Search Results

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.

Ask a specific question about this device

The L1P-1F intraoral scanner (IOS) system is intended for aid in diagnosis of caries.

The L1P-1F intraoral scanner (IOS) system is intended for aid in diagnosis of caries.

The L1P-1F system consists of a scanner and a detachable scanner tip which enables scanning using white and blue (fluorescence) Light Emitting Diodes (LEDs). A single-use scanner body sleeve is mounted on the scanner before being introduced into the mouth of a patient for scanning of the teeth.

The interface to the computer is handled by ScanSuite TRIOS which functions as a Hardware Abstraction Layer (HAL). The scan control of, and data transmission from the scanner is handled by the TRIOS module software, which holds the interface to the user.

The L1P-1F system also consists of the TRIOS Patient Monitoring software which aids in diagnosis of occlusal and surface caries.

The functional principle of L1P-1F (TRIOS 5) is to collect images of the object scanned by means of focus scanning, where light from the LEDs travels through the optical system to the object being scanned and back to an image sensor. 3D data collected by combining blue and white light in turn.

3Shape TRIOS A/S modifies L1P-1F (TRIOS 5) to include a single-use tip, TRIOS Ready Tip (TST-15), as an alternative to the already cleared reusable tip (TST-11).

This FDA 510(k) clearance letter for the TRIOS 5 (L1P-1F) device indicates that the clearance is primarily for a modification to an already cleared device, specifically the introduction of a new single-use tip (TRIOS Ready Tip, TST-15) as an alternative to an existing reusable tip (TST-11). The core functional and intended use of the device remain the same as the predicate.

Therefore, the information provided in this document focuses on the biological safety and design validation of the new tip, rather than a clinical study proving the device meets performance acceptance criteria for caries detection.

Based on the provided text, a direct table of acceptance criteria and reported device performance for caries detection cannot be generated as the document does not contain this information. The performance studies cited are related to the safety and functionality of the new tip, not the diagnostic accuracy of the caries detection functionality.

Here's a breakdown of what can and cannot be extracted from the document:

What is present in the document:

• Device Description: The L1P-1F intraoral scanner (IOS) system is intended for aid in diagnosis of caries, using white and blue (fluorescence) LEDs to collect images.
• Modification: The submission is for a modification to include a single-use scanner tip (TRIOS Ready Tip, TST-15).
• Predicate Device: TRIOS 5 (L1P-1F), K221249. The indications for use are identical to the predicate.
• Non-Clinical Tests: A risk analysis according to ISO 14971 was conducted. Non-clinical tests were performed to verify and/or validate risk control measures for the new tip, following FDA-recognized standards related to biological evaluation, cleanrooms, packaging integrity, electrical safety, usability, and photobiological safety.

What is NOT present in the document (and therefore cannot be answered based on the provided text):

• Specific acceptance criteria for caries detection performance (e.g., sensitivity, specificity, accuracy).
• Reported device performance data for caries detection.
• Sample sizes for clinical test sets used to assess caries detection accuracy.
• Data provenance (country of origin, retrospective/prospective) for clinical studies related to caries detection.
• Number of experts, qualifications, or adjudication methods for establishing ground truth for clinical caries detection data.
• Details of a Multi-Reader Multi-Case (MRMC) comparative effectiveness study for caries detection, including effect sizes.
• Standalone (algorithm-only) performance data for caries detection.
• Type of ground truth used for clinical caries detection (e.g., pathology, outcomes data).
• Sample size for training sets for the caries detection algorithm.
• How ground truth for the training set was established for the caries detection algorithm.

Addressing the points based on available information and limitations:

1. A table of acceptance criteria and the reported device performance

   • Cannot be provided for caries detection performance. The document states that the subject device's indications for use are the same as the predicate device (K221249) and that the technological difference is only the new single-use tip. The focus of this 510(k) is on the safety and functionality of the new tip, not a new clinical performance claim for caries detection. The non-clinical tests relate to the tip's characteristics.

