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The intraoral sensor is intended to convert x-ray photons into electronic impulses that may be stored, viewed and manipulated for diagnostic use by dentists.

The subject device SensorX device is an intraoral x-ray sensor for dental applications. It detects the x-rays and performs the image acquisition, digitizes the image and makes it available for the PC. The x-ray sensor is connected to the computer via the sensor cable, and if required, the USB extension. The x-ray sensor is equipped with protective cover sheaths (previously 510(k) cleared) and placed in the mouth of the patient. For patient comfort, the ergonomic design is based on human intraoral anatomy. SensorX enables high resolution with a minimum radiation dose. It is connected to a computer to produce an image almost instantaneously following exposure. The primary advantage of direct sensor systems such as SensorX, is the speed with which images are acquired. SensorX is activated via the imaging software VisionX (K192743) OR DBSWIN (K203287).

The provided document is a 510(k) Premarket Notification from DÜRR DENTAL SE for their device, SensorX. It primarily focuses on demonstrating substantial equivalence to a predicate device (DEXIS Titanium / KaVo IXS HD) rather than providing detailed acceptance criteria and a study proving the device meets those criteria in a traditional sense (e.g., a clinical trial with statistical endpoints).

Therefore, some of the requested information, particularly regarding specific performance metrics against pre-defined acceptance criteria, multi-reader multi-case studies, and detailed ground truth methodologies for a test set, is not explicitly present in this document. The document primarily relies on non-clinical data (i.e., technical specifications and compliance with standards) and a general statement about clinical images.

However, I can extract the available information as requested:

1. Table of Acceptance Criteria and Reported Device Performance

As specific, quantifiable acceptance criteria with corresponding performance results akin to a clinical trial are not presented in this 510(k) summary, I will infer the "acceptance criteria" from the technological characteristics compared to the predicate device, as substantial equivalence is the goal. The reported "device performance" will be the SensorX's specifications.

2. Sample Size Used for the Test Set and the Data Provenance

The document does not explicitly mention a "test set" in the context of an algorithm's performance with a specified sample size. Instead, it refers to "actual dental images were provided which showed excellent resolution and contrast" as part of the non-clinical data. The provenance of these images (e.g., country of origin, retrospective or prospective) is not specified.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts

This information is not provided in the document. The document states a "clinical evaluation was performed" and "actual dental images were provided," but it does not detail how ground truth was established for these images, nor the number or qualifications of any experts involved.

4. Adjudication Method for the Test Set

This information is not provided in the document.

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

The document does not mention any MRMC comparative effectiveness study. The SensorX is an intraoral x-ray sensor, not an AI-assisted diagnostic tool.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done

The SensorX device is a hardware component (an intraoral x-ray sensor) that captures images, not a standalone algorithm. Its performance is evaluated based on its technical specifications and image quality, not as an AI algorithm.

7. The Type of Ground Truth Used

The document states that "actual dental images were provided which showed excellent resolution and contrast." This implies an expert assessment of image quality, but the specific type of ground truth (e.g., expert consensus on specific pathologies, pathology reports, or patient outcomes data) is not detailed. Given the device's function as an imaging sensor, the ground truth would likely relate to image quality parameters such and resolution, contrast, and diagnostic interpretability by dentists, evaluated by experts.

8. The Sample Size for the Training Set

The document does not describe the use of a "training set" in the context of an AI algorithm, as the SensorX is a hardware device.

9. How the Ground Truth for the Training Set was Established

This is not applicable, as the document does not describe a training set for an AI algorithm.

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For light curing polymerization of dental composites, luting materials, cements and other light cured materials.

Delight, Delight ortho and B&Lite S are light-emitting diode (LED) type dental curing light that is used for polymerization of light cure resin based composites. They can be used on several different dental materials that are curable by light. The devices use LED that produce a narrow spectrum of blue light in the 430~490nm range, which is useful energy range for activating the CPQ molecule, most commonly used to initiate the photo polymerization of dental monomers. The devices are designed by considering lightweight and portability. They operate on a rechargeable battery, making it easier to carry and use.

The device is not provided sterile and is not intended to be sterilized when used. To prevent cross contamination, users must cover the device with FDA cleared barrier sheath (K132953/ TIDIShield™ Curing Light Sheath). It should be changed between each patient.

This document describes the non-clinical testing performed for the "Delight, Delight ortho, and B&Lite S" dental curing lights to demonstrate their substantial equivalence to a predicate device (Hi-Light, Hi-Light plus, K140432).

1. Table of Acceptance Criteria and Reported Device Performance

The main acceptance criteria are based on recognized standards for dental curing lights, specifically ANSI/ADA Specification No. 48 and ANSI/ADA Standard No. 48-2, as well as FDA guidance. The document highlights differences in operation modes and light intensity, and depth of cure between the subject devices and the predicate, stating that testing confirmed these differences did not raise safety and performance issues.

2. Sample Size Used for the Test Set and Data Provenance

The document does not explicitly state the sample size for the test set. It refers to "testing results" and "performance testing - nonclinical testing" without providing specific numbers of units or measurements.

The data provenance is from non-clinical testing conducted according to international (IEC) and national (US: ANSI/ADA, FDA Guidance) standards. The country of origin of the data is not explicitly stated as it's a non-clinical test, but the applicant (DENTALL Co., Ltd.) is from Korea, suggesting the testing was likely overseen or conducted there or by a recognized testing facility acting on their behalf. The data is prospective in nature, as it was generated specifically for this premarket notification.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

Since this is a non-clinical performance study of a device (dental curing light) assessing its physical properties and adherence to technical standards, the "ground truth" is established by adherence to predefined technical specifications and standards (e.g., optical power, wavelength, depth of cure, electrical safety). This type of study does not typically involve human experts establishing "ground truth" in the diagnostic sense (like for medical image interpretation). Instead, the "truth" is determined by calibration and measurement instruments and protocols.

4. Adjudication Method for the Test Set

Not applicable. As this is a non-clinical performance study based on objective measurements against engineering standards, an adjudication method for conflicting expert opinions is not relevant.

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

Not applicable. This is a submission for a dental curing light, which is a physical device, not an AI-based diagnostic aid. No MRMC study was performed.

6. If a Standalone (i.e., Algorithm Only Without Human-in-the-Loop Performance) Was Done

The performance testing described is for the device in a standalone capacity, measuring its direct output and effect (e.g., optical power, wavelength, depth of cure). This could be considered analogous to "algorithm only" performance in that it evaluates the device's intrinsic functional specifications.

7. The Type of Ground Truth Used

The ground truth used for these non-clinical tests is based on defined technical specifications and measurement criteria outlined in relevant standards:

• IEC 60601-1 (Electrical Safety)
• IEC 60601-1-2 (Electromagnetic Compatibility)
• ANSI/ADA Specification No. 48 (Visible Light Curing Units)
• ANSI/ADA Standard No. 48-2 (LED Curing Lights)
• FDA Guidance for Industry and FDA Staff, Dental Curing Lights - Premarket Notification - 510(k) Submissions

These standards provide the benchmarks for acceptable performance and safety.

8. The Sample Size for the Training Set

Not applicable. This is not an AI/machine learning device; therefore, there is no "training set."

9. How the Ground Truth for the Training Set Was Established

Not applicable. As there is no training set.

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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.

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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