(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.
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<914315
APR 1 7 1998
510 (k) Summary as required by 807.92 for the VXR-LS laser film digitizer Prepared on November 7, 1997
Submitted by: VIDAR SYSTEMS CORPORATION 460 Spring Park Place Herndon, Virginia 20170 Telephone 703 471-7070 Facsimile 703 471-1165
Howard Neal Contact Person: Medical Business Line Manager.
Device Trade Name: VXR-LS.
Laser film digitizer. Common Name:
Medical image digitizers were reviewed by the Radiology Classification: Panel and are classified in Class II per 21 CFR 892.2040 (proposed).
Lumiscan 75 (K934496). Predicate Device:
Lumisys, Inc., 225 Humboldt Court, Sunnyvale, California Manufactured by: 94089.
Description of Device:
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.
Intended Use of Device:
The Vidar VXR-LS Film Digitizer is intended for producing digital copies of medical x-ray films.
Substantial Equivalence to Predicate Device:
The VXR-LS is substantially equivalent is substantially equivalent to the Lumiscan 75 (K934496) laser film digitizer manufactured by Lumisys, Inc., 225 Humboldt Court, Sunnyvale, California 94089. The principal characteristics of the two devices that are pertinent to clinical performance are compared below.
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Image /page/1/Picture/0 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a stylized eagle or bird symbol, with three curved lines representing the wings or body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird symbol. The logo is in black and white.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
APR 17 1998
Bill Stamper Quality Control Manager Vidar System Corporation 460 Spring Park Place Herndon, Virginia 20170
Re:
K974315 VXR-LS Laser Film Digitizer Dated: March 18, 1998 Received: March 20, 1998 Regulatory class: Unclassified Procode: 90 LMA
Dear Mr. Stamper:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (OS) for Medical Devices: General regulation (2) CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predication for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (2) CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4613. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address "http://www.fda.gov/cdrh/dsmaldsmamain.html".
Sincerely yours,
William Yin
Lillian Yin, Ph Director, Division of Reproductiv Abdominal, Ear, Nose and Throa and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Vidar VXR-LS Film Digitizer Device Name:
Indications For Usc:
The Vidar VXR-LS Film Digitizer is intended for producing digital
ed to the first and films ine vidur medical x-ray films.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Thomas J. Callahan
(Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological Devi
510(k) Number K974315
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Prescription Use
(Per 21 CFR 801.109)
Over-The-Counter Use
(Oplinial Formal 1-2-46)
§ 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.