(20 days)
Revolution XR/d Digital Radiographic Imaging System is indicated for use in generating Tomographic images. Revolution XR/d Digital Radiographic Imaging System is not intended for mammographic applications.
The Revolution XR/d with Tomosynthesis is a radiographic x-ray system intended for examinations using digital Tomosynthesis acquisition techniques. Tomosynthesis is a hardware & software option to the Revolution XR/d Digital Radiography System. The Revolution XR/d with Tomosynthesis consists of a elevating radiographic table with integrated digital detector, a radiographic wall stand with integrated digital detector, and an x-ray tube hanger, Overhead Tube Crane or Floor Mounted Tube Stand.
The provided documents, K051967, contain limited information about the acceptance criteria and study details. Based on the "Summary of Safety and Effectiveness Prepared in accordance with 21 CFR Part 807.92(c)," here's what can be extracted:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Tomosynthesis diagnostic capability is as good as the predicate Tomo-link linear tomographic device. | "Tomosynthesis diagnostic capability is as good as the Tomo-link linear tomographic device." |
| Key features are consistent with traditional clinical procedures. | "other key features are consistent with traditional clinical procedures." |
Explanation of Implied Criteria: The document explicitly states the goal of the clinical tests was to show the tomosynthesis diagnostic capability is "as good as" the predicate device and that key features are "consistent." While no specific quantitative metrics or thresholds are provided as acceptance criteria, these qualitative statements serve as the basis for the reported performance.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: The document does not specify the sample size used for the clinical tests.
- Data Provenance: The document does not provide information on the country of origin of the data or whether the study was retrospective or prospective. It only states, "Clinical Tests: Clinical tests under the authority of an IRB..."
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- The document does not provide any information regarding the number of experts used or their qualifications for establishing ground truth.
4. Adjudication Method for the Test Set
- The document does not mention any adjudication method used for the test set.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
- The document does not indicate that a multi-reader, multi-case (MRMC) comparative effectiveness study was performed or provide any effect size information. The clinical tests simply aimed to compare the diagnostic capability to a predicate device.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- This device is a "Digital Radiographic Imaging System with Tomosynthesis," implying it's an imaging hardware and software system, not solely an algorithm. The clinical tests assessed its "diagnostic capability," which inherently involves the output of the system that would then be interpreted by a human. Therefore, a standalone algorithm-only performance assessment in the modern sense (e.g., AI output without human interpretation) is not explicitly described or implied in this context, given the 2005 date of the submission. The "Tomosynthesis" part is described as an "acquisition technique" and a "software option."
7. The Type of Ground Truth Used
- The document does not explicitly state the type of ground truth used (e.g., expert consensus, pathology, outcomes data). The comparison is made against the "Tomo-link linear tomographic device," suggesting the predicate device's diagnostic performance served as the benchmark.
8. The Sample Size for the Training Set
- The document refers to a "Revolution XR/d with Tomosynthesis" which is described as a "hardware & software option." Given the 2005 date, it is highly unlikely that "training set" in the context of modern machine learning was applicable in the same way. The document does not mention any training set or data used for algorithm development or machine learning.
9. How the Ground Truth for the Training Set Was Established
- As no "training set" for an AI algorithm is mentioned or implied, there is no information on how its ground truth would have been established.
Summary of the Study:
The provided 510(k) summary for the Revolution XR/d Digital Radiographic Imaging System with Tomosynthesis (K051967) indicates that clinical tests were conducted under the authority of an Institutional Review Board (IRB). The primary finding of these tests was that the "Tomosynthesis diagnostic capability is as good as the Tomo-link linear tomographic device" (K944967), which was the predicate device. Additionally, it was concluded that the device's "key features are consistent with traditional clinical procedures."
It's important to note that this submission dates back to 2005. The level of detail regarding clinical study design, acceptance criteria, and AI-specific performance metrics has evolved significantly in regulatory submissions since then. The information provided in this document is much less detailed than what would typically be required for a modern AI/ML-enabled device submission.
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051967
510(k) XR/d with Tomosynthesis GE Healthcare
AUG 9 - 2005
Attachment B:
Summary of Safety and Effectiveness Prepared in accordance with 21 CFR Part 807.92(c).
Image /page/0/Picture/5 description: The image shows the General Electric (GE) logo. The logo consists of the letters "GE" intertwined and enclosed within a circular shape. The logo is black and white.
GE Medical Systems
General Electric Company P.O. Box 414, Milwaukee, WI 53201
| Submitter: | GE Healthcare3000 N. Grandview Blvd.Waukesha, WI 53188 |
|---|---|
| Contact Person: | John L. SchmidtSafety and Regulatory EngineeringTelephone: 262-548-4964; Fax: 262-548-2032 |
| Date Prepared: | July 15, 2005 |
| Device Name: | Revolution XR/d Digital Radiographic Imaging System with Tomosynthesis |
| Marketed Device: | Revolution XR/d Digital Radiographic Imaging System, 510(k) Number K012389Tomo-Link, K944967, currently in commercial distribution. |
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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 is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three birds in flight, arranged in a row.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. John L. Schmidt Safety and Regulatory Engineer GE Healthcare GE Medical Systems LLC 3000 N. Grandview Blvd. WAUKESHA WI 53188
AUG 9 - 2005
Re: K051967
Trade/Device Name: Revolution XR/d with Tomosynthesis Regulation Number: 21 CFR 892.1650 Regulation Name: Image-intensified fluoroscopic x-ray system Regulation Number: 21 CFR 892.1680 Regulation Name: Stationary x-ray system Regulation Number: 21 CFR 892.1740 Regulation Name: Tomographic x-ray system Regulatory Class: II Product Code: KPR, MQB, and IZF Dated: July 15, 2005 Received: July 20, 2005
Dear Mr. Schmidt:
. "
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and 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) that do not require approval of a premarket approval application (PMA). 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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This letter will allow you to begin marketing your device as described in your Section 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 (o proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter:
| 21 CFR 876.xxxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|---|---|---|
| 21 CFR 884.xxxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 892.xxxx | (Radiology) | 240-276-0120 |
| Other | 240-276-0100 |
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Nancy C. Brogdon
Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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STATEMENT OF INDICATIONS FOR USE
510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
Device Name: Revolution XR/d with Tomosynthesis
Indications for Use
Revolution XR/d Digital Radiographic Imaging System is indicated for use in generating Tomographic Hevoldion AFVO Digital hadlographis maging System is manimographic applications.
(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_______________________________________________________________________________________________________________________________________________________
David A. Segerson
(Division Sign-Off)
(Division Sign-Off) Division of Renenduring Andominal and Padintoneal Devices 510(k) Number ________________________________________________________________________________________________________________________________________________________________
§ 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.