(85 days)
The Tuxedo Digital Dental Sensor is a CMOS sensor for the capturing of digital diagnostic x-ray images on a patient for evaluation by an appropriately trained oral healthcare professional.
The TUXEDO Dental Digital Sensor is used in the detection and diagnosis of anomalies in dental anatomy, as well as for the evaluation of performed treatment in dental care. The primary use is by general dental practitioners to detect the presence and extent of carious legions in the dentin and enamel of a tooth. Two different sized sensors (size 1 and size 2) are utilized to image different anatomy and different patient sizes. The TUXEDO Dental Digital Sensor functions by being placed in a patient's mouth lingually by a licensed dental practitioner, and is designed to capture collimated radiation which is converted into a digital image for viewing by a licensed dental practitioner. The capturing of the radiation is done within the TUXEDO sensor casing which contains a scintillator used to convert the radiation into visible light, and this visible light is immediately captured by the internal CMOS sensor. The digital image is transferred to a computer via USB 2.0 and can be viewed in most common imaging software programs, including LED Imaging Software. A software driver is available from LED Dental which will allow the TUXEDO sensor to be used in these software programs. The software supplied with the Tuxedo Digital Dental Sensor was cleared separately by FDA by Apteryx, Inc. The sensor is intended to be used with a disposable barrier sheath that should be replaced between patients. This is to reduce cross contamination between patients. The sensor is also sealed in a way that the portion of the device that is placed in the patient's mouth can be sterilized with liquid without the device being damaged.
Here's a breakdown of the acceptance criteria and study information for the Tuxedo Digital Dental Sensor, based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
The document doesn't present explicit "acceptance criteria" in a typical table format with pass/fail thresholds. Instead, it compares the Tuxedo Digital Dental Sensor's technological characteristics and performance against a legally marketed predicate device (RIO Sensor (RIS 500), K143000) to demonstrate substantial equivalence. The "Comparison Results" column effectively acts as the performance assessment against the predicate.
| Comparable Properties | Predicate Device (RIO Sensor (RIS 500), K143000) Performance | "Tuxedo Digital Dental Sensor" Performance | Comparison Results |
|---|---|---|---|
| Indications for Use | This system is intended to collect dental x-ray photons and convert them into electronic impulses that may be stored, views and manipulated for diagnostic use by dentists. | The Tuxedo Digital Dental Sensor is a CMOS sensor for the capturing of digital diagnostic x-ray images on a patient for evaluation by an appropriately trained oral healthcare professional. The Tuxedo sensor itself is a single piece comprised of the image capture components on one end, with a USB 2.0 plug on the other end. The sensor is designed to be used in conjunction with a disposable, single-use hygienic sheath as well as a positioning device to allow for proper alignment within the patient's mouth. Images are acquired with the Tuxedo sensor by plugging it into a USB port and properly placing it in the patient's mouth, while an operator exposes radiation toward the sensor from an approved intraoral x-ray generator. | These statements are functionally equivalent |
| Computer Interface | USB 2 | USB 2 | Identical |
| Sizes | Size 1: 39x25, Size 2: 42x30 | Size 1: 39 x 25 mm, Size 2: 41.9 x 30.4 mm | Identical. Predicate rounded off the numbers |
| Sensor Thickness | 5.6 mm | 5.3 ± 0.3 mm | Essentially identical |
| Imaging Technology | CMOS | CMOS | Identical |
| Pixel Size | 20.0 µm | 20.0 µm | Identical |
| Scintillator Technology | Csl Scintillator | Csl Scintillator | Identical |
| Image Sizes | Size 1: 1000x1500 pixel, Size 2: 1300x1700 pixel | 1000 x 1500 pixels, 1300 x 1700 pixels | Identical |
| Theoretical Resolution | 25 lp/mm | 25 lp/mm | Identical |
| MTF | More than 30% at 6 lp/mm | More than 30% at 6 lp/mm | Identical |
| DQE | More than 40% at 2.5 lp/mm | More than 40% at 2.5 lp/mm | Identical |
| Computer | Not specified | PC or Tablet with Windows Vista® SP2 or above, Windows® 7, Windows® 8, Windows Server® 2003 R2, Windows Server® 2008, and Windows Server® 2012 operating systems including Terminal Services and Citrix®. The software has been cleared by FDA in a separate submission. (Apteryx, Inc, K983111) | New device covers a wider range of operating systems |
| Infection Control | Requires a single patient use FDA cleared hygienic barrier | Requires a single patient use FDA cleared hygienic barrier, for example TIDIShield™ K132953. Sheaths: Code # 21041 for Size 1, Code # 21040 for Size 2 | Identical |
| Photo | Image: Dental sensor with USB | Image: Dental sensor with USB | The same sensor is being used by the predicate. |
2. Sample Size Used for the Test Set and Data Provenance
- Test Set (Clinical Images):
- Sample Size: A single "Phantom equivalent to a 51-year-old male" (DXTTR III Dental X-Ray Phantom (Human Skull)) was used.
