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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.

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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.

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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.

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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.

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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.

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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 Fluorescence Mode is intended to be used by dentist as an aid in the detection of dental caries

The Fluorescence Mode is an accessory to the EXTARO 300 surgical microscope to utilize a kind of LED light that illuminates the tooth surfaces in the blue light region with a narrow band ( around wavelength 405nm). The Fluorescence Mode is not a standalone device. It is a built-in feature (new components) to existing surgical microscope. These components include (1) an additional violet source in existing LED lamp, (2) a bandpass filter in existing OPMI (Operation Microscope) Head and (3) multi-function knob on existing OPMI Head.

The provided text describes information from a 510(k) submission for the "Fluorescence Mode" device, an accessory to the EXTARO 300 surgical microscope. However, it does not contain a discrete acceptance criteria table or a detailed study report proving the device meets specific performance acceptance criteria for detecting dental caries.

The document focuses on demonstrating substantial equivalence to a predicate device (VistaCam iX "Proof" (K150672)) by comparing technological characteristics, intended use, and general performance, rather than presenting a standalone study with defined performance metrics and acceptance thresholds for the "Fluorescence Mode" itself.

Here's a breakdown of the information available based on your request, highlighting what is present and what is missing:

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

• Acceptance Criteria: Not explicitly stated as a table with numerical or categorical thresholds for caries detection performance (e.g., sensitivity, specificity, accuracy). The document discusses general compliance with standards and safety.

• Reported Device Performance: Instead of performance metrics for caries detection, the document reports on the successful completion of various verification and validation tests to established specifications and standards.

  • Light Safety Testing: Conforms to IEC 62471:2006.
  • Environmental Testing: Performance not changed after various environmental tests (temperature, simulated transportation, moisture, pressure).
  • Usability Testing: Device could be used by intended users without serious errors or problems.
  • System Verification Testing: All System Requirement Specifications were met (product stability, ergonomics, dimensions, image quality, image filters, light sources).
  • EMC/ES Testing: Conforms to IEC 60601-1-2:2014.
  • Software Verification and Validation Testing: Performed in accordance with FDA Guidance for a Moderate Level of Concern.
  • Background Light Interference Verification: Expected levels of background light (40lx for CCT 4000K-6500K) do not impact device performance; carious teeth can be differentiated at 40lx and below.

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

• Sample Size for Test Set:
  • For Usability Testing: Total of 15 clinicians across 12 sites used the Fluorescence Mode to aid in the detection of caries in more than 40 cases in clinical practices.
  • For other performance tests like Light Safety, Environmental, System Verification, EMC/ES, Software V&V, and Background Light Interference, the sample sizes are not explicitly stated in terms of patient/tooth count, but rather the tests were conducted on the device hardware/software.
• Data Provenance: Not explicitly stated (e.g., country of origin, retrospective/prospective). The "clinical practices" mentioned for usability testing imply real-world usage, but no further details are given.

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)

• The document does not explicitly describe how ground truth was established for the "more than 40 cases" in usability testing for the purpose of evaluating the carie detection performance of the device. The usability testing primarily assessed the device's usability, not its diagnostic accuracy against a definitive ground truth.
• The "clinicians" involved in usability testing are dentists/users, but their role in establishing ground truth for performance evaluation is not detailed, nor are their specific qualifications provided beyond being "clinicians."

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

• No adjudication method for establishing ground truth for a test set (in terms of caries detection accuracy) is described. The usability study focused on user experience and safety, not diagnostic performance adjudication.

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 mentioned. The device is described as an "aid in the detection of dental caries," implying assistance to a dentist, but no study comparing human readers with and without the device is provided.
• The device is a "Fluorescence Mode" and not explicitly stated as an "AI" device, so the comparison of improvement with AI vs. without AI assistance is not applicable here based on the provided text.

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

• The document states, "The Fluorescence Mode is intended to be used by dentist as an aid in the detection of dental caries." This explicitly indicates a human-in-the-loop scenario.
• No standalone (algorithm only) performance study of the "Fluorescence Mode" for caries detection is described.

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

• As mentioned in point 3, the document does not specify the type of ground truth used for evaluating the device's performance in caries detection. The focus of the reported studies is on safety, usability, and system functionality. For the "more than 40 cases" in usability testing, the method of confirming actual caries presence or absence (ground truth) is not detailed.

8. The sample size for the training set

• The document describes verification and validation for the "Fluorescence Mode" feature but does not mention any "training set" or "training data." This typically implies that the device is based on a deterministic physical principle (fluorescence) rather than a machine learning model that requires training data.

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

• Since no training set is mentioned (as per point 8), the establishment of ground truth for a training set is not applicable.

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The Electronic Caries Detector is for use by dental professionals as an aid in the diagnosis and monitoring of dental caries.

The ECD is a portable instrument that provides an electrical current source, a meter with a digital read-out between 00 and 100, and indicator and reference electrodes to aid in the detection and monitoring of non-cavitated and cavitated caries lesions in teeth.

