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Primescan 2 can be used as a diagnostic aid by licensed dentists for detection of caries on visible tooth surfaces, proximal caries, and tooth cracks.

The Primescan 2 is an intraoral scanner that records and generates digital images to provide caries diagnosis support using additional light sources at 405 nm and 850 nm and an optical filter to filter out the excitation light. By illuminating the tooth with these two wavelengths, two diagnosis support modes are realized, the fluorescence mode and the near-infrared mode. The acquired 2D data from the scanner can be viewed in the software in a live stream video during acquisition. The images are also stored in the cloud platform software for later patient communication.

In fluorescence mode, the tooth (or teeth) are illuminated with UV light (405 nm). This stimulates an autofluorescence of the enamel in the green wavelength range. In addition, the red fluorescence is stimulated in carious areas on the teeth. All stimulated fluorescence responses are significantly weaker in terms of their light intensity compared to the back-reflected excitation light. For this reason, the excitation light is filtered out with the aid of an optical filter. The dental professional can use the 2D image data of the fluorescence response (live stream video) as additional information for caries diagnosis.

For near-infrared mode (NIR mode), the tooth or teeth are illuminated with 850 nm. Enamel is partially transparent in this wavelength. The illumination can therefore penetrate the tooth and is reflected by structural defects such as cracks and cavities, as well as from the dentin core. The reflected light is picked up by the 2D sensor of the scanner.

When used, a sleeve is placed over the distal end of the scanner. This sleeve is the only patient contacting component and is offered as either a single-use disposable or a multi-use sleeve that is reprocessed.

Here's the breakdown of the acceptance criteria and study information for the Primescan 2 device, based on the provided FDA 510(k) clearance letter:

Acceptance Criteria and Device Performance

The provided document does not explicitly state quantitative acceptance criteria or a specific table outlining them. However, it does mention that "in vivo bench tests demonstrated that Primescan-2 is effective as a diagnostic aid for occlusal caries using the fluorescence function and tooth cracks using the NIR function." This implies that the device met an unstated level of effectiveness for these diagnostic aids.

Since specific quantitative metrics (e.g., sensitivity, specificity, accuracy) are not provided in the summary, we cannot populate a detailed table with numerical acceptance criteria and performance outcomes.

Study Details

2. Sample size used for the test set and the data provenance

• Sample Size for Test Set: Not specified in the provided document.
• Data Provenance: The study was "in vivo bench tests," implying data was collected from living subjects. The country of origin and whether it was retrospective or prospective is not explicitly stated.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

• Number of Experts: Not specified.
• Qualifications of Experts: Not specified.

4. Adjudication method for the test set

• Adjudication Method: Not specified.

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

• MRMC Study: Not mentioned in the provided document. The study described is "Performance Validation Testing of the Caries diagnostic Aid - In vivo bench tests demonstrated that Primescan-2 is effective as a diagnostic aid..." This describes standalone device performance rather than human-in-the-loop improvement.

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

• Standalone Performance Study: Yes, a standalone performance study was done. The document states: "Performance Validation Testing of the Caries diagnostic Aid - In vivo bench tests demonstrated that Primescan-2 is effective as a diagnostic aid for occlusal caries using the fluorescence function and tooth cracks using the NIR function." This indicates the device's ability to provide a diagnostic aid on its own.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

• Type of Ground Truth: Not explicitly stated. For "in vivo bench tests" related to caries and tooth cracks, ground truth would typically be established through a combination of visual-tactile examination by experienced clinicians, potentially supplemented by radiography or even histology (though less common for a diagnostic aid). However, the document does not specify the method used here.

8. The sample size for the training set

• Sample Size for Training Set: Not applicable or not specified. This device appears to be a direct imaging and diagnostic aid rather than an AI/ML algorithm that requires a separate training set. The "diagnostic support" refers to the illumination and optical filtering techniques, not necessarily an AI algorithm trained on a dataset.

9. How the ground truth for the training set was established

• Ground Truth for Training Set: Not applicable, as there's no indication of an AI/ML algorithm with a training set. The device operates on optical principles.

Key Observations and Limitations of Information:

• The provided 510(k) summary focuses highly on technological comparisons, safety, and regulatory compliance (electrical safety, biocompatibility, reprocessing, software, cybersecurity).
• While it mentions "Performance Validation Testing," it lacks specific quantitative results (e.g., sensitivity, specificity, accuracy, AUC) that are typically associated with diagnostic device clearances.
• The clinical study details, such as sample size, expert qualifications, and ground truth establishment methods for the performance validation, are not provided in this specific document. This information would typically be in a more detailed study report submitted to the FDA, but is summarized very broadly here.
• The device is described as providing "diagnostic support" using optical modes (fluorescence and NIR), rather than an explicit AI algorithm.