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

   • Not specified for caries detection performance. The document only mentions non-clinical tests for the new tip, not clinical studies for caries detection accuracy.

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 specified for caries detection performance. (See point 2)

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

   • Not specified for caries detection performance. (See point 2)

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 for caries detection performance. (See point 2) This 510(k) is for a physical device modification, not typically the type of submission where MRMC studies for AI assistance would be detailed, especially if the underlying diagnostic algorithm is already cleared.

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

   • Not specified for caries detection performance. (See point 2 & 5)

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

   • Not specified for caries detection performance. (See point 2)

8. The sample size for the training set

   • Not specified for caries detection performance. (See point 2)

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

   • Not specified for caries detection performance. (See point 2)

Conclusion based on the provided document:

The provided FDA 510(k) clearance letter details a submission for a modification to an existing device (TRIOS 5 L1P-1F) to include a new single-use tip. The clearance process for this submission primarily involved demonstrating that the new tip, and the modified device as a whole, maintain safety and effectiveness with respect to the predicate, and that the changes do not raise new questions of safety and effectiveness. This was achieved through a risk analysis and non-clinical testing of the new tip's properties (biocompatibility, sterility/packaging integrity, electrical safety, usability, photobiological safety).

The document does not contain any information about clinical performance studies related to the device's ability to aid in the diagnosis of caries, nor does it describe the specific acceptance criteria or reported performance metrics (like sensitivity, specificity, or accuracy) for this diagnostic function. It should be assumed that these performance characteristics were established and cleared as part of the predicate device's original 510(k) submission (K221249), and are not being re-evaluated or re-demonstrated in this specific submission for a tip modification.

Ask a specific question about this device

The Qraycam PRO is intended to be used as an aid in the diagnosis of dental caries.

Qraycam PRO is a fluorescence caries detection aid, designed to assist dentists and dental specialists in identifying caries areas during oral health examinations. The device produces images that can be displayed on an LCD screen attached to the main body or on a computer monitor.

The provided text describes the Qraycam PRO device and its FDA 510(k) clearance. The information regarding acceptance criteria and the study proving it is extracted primarily from the "8. Performance data" section.

Acceptance Criteria and Device Performance:

The document mentions one specific performance criterion that was evaluated: the ΔF average value. This value is a measure of the fluorescence change, which is central to QLF-D (Quantitative Light-induced Fluorescence - Digital) technology used for caries detection.

Study Details:

The study referenced is a non-clinical bench test that evaluated the comparative performance between the Qraycam PRO (subject device) and the predicate device (Inspektor™ PRO).

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

• Sample size: Not explicitly stated. The document mentions "using the same teeth" for comparison, implying a set of teeth, but the specific number is not provided.
• Data provenance: The data is from a non-clinical bench test. The country of origin is not specified but is presumably where AIOBIO Co., Ltd. (South Korea) conducted its internal testing. The study is retrospective in the sense that it compares a new device against an established predicate device's performance characteristics.

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 study is a non-clinical bench test assessing a technical performance parameter (ΔF average value), not a clinical trial with human expert-based ground truth.

4. Adjudication method for the test set:

This information is not provided. As it was a non-clinical bench test focused on a technical parameter, an adjudication method in the context of expert review would not be 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:

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not explicitly mentioned or performed. The study described is a non-clinical bench test comparing the subject device's performance to a predicate device based on a technical parameter (ΔF average value). There is no mention of human readers or AI assistance in the context of this performance evaluation.

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

The device (Qraycam PRO) is described as an "aid in the diagnosis," indicating it is an assistive tool for dentists. The performance evaluation focuses on the device's ability to measure the ΔF average value, confirming its capability to function as intended. While the device itself processes images and utilizes QLF-D technology, the document does not distinguish between a standalone algorithm-only performance and its use as an aid. The "Qraycam PRO software" is mentioned for image analysis, implying an algorithmic component, but its standalone performance in isolation from clinical interpretation is not separately reported.

