(29 days)
The VIDAR dental film digitizer is used for making digital copies of x-ray film commonly used in dental practices. Images captured with this device are intended for use in primary, secondary and over-reading applications.
The Dental Film Digitizer is a medical device used to convert x-ray films into a digital format. The device uses high end imaging components and design characteristics specifically geared towards the complexity of x-ray film data; offering the user a low noise, high resolution reproduction of the medical film.
The provided 510(k) summary for the VIDAR Dental Film Digitizer does not contain information about acceptance criteria or a study proving the device meets specific acceptance criteria in the manner described in the request. The document states:
"VIDAR conducts extensive performance testing and the test results demonstrate the device meets the requirements for its intended use. Please see Section 19 Bench Testing."
However, Section 19 ("Bench Testing") is not included in the provided text. Therefore, the following information cannot be extracted:
- A table of acceptance criteria and reported device performance.
- Sample size used for the test set and data provenance.
- Number and qualifications of experts for ground truth.
- Adjudication method for the test set.
- Whether a multi-reader multi-case (MRMC) comparative effectiveness study was done, or the effect size of human readers with/without AI assistance.
- Whether a standalone (algorithm only) performance study was done.
- The type of ground truth used.
- The sample size for the training set.
- How the ground truth for the training set was established.
The document focuses on demonstrating substantial equivalence to a predicate device based on technological characteristics and intended use, rather than presenting a performance study with explicit acceptance criteria.
Information that could be extracted from the provided text includes:
- Device Description: The Dental Film Digitizer converts x-ray films to digital format, offering low noise and high-resolution reproduction.
- Intended Use: For making digital copies of x-ray film common in dental practices. Images are for primary, secondary, and over-reading applications by medical professionals or trained staff.
- Technological Characteristics (Performance Specifications, not Acceptance Criteria):
- Optical resolution: 300 dpi
- Grayscale: 16-bit
- Optical density sensitivity (DMAX): 4.1 OD
- Medical OD range: 0.2 - 3.6 (incorporates noise and linearity measurements)
- Predicate Device: VIDAR Sierra (P111), TeleRADPro and VXR-12 plus Film Digitizers (K993597).
§ 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.