(87 days)
X-Ray Film Development
SRX-701 Film Processor
The provided text is a 510(k) clearance letter from the FDA for the Konica SRX 701 Automatic X-ray Film Processor. It does not contain any information about acceptance criteria, device performance studies, or AI/algorithm-related details.
This device is an X-ray film processor, which is a physical piece of equipment for developing X-ray film, not a software algorithm or an AI-powered diagnostic device. Therefore, the questions regarding ground truth, expert consensus, sample size for training sets, or comparative effectiveness studies with AI assistance are not applicable to this particular device.
To directly answer your request based on the provided text, while acknowledging its limitations:
1. A table of acceptance criteria and the reported device performance
- Information Not Available: The document is a clearance letter, not a study report. It does not contain acceptance criteria or reported device performance metrics. Its purpose is to state that the device is "substantially equivalent" to legally marketed predicate devices.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Information Not Available: No such information is present as this is not a study report for an AI/diagnostic algorithm.
3. 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)
- Information Not Available: Not applicable to an X-ray film processor.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Information Not Available: 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
- Information Not Available: Not applicable, as this is an X-ray film processor, not an AI-assisted diagnostic device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Information Not Available: Not applicable.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Information Not Available: Not applicable.
8. The sample size for the training set
- Information Not Available: Not applicable.
9. How the ground truth for the training set was established
- Information Not Available: Not applicable.
{0}------------------------------------------------
Public Health Service
DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN 18 1999
Konica Medical Corporation ATTN: Russell D. Munves C/O Storch, Amini & Munves, P.C. The Chrysler Building 405 Lexington Avenue New York. New York 10174
RE: K990969
Konika SRX 701 Automatic X-ray Film Processor Dated: March 22, 1999 Received: March 23, 1999 Regulatory Class: II 21 CFR 892.1900/Procode: 90 IXW
Dear Mr. Munves:
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, 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 dass 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 requlatory 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/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
{1}------------------------------------------------
10
Page_1_of_1
510(k) Number (if known):_
Device Name:__SRX-701 Film Processor
Indications For Use: X-Ray Film Development
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) ..
Concurrence of CDRH, Office of Device Evaluation (ODE)
Uhind G. Segen
(Division Sign-Off)
።
Division of Reproductive, Abdominal, ENT, and Radiological Devig 510(k) Number
Prescription Use_L (Per 21 CFR 801.109)
OR
Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________
(Optional Format 1-2-96)
§ 892.1900 Automatic radiographic film processor.
(a)
Identification. An automatic radiographic film processor is a device intended to be used to develop, fix, wash, and dry automatically and continuously film exposed for medical purposes.(b)
Classification. Class II (special controls). 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.