(33 days)
The Computed Oral Radiology System is indicated for patients undergoing an intra-oral dental x-ray examination. It produces instant, digital, intra-oral images of a patient's mouth while reducing the necessary x-ray dosage.
The device and its predicates are small digital imaging receptors that may be used in place of dental x-ray film. The images are displayed on a computer workstation. The modified device uses wireless IEEE 802.11 b/g protocol for image data transfer and control signal transfer to and from the Power and Transceiver (PAT) and the host computer. A rechargeable battery power source is also included in the PAT. A Counter Top Dock (CTD) has been added to this system. The CTD is a support device that provides charging power to the PAT and is used to provide a temporary wired connection, via USB, from the host computer to the PAT to allow initial configuration to the host wireless network.
This 510(k) summary does not contain the detailed information necessary to fully answer all aspects of your request regarding acceptance criteria and the comprehensive study that proves the device meets those criteria. The provided document is primarily a summary for a 510(k) clearance, which focuses on demonstrating substantial equivalence to a predicate device rather than detailing extensive performance studies with specific acceptance criteria.
However, based on the information provided, here's what can be extracted and inferred:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state quantitative acceptance criteria or detailed performance metrics. The submission focuses on the modification of an already cleared device (K072134) to incorporate wireless functionality. Therefore, the "acceptance criteria" are mostly implicit in demonstrating that the wireless modification does not degrade the performance or safety of the existing device and maintains substantial equivalence to the predicate.
| Acceptance Criteria (Implied) | Reported Device Performance (Implied) |
|---|---|
| Functional Equivalence: Image data transfer and control signals function wirelessly. | The modified device uses wireless IEEE 802.11 b/g protocol for image data transfer and control signal transfer. |
| Image Quality Equivalence: Image quality is maintained despite wireless transfer. | "The modification does not alter the fundamental technology or the intended use." (Implies image quality is not negatively impacted). |
| Safety Equivalence: Wireless operation does not introduce new unacceptable risks. | "The modified system has had risks evaluated and mitigated as necessary." "Testing and design validation have been used to verify risk mitigation." |
| Intended Use Equivalence: Device continues to meet its intended use. | "The operational environment remains unchanged from the predicate. There are no changes to the indications for use from the predicate devices." |
| Predicate Equivalence: Device is substantially equivalent to predicate (K072134). | "Schick Technologies has concluded the modified system is substantially equivalent to its predicates. Risk analysis, testing and validation studies support this conclusion." |
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 provided in the 510(k) summary. The document mentions "Testing and design validation," but does not specify sample sizes, data provenance (e.g., country of origin), or whether these tests were retrospective or prospective.
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 provided in the 510(k) summary. It's unlikely that such a detailed ground truth establishment would be required or documented in a 510(k) for a modification focused on wireless connectivity, unless there were specific concerns about diagnostic image quality degradation, which are not raised.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not provided in the 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 is not applicable to this submission. The device is a digital imaging receptor (X-ray sensor) and associated software for displaying images. It is not an AI-assisted diagnostic tool designed to improve human reader performance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is not applicable in the context of an AI algorithm. The device, the Computed Oral Radiology System, is an imaging acquisition and display system. Its primary role is to provide images, not to perform independent diagnoses via an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
This information is not provided and likely not relevant for a 510(k) focusing on a wireless connectivity modification for an imaging device. The "ground truth" for the performance of such a device generally relates to objective image quality metrics (resolution, signal-to-noise ratio, contrast) and functional performance, rather than diagnostic accuracy against a clinical ground truth.
8. The sample size for the training set
This is not applicable in the context of a traditional "training set" for machine learning. The device is not described as involving machine learning or AI that would require a distinct training set. The "training" for this type of device would refer to internal development and testing, not an AI training data set.
9. How the ground truth for the training set was established
This is not applicable as there is no mention of a training set for an AI algorithm.
{0}------------------------------------------------
APR 2 0 2011
510(k) Summary
Schick Computed Oral Radiology System
Common/Classification Name: Solid State X-ray Imager 21CFR892.1650
Schick Technologies 30-30 47th Avenue Long Island City, NY 11101 718-937-5765 718-937-5962 (fax) Contact: Scott Doyle sdoyle@schicktech.com
A. Legally Marketed Predicate Devices
The computer oral radiology system was most recently cleared under K072134: November 2, 2007. The device and its predicates are small digital imaging receptors that may be used in place of dental x-ray film. The images are displayed on a computer workstation.
B. Modification Description
Modifications to the device from its immediate predicate (K072134) are related to making it a wireless (WiFi) device vice a USB connected device.
The modified device uses wireless IEEE 802.11 b/g protocol for image data transfer and control signal transfer to and from the Power and Transceiver (PAT) and the host computer. A rechargeable battery power source is also included in the PAT. A Counter Top Dock (CTD) has been added to this system. The CTD is a support device that provides charging power to the PAT and is used to provide a temporary wired connection, via USB, from the host computer to the PAT to allow initial configuration to the host wireless network.
The modification does not alter the fundamental technology or the intended use.
- C. Intended Use
The operational environment remains unchanged from the predicate. There are no changes to the indications for use from the predicate devices.
D. Substantial Equivalence Summary
The modified system has had risks evaluated and mitigated as necessary. Testing and design validation have been used to verify risk mitigation. The principal risk is imaging system failure causing a retake which may include additional X-ray exposure.
E. Conclusion
Schick Technologies has concluded the modified system is substantially equivalent to its predicates. Risk analysis, testing and validation studies support this conclusion
{1}------------------------------------------------
Image /page/1/Picture/0 description: The image shows the logo for the Department of Health & Human Services (HHS). The logo features a stylized depiction of an eagle or bird in flight, composed of three curved lines. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird symbol. The logo is black and white.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room - WO66-G609 Silver Spring, MD 20993-0002
Mr. Scott Doyle Project Manager Schick Technologies, Inc. 30-30 47th Avenue LONG ISLAND CITY NY 11101
APR 2 0 2011
Re: K110768
Trade/Device Name: Computed Oral Radiology System Regulation Number: 21 CFR 872.1800 Regulation Name: Extraoral source x-ray system Regulatory Class: II Product Code: MUH Dated: March 17, 2011 Received: March 22, 2011 .
Dear Mr. Doyle:
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 (reporting of
{2}------------------------------------------------
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.
Mary Pastel
Mary S. Pastel, Sc.D. Director Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
{3}------------------------------------------------
Indications for Use
510(k) Number (if known): K110768
Computed Oral Radiology System Device Name:
Indications for Use:
The Computed Oral Radiology System is indicated for patients undergoing an intra-oral dental x-ray examination. It produces instant, digital, intra-oral images of a patient's mouth while reducing the necessary x-ray dosage.
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 OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Mary Patel
(Division Sign-Off)
(Division Sign-Off)
Division of Radiological Devices
Office of In Vitro Diagnostic Device Evaluation and Safety
510K. K110768
Page 1_of 1
5
§ 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.