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This software is intended to generate digital radiographic images of the skull, spinal column, extremities, and other body parts in patients of all ages. Applications can be performed with the patient sitting, or lying in the prone or supine position and is intended for use in all routine radiography exams. The product is not intended for mammographic applications.

This software is not meant for mammography, fluoroscopy, or angiography.

The I-Q View is a software package to be used with FDA cleared solid-state imaging receptors. It functions as a diagnostic x-ray image acquisition platform and allows these images to be transferred to hard copy, softcopy, and archive devices via DICOM protocol. The flat panel detector is not part of this submission. In the I-Q View software, the Digital Radiography Operator Console (DROC) software allows the following functions:

• 1. Add new patients to the system; enter information about the patient and physician that will be associated with the digital radiographic images.
• 2. Edit existing patient information.
• 3. Emergency registration and edit Emergency settings.
• 4. Pick from a selection of procedures, which defines the series of images to be acquired.
• 5. Adiust technique settings before capturing the x-ray image.
• 6. Preview the image, accept or reject the image entering comments or rejection reasons to the image. Accepted images will be sent to the selected output destinations.
• 7. Save an incomplete procedure, for which the rest of the exposures will be made at a later time.
• 8. Close a procedure when all images have been captured.
• 9. Review History images, resend and reprint images.
• 10. Re-exam a completed patient.
• 11. Protect patient records from being deleted by the system.
• 12. Delete an examined Study with all images being captured.
• 13. Edit User accounts.
• 14. Check statistical information.
• 15. Image QC.
• 16. Image stitching.
• 17. Provides electronic transfer of medical image data between medical devices.

The provided document is a 510(k) summary for the I-Q View software. It focuses on demonstrating substantial equivalence to a predicate device through bench testing and comparison of technical characteristics. It explicitly states that clinical testing was not required or performed.

Therefore, I cannot provide details on clinical acceptance criteria or a study proving the device meets them, as such a study was not conducted for this submission. The document relies on bench testing and comparison to a predicate device to establish substantial equivalence.

Here's a breakdown of what can be extracted from the provided text regarding acceptance criteria and the "study" (bench testing) that supports the device:

1. Table of Acceptance Criteria and Reported Device Performance

Since no clinical acceptance criteria or performance metrics are provided, this table will reflect the general statements made about the device performing to specifications.

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

• Test Set Sample Size: Not applicable/not reported. The document describes bench testing, not a test set of patient data.
• Data Provenance: Not applicable. Bench testing generally involves internal testing environments rather than patient data from specific countries or retrospective/prospective studies.

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 test set was used, no experts were needed to establish ground truth for patient data. Bench testing typically relies on engineering specifications and verification.

4. Adjudication method for the test set

• Not applicable. No clinical test set or human interpretation was involved.

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, an MRMC comparative effectiveness study was not done. The document explicitly states: "Clinical Testing: The bench testing is significant enough to demonstrate that the I-Q View software is as good as the predicate software. All features and functionality have been tested and all specifications have been met. Therefore, it is our conclusion that clinical testing is not required to show substantial equivalence." The device is software for image acquisition, not an AI-assisted diagnostic tool.

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

• Yes, in a sense. The "study" described is bench testing of the software's functionality and its integration with solid-state detectors. This is an evaluation of the algorithm/software itself.

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

• For bench testing, the "ground truth" would be the engineering specifications and expected functional behavior of the software and its interaction with hardware components. It's about verifying that the software performs according to its design requirements.

8. The sample size for the training set

• Not applicable. The I-Q View is described as an image acquisition and processing software, not an AI/machine learning model that typically requires a training set of data.

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

• Not applicable, as there is no mention of a training set or AI/machine learning component.

Summary of the "Study" (Bench Testing) for K203703:

The "study" conducted for the I-Q View software was bench testing. This involved:

• Verification and validation of the software.
• Demonstrating the intended functions and relative performance of the software.
• Integration testing to verify that compatible solid-state detectors performed within specification as intended when used with the I-Q View software.

The conclusion drawn from this bench testing was that the software performs to specification and is "as safe and as functionally effective as the predicate software." This was deemed sufficient to demonstrate substantial equivalence, and clinical testing was explicitly stated as not required.

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The IC-WHCD100 (Inspire) is intended to be used as an aid in the detection and diagnosis of dental caries.