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The iTero Lumina Pro NRI functionality is a diagnostic aid for the detection of interproximal carious lesions above the gingiva and for monitoring the progress of such lesions.

The iTero Lumina Pro is an integrated intraoral imaging system capable of capturing 3D optical impressions for CAD/CAM of dental devices, 2D color images and Near Infrared (NIR) images. Scanning cycles are employed allowing the system to quickly alternate between the three modalities, creating a virtually simultaneous capture of the 3D optical impression, 2D color and NIR images.

The iTero Lumina Pro consists of the following main components:

• A. Scanning Wand used for intraoral scanning.
• B. Wand Cradle used to hold the Scanning Wand when not in use.
• C. Application Software that includes Graphical User Interface ("GUI").
• D. Computer platform

The scanning wand houses electronic, mechanical, and optical components, including projectors, LEDs and cameras which enables capturing 3D impression data as well as 2D color and NIRI images. The wand body is made of Aluminum, Copolyester and Glass. When not in use, it is stored in the Wand Cradle.

The iTero Lumina Pro features proprietary software that can be installed on the various configurations of the computer platform. The software is designed to manage the GUI, control the scanning process, display the scanned images, and connect to the stored patient data, including scanned data for display or export.

The iTero Lumina scanning wand is designed to be used with a single-use, non-sterile, disposable, wand barrier sleeve. The only patient-contacting materials are those contained within the wand barrier sleeve.

The provided text does not contain detailed information about specific acceptance criteria and a study that comprehensively proves the device meets these criteria in the format requested. The document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device rather than presenting a full clinical trial report with specific performance metrics against pre-defined acceptance criteria.

However, I can extract information related to performance data and testing methods mentioned in the "Performance Data" section to infer some aspects of device performance and the types of studies conducted.

Here's an attempt to answer your questions based on the provided text, while acknowledging the limitations of the available information:

1. Table of acceptance criteria and the reported device performance

The document does not explicitly state quantitative acceptance criteria for NIRI functionality or specific performance targets. Instead, it states that "All testing showed similar performance to the predicate system." This implies that the acceptance criterion was likely comparable performance to the predicate device across various technical attributes.

2. Sample size used for the test set and the data provenance

The document explicitly states that the company performed "bench testing" to support substantial equivalence. It does not provide details on sample sizes for the NIRI performance attributes (Field of View, Image Sharpness, etc.). It mentions ASTM standards for material testing of the wand barrier sleeve, which would imply defined sample sizes per those standards, but these are not enumerated in the text. There is no information provided about the origin or nature of the "test set" data in terms of patient population (e.g., country of origin, retrospective or prospective).

The testing described appears to be primarily non-clinical bench testing rather than clinical study data involving patient samples or diagnostic accuracy.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

The document does not describe a process for establishing ground truth using human experts for diagnostic accuracy. The performance data presented focuses on technical and engineering performance characteristics of the device itself (e.g., optical properties, material strength, electrical safety).

4. Adjudication method for the test set

Not applicable, as there is no description of a test set involving human interpretation and adjudication of diagnostic results.

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 study or AI assistance. The device is described as a "diagnostic aid" providing NIR images for a dentist's review. The NIRI functionality itself is the diagnostic aid, not an AI component assisting human readers.

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

The document does not describe any standalone algorithm performance testing. The device's NIRI functionality generates images that are then reviewed by a dentist.

7. The type of ground truth used

For the technical and engineering tests described, the ground truth would be established by the specifications and performance characteristics of the predicate device and relevant international standards (e.g., for electrical safety, biocompatibility, material properties). For the NIRI imagery itself, the comparison is made against the predicate device's image output, not against a clinical "ground truth" like pathology for caries detection in this summary.

8. The sample size for the training set

Not applicable. The document describes a medical device generating images, not a machine learning model that requires a training set.

9. How the ground truth for the training set was established

Not applicable, as there is no mention of a training set for a machine learning model.

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The TIA Tip is a diagnostic aid for viewing the interproximal areas of dental anatomy to detect and monitor the progression of proximal carious lesions above the gingiva.

The TIA Tip is an optional interchangeable component tip assembly that works with the Dental CAD/CAM System Scanner. With the TIA Tip installed the system allows for the simultaneous side by side visualization of live transilluminated and color imaging of the patient's dental anatomy, as well as providing the user with the ability to capture and save transilluminated static images to a patient digital file. The system consists of:

• Dental Scanner .
• TIA Tip ●
• Computer with Software ●

With one of the other provided interchangeable scanning tips installed, the system is also used to process dental restorations that are regulated under 21 CFR 872.3661, Optical Impression Systems for CAD/CAM of Dental Restorations.

The Scanner is a hand-held electronic device that consists of three parts: the scanner body, the TIA Tip and a custom USB data cable that connects the scanner to the computer. The scanner contains the electrical and opto-mechanical components.

