(28 days)
These radiographic intensifying screens have application whenever a high image quality radiographic examination such as mammography is required.
Ultra-Vision® Mammography Detail and Ultra-Vision® Mammography Fast Detail are ultraviolet activated rare earth intensifying screens. The phosphor is niobium activated lutetium tantalate.
The provided 510(k) summary for K974423 (Ultra-Vision® Mammography Detail and Ultra-Vision® Mammography Fast Detail) describes a comparison to a predicate device but does not contain a study or detailed acceptance criteria as one would expect for a modern AI/CAD device.
This submission is for radiographic intensifying screens, which are hardware components, not a software algorithm or AI device. Therefore, the questions related to AI/CAD performance (like MRMC studies, standalone performance, training sets, expert ground truth adjudication) are not applicable to this type of device.
Here's the information that can be extracted based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance:
The document doesn't explicitly state "acceptance criteria" but provides a comparison table against a predicate device, implying that performance similar to or better than the predicate is the basis for substantial equivalence. The "reported device performance" are the values for the new devices from this comparison.
| Metric | Acceptance Criteria (Implied by Predicate) | Ultra-Vision® Mammography Detail | Ultra-Vision® Mammography Fast Detail |
|---|---|---|---|
| Phosphor | Gadolinium Oxysulfide | Lutetium Tantalate | Lutetium Tantalate |
| Speed | 1.0 | 1.17 | 1.53 |
| MTF @ 4cycles/mm | .635 | .675 | .635 |
| X-ray Absorption @ 25 kVp | .60 | .61 | .83 |
| Imaging Application | Mammography | High Image quality | High Image quality |
Explanation: The "Acceptance Criteria (Implied by Predicate)" column represents the performance characteristics of the predicate device (Microvision™ Detail). The new devices are considered substantially equivalent because their performance in these metrics is comparable or improved. For example, the new devices show higher speed and potentially higher MTF and X-ray absorption, which are considered improvements for a mammography intensifying screen. The change in phosphor material is noted but acceptable if the performance metrics are met.
2. Sample size used for the test set and the data provenance:
- Not applicable / Not provided. This submission is for hardware components (intensifying screens). Performance metrics like Speed, MTF, and X-ray Absorption are typically measured in a laboratory setting using standardized testing methods, not a "test set" of patient data in the context of AI. Data provenance (country of origin, retrospective/prospective) is not relevant for this type of device.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. Ground truth in the context of expert review is for diagnostic accuracy of an AI or human reader on patient images. This device is an intensifying screen, whose performance is measured through physical properties, not diagnostic interpretation.
4. Adjudication method for the test set:
- Not applicable. See point 3.
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 is not an AI device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is not an AI device. The measurements of Speed, MTF, and X-ray Absorption are inherent standalone performance characteristics of the screen itself.
7. The type of ground truth used:
- Laboratory measurements/Physical properties. The "ground truth" for this device's performance relies on rigorous physical measurements of parameters like spectral sensitivity, light output, spatial resolution (MTF), and x-ray absorption, typically conducted under controlled laboratory conditions using established standards for radiographic screen testing.
8. The sample size for the training set:
- Not applicable. This is not an AI device, so there is no "training set."
9. How the ground truth for the training set was established:
- Not applicable. See point 8.
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STERLIN
Diagnostic Imaging
DEC 2 2 1997
510(k) SUMMARY OF SAFETY AND EFFECTIVENESS
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the This Summans of SMDA 1990 and 21 CFR 807.92.
SUBMITTED BY: Jean E. Bartlett (864) 421-1836 Regulatory Affairs and Quality Assurance STERLING DIAGNOSTIC IMAGING, INC. PO Box 19048, Mail Drop 102 Greenville, SC 29602-9048 Fax # (864) 421-1635
DEVICE NAME: Ultra-Vision® Mammography Detail Ultra-Vision® Mammography Fast Detail
PREDICATE DEVICE: Microvision™ Detail
DEVICE DESCRIPTION AND INTENDED USE:
DE VICE DESCRIPTION AN INTER Vision® Mammography Fast Detail are ultraviolethum astivated Ultra-Vision® Mammography Delan and Onlia- Priores Manziberghing Screens. The phosphor is niobium activated lutetium tantalate.
These screens are intended for use in radiographic procedures requiring high levels of image quality such as mammography.
DEVICE COMPARISON TO PREDICATE DEVICE:
DE VICE COMI ARCOTT TO Price Detail and Ultra-Vision® Mammography Fast Detail are substantially The Other Vision Online grappy Detail as summarized below:
| Ultra-Vision®MammographyDetail | Ultra-Vision®MammographyFast Detail | Microvision Detail | |
|---|---|---|---|
| Phosphor | Lutetium Tantalate | Lutetium Tantalate | Gadolinium Oxysulfide |
| Speed | 1.17 | 1.53 | 1.0 |
| MTF @ 4cycles/mm | .675 | .635 | .635 |
| X-ray Absorption @ 25 kVp | .61 | .83 | .60 |
| Imaging Application | High Image quality | High Image quality | Mammography |
SUMMARY OF PRODUCT SIMILARITIES/DIFFERENCES
Signature: Jare Sattlett
Date: 11-19-97
Sterling Diagnostic Imaging, Inc. 10 South Academy Street P.O. Box 19048 Greenville, SC 29602-9048
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Image /page/1/Picture/0 description: The image shows the logo for the Department of Health & Human Services. The logo consists of the department's name in a circular arrangement around a symbol. The symbol is composed of three stylized human figures, represented by flowing lines, suggesting a sense of movement and connection.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC 2 2 1997
JeanE Bartlett Regulatory Affairs & Compliance Manager Sterling Diagnostic Imaging, Inc. 10 South Academy Street P.O. Box 19048 Greenville, SC 29602-9048
Re: K974423
Ultra-vision® Mammography Detail Ultra-vision® Mammography Fast Detail Dated: November 21, 1997 Received: November 24, 1997 Regulatory Class: I, Tier II 21 CFR 892.1960/Procode: 90 EAM
Dear Ms. Bartlett:
We have reviewed your Section 5100k) 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 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 requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic OS 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 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 marked 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 device on our labeling regulation (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 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/dsmamain.html"
Sincerely yours,
W.Liau Yu
Lillian Yin, Ph.D. Director, Division of Reproductive, Abdominal. Ear. Nose and Throat. and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
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INDICATIONS STATEMENT
510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
Device Name: Ultra-Vision® Mammography Detail Ultra-Vision® Mammography Fast Detail
Indications for Use:
These radiographic intensifying screens have application whenever a high image quality radiographic examination such as mammography is required.
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Concurrence of CDRH, Office of Device Evaluation (ODE)
| Prescription Use(Per 21 CFR 801.109) | OR Over-The-Counter |
|---|---|
| ------------------------------------------ | --------------------- |
(Optional Format 1-2-96)
(Division Sign-Off)
Division of Reproductive, Abdominal, ENT, and Radiological Devices
| 510(k) Number | K974423 |
|---|---|
| --------------- | --------- |
§ 892.1960 Radiographic intensifying screen.
(a)
Identification. A radiographic intensifying screen is a device that is a thin radiolucent sheet coated with a luminescent material that transforms incident x-ray photons into visible light and intended for medical purposes to expose radiographic film.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 892.9.