(85 days)
The Diagnostic PRO, VXR-16, and VXR-16 DOSIMETRY PRO x-ray film digitizers are intended for producing digital copies of medical x-ray films.
The x-ray film digitizer is an electronic device that converts analog x-ray films into digital data. The maximum film width is 14".
This 510(k) summary (K993599) does not appear to contain the level of detail requested for a comprehensive study description and acceptance criteria. The document focuses on establishing substantial equivalence to a predicate device (MedScan 12) rather than providing extensive performance data from a specific study.
However, based on the provided text, here's what can be extracted and inferred regarding the "acceptance criteria" through the lens of substantial equivalence, and the "study" demonstrating this equivalence:
1. Table of Acceptance Criteria and Reported Device Performance
The concept of "acceptance criteria" in this 510(k) is tied directly to the performance of the predicate device, MedScan 12. The underlying assumption is that if the new devices (Diagnostic PRO, VXR-16, and VXR-16 DOSIMETRY PRO) perform comparably to the predicate device, they meet the necessary safety and effectiveness standards. The document states: "Technical differences between the devices and the predicate raise no new issues of safety and effectiveness." This implies that the current devices meet the same performance standards as the MedScan 12.
Without specific quantitative performance metrics listed for the predicate or the new devices in this summary, a direct table of numerical "acceptance criteria" and "reported device performance" is not available. However, based on general expectations for X-ray film digitizers, the acceptance criteria would implicitly revolve around:
| Acceptance Criteria (Implied from Predicate Equivalence) | Reported Device Performance (Implied) |
|---|---|
| Image Quality (Resolution, Density Range, D-max/D-min): Sufficient to accurately digitize medical X-ray films for diagnostic interpretation. | "Technical differences... raise no new issues of safety and effectiveness," implying comparable image quality to the MedScan 12 for diagnostic utility. |
| Accuracy of Digitization: Faithful reproduction of original film features. | Same as above. |
| Speed/Throughput: Practical operational speed for clinical use. | Same as above. |
| Reliability/Durability: Consistent operation without frequent malfunction. | Same as above. |
| Safety Features: Adherence to relevant electrical safety and electromagnetic compatibility standards. | Same as above. |
| Intended Use: Ability to produce digital copies of medical x-ray films. | Device is "intended for producing digital copies of medical x-ray films." |
2. Sample Size Used for the Test Set and Data Provenance
The 510(k) summary does not provide information on a specific test set, its sample size, or data provenance (e.g., country of origin, retrospective/prospective). The primary "study" presented here is a comparison to a predicate device, not an independent clinical or technical performance study with a defined test set. The claim relies on the established safety and effectiveness of the existing MedScan 12.
3. Number of Experts Used to Establish Ground Truth and Qualifications
Not applicable. The summary does not describe a study involving human expert review to establish ground truth. The basis of equivalence is technical comparison to a predicate device already on the market.
4. Adjudication Method
Not applicable. There is no mention of adjudication methods as no human expert review or formal "test set" evaluation is described in this summary for the purpose of establishing a new ground truth.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No. The K993599 summary does not describe an MRMC comparative effectiveness study, either with or without AI assistance. The devices are film digitizers, not AI-powered diagnostic tools. There is no mention of human readers or AI in the context of improving diagnostic accuracy.
6. Standalone Performance Study
The summary does not present a standalone (algorithm only) performance study with quantitative metrics. The "study" described is the assertion of substantial equivalence to a predicate device based on technical similarities and the absence of new safety/effectiveness concerns. The emphasis is on the digitizer's ability to convert analog films to digital data, implicitly assuming the digital output is faithful to the original film.
7. Type of Ground Truth Used
Not applicable in the typical sense of a diagnostic algorithm. For a film digitizer, the "ground truth" would implicitly be the physical X-ray film itself. The performance evaluation, if there were one detailed here, would relate to how accurately the digital representation matches the analog film. However, this 510(k) simply states that "Technical differences between the devices and the predicate raise no new issues of safety and effectiveness," indicating an assumption of equivalent fidelity without explicitly defining or evaluating a "ground truth" for the new devices.
8. Sample Size for the Training Set
Not applicable. The devices are film digitizers, not machine learning or AI algorithms that require a "training set."
9. How the Ground Truth for the Training Set was Established
Not applicable. As the devices are not AI or machine learning based, there is no training set or ground truth establishment method for it.
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K99 3599
'JAN 1 8 2000
510 (k) Summary As required by 807.92 For the Diagnostic PRO, VXR-16, and VXR-16 DOSIMETRY PRO x-ray film digitizers Prepared on September 9, 1999
| Submitted by: | VIDAR Systems Corporation460 Spring Park PlaceHerndon, VA 20170Telephone: (703) 471-7070Fax: (703) 471-1165 |
|---|---|
| Contact Person: | Mary "Pennie" DrinkardMedical Business Line Program Manager |
| Device Trade Name: | Diagnostic PRO, VXR-16, and VXR-16 DOSIMETRY PRO x-ray filmdigitizers. |
| Common Name: | X-ray film digitizer |
| Classification: | Medical image digitizers were reviewed by the Radiology panel and areclassified in Class 11 per CFR 892.2040 (proposed). |
| Predicate Device: | MedScan 12 (K933632) |
| Manufactured by: | VIDAR Systems Corporation, 460 Spring Park Place, Herndon, VA 20170 |
| Description of Device: | The x-ray film digitizer is an electronic device that converts analog x-ray filmsinto digital data. The maximum film width is 14". |
Intended use for the device:
The VIDAR Diagnostic PRO, VXR-16, and VXR-16 DOSIMETRY PRO x-ray film digitizers are intended for producing digital copies of medical x-ray films.
Substantial Equivalence to Predicate Device:
The Diagnostic PRO, VXR-16, and VXR-16 DOSIMETRY PRO are substantially equivalent to the MedScan 12 (K933632) film digitizer manufactured by VIDAR Systems Corporation, 460 Spring Park Place, Herndon, VA 20170. Technical differences between the devices and the predicate raise no new issues of safety and effectiveness.
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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA" written around it. Inside the circle is an abstract symbol that resembles an eagle or bird in flight, with three stylized lines representing the wings and body.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN 1 8 2000
Mary "Pennie" Drinkard Medical Business Line Program Manager Vidar Systems Corporation 460 Spring Park Place Herndon, VA 20170
Re: K993599 Diagnostic PRO, VXR-16 and VXR-16 Dosimetry PRO Dated: September 21, 1999 Received: October 25, 1999 Regulatory class: II 21 CFR 892.2030/90 LMA
Dear Ms. Drinkard:
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 legally marketed predicate 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 (Special Controls) or class III (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 (QS) for Medical Devices: General regulation (21 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 531 through 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 predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your labeling requlation (21 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 requiation 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/dsma/dsmamain.html".
Sincerely yours,
CAPT Daniel G. Schultz, M.D. Acting Director, Division of Reproductive, Abdominal, Ear, Nose and Throat, ~ and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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510 k) Number (if known): ____________________________________________________________________________________________________________________________________________________
Device Name: Diagnostic PRO, VXR-16, and VXR-16 DOSIMETRYPRO.
Indications for use:
.
The Diagnostic PRO, VXR-16, and VXR-16 DOSIMETRYPRO film digitizers are intended for making digital copies of 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)
Daniel A. Sigman
(Division Sign-Off) (Division of Reproductive, Abdominal, ENT, and Radiological Devices 510(k) Number
Prescription Use
(Per 21 CFR 801.109)
OR
Over-the-counter Use __
§ 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.