The USB cable uses industry standard USB 3.0 type-A and type-C connectors, and the cable assembly is detachable making it easily replaceable.

The TIA tip must be connected to the scanner to work. It incorporates two "probes" containing Light Emitting Diodes (LEDs) that emit 727nm near infrared light.

In operation the probes conform to dental anatomy to direct light into the desired area of inspection. The light penetrates the tooth surface due to the translucent nature of dental anatomy. This allows a user to visualize the inner structure of the tooth and specifically to detect irreqularities like caries that show up as dark areas or spots on the transilluminated image. The scattering light of the illuminated anatomy is reflected by the tip mirror and directed toward the camera in the scanner which allows for a digital image to be captured.

The tooth is illuminated with light from both the scanner's laser projection system (RGB) and the TIA Tip LED's. Timing of the light is controlled through the electronics and is divided into separate frames. Collecting and presenting these images at many frames per second allows simultaneous "live" views of transilluminated image and full color view to the system operator. This allows the user to better visualize caries that cannot be detected with standard color imaging. For example, a proximal dental cavity becomes visible as a dark region in the transilluminated image.

The software will also allow for the capture of static images throughout the inspection process if the user wishes to document an area of interest and show the patient to discuss treatment options.

The software operates on a laptop or desktop pc. A network connection is required for interoperability.

When the TIA Tip is installed, it is automatically detected by the scanner and the operator is presented with both a transilluminated view and a live view simultaneously. The operator is provided with controls on the scanner to start/stop and toggle TIA illumination from Both/Right/Left LEDs to enhance TIA viewing. Additionally, on screen controls allow for TIA illumination intensity control for further TIA view optimization. Image capture of simultaneous TIA and live view images is provided which can be used for later reference. No digitization occurs during TIA viewing.

The provided text describes the TIA Tip, Cariosity, Transillumination Accessory Tip, P/N 156930xx and its substantial equivalence to a predicate device. However, the document explicitly states that "Clinical testing is not required and has not been performed," and therefore it does not contain a study proving the device meets acceptance criteria.

Instead, the document focuses on non-clinical performance testing to demonstrate substantial equivalence to a predicate device.

Here's a breakdown of the requested information based on the provided text, noting where information is not available:

1. Table of acceptance criteria and the reported device performance

Since no clinical study was performed to establish acceptance criteria for detection performance, this table cannot be provided from the given text. The document refers to "Key performance attributes tested and compared include: a. LED illumination and output power, b. Image Quality" to demonstrate similar performance to the predicate device, not to meet specific acceptance criteria for caries detection.

2. Sample size used for the test set and the data provenance

Not applicable, as no clinical or comparative performance study using a test set was conducted for caries detection. The non-clinical tests relate to hardware performance and safety.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable, as no clinical study or test set requiring expert ground truth was conducted.

4. Adjudication method for the test set

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

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

No MRMC comparative effectiveness study was done. The device does not incorporate AI; it is a transillumination accessory for direct visualization.

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

Not applicable, as the device is a diagnostic aid for human viewing and does not involve a standalone algorithm for performance.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

Not applicable, as no ground truth for caries detection performance was established due to the absence of a clinical study for this purpose.

8. The sample size for the training set

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

9. How the ground truth for the training set was established

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

Summary of Non-Clinical Performance Testing (as described in the document):

The TIA Tip was evaluated through non-clinical performance testing to demonstrate substantial equivalence to the predicate device, the CamX Triton HD Proxi. The key aspects tested and compared were:

• LED illumination and output power: The comparison table indicates that while the TIA Tip uses 727nm wavelength LEDs and the predicate uses 850nm, the output power (Max 3.74mW/cm² for TIA Tip at 3.845 mm vs. Max 2.00 mW/cm² for predicate at 7mm) was considered "almost the same" when measured side-by-side using the same equipment and test environment, accounting for measuring distance differences.
• Image Quality: Specific metrics or quantitative results for image quality are not provided in this summary, but it states "image quality of potential caries detection products are similar for both Duerr Dental AG's CamX Triton HD Proxi and E4D's TIA Tip."

Additionally, the device complied with several safety and biocompatibility standards:

• IEC 60601-1 Edition 3.1 - Medical Electrical Equipment - Part 1: General requirements for basic safety and essential performance
• IEC 60601-1-2:2014 – Medical Electrical Equipment – Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests
• ISO 17665-1 (Sterilization validation – Moist Heat)
• ISO 10993 series (Biocompatibility Testing), specifically ISO 10993-10 for Irritation and Delayed Hypersensitivity, and ISO 10993-5 for Cytotoxicity.

Conclusion stated in the document:
Based on similarities in indications for use and technological characteristics, together with results of non-clinical performance testing, it is concluded that the TIA Tip is substantially equivalent to the CamX Triton HD Proxi Head system. This substantial equivalence determination allows the device to be marketed without the need for a new clinical study demonstrating specific acceptance criteria for caries detection performance.