The ECD indicator electrode is comprised of a replaceable, single-use, stainless steel probe tip. This component is sized and dimensionally configured to achieve close contact with the tooth being examined. The tip ensures electrical contact with dentinal fluid at sites that are not readily accessible or evaluated using traditional means. The ECD indicator electrode is paired with a reference electrode to complete the necessary electrical circuit. The reference electrode is a stainless steel lip hook that rests on the patient's lower lip.

The device is powered by a 9 volt alkaline battery, regulated down to 5 volts. The unit has a 2 ½ digit LCD display, two timer circuits, and a beeper. The first timing circuit is triggered upon circuit completion. The beeper sounds for 3 seconds, the probe is then removed, and the second timer holds the display for 5 seconds. Then the display returns to zero, ready for the next measurement.

Here's a breakdown of the acceptance criteria and study information for the Electronic Caries Detector, based on the provided text:

Electronic Caries Detector Study Information

1. Acceptance Criteria and Reported Device Performance

Note: The document does not explicitly state "acceptance criteria" but rather presents performance metrics from a comparative study to establish substantial equivalence.

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

The document states that the testing included:

• In vitro performance testing on extracted teeth
• In vivo performance testing on teeth before and after extraction

However, it does not specify the sample size for either of these test sets, nor does it explicitly state the country of origin or whether the data was retrospective or prospective. The term "in vivo" implies prospective collections from human subjects, and "in vitro on extracted teeth" would be a lab-based study with human teeth.

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

The document does not provide information on the number of experts used or their qualifications for establishing the ground truth.

4. Adjudication Method for the Test Set

The document does not specify any adjudication method used for the test set.

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

There is no mention of a Multi-Reader Multi-Case (MRMC) comparative effectiveness study or any effect size of human reader improvement with or without AI assistance. The device description suggests it's a direct measurement tool, not an AI-assisted diagnostic.

6. Standalone Performance Study (Algorithm Only)

The provided text describes performance testing of the device itself, stating "In vitro performance testing on extracted teeth" and "In vivo performance testing on teeth before and after extraction." The reported sensitivity and specificity values are for the device's performance when compared to biopsy. This indicates a standalone performance study of the device's measurement capabilities.

7. Type of Ground Truth Used

The ground truth used for the reported performance metrics (sensitivity and specificity) was biopsy. The document states, "Performance: When compared to biopsy: 92% sensitivity, 100% specificity." It further notes, "Ortek believes that biopsy is considered the current gold standard and the performance scores are more significant compared to visual-tactile readings."

8. Sample Size for the Training Set

The document does not provide information on a separate training set or its sample size. The testing described appears to be for validation/performance evaluation rather than machine learning model training.

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

Since no separate training set is mentioned for a machine learning model, there is no information on how ground truth for a training set was established. The ground truth for the performance evaluation was established via biopsy.

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The VistaCam iX "Proof" is intended to be used as an aid in the detection and diagnosis of dental caries.

The VistaCam iX "Proof" aids in the detection and diagnosis of caries. It consists of a toothbrush-sized handpiece and a "Proof" head. A USB cable connects the handpiece to a personal computer with PACS software such as DBSWIN to enable communication between a PC computer and the handpiece.

After a camera cover is placed over the distal end, and an autoclave-able spacer is installed, the Handpiece is positioned over the tooth to be examined. The camera functions by illuminating the tooth surface with a light that causes the bacteria resident in carries to fluoresce. The fluoresced light is then converted into an electrical signal, sent to a computer, converted into an image (by imaging software) and presented on a monitor in multiple colors to illustrate suspected areas of decay.

Here's an analysis of the provided text regarding the acceptance criteria and study for the VistaCam iX "Proof" device, formatted to answer your questions.

It's important to note that this document is a 510(k) premarket notification, which primarily focuses on demonstrating substantial equivalence to a predicate device rather than presenting a comprehensive standalone clinical trial. Therefore, detailed information on certain aspects you asked for (like MRMC study effect sizes or ground truth establishment for a training set) might not be explicitly present if the submission relies heavily on non-clinical comparative data.

Acceptance Criteria and Reported Device Performance

The submission focuses on demonstrating substantial equivalence to a predicate device (Air Techniques' Spectra Fluorescence Caries Detection Aid Device, 510K# K090169). Therefore, the "acceptance criteria" are implicitly tied to demonstrating similar performance attributes rather than a specific clinical performance metric like sensitivity or specificity.

Table 1: Acceptance Criteria and Reported Device Performance

Study Details

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

   • The document does not specify a sample size for a clinical "test set" in terms of patients or lesions. The studies mentioned are primarily non-clinical validation and verification tests comparing the new device to the predicate device in terms of LED illumination, output, image quality, and color separation.
   • The data provenance is not explicitly stated as country of origin, nor is it classified as retrospective or prospective clinical data, as this is a non-clinical equivalence submission for performance.