The IC-WHCD100 is a toothbrush-sized handpiece used for diagnosis of caries. A USB cable is used to connect the handpiece to a personal computer with a dental imaging software. After a camera cover is placed over the end, the handpiece is positioned over the tooth to be examined. The camera takes images by illuminating the tooth surface with a white LED light for regular tooth image. With fluoresced light, the device can show bacteria on the surface of tooth. With infrared light, the device can show tooth cavity by highlighting enamel. The user can view the images on 510k cleared dental imaging software such as Apteryx vision (K983111), Romexis (K171385), Sidexis (K132773), etc.

The provided text details the FDA 510(k) summary for the IC-WHCD100 (Inspire) device, which is an intraoral camera intended as an aid in the detection and diagnosis of dental caries. However, the document primarily focuses on demonstrating substantial equivalence to predicate devices and provides limited information regarding specific acceptance criteria and detailed study results. Critical information needed to fully answer the request, such as a precise table of acceptance criteria and reported device performance with numerical metrics (e.g., sensitivity, specificity for caries detection), detailed sample size for the test set, number and qualifications of experts for ground truth, adjudication methods, details of comparative effectiveness studies (MRMC), or a comprehensive standalone performance study report are not explicitly present in the provided text.

Based on the available information, here's what can be extracted and what remains unknown:

1. Table of Acceptance Criteria and Reported Device Performance

The document mentions "Performance Test for imaging (Image Sharpness, Image Size, Image Resolution, tooth Caries Detection)" as a non-clinical test. However, it does not provide a specific table of acceptance criteria or the reported device performance metrics (e.g., sensitivity, specificity, accuracy) for caries detection. It only broadly states that "the performance test results of the subject device supports that the transillumination mode works well despite this difference." and "the performance test result supports that the subject device is substantially equivalent to the predicate devices."

Unfortunately, a specific table with numerical acceptance criteria and corresponding performance data for caries detection is not found in the provided text.

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

The document states "performance test results of the subject device supports that the transillumination mode works well despite this difference." and refers to "Performance Tests (Non-clinical)". However, the specific sample size used for the test set (number of teeth, lesions, or patients) and the data provenance (e.g., country of origin of the data, retrospective or prospective nature of data collection) are not disclosed in this 510(k) summary.

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

The provided text does not specify the number of experts used to establish ground truth or their qualifications. It only refers to "Performance Tests" related to caries detection, implying some form of ground truth was used, but details are absent.

4. Adjudication Method for the Test Set

The document does not describe any adjudication method (e.g., 2+1, 3+1, none) used for establishing the ground truth for the test set.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done

The provided text does not mention or describe a Multi Reader Multi Case (MRMC) comparative effectiveness study where human readers' performance with and without AI assistance was evaluated. The focus is on the device's performance relative to predicate devices, not human-AI collaboration.

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

The document broadly states "Performance Test for imaging... tooth Caries Detection)". While the device has a caries detection aid capability, the summary does not explicitly detail a standalone algorithm-only performance study with specific metrics (e.g., sensitivity, specificity of the algorithm itself). The device is described as an "aid in the detection and diagnosis," implying human involvement.

7. The Type of Ground Truth Used

The document refers to "tooth Caries Detection" as one of the performance tests. However, the specific type of ground truth used (e.g., expert consensus, pathology/histology, clinical outcomes data, or a combination) is not explicitly stated.

8. The Sample Size for the Training Set

The 510(k) summary does not provide any information regarding a training set sample size. This type of document typically focuses on performance testing for regulatory clearance rather than details of model development. Given that the device is an "intraoral camera with Caries Detection Aid" using specific light sources (405nm and 940nm) to highlight bacteria and cavities, it's possible its "detection aid" might be based on optical properties rather than a complex AI model requiring extensive training data in the traditional sense, but this is speculative given the lack of detail.

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

Since there is no mention of a training set, there is no information on how its ground truth was established.

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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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Intended for use in generating radiographic images of human anatomy. This device is intended to replace film/screen systems in all general purpose diagnostic procedures. This device is not intended for mammography applications. This device is intended for use by qualified medical personnel and is contraindicated when, in the physician, procedures would be contrary to the best interest of the patient.