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The iTero Element 5D is a diagnostic aid for the detection of interproximal caries lesions above the gingiva and for monitoring the progress of such lesions.

The iTero Element 5D is an integrated intraoral imaging system capable of 3D confocal optical impressions for CAD/CAM of dental devices, which also captures 2D color images and Near Infrared (NIR) images.

The iTero Element 5D consists of a scanning wand cradle, single-use, disposable, 5D barrier sleeve, iTero Element 5D Sleeve (protective sleeve), software (including GUI), and a computer hardware platform that is offered in two configurations:

1. Laptop Configuration, where the GUI is presented on a customer-provided PC Laptop Touchscreen;
2. Wheel Stand Configuration where the GUI is presented on a display panel that is mounted on a wheel stand base unit.
   The scanning wand and software, including the GUI, are common to both configurations.

The scanning wand which has 3 imaging capabilities: 1) 3D confocal optical impression, 2) 2D color imaging and 3) near infrared imaging (NIRI), is designed to be used with a single-use, disposable, scanning wand barrier sleeve ("5D barrier sleeve") during scans and a protective sleeve during storage. At the beginning of every scan, the single-use, disposable, 5D barrier sleeve is placed on the scanning wand's head. The wand tip is placed slightly above the patient's teeth and the scan is initiated. At the end of the scan, proprietary imaging software converts the scan into an image that is simultaneously presented alongside the 2D color images on the GUI display. The 3D confocal optical impression and 2D color images assist in orientation by providing an enhanced view of the scanned teeth, thus helping the user identify which areas (i.e. occlusal direction/angles) to view as NIR images. The 2D color image displays a close-up view of the teeth while the NIR Image translates the teeth structure (enamel and dentin) to different brightness levels.

Here's an analysis of the provided text regarding the iTero Element 5D device, focusing on its acceptance criteria and the supporting study information.

It is important to note that the provided document is a 510(k) summary for a medical device cleared by the FDA. Such documents often focus on demonstrating substantial equivalence to a predicate device rather than presenting extensive de novo clinical trial data. Therefore, some of the requested information, particularly detailed clinical study specifics, might not be explicitly present.

1. Table of Acceptance Criteria and Reported Device Performance

Based on the non-clinical performance testing section, the acceptance criteria are implicitly defined by the demonstration of "substantially equivalent manner relative to the predicate" for various parameters. The reported performance is a statement of this equivalence.

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

The document does not specify sample sizes for the test sets in the non-clinical performance testing. It mentions "comparison testing" and "system level testing" but does not quantify the number of devices or scenarios tested for each parameter.

Data provenance (e.g., country of origin, retrospective/prospective) is also not mentioned. Given the nature of a 510(k) summary and the non-clinical focus, this information is typically not included.

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

This information is not provided. The performance testing described is non-clinical, primarily focusing on physical and technical characteristics of the device and its components, rather than clinical evaluation against a "ground truth" established by experts in a diagnostic context. This would be more relevant in a clinical study for diagnostic accuracy.

4. Adjudication Method for the Test Set

This information is not provided. As the testing is non-clinical, an adjudication method in the traditional sense (e.g., for expert disagreement on ground truth) is not applicable.

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

A Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not explicitly stated as performed. The document explicitly states: "Clinical performance testing was not conducted/provided." The device is described as a "diagnostic aid" but the primary focus of the submission is non-clinical equivalence. There is no mention of an AI component improving human reader performance.

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

A standalone performance study in the sense of algorithm-only diagnostic accuracy was not conducted or reported in this document. The device is hardware-based with integrated software and its function relies on a human operator to perform the scan and interpret the images. The testing focused on the performance of the device's imaging capabilities (e.g., image sharpness, signal-to-noise ratio).

7. The Type of Ground Truth Used

For the non-clinical performance tests, the "ground truth" would be objective measurements and established engineering standards. For example:

• Image Quality: Calibrated measurement systems for sharpness, field of view, signal-to-noise ratio against known targets.
• Barrier Testing: Standardized material property tests (e.g., ASTM standards) with defined thresholds for tensile strength, tear resistance, etc.
• Biocompatibility: Adherence to ISO 10993 series for material compatibility.
• Safety/EMC: Compliance with IEC standards.

There is no mention of ground truth established by expert consensus, pathology, or outcomes data, as these typically relate to clinical diagnostic accuracy which was not performed.

8. The Sample Size for the Training Set

The document does not mention a "training set" in the context of machine learning or AI development. The device described appears to leverage established imaging principles (Near Infrared Transillumination) rather than a deep learning model that requires a large training dataset. The software discussed controls display, storage, live stream, and camera functions, rather than performing automated diagnostic interpretations based on trained algorithms.

