(90 days)
The ADC Pediatric is indicated for use to provide diagnostic quality images to aid in physician diagnosis. The ADC Pediatric is intended to be used in pediatric imaging applications.
The ADC Compact, the predicate device, is a computed radiography imaging system. Instead of screens and photographic film for producing the diagnostic image, the ADC Compact system utilizes an "imaging plate," a plate coated with photo-stimulatable storage phosphors that are sensitive to X-rays and capable of retaining a latent image. This imaging plats is inserted into a device that scans it with a laser and releases the latent image in the form of light which is converted into a digital bit stream. The bit stream of image data is stored locally and can also be stored in the PACS network in DICOM format.
The ADC Pediatric is identical in hardware and software to the ADC Compact. The only difference is in a data file that is provided that is accessed by the (unchanged) suftware, where preselected image processing parameters are paired with typical pediatric exposure parameters by age and exam type (assuming that the exposures follow the European Guidelings on Quality Criteria for Diagnostic Radiographic Images in Pacdiatrics). Rather than entering the exposure parameters manually. as would be the case for pediatric exams using the ADC Compact, the user would simply select the exam and patient age, and the proper image processing parameters would be selected automatically and applied to the image.
I am unable to provide a table of acceptance criteria and reported device performance from the provided text. The document does not specify any quantitative acceptance criteria or detailed device performance metrics. It primarily focuses on demonstrating substantial equivalence to a predicate device for the purpose of a 510(k) submission, rather than a detailed performance study with defined criteria.
However, I can extract other requested information:
1. A table of acceptance criteria and the reported device performance:
- Acceptance Criteria: Not specified in the document. The document's goal is to demonstrate "substantial equivalence" to a predicate device, not meet specific performance criteria for a new clinical claim.
- Reported Device Performance: Not quantified. The device is stated to "provide diagnostic quality images to aid in physician diagnosis" and is "identical in hardware and software" to the predicate device, with the only difference being preselected image processing parameters for pediatric applications.
2. Sample size used for the test set and the data provenance:
- Test Set Sample Size: Not explicitly stated. The document mentions "two hospitals" were used for testing to refine image processing parameters, but no specific number of images or patients is provided.
- Data Provenance: The images were exposed "according to the recommendations of the European Guidelines on Quality Criteria for Diagnostic Radiographic Images in Paediatrics." The country of origin of the data is not specified beyond this reference to European guidelines. The study appears to be retrospective in the sense that the parameter sets were optimized based on existing guidelines, but the exact nature of the image acquisition for this optimization is not detailed as a prospective clinical trial.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This information is not provided in the document. The text states that "parameter sets were optimized" based on the European Guidelines, but it does not describe a process involving experts establishing a ground truth for a test set.
4. Adjudication method for the test set:
- This information is not provided in the document.
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:
- No, an MRMC comparative effectiveness study was not done. The document describes a device that is substantially equivalent to a previous version, with the only change being optimized image processing parameters for pediatric use. There is no mention of AI or any study comparing human reader performance with or without the device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- The device is a Computed Radiography imaging system, not an AI algorithm. Its performance is inherent to the imaging process and processing parameters. Therefore, the concept of a "standalone algorithm" performance as typically understood for AI devices does not apply to this submission. The device itself is "standalone" in generating the image, which is then interpreted by a human.
7. The type of ground truth used:
- The ground truth, if any, for the "optimization" of parameter sets was based on the "recommendations of the European Guidelines on Quality Criteria for Diagnostic Radiographic Images in Paediatrics." This points to a guideline-based/expert consensus approach to image quality, rather than pathology or outcomes data.
8. The sample size for the training set:
- The document does not explicitly mention a distinct "training set" with a specified sample size. The "optimization" of parameters occurred through testing in "two hospitals," which implicitly served as the data source for refining these parameters.
9. How the ground truth for the training set was established:
- The "ground truth" for the training (optimization) was established by aligning with the "recommendations of the European Guidelines on Quality Criteria for Diagnostic Radiographic Images in Paediatrics." This suggests that optimal image quality and diagnostic interpretability, as defined by these guidelines, served as the benchmark for parameter refinement. There is no mention of specific medical diagnoses or outcomes being used as ground truth for this optimization.