Intended for digital image capture use in general radiographic examinations, wherever conventional screen-film systems may be used, excluding fluoroscopy, angiography and mammography. The kit allows imaging of the skull, chest, shoulders, spine, abdomen, pelvis, and extremities.

This is a Windows 10 based software to be used in conjunction with an FDA cleared digital x-ray receptor panel. It can be used to upgrade film-based systems. This upgrade allows to acquire digital medical diagnostic X-ray images and transfer the images to hardcopy, softcopy, and archive devices on the same network. Some functions allowed with the E-COM DR-2000 DR software:
a. Add new patients to the system, enter information about the patient and physician that will be associated with the digital radiographic images.
b. Edit existing patient information.
c. Emergency registration and edit Emergency settings.
d. Pick from a selection of procedures, which defines the series of images to be taken.
e. Adjust technique settings before capturing the X-ray image.
f. Preview the image, accept or reject the image entering comments or rejection reasons to the image. Accepted images will be sent to the selected output destinations.
g. Save an incomplete procedure, for which the rest of the exposures will be made at a later time.
h. Close a procedure when all images have been captured.
i. Review History images, resend and reprint images.
j. Re-exam a completed patient.
k. Protect patient records from being deleted by the system.
l. Delete an examined Study with all images being captured.
m. Edit user accounts.
n. Check statistical information.
o. Image QC.
p. Image stitching.

This document describes the FDA 510(k) premarket notification for the E-COM DR-2000 DR, a stationary x-ray system. However, it does not provide details regarding specific acceptance criteria, a study proving the device meets those criteria, or information on AI/standalone performance, expert adjudication, or ground truth establishment typically associated with such studies.

Here's a breakdown of the requested information based only on the provided text, highlighting what is missing:

1. Table of Acceptance Criteria and Reported Device Performance

This information is not provided in the document. The submission focuses on demonstrating substantial equivalence to a predicate device rather than presenting specific quantitative performance metrics against acceptance criteria.

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

This information is not provided in the document. No specific test set for performance evaluation is mentioned. The submission states "Clinical Testing: Not required for a showing of substantial equivalence," implying a lack of a dedicated clinical test set for new performance evaluation.

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

This information is not provided in the document. Since no clinical testing or performance study is detailed, there's no mention of experts establishing ground truth for a test set.

4. Adjudication Method for the Test Set

This information is not provided in the document. As no test set is described, no adjudication method is mentioned.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance

This information is not provided in the document. The device is a "Stationary X-ray System" with software for image acquisition and management. There is no indication that it includes AI for interpreting images or assisting human readers. Therefore, an MRMC study related to AI assistance is not applicable and not mentioned.

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

This information is not provided in the document. As there is no mention of an algorithm for image interpretation or analysis, a standalone performance study is not applicable and not mentioned. The device's software functions are primarily for image acquisition, processing, and management.

7. The Type of Ground Truth Used

This information is not provided in the document. Since no clinical performance study is described, there's no mention of the type of ground truth used (e.g., expert consensus, pathology, outcomes data).

8. The Sample Size for the Training Set

This information is not provided in the document. The submission pertains to a conventional x-ray system and its control software. There is no discussion of machine learning or AI components that would require a "training set."

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

This information is not provided in the document. As no training set is discussed (see point 8), the establishment of its ground truth is also not mentioned.

Summary of the Document's Content Regarding Testing:

The K193644 submission's primary focus is on demonstrating substantial equivalence to a predicate device (K130883, Sedecal Digital Radiographic Upgrade Model SDRU-T). This is achieved by comparing the new device's indications for use and technological characteristics to the predicate.

The document states:

• "Bench/Performance Testing: The results of bench testing (software validation and risk analysis for a moderate level of concern device) shows that this new device poses no new issues of safety or effectiveness, has essentially the same technological characteristics as the predicate, and is therefore substantially equivalent to the predicate device."
• "Clinical Testing: Not required for a showing of substantial equivalence."

This indicates that the FDA clearance for E-COM DR-2000 DR was based on demonstrating similar technical specifications and safety/effectiveness profiles to an already cleared device, along with adherence to relevant software development and risk management guidance documents. It does not involve a new performance study with specific quantitative acceptance criteria or extensive clinical data as would be required for a novel device or one incorporating advanced AI algorithms.

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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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