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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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Battery driven electrical drive unit with wireless foot controller for use with disposable prophylaxis angles in hygiene operatory to perform cleaning and polishing of tooth surfaces and fillings.

The proposed device, the Young INFINITY Cordless Handpiece System, is a cordless handpiece which is intended for use by a dental clinician during dental cleaning and polishing of tooth surfaces and fillings. The Young INFINITY Cordless Handpiece System is comprised of a cordless, battery-powered handpiece, a removable nosecone, a cradle for the cordless handpiece, a direct current (DC) power supply and charging cord, and a wireless foot controller. Accessories to the Young INFINITY Cordless Handpiece System include a single-use doriot style Disposable Prophy Angle (DPA), which can be purchased from any DPA manufacturer. Additionally, the Young Infinity Cordless Handpiece System must be used with a disposable barrier (cleared as Class II, Product Classification Code PEM, under premarket notification K151123 in 03/03/2016 as Cover-It™ Barrier Film). The handpiece features a removable nosecone that is to be cleaned and steam sterilized prior to first use and after each patient use. The handpiece utilizes an on-board user control for on/off and an LED indicator to communicate handpiece battery life, handpiece battery charging, foot control low power level, excessive pressure being applied, and wireless pairing status, The handpiece can only be operated by the appropriately paired wireless foot controller. The Young INFINITY Cordless Handpiece System is operated by using a wireless foot controller, where the amount of vertical actuation on the wireless foot controller correlates to the speed of the handpiece supplied to the DPA. The corresponding variable speed range of the DPA is between 500RPM and 3000RPM. The wireless foot controller operates using a Bluetooth low energy (BLE) communication protocol. When the handpiece has been turned ON, engaging the wireless foot controller activates the (BLE) mode of both the cordless handpiece and the wireless foot controller. The wireless foot controller features LEDs to indicate when the BLE mode on the foot controller has been activated, battery charging and adequate battery power level.

The provided text is a 510(k) summary for the Young INFINITY Cordless Handpiece System, which is a dental handpiece. It aims to demonstrate substantial equivalence to a predicate device.

The document describes performance data for the device, but it does not contain information about acceptance criteria or a study that specifically proves the device meets acceptance criteria related to artificial intelligence, machine learning, or complex algorithmic performance involving human-in-the-loop interaction, ground truth establishment by experts, or large-scale data sets for training/testing.

The performance data mentioned relates to standard medical device testing for safety, functionality, and biocompatibility, such as:

• Sterilization/Cleaning validation: Per ISO 17665-1 and ISO 17665-2, and FDA Guidance Document.
• Electrical Safety and Electromagnetic Compatibility: Per IEC 60601-1 and IEC 60601-1-2.
• Biocompatibility validation: Per FDA Guidance Document for Use of ISO 10993-1, and ISO 10993-5 cytotoxicity testing.
• Risk Analysis: Per ISO 14971 (hardware and software).
• Software documentation: For software of moderate level of concern per FDA Guidance Document Software Contained in Medical Devices.
• Hardware Performance/Safety Verification/Validation: Including conformance to ISO 14457 Dentistry -- Handpieces and motors.
• Verification of component specifications, speed and torque control, connectivity, battery life, noise testing, chemical compatibility, fluid ingress, weight, and dimensions.

Given the nature of the device (a cordless dental handpiece) and the type of performance data presented, the questions about AI/ML specific study design elements (human readers, effect size, standalone algorithm performance, expert adjudication, training/test set sample sizes for algorithms, ground truth for AI) are not applicable to this 510(k) submission.

Therefore, I cannot populate the table or answer the specific questions related to AI/ML acceptance criteria and studies based on the provided document. The document describes a traditional medical device premarket notification demonstrating substantial equivalence based on engineering, safety, and performance characteristics, not AI/ML performance.

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The DEXIS / KaVo sensor is a USB-driven digital sensor which is intended to acquire dental intraoral radiographic images. The DEXIS / KaVo sensor shall be operated by healthcare professionals, who are educated and competent to perform the acquisition of dental intra-oral radiographs. The DEXIS / KaVo sensor can be used either in combination with special positioning devices to facilitate positioning and alignment with the x-ray beam or it may also be positioned by hand with the assistance of the patient.

The DEXIS Titanium, Kavo IXS HD (Size 1, Size 2) intraoral sensors are an indirect converting x-ray detector, e.g. incident x-rays are converted by a scintillating material into (visible) light, this light is coupled optically to a light detection imager based on CMOS technology. The design of the sensor assembly supports the automatic detection of the incident x-rays to generate digital images for dental intra oral applications. The DEXIS Titanium, Kavo IXS HD (Size 1, Size 2) intraoral sensors supports USB2.0 connectivity to personal computers using a dedicated electronic assembly and a sensor software driver.

The provided text describes the KaVo Dental Technologies, LLC DEXIS Titanium, KaVo IXS HD (Size 1, Size 2) intraoral sensors. It concludes that clinical performance data was not needed to characterize performance and establish substantial equivalence. Therefore, there is no information about specific acceptance criteria related to clinical performance or a study proving the device meets such criteria.

The document focuses on non-clinical test data and substantial equivalence to a predicate device (DEXIS Sensor - K090458). It states that substantial equivalence is based on a comparison of intended use, indications, technological characteristics, principle of operation, features, and non-clinical performance data.

Here's an overview of the non-clinical performance testing and device characteristics provided, which indirectly serve as acceptance criteria for regulatory clearance:

1. Table of Acceptance Criteria (Implied Non-Clinical) and Reported Device Performance:

Since clinical performance criteria are explicitly stated as "not needed," the acceptance criteria are derived from the performance bench testing and conformance to international standards for extraoral source X-ray systems. The reported device performance is presented in the comparison table with the predicate device and in the list of standards met.

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

The document states "Clinical data is not needed to characterize performance." Therefore, there is no test set of patient data described for clinical validation. The testing described is non-clinical bench testing. The provenance of the data is not specified beyond being "non-clinical test data."

3. Number of Experts Used to Establish Ground Truth and Qualifications:

Not applicable, as no clinical study with a test set requiring expert ground truth establishment was conducted. The assessment relied on engineering and scientific principles and adherence to recognized standards.

4. Adjudication Method for the Test Set:

Not applicable, as no clinical study with a test set requiring adjudication was conducted.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

No MRMC study was performed or cited, as clinical data was deemed unnecessary for substantial equivalence. Therefore, there is no information on the effect size of AI assistance on human readers.

6. Standalone Performance Study:

A standalone performance assessment was effectively done through the non-clinical bench testing, where the device's technical specifications and adherence to international standards were evaluated independently. However, this is not a standalone clinical performance study in the sense of an algorithm-only evaluation against ground truth in a clinical context.

7. Type of Ground Truth Used:

For the non-clinical testing, the "ground truth" was based on established engineering principles, reference standards (e.g., test phantoms for X-ray resolution if applicable, though not explicitly stated), and regulatory compliance requirements for medical devices. There was no clinical ground truth (e.g., pathology, outcomes data) used in this submission.

8. Sample Size for the Training Set:

Not applicable, as this device is a hardware sensor, not an AI/ML algorithm that requires a training set in the conventional sense.

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

Not applicable, as it is a hardware device and not an AI/ML algorithm that requires a training set.

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