7. The type of ground truth used:

The ground truth for the non-clinical bench test appears to be based on the established standard for the ΔF average value, which is a quantitative measure derived from QLF-D technology. The document states that "the ΔF average value, the performance criterion, was found to meet the standard." This suggests a quantitative, objective measure rather than expert consensus, pathology, or outcomes data in a clinical sense.

8. The sample size for the training set:

The document does not provide information about a training set. The descriptions relate to a performance evaluation of the final device, not the development or training of an AI model within it.

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

Since no training set information is provided, how its ground truth was established is not applicable based on the given text.

Ask a specific question about this device

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.

Ask a specific question about this device

For use as an aid in the diagnosis of dental caries

SmarTooth (STL-02-BK) is an optical dental caries diagnostic device that uses a laser to help diagnose dental caries. The SmarTooth (STL-02-BK) is composed of a portable hardware main body with batteries, a main body holder, and a mobile application. The hardware components provide a laser source, an LED indicator, and a zero point adjustment (calibration) unit to aid in the detection and monitoring of dental caries lesions in teeth. The software component provides a meter with a digital read-out between 0 and 99. The hardware device is a pen-type device consisting of a laser diode that generates a laser and a photodiode sensor to detect fluorescent light. Both the sensor and laser diode are mounted at the tip of the device to be introduced into the mouth of the patient for scanning of the teeth. The tooth is exposed to irradiation of a 650 nm wavelength laser by this device, and a value from the detected fluorescent light is displayed to refer to the diagnosis of dental caries. The information from the scanner is handled by the Software, which holds the interface to the user.

As a battery-operated, portable laser source with a photodiode sensor, the subject device is designed for handheld operation. The dental probe is a replaceable, single-use component made from ABS material. This component is sized and dimensionally configured to achieve close contact with the tooth being examined. The tip ensures physical and optical contact with dentinal fluid at sites that are not readily accessible or evaluated using traditional means. The main body holder is used to calibrate the device before measuring the teeth.

The main body is powered by a 1.5-volt AA-type alkaline battery. This unit has two LED lamps (status and measurement), one power button, one laser output, and a beeper sounds one time when pushing the power button for 1 second to turn on and 3 seconds to turn off the device. The main body should be paired with the zero point adjustment unit on the main body holder before use to calibrate the necessary optical zero point. Users can start the measurement by clicking the "Measure" button on the application screen.

Unfortunately, the provided text does not contain the information requested about the acceptance criteria and the study that proves the device meets those criteria.

The document is an FDA 510(k) clearance letter and a 510(k) summary. These documents primarily focus on:

• Substantial Equivalence: Comparing the new device (SmarTooth) to a legally marketed predicate device (KaVo DIAGNOdent 2190).
• Technological Characteristics: Highlighting similarities and differences between the new device and the predicate.
• Non-Clinical Testing: Listing standards met for electrical safety, EMC, biocompatibility, and software validation.
• Absence of Clinical Testing: Stating that clinical testing was not necessary due to the nature of the device and sufficient bench testing.

Therefore, I cannot provide the detailed information requested in the prompt, such as:

1. A table of acceptance criteria and reported device performance: This information is not present. The document states "Adequate bench testing results should be sufficient in supporting our claim of substantial equivalence," implying that the performance was likely compared to the predicate's known operating characteristics rather than against specific, predefined acceptance metrics with reported values.
2. Sample size, data provenance, number of experts, adjudication method, MRMC study, standalone performance, type of ground truth, training set size, and training set ground truth establishment: Since no clinical study was performed or needed for this 510(k) submission, none of this information is available or relevant to the data provided. The "performance test - bench" section is very brief and does not offer these details.

In summary, based only on the provided text, there is no clinical study described that proves the device meets specific acceptance criteria in the manner requested. The clearance was based on demonstrating substantial equivalence through non-clinical testing and similarity to a predicate device.

