(72 days)
The Silhouette VR is indicated for use in generating radiographic images of human anatomy in all general purpose diagnostic procedures. This device is not intended for mammographic applications.
The Silhouette VR consists of an integrated table and tube stand, under-the-table generator and power distribution unit, wall stand, dual focal spot x-ray tube and operator's console.
The provided text is a 510(K) Summary of Safety and Effectiveness for the "Silhouette VR" Stationary X-ray System. This document focuses on demonstrating substantial equivalence to pre-existing devices, rather than presenting a study proving the device meets specific acceptance criteria in terms of performance metrics like sensitivity, specificity, or image quality, as would be expected for an AI/software device.
Therefore, many of the requested categories about acceptance criteria, study details, and AI-specific metrics cannot be answered directly from the provided text. The document is essentially a regulatory submission for a hardware medical device (an X-ray system) asserting its conformance to existing standards and its equivalence to other marketed devices.
Here's an attempt to extract what is available, with explicit notes on what is not provided:
- A table of acceptance criteria and the reported device performance
- Acceptance Criteria (Implied): Conformance to applicable sections of 21 CFR 1020.30 and 1020.31 (for X-ray equipment), UL 2601-1 (which includes IEC 601-1 and UL 187), and IEC 601-1-2 for EMC. The primary "acceptance criteria" for this type of submission is substantial equivalence to a predicate device.
- Reported Device Performance: The document does not provide specific performance metrics (e.g., spatial resolution, contrast resolution, tube output, image quality scores) that would typically be reported for testing against acceptance criteria for a new, innovative device. Instead, it asserts conformance to safety and performance standards.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Conformance to 21 CFR 1020.30 and 1020.31 (X-ray equipment) | Stated conformance. |
| Conformance to UL 2601-1 (including IEC 601-1 and UL 187) | Stated conformance. |
| Conformance to IEC 601-1-2 (EMC) | Stated conformance. |
| Substantial equivalence to predicate devices for general purpose diagnostic procedures (excluding mammography) | Stated that GE considers the Silhouette VR to be equivalent with other marketed devices. FDA concurred with substantial equivalence. |
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Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not provided. This device is a hardware X-ray system, not an AI or imaging analysis software that operates on a dataset. The "test set" would typically refer to engineering tests and compliance measurements against standards, not a patient image dataset.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not applicable/Not provided. This information is relevant for AI or diagnostic software. For an X-ray machine, ground truth relates to physical measurements and engineering specifications, not expert consensus on images.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable/Not provided. This is specific to diagnostic performance studies, typically involving human readers or AI algorithms.
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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
- No. This device is an X-ray system, not an AI-assisted diagnostic tool.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- No. This device is an X-ray system, not an algorithm.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not applicable/Not provided. For a hardware device, "ground truth" would be against physical standards and engineering benchmarks.
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The sample size for the training set
- Not applicable/Not provided. This device does not use a "training set" in the context of machine learning.
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How the ground truth for the training set was established
- Not applicable/Not provided. This device does not use a "training set" in the context of machine learning.
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NOV 4 1998 P O Box 414 Milwaukee WI 53201-041.
982955
510(K) SUMMARY OF SAFETY AND EFFECTIVENESS
This 510(k) summary of safety and effectiveness information is submitted in accordance with the requirements of 21 CFR Pat 807.87(h).
| Identification of Submitter: | Larry A. Kroger, Ph.D.Senior Regulatory Programs ManagerGE Medical SystemsTel. (414) 544-3894Summary prepared: 7 August, 1998 |
|---|---|
| ------------------------------ | ----------------------------------------------------------------------------------------------------------------------------------------------- |
Identification of Product: Silhouette VR
- Classification Name: Stationary X-ray System
- GE HuaLun Medical Systems Co., Ltd. Manufacturer: No. 11 Jiuzhong Road, Jiugong Zone. Daxing County, Beijing (100076) P.R. China
- The Silhouette VR consists of an integrated table and tube stand. Device Description: under-the-table generator and power distribution unit, wall stand, dual focal spot x-ray tube and operator's console.
- Indications for Use: The Silhouette VR is indicated for use in generating radiographic images of human anatomy in all general purpose diagnostic procedures. This device is not intended for mammographic applications.
- The Silhouette VR will conform the applicable sections of 21CFR Conformance 1020.30 and 1020.31, and UL 2601-1 (which includes IEC 601-1 and UL 187). The Silhouette VR also meets the IEC 601-1-2 standard for EMC.
- GE considers the Silhouette VR to be equivalent with other Conclusions: marketed devices with the same indications for use and meeting similar standards.
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Image /page/1/Picture/0 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized abstract symbol resembling a person with outstretched arms, with three curved lines forming the body and arms. The symbol is enclosed within a circular border, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter of the circle.
Re:
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
4 1998 NOV
Larry A. Kroger, Ph.D. Senior Regulatory Programs Manager GE Medical Systems P.O. Box 414 , W-709 Milwaukee, WI 53201
K982955 Silhouette VR Dated: August 21, 1998 Received: August 24, 1998 Regulatory class: II 21 CFR 892.1680/Procode: 90 KPR
Dear Dr. Kroger:
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 (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 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/odrividsmaldsmamain.html".
Sincerely yours,
Lillian Yin, Ph.D.
Lillian Yin, Ph.D Director, Division of Reproductiv Abdominal, Ear, Nose and Thro and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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STATEMENT OF INTENDED USE
510(k) Nun ber (if known): K982955
Device Name: Silhouette VR
Indications for Use
The Silhou ette VR is indicated for use in generating radiographic images of human anatomy in The Simot site VYT is Indicated for ass in generaling halls not intended for mammographic applicatior s.
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| Prescription Use (Per 21 CFR 801-109) | OR Over-The-Counter Use |
|---|---|
| --------------------------------------- | ------------------------- |
| (Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological Devices, | |
|---|---|
| 510(k) Number | K982955 |
§ 892.1680 Stationary x-ray system.
(a)
Identification. A stationary x-ray system is a permanently installed diagnostic system intended to generate and control x-rays for examination of various anatomical regions. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II (special controls). A radiographic contrast tray or radiology diagnostic kit intended for use with a stationary x-ray system only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.