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

As no training set is mentioned (see point 8), this information is not applicable.

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The DEXIS CariVu 3-in-1 by KaVo acquires patient images as a diagnostic aid for detection of smooth surface caries, occlusal caries, proximal caries, secondary caries, and tooth cracks. The DEXIS Cari Vu 3-in-1 by KaVo is designed for use by a trained professional in the field of dentistry.

The device is used as an intraoral camera to acquire images in the oral cavity of the patient. The camera combines three different known applications from available intraoral cameras in one device. These applications are standard camera functionality, transillumination and fluorescence caries detection. Therefore, the camera uses different light colors for each of the three applications to illuminate the tooth. In combination with an optical system, CMOS sensor, and an internal image processing unit, a digital image of the tooth is generated. The live images are transferred as a standard mjpg video stream via USB interface to a running computer and can interface with a dental imaging software such as for example CONEXIO for basic intraoral camera management functionality.

The device may be used as an aid for monitoring caries lesion size and shape by comparing images taken with the Dexis CariVu 3-in-1 by KaVo over time, by using different reference points, such as tooth contour and position the device to optimize capturing tooth features previously recorded in a still or video image.

For easy use the camera is equipped with an autofocus mechanism which will provide a sharp representation of the tooth which is placed in the center of the imaqe. The autofocus provides the ability to have sharp images from close distances of about 2mm to about 120mm distance.

The different operation modes are described as follows:

1.) Color mode:
For normal color images, a white LED for illumination is used. With this light the camera provides coloured images or videos. The camera can be used with or without a Tip Vision Full HD which is required for illumination for the transillumination mode.

2. Fluorescence mode:
   For the fluorescence mode the blue LED illumination is used. The blue light excites bacterial porphorines as an aid to detect caries.

To enhance the image quality and to minimize external light influence on the fluorescence effect the accessories Fluorescence Cover Vision Full HD can be used optionally with the camera. The Fluorescence Cover Vision Full HD is a rubber cap which can be slipped on the front camera head and prevent or minimize external light on the images surface of the tooth. After each usaqe the Fluorescence Cover Vision Full HD will be reprocessed separately.

The camera can be used with or without a Tip Vision Full HD which is required for illumination for the transillumination mode. This mode is used to record images and videos to aid in the diagnosis of caries (mainly in the occlusal area) and plaque by means of fluorescent effect.

3. Transillumination mode (by the use of near infrared light):
   The transillumination mode provides images to aid in the detection of caries. For this mode near infrared light will be used. The near infrared light penetrates the side of the tooth near gingiva and illuminates the enamel of the tooth to produce gray scale images whereby intact enamel appears bright, and defects such as caries or cracks result in diffusion of light path and create an area of dark appearance.

To use this mode, the Tip Vision Full HD must be attached to the device as the LEDs for the illumination are located inside the Tip Vision Full HD. The Tip Vision Full HD touches the side of the tooth and gingiva and illuminates it from two sides whereas the image is taken from the top.

The DEXIS CariVu 3-in-1 by KaVo is available in two similar models. The differences between the models are a wall mounted version to store the device with a cable length of 2.5 meters (model 1.011.4444) and a table holder version to store the device on a dental unit with a cable length of 1.55 meters (model 1.013.1700). All critical components within the DEXIS CariVu 3in-1 by KaVo are common. A disposable sheath is used with the device to mitigate the potential for cross contamination.

The provided text does not contain detailed information about specific acceptance criteria or an in-depth study proving the device meets those criteria, especially in the format requested. The document is a 510(k) summary for the DEXIS CariVu 3-in-1 by KaVo, primarily focusing on demonstrating substantial equivalence to predicate devices rather than presenting the results of a primary clinical study with predefined acceptance criteria.

However, I can extract the following information from the text:

1. Table of acceptance criteria and reported device performance:

The document does not provide a table of acceptance criteria with corresponding performance metrics like sensitivity, specificity, accuracy, or AUC. It focuses on comparison of capabilities and safety standards with predicate devices.

2. Sample size used for the test set and the data provenance:

• Clinical Testing: "Clinical testing was not conducted on this product." This indicates that there was no clinical test set for performance evaluation in the context of this 510(k) submission.

3. Number of experts used to establish the ground truth for the test set and their qualifications:

• Since no clinical testing was performed, there were no experts used to establish ground truth for a test set.

4. Adjudication method for the test set:

• Since no clinical testing was performed, there was no adjudication method for a test set.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done:

• No MRMC study was done, as "Clinical testing was not conducted on this product."

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

• The device description indicates it's an intraoral camera with various modes (color, fluorescence, transillumination) "as a diagnostic aid for detection." It is designed "for use by a trained professional in the field of dentistry." This implies a human-in-the-loop scenario. No standalone performance data for an algorithm alone is provided.