- Data Provenance: This was a simulated, prospective test using a phantom in a laboratory setting. The origin of the phantom itself is not specified as a country.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- The document states, "All images acquired demonstrated excellent diagnostic imaging quality on both the size #1 and the size #2 sensor." However, it does not specify the number or qualifications of experts who made this determination for the phantom images. It implies an internal assessment.
4. Adjudication Method for the Test Set
- The document does not describe an explicit adjudication method for the phantom images. The assessment of "excellent diagnostic imaging quality" appears to be a general conclusion rather than a formal adjudication process involving multiple readers.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size
- No, an MRMC comparative effectiveness study was not done. The study's purpose was to demonstrate substantial equivalence to a predicate device, not to compare AI-assisted performance with unassisted human readers or to quantify an effect size for human improvement with AI. The device itself is a digital dental sensor, not an AI diagnostic tool.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- Yes, in essence, standalone performance was assessed though not in the context of an "algorithm." The device's imaging performance (MTF, DQE, theoretical resolution, stability of sensitivity, dark output, offset value) was tested independently of a human interpreter, using standardized methodologies (IEC6220-1). The phantom imaging also represents a standalone assessment of the device's image capture capabilities.
7. The Type of Ground Truth Used
- For the technical performance aspects (MTF, DQE, resolution), the ground truth is based on physical measurements and standardized testing protocols (IEC6220-1).
- For the "clinical images" using the phantom, the ground truth is implied to be the known anatomical structures and potential anomalies within the DXTTR III Dental X-Ray Phantom, against which the captured images were visually assessed for diagnostic quality. This is a form of expert assessment of image quality against a known physical standard, though detailed methodology is not provided.
8. The Sample Size for the Training Set
- Not Applicable (N/A). The Tuxedo Digital Dental Sensor is a hardware device (CMOS sensor) for image capture, not an AI algorithm that requires a training set of data. The document does not mention any machine learning or AI components that would necessitate a training set.
9. How the Ground Truth for the Training Set Was Established
- Not Applicable (N/A). As mentioned above, there is no training set for this device in the context of AI/machine learning.
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Image /page/0/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo features a stylized depiction of a human figure, represented by three curved lines, next to the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA". The text is arranged in a circular fashion around the figure.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
March 18, 2016
LED Dental, Inc. % Mr. Daniel Kamm Principal Engineer Kamm and Associates 8870 Ravello Court NAPLES FL 34144
Re: K153710
Trade/Device Name: Tuxedo Digital Dental Sensor Regulation Number: 21 CFR 892.1680 Regulation Name: Stationary x-ray system Regulatory Class: II Product Code: MOB Dated: February 24, 2016 Received: February 26, 2016
Dear Mr. Kamm:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. 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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours.
Robert Ocks
Robert Ochs, Ph.D. Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K153710
Device Name Tuxedo Digital Dental Sensor
Indications for Use (Describe)
The Tuxedo Digital Dental Sensor is a CMOS sensor for the capturing of digital diagnostic x-ray images on a patient for evaluation by an appropriately trained oral healthcare professional. The Tuxedo sensor itself is a single piece comprised of the image capture components on one end, with a USB 2.0 plug on the other end. The sensor is designed to be used in conjunction with a disposable, single-use hygienic sheath as well as a positioning device to allow for proper alignment within the patient's mouth. Images are acquired with the Tuxedo sensor by plugging it into a USB port and properly placing it in the patient's mouth, while an operator exposes radiation toward the sensor from an approved intraoral x-ray generator.
Type of Use (Select one or both, as applicable)
| ☑ Prescription Use (Part 21 CER 801 Subpart D) |
|---|
| □ Over The Counter Use (21 CER 801 Subpart C) |
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Image /page/3/Picture/0 description: The image shows the logo for LED DENTAL. The logo features the company name in a stylized font, with "LED" in gray and "DENTAL" in blue. To the left of the name is a cluster of green and blue circles arranged in a pattern. Below the company name, in smaller font, is the text "A SUBSIDIARY OF LED MEDICAL DIAGNOSTICS INC."
510(k) Summarv: LED Dental INC. Tuxedo Dental Digital Sensor
This 510(k) summary of safety and effectiveness information is being submitted in accordance with the requirements of 21 CFR §807.92.
General Information 1.
