(38 days)
The VIDAR TeleradPRO film digitizer is used for making digital copies of medical x-ray films.
The TeleradPRO film digitizer is intended for making digital copies of medical xray films.
The device consists of a film digitizer with single-film or 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 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.
The provided text describes the TeleradPRO X-Ray Film Digitizer and its substantial equivalence to a predicate device (TeleRADPro Film Digitizers, K993597). However, it does not contain detailed information about specific acceptance criteria or an in-depth study that proves the device meets those criteria in a quantitative manner as typically expected for medical device performance studies.
The document primarily focuses on establishing substantial equivalence to a predicate device, which often relies on demonstrating similar technological characteristics and intended use, rather than presenting a novel clinical study with detailed performance metrics against predefined acceptance criteria.
Based on the provided text, here's the information that can be extracted, and where information is missing:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Optical Resolution | 300 dpi |
| Grayscale Depth | 16-bit |
| Optical Density Sensitivity (DMAX) | 4.8 OD |
| Medical OD Range | 0.2 - 3.2 (incorporates noise and linearity measurements) |
| Intended Use | Making digital copies of medical x-ray films (met by design) |
| Function, Safety, Operating Environmental Conditions, Effectiveness | Determined to be substantially equivalent to predicate device |
Missing Information: Specific quantitative acceptance thresholds for DMAX, medical OD range linearity, and noise are not provided, nor are detailed test results demonstrating compliance against these thresholds. The document states "VIDAR conducts extensive performance testing and the test results demonstrate the device meets the requirements for its intended use" but does not elaborate on the specific tests or their outcomes beyond the summary characteristics.
2. Sample Size Used for the Test Set and Data Provenance
This information is not provided in the document. The document refers to "extensive performance testing" and "Bench Testing" (Section 22, which is not included in the provided text), but it does not specify any test set sample sizes or the provenance of any data (e.g., country of origin, retrospective/prospective). It suggests that the testing was primarily to demonstrate the device's technical specifications and substantial equivalence, not necessarily a clinical or reader study with a specific test set of images.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not provided in the document. As no clinical or reader study with a "test set" and "ground truth" established by experts is described, this information is not applicable. The device is a digitizer, not an AI diagnostic tool, so "ground truth" would relate to the fidelity of the digitization process itself, not an interpretation of medical images.
4. Adjudication Method for the Test Set
This information is not provided in the document. See point 3 above.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance
No MRMC study was done, nor is it relevant given the device is an X-ray film digitizer, not an AI diagnostic tool designed to assist human readers. The document does not mention any AI components.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Study Was Done
The document describes "Performance Testing" and "Bench Testing" which would likely be standalone evaluations of the digitizer's technical specifications (e.g., resolution, DMAX, linearity). However, details of these studies are not provided beyond the summary characteristics listed in Section 1.
7. The Type of Ground Truth Used
Given that the device is a digitizer, the "ground truth" for its performance would typically involve comparing the digitized image to the original film's characteristics or a known standard. The document mentions "incorporates noise and linearity measurements" for the medical OD range, implying that instrumental measurements were used to verify the fidelity of the digitization process. There is no mention of "expert consensus, pathology, or outcomes data" as ground truth, as those would be relevant for diagnostic interpretation, not for a digitizing device.
8. The Sample Size for the Training Set
This information is not provided and is not applicable. The device is a film digitizer, which typically does not involve machine learning "training sets." Its operation is based on optical and electronic principles, not learned algorithms.
9. How the Ground Truth for the Training Set Was Established
This information is not provided and is not applicable. See point 8 above.
§ 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.