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NOV 1 4 2001
510(k) Summarv
3
ADC Pediatric
Common/Classification Name: Computed Radiography, 21 CFR 892.1680
Agfa Corporation 10 South Academy Street Greenville, SC 25602-9048
Contact: Jeff Jedlicka, Prepared: June 22, 2001
A. LEGALLY MARKETED PREDICATE DEVICES
The predicate device is the crevious version of the same device, namely the ADC Compact, which was cleared by FDA on 09 March 1998 as K974597.
DEVICE DESCRIPTION 8.
The ADC Compact, the predicate device, is a computed radiography imaging system. Instead of screens and photographic film for producing the diagnostic image, the ADC Compact system utilizes an "imaging plate," a plate coated with photo-stimulatable storage phosphors that are sensitive to X-rays and capable of retaining a latent image. This imaging plats is inserted into a device that scans it with a laser and releases the latent image in the form of light which is converted into a digital bit stream. The bit stream of image data is stored locally and can also be stored in the PACS network in DICOM format.
The ADC Pediatric is identical in hardware and software to the ADC Compact. The only difference is in a data file that is provided that is accessed by the (unchanged) suftware, where preselected image processing parameters are paired with typical pediatric exposure parameters by age and exam type (assuming that the exposures follow the European Guidelings on Quality Criteria for Diagnostic Radiographic Images in Pacdiatrics). Rather than entering the exposure parameters manually. as would be the case for pediatric exams using the ADC Compact, the user would simply select the exam and patient age, and the proper image processing parameters would be selected automatically and applied to the image.
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C. INTENDED USE
The ADC Pediatric is indicated for use to provide diagnostic quality images to aid in physician diagnosis. The ADC Pediatric is intended to be used in pediatric imaging applications.
D. SUBSTANTIAL EQUIVALENCE SUMMARY
The ADC Pediatric has the same indications for use as the legally marketed predicate device except for the explicit inclusion of pediatric applications. This change does not affect the intended diagnostic effect. The ADC Pediatric has the same (identical) technological characteristics as the predicate device. This premarket notification has described the characteristics of the ADC Pediatric in sufficient detail to assure substantial equivalence.
E. TECHNOLOGICAL CHARACTTER'STICS
The technological characteristics are identical in the proposed and predicate devices.
F. TESTING
The ADC Pediatric was tested in two hospitals to refine the image processing parameter sets for pediatric applications. Images were exposed according to the recommendations of the European Guidelines on Quality Criteria for Diagnastic Rediographic Images in Paediatrics. and the parameter sets were optimized for those exposures.
G. CONCLUSIONS
This pre-market submission has demonstrated Substantial Equivalence as defined and understood in the Federal Food Drug and Cosmetic Act and various guidance documents issued by the Center for Devices and Radiological Health.
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Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room - WO66-G609 Silver Spring, MD 20993-0002
Agfa Corporation % T. Whit Athev. Ph.D. Senior Consultant C. L. McIntosh 12300 Twinbrook Pkwy, Suite 625 ROCKVILLE MD 20850
AUG 2 3 2013
Re: K012750
Trade/Device Name: ADC Pediatric Computed Radiographic (CR) Medical Imaging Device
Regulation Number: 21 CFR 892.1680 Regulation Name: Stationary x-ray system Regulatory Class: II Product Code: MQB Dated: August 16, 2001 Received: August 16, 2001
Dear Dr. Athey:
This letter corrects our substantially equivalent letter of November 14, 2001.
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. Iisting of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into class II (Special Controls), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. 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 Parts 801 and 809); medical device reporting (reporting of
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medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). 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 to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Parts 801 and 809), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 796-5450. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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) 796-7100 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely Yours,
Janine M. Morris
Acting Director Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
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NOV 1 4 2001
510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
Device Name:
Indications For Use:
The ADC Pediatric is indicated for use to provide diagnostic quality images to aid in physician diagnosis. The ADC Pediatric is intended to be used in pediatric imaging 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
Manavic Broolin
(Division Sign-Off)
Division of lepreductive, Abdominal,
and Radiological Devices K012750
000019
§ 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.