Ask a specific question about this device

C50 is intended for clinical practice of general dentistry, as an aid in the diagnosis of pit and fissure caries, as an aid to highlight dental plaque and gingival inflammations (restricted to gingival inflammations which lead to bleeding upon probing) and as intra-oral camera to visualize anatomical details invisible to the naked eye or with a mirror (thanks to magnification).

The C50 is an intraoral video camera equipped with LEDs to illuminate the inspection site. The C50 optics and its complementary metal oxide semiconductor (CMOS) sensor capture the natural fluorescence of the site under observation and convert the images into a video signal that is sent to the computer via a USB interface. The dental practitioner can use the images displayed on the computer screen as an aid in diagnosis. A USB Type-C (camera) to USB-A cable is provided to connect the C50 to a computer. The C50 provides the following functions: Aid in the detection of pit and fissure caries Information about patient dental hygiene Highlighting of dental plaque Highlighting of gingival inflammations (restricted to gingival inflammation that leads to bleeding upon probing) Showing the difference between "before" and "after" care (follow-up). In CARIO mode (blue mode), the camera assists the dental practitioner by highlighting potential carious areas in pits and fissures on the occlusal surface of the teeth. In DAYLIGHT mode (white mode), the camera enables visualization of anatomical details invisible to the naked eye or with a mirror (thanks to its magnification). DAYLIGHT+ mode (white mode) is a shortcut version of DAYLIGHT mode where the contrast has been pushed from 20 to 70. In PERIO mode (yellow mode), the camera helps the dental practitioner to visualize dental plaque, in addition to highlighting areas of gingival inflammation (restricted to gingival inflammation that leads to bleeding upon probing).

The C50 is an intraoral camera intended for use in general dentistry. Its indications for use include aid in the diagnosis of pit and fissure caries, highlighting dental plaque and gingival inflammations (restricted to those leading to bleeding upon probing), and functioning as an intra-oral camera for magnified visualization of anatomical details.

Here's the breakdown of acceptance criteria and the study that proves the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance

The provided document describes comparison testing and other verification and validation tests rather than specific quantitative acceptance criteria for clinical performance metrics (e.g., sensitivity, specificity for caries detection). Instead, the performance testing focuses on demonstrating substantial equivalence to the predicate device and compliance with relevant safety and technical standards.

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

The document does not explicitly state a test set in the traditional sense of a clinical diagnostic study with patient data used for accuracy evaluation. Instead, it refers to "comparison testing of image quality" and "mechanical performance testing" conducted on the device and its accessories (C50, C50TIPS, protective sheath, USB cable).

• Sample Size: Not specified in terms of number of patients or cases. The testing appears to have been performed on the devices themselves and associated accessories.
• Data Provenance: Not applicable in the context of device performance testing. The "data" generated comes from direct laboratory and safety testing of the device hardware and software. No patient or human subject data is mentioned for performance evaluation.

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

Not applicable. As described above, the testing performed was focused on device characteristics and substantial equivalence to a predicate, not on a diagnostic accuracy study requiring expert ground truth establishment for patient cases.

4. Adjudication Method for the Test Set

Not applicable, as no clinical diagnostic test set with multiple reader interpretations requiring adjudication is described.

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 is described. The C50 is an intraoral camera and not an AI-powered diagnostic algorithm that assists human readers in interpretation. It provides visual information to the dental practitioner.

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

The C50 is a hardware device (intraoral camera with different illumination modes) that provides visual information. It is not an algorithm, and therefore, a standalone algorithm performance study is not applicable. The device's "diagnosis aid" function relies on the visual information it provides to the human practitioner.

