(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.
§ 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.