(16 days)
The BIO-RAY SDX digital x-ray system is intended to be used with standard x-ray systems to collect dental x-ray photos and convert them into electronic data that may be stored, viewed, and manipulated by dentists for the diagnosis of the tecth, jaw and oral structures with the use of computer imaging sollware provided by other 30 parties, readily available from numerous sources.
This device is only to be sold as a prescription device sold to doctors or dental dealers selling directly to doctors,
Digital Dental Intraoral X-Ray Sensor This device is intended to be used for the dental radiographic examination for the diagnosis of diseases of the teeth, jaw, and oral structures.
The provided document is a 510(k) summary for the Bio-Ray SDX Digital X-Ray System, a dental intraoral x-ray sensor. It focuses on establishing substantial equivalence to a predicate device and does not contain information about acceptance criteria or a specific study proving the device meets acceptance criteria in the manner typically seen for performance studies of AI/ML-enabled devices.
Therefore, most of the requested information cannot be extracted from this document regarding acceptance criteria and performance studies. This document is a regulatory submission for a traditional medical device (an intraoral x-ray sensor), not an AI/ML device, and thus the structure of its validation is different.
However, based on the information provided, here's what can be stated:
1. A table of acceptance criteria and the reported device performance:
This information is not available in the provided 510(k) summary. Acceptance criteria for a device like this would typically involve image quality metrics (e.g., spatial resolution, contrast resolution, signal-to-noise ratio), dose reduction capabilities, and mechanical/electrical safety standards. The document states the device is "substantially equivalent" to a legally marketed predicate device, implying it meets similar performance and safety standards, but no specific criteria or performance data are reported.
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):
This information is not available in the provided 510(k) summary regarding a specific performance test set. The submission focuses on device description and indications for use, not a clinical or technical performance study with a distinct test set of images or patients.
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):
This information is not available in the provided 510(k) summary. Ground truth establishment with experts is usually part of a performance study, which is not detailed here.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
This information is not available in the provided 510(k) summary.
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:
This information is not available in the provided 510(k) summary. The Bio-Ray SDX Digital X-Ray System is described as a device to "collect dental x-ray photos and convert them into electronic data" and is used with "computer imaging software provided by other 3rd parties." It is not an AI-enabled device itself, and therefore, an MRMC study comparing human readers with and without AI assistance would not be relevant to its specific submission.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
This information is not available in the provided 510(k) summary. As it's not an AI-enabled device, a standalone algorithm performance study is not applicable.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
This information is not available in the provided 510(k) summary.
8. The sample size for the training set:
This information is not available in the provided 510(k) summary. Training sets are relevant for AI/ML models, which this device is not stated to be.
9. How the ground truth for the training set was established:
This information is not available in the provided 510(k) summary.
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FER 8 2006
Image /page/0/Picture/2 description: The image shows the logo for Sigma Biomedics. The logo consists of two hexagons, one filled in black and the other outlined in black. To the right of the hexagons is the text "SIGMA BIOMEDICS" in a sans-serif font. The word "SIGMA" is above the word "BIOMEDICS".
510(k) Summary
Sigma Biomedics, Inc. 65 E. Palatine Rd., Blg.#201 Prospect Heights, IL 60070 847-419-0669
Name of Contact person: Kim Antol
Date Summary was prepared: January 9, 2006
Name of Device
| Trade/Proprietary Name: | Bio-Ray SDX Digital X-Ray System |
|---|---|
| Common/Usual Name: | Intraoral X-Ray Sensor |
| Classification Name: | Extraoral Source Dental X-Ray, Digital System |
The legally marketed device to which we are claiming equivalence [807.92(a)(3)]
Description of the Device:
Digital Dental Intraoral X-Ray Sensor This device is intended to be used for the dental radiographic examination for the diagnosis of diseases of the teeth, jaw, and oral structures.
65 E. Palatine Rd., #201, Prospect Heights, 11, 60070, (800) 331-6077, (847) 419-0669, Fax-(847) 419-0675
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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three stripes extending from its back, symbolizing growth and progress. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular pattern around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB 8 2006
2006
Ms. Kim Antol President Sigma Biomedics, Inc. 65 E. Palatine Rd., Bldg. 201 PROSPECT HEIGHTS IL 60070-1845 Re: K060179 Trade/Device Name: BIO-Ray SDX Digital X-Ray System Regulation Number: 21 CFR 872.1800 Regulation Name: Extraoral source x-ray system Regulatory Class: II Product Code: MUH Dated: January 20, 2006 Received: January 24, 2006
Dear Ms. Antol:
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 to 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
Nanev 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
510(k) Number (if known): K060179
Device Name: BIO-Ray SDX Digital X-Ray system
Indications For Use:
The BIO-RAY SDX digital x-ray system is intended to be used with standard x-ray systems to collect dental x-ray photos and convert them into electronic data that may be stored, viewed, and manipulated by dentists for the diagnosis of the tecth, jaw and oral structures with the use of computer imaging sollware provided by other 30 parties, readily available from numerous sources.
This device is only to be sold as a prescription device sold to doctors or dental dealers selling directly to doctors,
Prescription Use X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
David A. Lippman
(Division Sign-Off) Division of Reproductive, Abdomina and Radiological Devices 510(k) Number _
Page I of 1
§ 872.1800 Extraoral source x-ray system.
(a)
Identification. An extraoral source x-ray system is an AC-powered device that produces x-rays and is intended for dental radiographic examination and diagnosis of diseases of the teeth, jaw, and oral structures. The x-ray source (a tube) is located outside the mouth. This generic type of device may include patient and equipment supports and component parts.(b)
Classification. Class II.