7. The Type of Ground Truth Used

The ground truth used for relevant testing was based on:

• Comparison to a predicate device (SOPROCARE): Many aspects of the C50's performance (image quality, temperature elevation, functional modes) were evaluated against the known performance of the predicate device to establish substantial equivalence.
• Compliance with established standards: Electrical safety, EMC, photobiological safety, software validation, reprocessing validation, and biocompatibility were evaluated against recognized international and FDA standards.
• Engineering specifications/functional requirements: Mechanical tests ensured specific physical functionalities like the fit of accessories and light blocking.

8. The Sample Size for the Training Set

Not applicable. The C50 is a medical device, not an AI/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 training set for this device.

Ask a specific question about this device

The L1P-1F intraoral scanner (IOS) system is intended for aid in diagnosis of caries.

The L1P-1F intraoral scanner (IOS) system is intended for aid in diagnosis of caries. The L1P-1F system consists of a scanner and a detachable scanner tip which enables scanning using white and blue (fluorescence) Light Emitting Diodes (LEDs). A single-use scanner body sleeve is mounted on the scanner before being introduced into the mouth of a patient for scanning of the teeth.

The interface to the computer is handled by ScanSuite TRIOS which functions as a Hardware Abstraction Layer (HAL). The scan control of, and information from the scanner is handled by the TRIOS module software, which holds the interface to the user.

The L1P-1F system also consists of the TRIOS Patient Monitoring software which aids in diagnosis of occlusal and surface caries.

The functional principle of L1P-1F (TRIOS 5) is to collect images of the object scanned by means of focus scanning, where light from the LEDs travels through the optical system to the object being scanned and back to an image sensor. 3D true colored images of the teeth combined with 2D green and red image as an additional texture are generated by emitting blue and white light in turn.

The provided text describes the 3Shape TRIOS 5 (L1P-1F) intraoral scanner system, which is intended to aid in the diagnosis of caries. The documentation focuses on demonstrating substantial equivalence to a predicate device (DÜRR DENTAL AG – VistaCam iX "Proof" – K150672). However, it does not explicitly provide a table of acceptance criteria and reported device performance in the format requested, nor does it detail a specific study proving the device meets acceptance criteria with all the requested information.

The document discusses key performance attributes tested and compared, which serve as implicit acceptance criteria for establishing substantial equivalence. These include:

1. Fluorescence scanning
2. Color Separation
3. In vitro caries detection study
4. Spatial resolution

Based on the available information, here's an attempt to structure the response, acknowledging where specific details for the requested categories are not explicitly provided in the document:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document mentions an "In vitro caries detection study" and performance testing, but does not specify the sample size used for the test set or the data provenance (e.g., country of origin, retrospective/prospective nature).

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

The document does not provide information regarding the number or qualifications of experts used to establish ground truth for any test sets.

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

The document does not specify any adjudication method used for establishing ground truth in a test set.

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

The document does not indicate that an MRMC comparative effectiveness study was done involving human readers with and without AI assistance for the L1P-1F device. The focus is on the device's standalone performance compared to a predicate device.

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

The document describes "Performance Testing" including fluorescence scanning, color separation, in vitro caries detection, and spatial resolution. These tests would inherently involve the device's standalone performance to characterize its technical capabilities, which is then concluded to be "as safe and effective as a legally marketed device." While not explicitly termed "standalone performance study," the non-clinical data and performance testing sections describe the device's intrinsic capabilities.

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

The document mentions an "in vitro caries detection study," which suggests that the ground truth would likely be established by a recognized method for in vitro caries assessment, such as histology, micro-CT, or a standardized artificial caries model assessed by experts, but this is not explicitly stated.

8. The sample size for the training set

The document does not specify the sample size for any training set. Given the nature of the device (an intraoral scanner with integrated fluorescence technology), it's possible that machine learning or AI components might be involved in the "TRIOS Patient Monitoring software," but details on specific training sets are absent.

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

Since no training set details are provided, how its ground truth was established is not mentioned.

Ask a specific question about this device

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.

Ask a specific question about this device

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.

Ask a specific question about this device

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.

Ask a specific question about this device