(30 days)
SIDEXIS is a digital imaging system intended to replace conventional radiographic film for dental radiographic examination and diagnosis of diseases of the teeth, jaw, and oral structures.
SIDEXIS consists of intraoral and extraoral digital X-ray sensors, image acquisition boards, and software to be installed into an IBM-compatible personal computer. This Special 510(k) is being submitted to document a new sensor and associated software for digital transverse slice imaging in conjunction with the Orthophos Plus DS / Plus DS Ceph family of digital extraoral source X-ray imaging devices. Other minor modifications discussed in this Special 510(k) include: 1) a new XAB image acquisition board to interface SIDEXIS to the Orthophos X-ray systems via the Ethernet; 2) a new USB (Universal Serial Bus) Box to interface the SIDEXIS with the intraoral sensors; and 3) software enhancements to improve the overall function of SIDEXIS (resulting in software version 5.5).
Based on the provided text, the document is a 510(k) summary for a modified medical device, not a study report detailing acceptance criteria and performance evaluation against them. Therefore, many of the requested details about acceptance criteria, study design, and performance metrics are not present in the provided text.
The document states that the SIDEXIS Digital Radiography Imaging System is a modification of a previously cleared device (K992644). The basis for substantial equivalence is that the modified device has the "same intended use and principles of operation... as well as substantially equivalent technical specifications."
Here's a breakdown of what can and cannot be extracted from the provided text regarding your request:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Inferred from "Substantially Equivalent") | Reported Device Performance |
|---|---|
| Intended Use: Replace conventional radiographic film for dental radiographic examination and diagnosis of diseases of the teeth, jaw, and oral structures. | The device maintains the "same intended use" as the predicate device (K992644). This implies it performs this function acceptably. |
| Principles of Operation: (Not explicitly stated, but implied to be similar to predicate) | The device has the "same principles of operation" as the predicate device. |
| Technical Specifications: (Not explicitly detailed, but implied to be similar to predicate) | The device has "substantially equivalent technical specifications" to the predicate device. |
| Safety and Effectiveness: (Implied by 510(k) clearance) | A hazard analysis and validation testing were submitted to support substantial equivalence. |
| Performance in digital transverse slice imaging (for new sensor and software) | The new sensor and associated software are for "digital transverse slice imaging in conjunction with the Orthophos Plus DS / Plus DS Ceph family." The 510(k) clearance indicates this functionality is deemed substantially equivalent. |
| Performance of new XAB image acquisition board | The new board interfaces SIDEXIS to Orthophos X-ray systems via Ethernet, and its performance is considered substantially equivalent. |
| Performance of new USB Box | The new USB Box interfaces SIDEXIS with intraoral sensors, and its performance is considered substantially equivalent. |
| Overall function of software version 5.5 | Software enhancements are made to "improve the overall function of SIDEXIS," and the improved version is considered substantially equivalent. |
Missing Information: Specific quantitative acceptance criteria (e.g., specific image resolution, contrast, diagnostic accuracy metrics like sensitivity/specificity) are not provided in this 510(k) summary. The "performance" is primarily described as being "substantially equivalent" to the predicate device, or "improved" for software, which is a regulatory conclusion rather than a detailed performance report.
2. Sample size used for the test set and the data provenance
- Sample Size for Test Set: Not provided. The document mentions "validation testing" but gives no details on the sample size (number of images, patients, etc.) used for this testing.
- Data Provenance: Not provided. There is no mention of the country of origin of data or whether it was retrospective or prospective.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not provided. Since specific performance data and test sets are not detailed, there's no information about expert involvement in establishing ground truth.
4. Adjudication method for the test set
- Not provided. No details on adjudication methods are given.
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 indication of an MRMC study related to AI assistance. The document describes a "digital radiography imaging system," which replaces film, but does not mention Artificial Intelligence (AI) or machine learning components that would typically be evaluated with MRMC studies for human reader improvement. The 510(k) process here focuses on substantial equivalence to a predicate, not necessarily a comparative effectiveness study showing human improvement with AI.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not explicitly stated as a "standalone" algorithm performance study. The device is presented as a system for "dental radiographic examination and diagnosis," implying human involvement. The 510(k) is for the imaging system itself, not necessarily an AI algorithm to be used stand-alone.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Not provided. Given the lack of detail on the "validation testing," the type of ground truth is not specified. For dental imaging, this typically involves expert reads, but the document does not confirm this.
8. The sample size for the training set
- Not applicable/Not provided. This document does not describe a machine learning algorithm that would require a "training set." It describes a hardware and software system for digital radiography.
9. How the ground truth for the training set was established
- Not applicable/Not provided. As above, this isn't a machine learning algorithm with a training set.
Summary of the Study (as described in the 510(k) Summary):
The "study" described in this 510(k) summary is not a detailed clinical trial or performance study against specific acceptance criteria in the conventional sense. Instead, it's a regulatory submission for a modified device. The "proof" that the device meets its requirements is based on demonstrating substantial equivalence to a legally marketed predicate device (SIDEXIS Digital Radiography System -- K992644).
