(151 days)
The Vidar VXR-LS Film Digitizer is intended for producing digital copies of medical x-ray films.
The Vidar VXR-LS is a digitizer of radiographic film transparencies incorporating a laser beam scanned in one direction, a mechanical stage that moves a sheet of film in the orthogonal direction, a light collector and photomultiplier and electronic circuity for analog-to-digital conversion, system operation, and connection to external networks.
The provided text describes a 510(k) summary for the VIDAR VXR-LS laser film digitizer. This device is a film digitizer, not an AI-powered diagnostic tool, and therefore the information typically requested for AI device studies (like expert ground truth, MRMC studies, training set details, and specific performance metrics like sensitivity/specificity) is not applicable or present in this type of submission.
The 510(k) process focuses on demonstrating substantial equivalence to a legally marketed predicate device, primarily through comparing technical characteristics and intended use. Performance in terms of accuracy for diagnostic tasks is not typically assessed in the same way as an AI algorithm that interprets images.
However, based on the provided text, I can infer and summarize what is available regarding acceptance criteria and the study for this device:
1. Table of Acceptance Criteria and Reported Device Performance
For a film digitizer, "acceptance criteria" primarily relate to demonstrating that its core functionalities (capturing film, converting it to digital) are comparable to a predicate device, focusing on technical specifications. The document compares the VXR-LS to the Lumiscan 75 (K934496).
| Feature | Acceptance Criteria (Predicate Device: Lumiscan 75) | Reported Device Performance (VIDAR VXR-LS) |
|---|---|---|
| Description of Device | Laser film digitizer, mechanical stage for film movement, light collector, photomultiplier, analog-to-digital conversion, system operation, network connection (implied by predicate device type) | Laser beam scanned in one direction, mechanical stage for orthogonal film movement, light collector, photomultiplier, electronic circuitry for analog-to-digital conversion, system operation, connection to external networks. |
| Intended Use | Producing digital copies of medical x-ray films (implied by predicate device's function) | Producing digital copies of medical x-ray films. |
| Principal Characteristics Pertinent to Clinical Performance | (Not explicitly listed as quantitative criteria, but implicitly met by demonstrating similar technological approach and intended use) | (Claimed to be substantially equivalent based on matching the description and intended use of the predicate) |
Note: The document does not provide specific quantitative performance metrics (e.g., resolution, Dmax, Dmin, signal-to-noise ratio) for either the predicate or the VXR-LS. Substantial equivalence in this context is often argued based on similar technology, design, and intended use as described in the 510(k) submission.
2. Sample size used for the test set and the data provenance:
- Sample Size: Not applicable. This is not a study assessing diagnostic accuracy with a test set of patient cases. The "study" here refers to the engineering and design verification that the device functions as intended and is comparable to the predicate.
- Data Provenance: Not applicable.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. There is no ground truth, expert consensus, or clinical performance evaluation of diagnostic accuracy in the context of this 510(k) summary.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- Not applicable. This device is a film digitizer, not an AI-powered diagnostic tool. It does not involve human readers interpreting images with or without AI assistance.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is not an algorithmic device in the sense of AI. Its "performance" is based on its ability to digitize film, which is a standalone function. The assessment is of its technical specifications and equivalence to a predicate, not diagnostic accuracy.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Not applicable. The equivalence is based on technical specifications and intended use comparison to an existing device, not on diagnostic truth.
8. The sample size for the training set:
- Not applicable. This device does not use machine learning or AI models that require a "training set."
9. How the ground truth for the training set was established:
- Not applicable.
§ 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.