Enhancer like the FluoroVision, may be used in any application where a viewing device (fluoroscope, endoscope, laparoscope, etc.) and monitor is incorporated to aid in diagnosis and treatment of a disease such as an arthroscopy or cholecystectomy. Despite the different indication statements, both devices have the same function and purpose and the differences in intended use does not create new safety or effectiveness issues.
{2}------------------------------------------------
510K SUMMARY
Technological Characteristics
The technology of both the CE-3000 and the FluoroVision are similar. The CE-3000 takes advantage of advances in electronics technology (since the development of the Fluoro Vision) which allows the reduction of the size and quantity of components. All other comparable (i.e., Hospital power cord, Input/Output cords, metal case, etc.).
Performance
Since these two devices use the same algorithm, the output and performance is identical. We have included some pictures of examples of processing (see Pictures of Processing).
Safety and Effectiveness
DigiVision has no knowledge of any adverse safety or effectiveness issues nor do we expect such problems. The CE-3000 design and use precludes any output of information that could plausibly produce a decision-maker to cause an error. Should the CE-3000 fail in any way it may be removed from the system (i.e., connect the camera directly to the monitor).
The CE-3000 has been evaluated by Underwriters Laboratories and found to pass electrical safety tests to UL 544, IEC 601-1, and approved to bear the UL 544 Listing Mark, IEC 601 Classification Mark and the C-UL IEC 601 Classification Mark.
The CE-3000 is in compliance with the EMC requirements as defined in European Standard EN60601-1-2: 1993.
Classification
Although the cover sheet of this submission indicates that the classification sought is Endoscope and/or Accessories, we request clearance to market the device for similar applications where video image enhancement is desired classified elsewhere in the Code of Federal Regulations. The CE-3000 could be classified in the same way monitors or scopes (i.e., broncoscopes, esophagoscope, etc.) are. provided they accept RS-170, RS-170A or CCIR video.
§ 892.2050 Medical image management and processing system.
(a)
Identification. A medical image management and processing system is a device that provides one or more capabilities relating to the review and digital processing of medical images for the purposes of interpretation by a trained practitioner of disease detection, diagnosis, or patient management. The software components may provide advanced or complex image processing functions for image manipulation, enhancement, or quantification that are intended for use in the interpretation and analysis of medical images. Advanced image manipulation functions may include image segmentation, multimodality image registration, or 3D visualization. Complex quantitative functions may include semi-automated measurements or time-series measurements.(b)
Classification. Class II (special controls; voluntary standards—Digital Imaging and Communications in Medicine (DICOM) Std., Joint Photographic Experts Group (JPEG) Std., Society of Motion Picture and Television Engineers (SMPTE) Test Pattern).