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510(k) Data Aggregation
(89 days)
DIGIVISION, INC.
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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