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

   • This information is not provided as the submission relies on non-clinical performance comparison rather than a clinical study requiring expert-established ground truth on patient data.

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

   • This information is not provided as there is no described clinical test set with human adjudication.

4. 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. This device is a "Laser Fluorescence Caries Detection Device," not an AI-based system. The submission focuses on comparing its physical and functional characteristics to a predicate device.

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

   • This is not applicable in the context of an AI algorithm, as this device is a hardware-based fluorescence detection system. The "algorithm" mentioned (page 7) refers to the image processing algorithm for fluorescence ratios, which is the same as the predicate device. The performance evaluated was the device's ability to produce similar illumination, output, image quality, and color separation to the predicate.

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

   • For the non-clinical performance tests (LED illumination, output, image quality, color separation), the "ground truth" was effectively the established performance characteristics of the predicate device. The new device had to demonstrate performance "similar" or "equivalent" to the predicate.
   • For biocompatibility, the ground truth was compliance with ISO 10993 standards.
   • For electrical safety, the ground truth was compliance with IEC 60601 standards.

7. The sample size for the training set:

   • This information is not applicable as the document describes a hardware device using fluorescence technology and a shared image processing algorithm (the same as the predicate), not a machine learning or AI model that requires a training set.

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

   • This information is not applicable for the reasons stated above (not an AI/ML device requiring a training set).

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The New Device 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 its magnification).

The New Device is an intra-oral video camera equipped with LEDs to light the inspection site. Thanks to its technology based on fluorescence phenomenon (given by its LED lamps) and chromatic amplification, this camera will permit a global care of the patient. The optics and the charge coupled device (CCD) sensor in the New Device picks up the images containing this fluorescence highlight site and converts them to a video signal that is sent to a video monitor or computer monitor. Dental practitioner and/or hygienist, as an aid for diagnosis, can use the results of this image.

Here's a detailed breakdown of the acceptance criteria and study information for the SOPROCARE device, based on the provided text:

Acceptance Criteria and Reported Device Performance

Note: The document states the "aims of this study were to determine if: New Device has a comparable effectiveness as Predicate Device SOPROLIFE." It then presents the performance metrics of the new device and the practitioner's eyes. The acceptance criteria are implicitly defined by requiring "high accuracy," "high sensitivity," and "high specificity" and comparing them against the "gold standard."

Study Information

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

   • Test Set Sample Size:
     • Dental plaque and inflammation analysis: 120 teeth
     • Pit and fissure caries detection: 128 teeth
     • Number of participants: 20 people (9 women, 11 men)
   • Data Provenance:
     • Country of Origin: Marseille, France (study conducted from January 6 to February 7, 2012)
     • Retrospective or Prospective: Prospective (clinical data was "collected during the following study").

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

   • The document states that the predicate devices (SOPROLIFE for caries, GC Tri Plaque ID Gel for dental plaque, and bleeding upon probing technique for gingival inflammations) were used as "gold standards." It defines a gold standard as "the best available under reasonable conditions... supposed to never be wrong and so have sensitivity and specificity of 100%."
   • It does not specify a number of human experts used to establish the ground truth for the test set, nor does it provide qualifications for any such experts. The "gold standard" here refers to the performance of the predicate device or technique itself.

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

   • The document does not describe an adjudication method for the test set; the ground truth was established by the "gold standard" predicate devices/techniques.

4. 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 comparative effectiveness study was done comparing the device's performance to "practitioner eyes" (human readers without the device).
   • This was not an MRMC study in the typical sense of evaluating human readers with vs. without AI assistance. Instead, it evaluated the standalone performance of the device against a "gold standard" and also documented the performance of "practitioner eyes" against the same "gold standard."
   • The document implies that the device improves diagnosis capability compared to practitioner using only visual inspection. However, it doesn't quantify "human readers improve with AI vs without AI assistance" as a direct effect size, but rather presents the device's performance separately from the "practitioner eyes."
     • SOPROCARE (Device) Performance: Accuracy 87%, Sensitivity 91%, Specificity 90%
     • Practitioner Eyes Performance (without device): Accuracy 66%, Sensitivity 25%, Specificity 97%

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

   • Yes, the performance metrics for "New Device" (SOPROCARE) described as "High accuracy (87% in average)", "High Sensitivity (91% in average)", and "High specificity (90% in average)" represent the standalone, algorithm-only performance, as it is compared directly to the "gold standard."

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

   • The ground truth was established by using predicate devices/techniques as "gold standards":
     • For pit and fissure caries detection: SOPROLIFE (K092583)
     • For dental plaque highlight: GC Tri Plaque ID Gel (Predicate Device)
     • For gingival inflammations: Bleeding upon probing technique (Predicate Device)

7. The sample size for the training set:

   • The document does not mention a separate training set or its sample size. The clinical study described appears to be for performance evaluation.

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

   • Since no training set is explicitly mentioned, the method for establishing its ground truth is not provided.

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