(350 days)
The SOPIX 2 SYSTEM is intended to be used by qualified dentist in general to provide instant X-Ray images, typically of tooth, bone and surrounding tissues.
The SOPIX2 system is a digital x-ray sensor system for human and non human use in dental and veterinary applications. It is used to provide instant Xray images, typically of teeth, bone and surrounding tissues.
This document is a 510(k) summary for the SOPRO SOPIX2 system, an intraoral digital X-ray sensor for dental applications. It primarily focuses on demonstrating substantial equivalence to a predicate device rather than providing a detailed study with specific acceptance criteria and performance metrics.
Therefore, many of the requested details about acceptance criteria, study design, and performance metrics are not available in the provided text. The document acts more as a regulatory submission for market clearance based on equivalence rather than a detailed performance study report.
Here's a breakdown of what can be extracted and what is missing:
1. Table of Acceptance Criteria and Reported Device Performance
- Acceptance Criteria: Not explicitly stated in the provided text. The document's purpose is to argue for substantial equivalence to a predicate device, implying that its performance should be comparable to the predicate. There are no quantitative performance goals or thresholds mentioned.
- Reported Device Performance: No specific quantitative performance metrics (e.g., sensitivity, specificity, accuracy, image quality scores) are reported for the SOPIX2 system. The document generally states that "Differences that exist between the devices relating to technical specifications, performances and intended use are minor and do not affect the safety and effectiveness of the SOPIX2." This is a qualitative statement of equivalence, not a quantitative performance report.
2. Sample size used for the test set and the data provenance
- Sample Size: Not mentioned. No specific test set or study size is described.
- Data Provenance: Not mentioned. There is no information about the origin of any data used for testing (e.g., country of origin, retrospective or prospective).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Number of Experts: Not mentioned.
- Qualifications of Experts: Not mentioned.
- Reasoning: Since no specific performance study with a test set generating ground truth is described, information on experts is absent.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
- Adjudication Method: Not mentioned.
- Reasoning: Similar to the above, no specific ground truth establishment or adjudication process for a test set is described.
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
- MRMC Study: No, there is no indication that an MRMC comparative effectiveness study was done.
- AI Assistance: The device described is an X-ray sensor system, not an AI-based diagnostic tool. Therefore, the concept of "human readers improve with AI vs without AI assistance" is not applicable.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
- Standalone Performance: Not explicitly done in the context of an algorithm. The device is a hardware sensor. Its performance is inherent to its image acquisition capabilities, which are argued to be equivalent to the predicate device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Type of Ground Truth: Not mentioned. No formal ground truth establishment is described in the provided summary.
8. The sample size for the training set
- Sample Size: Not applicable. This device is a hardware sensor, not an AI algorithm that requires a training set.
9. How the ground truth for the training set was established
- Ground Truth Establishment: Not applicable, as there is no training set for this hardware device.
In summary, the provided document is a regulatory submission for market clearance based on substantial equivalence to a predicate device. It does not contain the detailed performance study information, acceptance criteria, or ground truth establishment methods typically found in reports for novel diagnostic algorithms or devices requiring extensive clinical validation beyond equivalence to an existing product.
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9. Summary of Safety and Effectiveness – "510(k) Summary"
- A. Submitter Information
SOPRO ZAC Athélia Avenue des Genévriers 13705 La Ciotat Cedex FRANCE
JUL 2 0 2010
Telephone: 33 (0) 442 98 01 01 · Fax: 33 (0) 442 71 76 90
Contact Person: Rick Rosati SOPRO c/o ACTEON, Inc. 124 Gaither Drive, Suite 140 Mt. Laurel, NJ 08054 Tel: 800 289-6367 Ext. 39 Fax: 856 222-4726 E-mail: Rick.Rosati@us.acteongroup.com
Date Prepared:
July 30, 2009
B. Device Identification
Classification Name:
system,x-ray,extraoral source,digital
Common Usual Name:
x_ray system
SOPIX2
Proprietary Name:
C. Identification of Predicate Device
| Device | Applicant | 510(k) No. | Date Cleared |
|---|---|---|---|
| Accent | Air Techniques | K050693 | 05/26/2005 |
The SOPIX2 system is substantially equivalent to the predicate device by Air Techniques Accent (K050963) previously cleared by the FDA and currently marketed.
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D. Device Description
The SOPIX2 system is a digital x-ray sensor system for human and non human use in dental and veterinary applications. It is used to provide instant Xray images, typically of teeth, bone and surrounding tissues.
E. Intended Use
The SOPIX2 system is intended to be used by qualified dentist in general to provide instant X-ray images, typically of teeth, bone and surrounding tissues
F. Substantial Equivalence
The SOPIX2 system and the predicate device Accent , are both in Class II X-ray sensor intended to be used by qualified dentist in general to provide instant Xray images, typically of teeth, bone and surrounding tissues .Differences that exist between the devices relating to technical specifications, performances and intended use are minor and do not affect the safety and effectiveness of the SOPIX2.
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Image /page/2/Picture/0 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three stripes representing the department's mission. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room - WO66-G609 Silver Spring, MD 20993-0002
SOPRO % Mr. Rick Rosati Official Correspondent ACTEON. Inc. 124 Gaither Drive, Suite 140 MT. LAUREL NJ 08054
Re: K092329
Trade/Device Name: SPOIX 2 System Regulation Number: 21 CFR 872.1800 Regulation Name: Extraoral source x-ray system Regulatory Class: II Product Code: MUH Dated: April 14, 2010 Received: April 15, 2010
Dear Mr. Rosati:
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. Ilsting of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
JUL 20 2010
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,
Donald J. St.Pierre 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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Indications for Use
510(k) Number:
1-09 2339
Device Name:
SOPIX 2 System
Indications for Use:
The SOPIX 2 SYSTEM is intended to be used by qualified dentist in general to provide instant X-Ray images, typically of tooth, bone and surrounding tissues.
Prescription Use _ X (Part 21 CFR 801 Subpart.D) AND/OR
Over-The-Counter Use_ (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)
DAR
(Division Sign-Off)
Division of Radiological Devices Office of In Vitro Division of Radiological Devices
Office of In Vitro Diagnostic Device E.valuation and Safety
510K [K092329](https://510k.innolitics.com/search/K092329)
§ 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.