7. The type of ground truth used:

• Not applicable as no clinical testing was performed to establish performance metrics against a ground truth.

8. The sample size for the training set:

• The document does not mention a training set or its size, as it states clinical testing was not conducted. This implies that the device's development and evaluation for this submission did not involve a supervised learning approach requiring a distinct training set in the context of a clinical performance study.

9. How the ground truth for the training set was established:

• Not applicable as no training set is mentioned in the context of clinical performance evaluation.

Summary of what is present in the document relevant to performance and equivalence:

The document primarily focuses on non-clinical bench testing to demonstrate performance according to international standards for medical electrical equipment, sterilization, biocompatibility, risk management, and cybersecurity. These are safety and engineering performance criteria, not clinical diagnostic performance criteria.

• Non-Clinical Test Data: Performance bench testing focused on:
  • IEC 60601-1-2 Forth Edition (Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance)
  • ANSI AAMI ES60601-1 and IEC 60601-1:2005 (Medical electrical equipment - Part 1: General requirements for basic safety and essential performance)
  • CAN/CSA-C22.2 No. 60601-1 (Medical Electrical Equipment - Part 1: General Reg. for Basic Safety & Essential Performance)
  • IEC 62304: 2006 Edition 1.1 (Medical device software - Software life cycle processes)
  • ISO 17665-1 First edition (Sterilization of health care products - Moist heat)
  • AAMI / ANSI ST79 2017 (Comprehensive guide to steam sterility assurance in health care facilities)
  • ISO 10993-1 Fourth Edition (Biological evaluation of medical devices)
  • ISO 7405 Second edition (Dentistry - Evaluation of biocompatibility of medical devices used in dentistry)
  • ISO 14971 2007 and 2012 (Medical devices - Application of risk management to medical devices)
  • Guidance for Industry and FDA Staff 2014-10-02 Content of Premarket Submissions for Management of Cybersecurity in Medical Devices
  • Guidance for Industry and FDA Staff 2017-06-09 Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling

The conclusion of the 510(k) process states: "Based upon a comparison of indications for use and technological characteristics, together with results from non-clinical performance testing, we believe that DEXIS CariVu 3-in-1 by KaVo is substantially equivalent to the predicate devices." This highlights that the equivalence was demonstrated without direct clinical performance data for the new device.

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The CamX Triton HD Proxi Head is a diagnostic aid for the detection of interproximal caries lesions above the gingiva and for monitoring the progress of such lesions.

The CamX Triton HD "Proxi" aids in the detection and diagnosis of proximal caries. It consists of a toothbrush-sized handpiece and a "Proxi" head. A USB cable connects the handpiece to a personal computer with PACS software such as DBSWIN to enable communication between a PC computer and the handpiece. After a camera cover (single patient disposable sheath, K132953) is placed over the distal end, and an autoclave-able spacer is installed, the Handpiece is positioned over the teeth to be examined. The camera functions by transilluminating sound tooth enamel with infrared light. Areas that spread and reflect the light (e.g. caries lesions) show up clearly delimited bright areas. A digital camera converts the object situation into an electrical signal, sent it over USB to a computer, converted into an image (by imaging software) and presented on a monitor in monochrome colors to illustrate suspected areas of decay.

This document is a 510(k) Pre-Market Notification, which focuses on demonstrating substantial equivalence to a predicate device rather than fulfilling specific acceptance criteria through a clinical study. Therefore, comprehensive information regarding acceptance criteria and a detailed study proving the device meets them, as typically found in a clinical trial report, is not present.

However, based on the provided text, 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 acceptance criteria in a quantitative table format with corresponding performance results. Instead, it relies on a comparison to the predicate device and validation of key performance attributes.

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)

The document explicitly states: "11. Clinical Data: Not required for a finding of substantial equivalence." This means a clinical test set of patient data, as would be used in a typical clinical study, was not required or performed for this submission. The performance assessment was based on non-clinical data.

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)

Given that clinical data was not required, there is no mention of experts establishing ground truth for a clinical test set. The "ground truth" concept in a clinical context (e.g., confirmed caries presence) is not applicable here as no clinical study was performed.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set

Not applicable, as no clinical test set requiring adjudication was used.

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 device for detecting caries, not an AI-assisted diagnostic tool for human readers in the context of an MRMC study.

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

The device is described as "a diagnostic aid," implying human-in-the-loop use. The primary mode of operation described is a digital camera converting the object situation into an electrical signal, sent to a computer, converted into an image, and "presented on a monitor in monochrome colors to illustrate suspected areas of decay." This suggests the image is then interpreted by a dentist. A standalone algorithm performance was not reported.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

For the non-clinical testing of "illumination and image quality," the ground truth implicitly would be objective measurements and comparisons against the predicate device's characteristics and output. For biocompatibility and sterilization, the ground truth is adherence to established international standards and successful completion of specified tests.

