(69 days)
The DiagnosticPRO Edge digitizer is used for making digital copies of medical x-ray film, .including .printed and .radiographic .film. The .target users of these devices are .medical professionals or trained staff for use as secondary capture images for consultation, review and final interpretation.
The devices are indicated for the digitization of mammography images for review and analysis, but not as the sole basis for screening or diagnosis.
The device consists of a film digitizer with multi-film feeder, external power adapter, and Windows driver software. The film digitizer will convert the X-ray film into digital data representing the X-ray film, and the windows driver software is used to import the digital data into a compatible software application. The digitizer is used with DICOM standard software that meets or exceeds ACR and DICOM standards for use of secondary capture images for consultation, review and final interpretation.
The digitizer is connected to a PC through a USB 2.0 interface. The digitizer utilizes rollers driven by a stepper motor to feed the X-ray film past the scan optics. The scan optics consists of a white LED illuminator, a lens, mirrors, and a CCD linear array detector.
This device has no patient contact and does not supply a diagnostic result. The film digitizer only provides digital data representing the film.
The provided document is a 510(k) summary for the VIDAR DiagnosticPRO Edge X-Ray Film Digitizer. It states that "VIDAR conducts extensive performance testing and the test results demonstrate the device meets the requirements for its intended use" and refers to "Section 19 Bench Testing." However, Section 19 Bench Testing and the specific details of the performance testing results and acceptance criteria are not included in the provided text.
Therefore, I cannot provide a table of acceptance criteria or the specific details of the study that proves the device meets the acceptance criteria based only on the provided input. The document mentions "Bench Testing" in Section 19, which implies performance evaluation, but the content of that section is missing.
Based on the available information, I can only provide general information about the device and point out the missing details.
Here's an outline of the information that would be provided if the "Section 19 Bench Testing" were available:
Missing Information from Provided Document:
The provided 510(k) summary states that performance testing was conducted and refers to "Section 19 Bench Testing" for details. However, the content of Section 19 is not included in the provided text. Therefore, I cannot extract specific acceptance criteria, reported device performance data, study design, or ground truth establishment.
§ 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.