The evidence provided to the FDA for this substantial equivalence included:
- A hazard analysis.
- Validation testing (specifics not detailed).
- A Declaration of Conformity to Design Controls.
The conclusion is that the modified SIDEXIS system has the "same intended use and principles of operation as the original SIDEXIS, as well as substantially equivalent technical specifications." The FDA agreed with this assessment, issuing a letter that "allows you to begin marketing your device as described in your 510(k) premarket notification."
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1L0/3459
Special 510(k) Summary
for
SIDEXIS Digital Radiography Imaging System
SPONSOR 1.
DEC 0 6 2001
Sirona Dental Systems GmbH Fabrikstraße 31 D-64625 Bensheim Germany
Contact Person: Fritz Kolle 49 6251 16 3294 Telephone:
November 5, 2001 Date Prepared:
DEVICE NAME 2.
SIDEXIS Digital Radiography Imaging System Proprietary Name: Common/Usual Name: Digital X-ray Imaging System Accessory to Extraoral Source X-ray System Classification Name:
PREDICATE DEVICE 3.
SIDEXIS Digital Radiography System -- K992644
4. INTENDED USE
.
The SIDEXIS is a digital imaging system intended to replace conventional radiographic film for dental radiographic examination and diagnosis of diseases of the teeth, jaw, and oral structures.
DEVICE DESCRIPTION હ્
SIDEXIS consists of intraoral and extraoral digital X-ray sensors, image acquisition boards, and software to be installed into an IBM-compatible personal computer. This
November 5, 2001 Sirona Dental Systems GmbH Special 510(k) SIDEXIS Digital Radiography Imaging System
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Special 510(k) is being submitted to document a new sensor and associated software for digital transverse slice imaging in conjunction with the Orthophos Plus DS / Plus DS Ceph family of digital extraoral source X-ray imaging devices. Other minor modifications discussed in this Special 510(k) include: 1) a new XAB image acquisition board to interface SIDEXIS to the Orthophos X-ray systems via the Ethernet; 2) a new USB (Universal Serial Bus) Box to interface the SIDEXIS with the intraoral sensors; and 3) software enhancements to improve the overall function of SIDEXIS (resulting in software version 5.5).
BASIS FOR SUBSTANTIAL EQUIVALENCE 6.
The SIDEXIS system that is the subject of this 510(k) premarket notification is a modification of SIDEXIS as previously cleared for marketing under K992644. The modified SIDEXIS has the same intended use and principles of operation as the original SIDEXIS, as well as substantially equivalent technical specifications. A hazard analysis, validation testing, and Declaration of Conformity to Design Controls were submitted to support the substantial equivalence of the modified SIDEXIS Digital Radiography Imaging System.
Sirona Dental Systems GmbH Special 510(k) SIDEXIS Digital Radiography Imaging System
November 5, 2001
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Image /page/2/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 an abstract image of an eagle or bird-like figure with three stylized wing segments.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC 0 6 2001
Sirona Dental Systems, Inc. % Ms. Sheila M. Hemeion-Heyer Medical Device Consultants 49 Plain Street NORTH ATTLEBORO MA 02760 Re: K013659 Trade/Device Name: SIDEXIS Digital Radiography Imaging System Regulation Number: 21 CFR 872.1800 Regulation Name: Extraoral source x-ray system Regulatory Class: II Product Code: 90 MUH Dated: November 5, 2001 Received: November 6, 2001
Dear Ms. Hemeion-Heyer:
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 (PMA), it may be subject to 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 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed notification. The I Drice 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 If you desire specific acvies to your as a one of the following numbers, based on the regulation number at the top of this letter:
| 8xx.1xxx | (301) 594-4591 |
|---|---|
| 876.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4616 |
| 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | (301) 594-4616 |
| 892.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4654 |
| Other | (301) 594-4692 |
Additionally, for questions on the promotion and advertising of your device, please contact the Additionally, for questions of (301) 594-4639. Also, please note the regulation entitled, "Misbranding Other of Compilance at (2017 22ation" (21 CFR Part 807.97). Other general information on of felected to premained nothers and the Division of Small Manufacturers, your responsional and Consumer 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,
Nancy C. Snogdon
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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510(k) Number (if known):
Device Name: SIDEXIS DIGITAL RADIOGRAPHY IMAGING SYSTEM
Indications For Use:
SIDEXIS is a digital radiography imaging system intended to replace conventional radiographic film for dental radiographic examination and diagnosis of diseases of the teeth, jaw, and oral structures.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NECESSARY)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Elmer A. Sperry
(Division Sign-Off) Division of Reproductive, and Radiological Devic 510(k) Number
Prescription Use
(Per 21 CFR 801.109)
OR
Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________
(Optional Format 1-2-96)
Sirona Dental Systems GmbH Special 510(k) SIDEXIS Digital Radiography Imaging System November 5, 2001
§ 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.