8. The sample size for the training set

Not applicable. This device does not appear to be an AI/machine learning product that would require a "training set" in the conventional sense. Its function is based on transillumination and image capture.

9. How the ground truth for the training set was established

Not applicable, as there is no mention of a training set for an AI/machine learning model.

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The DIAGNOcam 2170 Is a diagnostic ald for the detection of open or includent carles lesions above the gingiva and for monitoring the progress of such lesions.

Indications:

• Detection of smooth surface caries
• Detection of occlusal carries
• Detection of proximal carles
• Detection of Initial caries
• Detection of secondary caries
• Detection of cracks

The DIAGNOcam 2170 is a handheld laser fluorescence caries detection device which uses the DIFOTI technology (Digital Imaging Fiberoptic Transillumination) as the functional principle. KaVo DIAGNOcam 2170 delivers images, which are reminiscent of X-rays but which are completely radiation free - by means of a light that is especially adapted to this examination method. The tooth structures allow the passage of light from the entry site to the camera. Areas that block light transmission (e.g. carious lesions) show up clearly as well delimited, dark areas. A digital camera captures the actual situation and makes it visible in real-time on the screen. The USB connector provides electric power to the unit. The DIAGNOcam 2170 will be delivered with a firmware (unit) at the handheld device which is responsible for steering of the camera functions and a computer based software (image) which is responsible to show / display the pictures, store / save the pictures and the possibility of a life stream. The internal laser diode generates an exact wavelength being detectable by the CCD sensor. The DIAGNOcam 2170 follows the international standards for electrical safety and electromagnetic compatibility which are applicable for the use with human beings. The DIAGNOcam 2170 works with a laser wavelength at 788 nm and an output power of 2mW for each laser diode (2 sources). The maximum output power is 21mW/cm2.

Here's an analysis of the provided text regarding the DIAGNOcam 2170, focusing on acceptance criteria and study details:

Overall Conclusion: The provided document does not contain any acceptance criteria or a study proving the device meets them. It is a 510(k) summary, which focuses on demonstrating substantial equivalence to predicate devices, rather than presenting de novo performance studies against pre-defined acceptance criteria.

The document explicitly states: "Clinical testing has not been conducted on this product."

Therefore, I cannot populate the table or provide answers to most of your specific questions as the relevant information is not present in the provided text.

Here's how I can address the prompts based on the available information:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Sample Size for Test Set: Not applicable, as no clinical test data is presented.
• Data Provenance: Not applicable.

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)

• Not applicable, as no clinical test data is presented.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

• Not applicable, as no clinical test data is presented.

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

• No MRMC comparative effectiveness study was done. The document explicitly states: "Clinical testing has not been conducted on this product." The device is a diagnostic aid, not an AI system.

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

• This question is largely not applicable in the context of this device. The DIAGNOcam 2170 is a hardware device (laser fluorescence caries detection device) that produces images for a dentist to interpret in real-time or from stored images. It's not an "algorithm only" device in the sense of AI performing a diagnosis without human input.
• However, the document mentions "the DIAGNOcam 2170 software has been successfully validated to confirm the performance of the device." This software handles camera functions, image display, storage, and live streaming. This validation is likely focused on the software's functional correctness rather than its diagnostic performance in a standalone capacity for caries detection.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

• Not applicable, as no clinical test data or ground truth establishment for diagnostic performance is presented.

8. The sample size for the training set

• Not applicable, as no machine learning or AI training is discussed. The device operates on the physical principle of transillumination for caries detection, not through a trained AI model.

9. How the ground truth for the training set was established

• Not applicable, as no machine learning or AI training is discussed.

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The Ti2200 Transillumination Cable is a diagnostic aid used to locate decay, calculus, fracture lines, endodontic orifices, cracks and fissures underneath the tooth surface utilizing a fiber optic cable and handle attached to a light source.

The Ti2200 Transillumination Cable is a fiber optic transilluminator connected directly to a light source. The Ti2200 Transillumination Cable uses a 2.1mm fiber-optic bundle with a 45 degree stainless steel end-tip. The end-tip, when placed on the tooth surface (and when other sources of light are minimized), creates an illuminated tooth structure to help locate decay, calculus, fracture lines, endodontic orifices, cracks and fissures. These clinical entities reduce the ability to transmit light and therefore show up as dark areas in an otherwise bright structure thus aiding in diagnosis.

The provided text describes a 510(k) submission for the Ti2200 Transillumination Cable. This device is a fiber optic transilluminator intended to help locate dental issues like decay, calculus, and cracks by illuminating the tooth structure.

The document discusses the device description, intended use, and claims substantial equivalence to a predicate device (Addent Inc., Microlux Transilluminator). The FDA's letter states that the device is substantially equivalent to legally marketed predicate devices.

