(68 days)
This device is a Charge Coupled Device (CCD) video camera for use in digital radiography, including DSA, high resolution cardiology, and low dose fluoroscopy. It is designed for use with X-ray image intensifiers in diagnostic imaging chains.
This device is a Charge Coupled Device (CCD) video camera for use in digital radiography, including DSA, high resolution cardiology, and low dose fluoroscopy. It is designed for use with X-ray image intensifiers in diagnostic imaging chains.
The provided document is a 510(k) summary for the Camtronics CCD Camera, K990066. It claims substantial equivalence to a predicate device, K953974 MediCal Imaging Ltd. "Camvision 1000".
However, the 510(k) summary explicitly states two crucial points:
- "Performance data: Not required for determination of substantial equivalence for this class of device."
- "Conclusions drawn from clinical and nonclinical test data: Not required for determination of substantial equivalence for this class of device."
Therefore, based on the provided text, there is no acceptance criteria or study data presented that proves the device meets specific acceptance criteria in terms of performance metrics. The submission relies solely on demonstrating substantial equivalence to a predicate device through a comparison of specifications.
Given this, I cannot provide the requested information in the format requested. The document does not contain:
- A table of acceptance criteria and the reported device performance: No performance data or acceptance criteria are reported.
- Sample sized used for the test set and the data provenance: No test set or data provenance is mentioned as performance data was not required.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable, as no test set requiring ground truth was presented.
- Adjudication method: Not applicable.
- MRMC comparative effectiveness study: Not applicable.
- Standalone performance study: Not applicable.
- Type of ground truth used: Not applicable.
- Sample size for the training set: Not applicable, as this is a device submission, not an AI/ML algorithm submission in the modern sense.
- How the ground truth for the training set was established: Not applicable.
Instead, the submission focuses on a direct comparison of technical specifications between the proposed device and the predicate device, as shown in the table below:
Predicate Device Specifications Comparison (as presented in the 510(k) Summary)
| Principal Device (Camtronics CCD Camera) | Predicate Device (K953974 MediVision-Medical Imaging Ltd. “Camvision 1000”) | |
|---|---|---|
| CCD and analog circuitry | ||
| CCD type | interline | interline |
| Scanning | progressive | progressive |
| Resolution | 1024 x 1024 | 1024 x 1024 |
| Contrast resolution | 12 bit, 4096 gray levels | 10 bit, 1024 gray levels |
| Anti-blooming | automatic control, up to 100:1 | automatic control, up to 100:1 |
| TV parameters | ||
| Video output | High-line interlaced, 1.0 V peak to peak on 75 ohm | composite video RS-343A or progressive scan, 50 or 60 Hz, 1.0 V peak-to-peak on 75 ohm |
| Digital output | RS 644 | RS-422 AIA compatible |
| Bandwidth | 12 bit 40 MHz | input equivalent to 20 MHz, output equivalent to 40 MHz |
| Dynamic range | 66 dB | 60 dB |
| Signal to noise ratio | greater than 1000:1 | 1000:1 at camera's connector |
| Gamma | adjustable or linear | adjustable, 0.45-1.0 |
| Frame rate | up to 25 or 30 frames per second | up to 25 or 30 frames per second |
| Fast frame rate | 50 or 60 frames per second at 1024 x 512. 30 fps at 1024 x 1024 | 50 or 60 frames per second at 1024 x 512 |
| X-ray and image control | ||
| Internal controls | automatic gain control (AGC), automatic anti-blooming level (AAL) | automatic gain control (AGC), automatic anti-blooming level (AAL), automatic integration control (AIC) |
| External controls | video gain select, horizontal scan reverse, vertical scan reverse, black level select | video gain select, anti-blooming level select, horizontal scan reverse, vertical scan reverse, black level select |
| Video synchronization | internal or external | internal or external |
| Fluoroscopy control | automatic brightness control (ABC) | automatic brightness control (ABC) |
| Iris control | motorized control | automatic control |
The conclusion of the 510(k) summary is that the Camtronics CCD Camera is "substantially equivalent to a legally marketed predicate device" and that "No new safety or effectiveness issues are raised." This determination is based on the "substantially equivalent technological characteristics, features, specifications, materials, modes of operation, and intended uses."
§ 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.