(29 days)
The Point-of-Care is intended for digital radiography using a phosphor storage screen for standard radiographic diagnostic images.
The LLI is indicated for Long Length Imaging examinations of long areas of anatomy such as the leg and spine.
Point of care including LLI is a Computer Radiography (CR) acquisition scanner, which includes mechanical and software interface to the LLI cassette. The device is constructed from a Man Machine Interface panel, a CR scanner and infrastructure, which enables connection to external applications, i.e. to import command messages, to export images and provide status messages. The LLI is a CR cassette, which is used for Long Length Imaging X Ray examinations of long areas of anatomy.
Here's an analysis of the provided text regarding the acceptance criteria and study information for the OREX Computed Radiography Ltd. "Point of care including LLI" device:
The provided 510(k) summary (K073670) is very high-level and does not contain the detailed information required to fully answer all aspects of your request. Specifically, it lacks quantitative acceptance criteria and detailed study parameters.
However, I can extract and infer some information based on typical 510(k) submissions:
1. Table of Acceptance Criteria and Reported Device Performance
The document states: "Bench and clinical data demonstrate that the device meets the required specifications." However, it does not explicitly list quantitative acceptance criteria (e.g., specific imaging parameters like DQE, spatial resolution, contrast-to-noise ratio, or specific clinical performance metrics). Therefore, a table with specific numbers cannot be generated from this text.
2. Sample Size Used for the Test Set and Data Provenance
The document mentions "Bench and clinical data" but does not specify the sample size for any test set or the data provenance (e.g., country of origin, retrospective/prospective).
3. Number of Experts Used to Establish Ground Truth and Qualifications
The document does not provide any information about the number of experts, their qualifications, or how ground truth was established for any clinical evaluations.
4. Adjudication Method
The document does not specify any adjudication method for a test set.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
The document does not mention or describe a multi-reader multi-case (MRMC) comparative effectiveness study.
6. Standalone (Algorithm Only) Performance Study
The device is a Computer Radiography (CR) acquisition scanner. The "LLI" component is a CR cassette for Long Length Imaging. This is a hardware and software system for image acquisition, not an AI algorithm for image interpretation. Therefore, a "standalone algorithm only" performance study in the context of AI without human-in-the-loop is not applicable to this type of device as described. Its performance would be evaluated on image quality metrics and clinical utility for capturing long-length images.
7. Type of Ground Truth Used
The document mentions "clinical data" but does not specify the type of ground truth used (e.g., expert consensus, pathology, outcomes data). For an image acquisition system, the ground truth would typically relate to the accuracy and quality of the acquired image compared to a reference standard, and the ability of the acquired image to allow for accurate diagnosis by radiologists.
8. Sample Size for the Training Set
The document does not provide any information about a training set size. As this is a CR acquisition scanner and cassette, not an AI diagnostic algorithm, the concept of a "training set" in the machine learning sense is unlikely to apply in the same way.
9. How Ground Truth for the Training Set Was Established
The document does not provide any information about how ground truth for a training set was established, as it does not mention a training set.
Summary of what can be extracted/inferred:
- Acceptance Criteria: Stated as "required specifications" and met by "Bench and clinical data," but no quantitative details are provided.
- Study Type: Bench and clinical data were collected.
- Device Type: CR acquisition scanner with a long-length imaging cassette. Its evaluation would focus on image quality, safety, and functionality, rather than diagnostic accuracy of an AI algorithm.
- Regulatory Pathway: Special 510(k), indicating modifications to an existing predicate device (Orex K003256 and Kodak K021829). This often implies that the modifications are minor and do not significantly alter the fundamental scientific technology or risks, and therefore, extensive new clinical studies with detailed acceptance criteria might not be required if performance is shown to be equivalent to the predicate.
In conclusion, the provided 510(k) summary is insufficient to answer many of your specific questions, particularly those related to quantitative acceptance criteria, clinical study parameters, and AI-specific evaluation metrics. This is common for 510(k) summaries, which aim to provide a high-level overview rather than the full detailed submission. The full 510(k) submission would contain this information, but it is not publicly available in this snippet.
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Image /page/0/Picture/0 description: The image shows a handwritten string of alphanumeric characters. The string appears to be "K073670". The characters are written in black ink on a white background. The handwriting is somewhat stylized, with some characters connected and others distinct.
510(k) Summary of Safety and Effectiveness (in accordance to 21 CFR 807.87(b)
Device Name
Proprietary Device Name: Point of care including LLI
Establishment Name and Registration Number of Submitter
Name: OREX Computed Radiography Ltd Registration: 3003343596 Owner: CARESTREAM HEALTH, INC Submission contact: Dan Laor
Device Classification
Device Code: MOB CFR Section: 892.1650 Name: CR- Computerized radiography Classification: Class II Product Review Advisory Committee: Radiology
Reason for 510(k) Submission
Special 510(k) Submission
Identification of Legally Marketed predicate Devices
- Kodak unmodified predicate device: (K021829) Kodak DirectView CR ii Long Length
Device Description
Point of care including LLI is a Computer Radiography (CR) acquisition scanner, which includes mechanical and software interface to the LLI cassette. The device is constructed from a Man Machine Interface panel, a CR scanner and infrastructure, which enables connection to external applications, i.e. to import command messages, to export images and provide status messages. The LLI is a CR cassette, which is used for Long Length Imaging X Ray examinations of long areas of anatomy.
Indications for use
The Point-of-Care is intended for digital radiography using a phosphor storage screen for standard radiographic diagnostic images.
The LLI is indicated for Long Length Imaging examinations of long areas of anatomy such as the leg and spine.
Safety & Effectiveness
The device has been designed, verified and validated in compliance with the 21CFR 820.30 regulations. Bench and clinical data demonstrate that the device meets the required specifications. No adverse affects have been detected.
Substantial Equivalency
Orex opines that the Point of Care including the LLI is substantially equivalent in terms of safety and effectiveness to the predicate devices.
JAN 25 2008
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized symbol that resembles an abstract eagle or bird in flight, composed of three curved lines.
1 25 2008
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Moshe Shenhav Director, QA & Regulatory Affairs OREX Computed Radiography Ltd. Star Bldg. Yokneam, P.O. Box 505 Yokneam 20692 ISRAEL
K073670 Re:
Trade/Device Name: Point of Care including LLI Regulation Number: 21 CFR §892.1650 Regulation Name: Image-intensified fluoroscopic x-ray system Regulatory Class: II Product Code: MQB Dated: December 6, 2007 Received: December 27, 2007
Dear Mr. Shenhav:
We have reviewed your Section 510(k) premarket notification of intent to market the devicereferenced 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 either class II (Special Controls) or class III (PMA), 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.
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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.
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 Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) 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" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrb/industry/support/index.html.
Sincerely yours.
Nancy Cbrogdon
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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Indications for Use
K073670 510(k) Number (if known):
Point of Care including LLI Device Name:
Indications for Use: The Point-of-Care is intended for digital radiography using a phosphor storage screen for standard radiographic diagnostic images.
The LLI is indicated for Long Length Imaging examinations of long areas of anatomy such as the leg and spine.
Prescription Use: YES (Part 21 CFR 801 Subpart D)
AND/OR
Over-the-Counter Use: NO (Part 21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Concurrence of CDRL
(Division Sign-Off)
Division of Reproductive, Abdominal and Radiological Devices 510(k) Number _
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§ 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.