However, the provided text does not contain any information regarding acceptance criteria, performance studies, sample sizes, ground truth establishment, expert qualifications, adjudication methods, or MRMC studies. The document is a regulatory submission for premarket notification, focusing on demonstrating substantial equivalence rather than reporting a detailed clinical or performance study.

Therefore, I cannot fulfill the request to describe the acceptance criteria and the study that proves the device meets the acceptance criteria, as this information is not present in the provided input.

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The Microlux Transilluminator is a device used upon initial examination of the dental patient to help locate crown fractures, posterior and anterior caries.

The Microlux Transilluminator is a screening device used to help locate caries and crown fractures. It also functions as an auxiliary light source to aid in operative procedures and preventive dentistry.

The Microlux Transilluminator consists of a battery powered, high output L.E.D. light source, (three 'N" size batteries are included) and a fiber-optic glass light guide with either a 3mm or 2mm tip. The fiber-optic glass light guide snaps into the light source. The fiber-optic light guide is autoclaveable. The light source can be wiped with disinfectant. Disposable custom fitted sleeves are also available the cover the entire unit to prevent cross contamination.

The provided text is a 510(k) summary for the Microlux Transilluminator, a device used to aid in visualizing caries and crown fractures. It does not contain information about acceptance criteria or a study proving that the device meets such criteria.

The 510(k) summary focuses on establishing substantial equivalence to legally marketed predicate devices, primarily highlighting the difference in light source technology (LED vs. halogen/incandescent lamps). It does not describe any performance studies or clinical trials with acceptance criteria, sample sizes, ground truth establishment, or expert evaluations.

Therefore, I cannot provide the requested information about acceptance criteria and the study that proves the device meets them based on the given input.

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For use as an aid in the detection and localization of subgingival dental calculus.

This submission is for a modification of a device system cleared under K042394, the DIAGNOdent® 2095 with periodontal probe, and Diagnodent Pen, K051909. The modification is in the form of adding a periodontal probe to the Diagnodent Pen product.

The provided text for device K0600080 is a 510(k) summary and not a full study report or clinical trial document. Therefore, it does not contain detailed information about specific acceptance criteria, study sizes, ground truth establishment, or specific performance metrics as would be found in a comprehensive clinical study.

The document primarily focuses on establishing substantial equivalence to a predicate device, the DIAGNOdent® 2095 (K042394), by demonstrating that the new device, DIAGNOdent® 2190 with Periodontal Probe, has the "SAME" indications for use and similar technical specifications. The conclusion statement mentions "bench, in-vitro, and clinical studies" were conducted, but no details of these studies or their results are provided in this extract.

As a result, I cannot provide a detailed table of acceptance criteria versus reported performance, sample sizes for test sets, data provenance, number or qualifications of experts, adjudication methods, MRMC study results, or training set details from the information given.

However, based on the principle of establishing substantial equivalence, we can infer that the implicit acceptance criterion would be that the device performs at least as well as the predicate device in its intended use, or that any differences do not raise new questions of safety or effectiveness.

Here is what can be extracted and what cannot:

1. Table of Acceptance Criteria and Reported Device Performance

• Acceptance Criteria (Inferred): Performance comparable to the predicate device (DIAGNOdent® 2095, K042394) for "detection and localization of subgingival dental calculus." The document does not specify quantitative acceptance criteria for clinical performance. It relies on demonstrating similarity in technology and intended use.
• Reported Device Performance: Not explicitly stated in quantitative terms. The document concludes that "In all important respects, the DIAGNOdent® 2190 with periodontal probe is substantially equivalent to the DIAGNOdent® K042394." This implies similar performance, but no specific metrics are given.

2. Sample size used for the test set and the data provenance

• Sample Size: Not specified.
• Data Provenance: Not specified, beyond the mention of "bench, in-vitro, and clinical studies."

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

• Not specified.

4. Adjudication method for the test set

• Not specified.

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 specified. This device is a laser fluorescence device, not an AI system, so this type of study would not be applicable in the context of "human readers improve with AI vs without AI assistance."

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

• Not applicable as it's a diagnostic device in the hands of a practitioner, not a standalone algorithm. Its performance is inherent in its ability to detect fluorescence indicating calculus.

7. The type of ground truth used

• Not specified. Given the indication for "detection and localization of subgingival dental calculus," ground truth would likely involve direct visual inspection by an expert, tactile probing, or potentially histological examination of extracted teeth/calculus if an in-vitro study was involved.

8. The sample size for the training set

• Not applicable/specified. This type of device does not typically involve a "training set" in the machine learning sense. Its detection mechanism is based on physical principles (laser fluorescence) rather than learned patterns from data.

9. How the ground truth for the training set was established

• Not applicable/specified, for the same reasons as #8.

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