(276 days)
The Alara T210 Computed Radiography System is indicated for use in generating radiographic images of human anatomy. It is intended to replace radiographic filmscreen systems in all general-purpose diagnostic procedures. The T210 is not indicated for use in mammography.
The Alara T210 is a desktop Computed Radiography (CR) system designed to generate digital x-ray images by reading photostimulable phosphor imaging plates exposed using standard x-ray systems and techniques. The system consists of a CR read or iposeing plates, and cassettes. A computer workstation and OC Acquisition software, will be optionally provided by either Alara or the distribution channel.
The provided document describes the Alara T210 Computed Radiography System as a modification of a predicate device (CRystalView T-Series Computed Radiography System, K071682). The rationale for substantial equivalence is based on the new device having the same indications for use and similar technological characteristics, with the main change being image size and system form factor.
The document does not provide detailed information on specific acceptance criteria or a dedicated study with performance metrics for the Alara T210. Instead, it states that "Alara has performed laboratory studies comparing the T210's performance characteristics to those for the predicate," and concludes that "Performance testing of the Alara T210 Computed Radiography system has demonstrated that it is substantially equivalent to the predicate device."
Therefore, I cannot fill out all parts of your request as the information is not present in the provided text.
Here's a summary of what can be extracted and what is missing:
1. Table of Acceptance Criteria and Reported Device Performance
Not explicitly provided. The document states that the new device's performance characteristics were compared to the predicate device, but no specific performance metrics or acceptance criteria are detailed.
2. Sample size used for the test set and the data provenance
Not provided. The document mentions "laboratory studies" and "performance testing" but does not specify sample sizes or data provenance.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not provided. There is no mention of expert involvement in establishing ground truth for any test set.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
Not provided.
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. The device is a Computed Radiography System, not an AI-powered diagnostic tool. Therefore, an MRMC study comparing human readers with and without AI assistance is not applicable and was not performed.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Yes, implicitly. The "performance testing" and "laboratory studies" would have evaluated the device itself (the CR system's image generation capabilities) which is a standalone performance by definition for such a device. However, no specific metrics or study details are provided.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
Not provided. Given that the device generates radiographic images, the "ground truth" for evaluating image quality would likely involve metrics such as spatial resolution, contrast resolution, detective quantum efficiency (DQE), MTF (Modulation Transfer Function), and noise characteristics, which are objectively measurable rather than based on expert consensus for clinical findings, pathology, or outcomes for a diagnostic claim. However, the document does not specify which of these or other metrics were used.
8. The sample size for the training set
Not applicable. This device is a Computed Radiography system for image acquisition, not an AI or machine learning algorithm that requires a training set in the conventional sense.
9. How the ground truth for the training set was established
Not applicable. (See point 8)
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JUN - 2 2011
Attachment D: 510(k) Summary
Alara T210 Computed Radiography System
This summary of safety and effectiveness information is submitted in accordance with the requirements of 21 CFR 807.92.
| Submitter: | Alara, Inc. |
|---|---|
| 47505 Seabridge Drive | |
| Fremont, CA 94538 |
Contact Person: Christopher R. Mitchell Chief Scientific Officer Phone: (510) 315-5172 Fax: (510) 315-5201 Email: cmitchell @alara.com
Date Prepared: August 5, 2010
Trade Name: Alara T210 Computed Radiography System
Common Name: Computed Radiography (CR) System
Classification Name: Solid State X-Ray Imager (per 21 CFR 892.1650)
Predicate Device: CRystalView T-Series Computed Radiography System (510(k) No. K071682, August 15, 2007)
Product Description:
The Alara T210 is a desktop Computed Radiography (CR) system designed to generate digital x-ray images by reading photostimulable phosphor imaging plates exposed using standard x-ray systems and techniques. The system consists of a CR read or iposeing plates, and cassettes. A computer workstation and OC Acquisition software, will be optionally provided by either Alara or the distribution channel.
Indications for Use:
The T210 Computed Radiography System is indicated for use in generating radiographic images of human anatomy. It is intended to replace radiographic film-screens systems in all general-purpose diagnostic procedures. The T210 is not indicated for use in mammography.
Rationale for Substantial Equivalence:
The T210 Computed Radiography System is a modification of the predicate device. It has the same indications for use as the predicate device. It has the same technological characteristics as the predicate device, including using the same optical subassembly. The
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change in image size and system form factor resulted in Alara's decision to conduct substantial equivalence testing through verification and image quality performance testing. The results of this testing demonstrate that the T210 is substantially equivalent to the predicate device.
Safety and Effectiveness Information:
The T210 is a Class II medical device and a Class I laser product. It complies with applicable FDA and international standards pertaining to electrical, mechanical, EMC, and laser safety of medical and/or laser devices.
Alara has performed laboratory studies comparing the T210's performance characteristics to those for the predicate.
Conclusion:
Performance testing of the Alara T210 Computed Radiography system has demonstrated that it is substantially equivalent to the predicate device.
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Image /page/2/Picture/0 description: The image shows the logo of the Department of Health & Human Services. The logo consists of an emblem on the left and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES" on the right. The emblem features a stylized depiction of a bird or a wing-like shape in blue. The text is also in blue and is written in a clear, sans-serif font.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room - WO66-G609 Silver Spring, MD 20993-0002
Mr. Christopher Mitchell Chief Scientific Officer Alara, Inc. 47505 Seabridge Drive FREMONT CA 94538
AUG 2 3 2013
Re: K102479
Trade/Device Name: Alara T210 Computed Radiography System Regulation Number: 21 CFR 892.1680 Regulation Name: Stationary x-ray system Regulatory Class: II Product Code: MOB Dated: March 22, 2011 Received: March 24, 2011
Dear Mr. Mitchell:
This letter corrects our substantially equivalent letter of June 2, 2011.
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 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 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
Janine M. Morri 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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Attachment B: Indications for Use Statement
510(k) Nümber: _________
Device Name:
Alara T210 Computed Radiography System
Indications for Use: The Alara T210 Computed Radiography System is indicated for use in generating radiographic images of human anatomy. It is intended to replace radiographic filmscreen systems in all general-purpose diagnostic procedures. The T210 is not indicated for use in mammography.
Macy Slew
(Director Sign Off)
Office of In Vitro
510K K182479
N/A