Business Name: Address:
Phone Number: Contact Person: Date of 510(k) Preparation: LED Dental INC No. 235-5589 Byrne Rd. Burnaby, BC, CANADA V5J 3J1 404-432-2819 Weslev Newsom November 23, 2015
2. Device Name and Classification
Proprietary-Trade Name: "Tuxedo Digital Dental Sensor" Device: Solid State X-Ray Imager (Flat Panel/Digital Imager) Regulation Description: Stationary x-ray system Regulation Medical Specialty: Radiology Review Panel: Radiology Regulatory Class: Class II Product Code: MQB Regulation Number 892.1680
3. Equivalent legally marketed device: K143000
| Proprietary-Trade Name: | RIO Sensor (RIS 500) |
|---|---|
| Device: | Solid State X-Ray Imager (Flat Panel/Digital Imager) |
| Regulation Description: | Stationary x-ray system |
| Regulation Medical Specialty: | Radiology |
| Review Panel: | Radiology |
| Regulatory Class: | Class II |
| Product Code: | MQB |
| Regulation Number | 892.1680 |
-
- Indications for Use: The Tuxedo Digital Dental Sensor is a CMOS sensor for the capturing of digital diagnostic x-ray images on a patient for evaluation by an appropriately trained oral healthcare professional. The Tuxedo sensor itself is a single piece comprised of the image capture components on one end, with a USB 2.0 plug on the other end. The sensor is designed to be used in conjunction with a disposable, single-use hygienic sheath as well as a positioning device to allow for proper alignment within the patient's mouth. Images are acquired with the Tuxedo sensor by plugging it into a USB port and properly placing it in the patient's mouth. while an operator exposes radiation toward the sensor from an approved intraoral x-ray generator.
-
- Device Description: The TUXEDO Dental Digital Sensor is used in the detection and diagnosis of anomalies in dental anatomy, as well as for the evaluation of performed treatment in dental care. The primary use is by general dental practitioners to detect the presence and extent of carious legions in the dentin and enamel of a tooth. Two different sized sensors (size 1 and size
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- are utilized to image different anatomy and different patient sizes. The TUXEDO Dental Digital Sensor functions by being placed in a patient's mouth lingually by a licensed dental practitioner, and is designed to capture collimated radiation which is converted into a digital image for viewing by a licensed dental practitioner. The capturing of the radiation is done within the TUXEDO sensor casing which contains a scintillator used to convert the radiation into visible light, and this visible light is immediately captured by the internal CMOS sensor. The digital image is transferred to a computer via USB 2.0 and can be viewed in most common imaging software programs, including LED Imaging Software. A software driver is available from LED Dental which will allow the TUXEDO sensor to be used in these software programs. The software supplied with the Tuxedo Digital Dental Sensor was cleared separately by FDA by Apteryx, Inc. The sensor is intended to be used with a disposable barrier sheath that should be replaced between patients. This is to reduce cross contamination between patients. The sensor is also sealed in a way that the portion of the device that is placed in the patient's mouth can be sterilized with liquid without the device being damaged.
| ComparableProperties | RIO Sensor (RIS 500), K143000 | "Tuxedo Digital Dental Sensor" | ComparisonResults |
|---|---|---|---|
| Indicationsfor Use | This system is intended to collectdental x-ray photons and convertthem into electronic impulses thatmay be stored, views andmanipulated for diagnostic use bydentists. | The Tuxedo Digital Dental Sensor is aCMOS sensor for the capturing ofdigital diagnostic x-ray images on apatient for evaluation by anappropriately trained oral healthcareprofessional. The Tuxedo sensor itselfis a single piece comprised of theimage capture components on one end,with a USB 2.0 plug on the other end.The sensor is designed to be used inconjunction with a disposable, single-use hygienic sheath as well as apositioning device to allow for properalignment within the patient's mouth.Images are acquired with the Tuxedosensor by plugging it into a USB portand properly placing it in the patient'smouth, while an operator exposesradiation toward the sensor from anapproved intraoral x-ray generator. | Thesestatementsarefunctionallyequivalent |
| ComputerInterface | USB 2 | USB 2 | Identical |
| Sizes | Size 1: 39x25Size 2: 42x30 | Size 1 39 x 25 mmSize 2 41.9 x 30.4 mm | Identical.Predicaterounded offthe numbers |
| SensorThickness | 5.6 mm | 5.3 ± 0.3 mm | Essentiallyidentical |
| ImagingTechnology | CMOS | CMOS | Identical |
| ComparableProperties | RIO Sensor (RIS 500), K143000 | "Tuxedo Digital Dental Sensor" | ComparisonResults |
| Pixel Size | 20.0 µm | 20.0 µm | Identical |
| ScintillatorTechnology | Csl Scintillator | Csl Scintillator | Identical |
| Image Sizes | Size 1: 1000x1500 pixelSize 2: 1300x1700 pixel | 1000 x 1500 pixels1300 x 1700 pixels | Identical |
| TheoreticalResolution | 25 lp/mm | 25 lp/mm | Identical |
| MTF | More than 30% at 6 lp/mm | More than 30% at 6 lp/mm | Identical |
| DQE | More than 40% at 2.5 lp/mm | More than 40% at 2.5 lp/mm | Identical |
| Computer | Not specified | PC or Tablet with Windows Vista®SP2 or above, Windows® 7,Windows® 8, Windows Server®2003 R2, Windows Server® 2008,and Windows Server® 2012operating systems includingTerminal Services and Citrix®.The software has been cleared byFDA in a separate submission.(Apteryx, Inc, K983111) | New devicecovers awider rangeof operatingsystems |
| Infectioncontrol | Requires a single patient useFDA cleared hygienic barrier | Requires a single patient use FDAcleared hygienic barrier, forexample TIDIShield™ K132953.Sheaths:Code # 21041 for Size 1Code # 21040 for Size 2 | Identical |
| Photo | Image: Dental sensor with USB | Image: Dental sensor with USB | The samesensor isbeing usedby thepredicate. |
-
- Substantial Equivalence
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-
- Summary of Technological Characteristics of the Subject Device as Compared with the Predicate Device: The comparison results show essentially identical characteristics or negligible differences. We conclude that our Tuxedo device is substantially equivalent in terms of safety and effectiveness. Looking at the photo and the specification comparisons, it appears that the predicate is using the same exact sensor as ours.
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- Performance Testing: Successful standards testing was done according to the following: Radiated Emission IEC60601-1-2: 2007, including Radiated Immunity EN61000-4-3, and Electrostatic Discharge (ESD) EN61000-4-2.
Dielectric strength and PATIENT LEAKAGE CURRENT and Temperature of APPLIED PARTS: IEC60601-1:2005.
- Performance Testing: Successful standards testing was done according to the following: Radiated Emission IEC60601-1-2: 2007, including Radiated Immunity EN61000-4-3, and Electrostatic Discharge (ESD) EN61000-4-2.
Imaging performance tests were conducted according to IEC6220-1, Characteristics of digital X-ray imaging devices - Part 1: Determination of the detective quantum efficiency.
Other testing: The stability of sensitivity, dark output and offset value.
Mechanical Strength Testing: Bending and Pulling Test of Cable
Other Reliability Test Reporting: Dropping, Alcohol Dipping, Air leakage, Mechanical Strength of APPLIED PART, and Transport testing.
Although the device does not directly contact the patient, biomedical conformity was evaluated according to food utensil safety requirements of Japan.
We also conducted a risk analysis according to the recommendations of IEC 14971, Application of Risk Management to Medical Devices. There are three broad categories of risk: Broadly Acceptable Region; Marginal; countermeasure required to reduce risk to acceptable level (ALARP) and Intolerable; countermeasure required to reduce risk to acceptable level. After applying countermeasures, all risks were reduced to the BA (broadly acceptable) category. The application of the standards testing (above) was the main method of risk reduction, as well as relying on the use of FDA cleared components such as the sanitary barriers and the software. The sensor has been previously cleared as well.
-
- Clinical Testing: Clinical images were provided using a Phantom equivalent to a 51 year old male. Phantom Utilized for Image Capture:
DXTTR III Dental X-Ray Phantom (Human Skull): A training phantom. With real skull and teeth with silicone face etc.
- Clinical Testing: Clinical images were provided using a Phantom equivalent to a 51 year old male. Phantom Utilized for Image Capture:
Intra-Oral X-Ray Generator Utilized: Gendex Expert DC
These images were not necessary to establish substantial equivalence based on the modifications to the device (note CMOS detector that is very similar to the predicate dental detector Rio), but they provide further evidence in addition to the laboratory performance data to show that the complete system works as intended. All images acquired demonstrated excellent diagnostic imaging quality on both the size #1 and the size #2 sensor. The sensors demonstrated a good latitude response from variations in generator settings. Contrast and spatial resolution on all images were good to excellent on all images acquired.
-
- Conclusion as to Substantial Equivalence: In accordance with the federal Food, Drug and Cosmetic Act, 21 CFR Part 807 and based on the information provided in this premarket notification. LED Dental concludes that the Tuxedo Digital Dental Sensor is safe and effective to perform its intended use as well as substantially equivalent to the predicate device.
§ 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.