Search Results

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

To aid the dental professional in the visualization of carious lesions.

BlueCheck™ Caries Detection & Monitoring is a solution containing colored agents that, when applied to tooth surfaces following a dental prophylaxis procedure, binds to surface porosities utilizing natural hydroxyapatite-binding chemistry of the protein component of the device. This allows dental professionals to observe the visual change in tooth surface color as blue on accessible tooth surfaces. BlueCheck is intended to be used in routine dental examinations as a diagnostic tool that assists dental professionals to visualize and assess caries. BlueCheck is supplied as a liquid product in single use vials (in a pack of 10 vials).

The provided text is a 510(k) summary for the BlueCheck™ Caries Detection & Monitoring device. It focuses on demonstrating substantial equivalence to a predicate device based on indications for use, technology, and performance data from non-clinical testing.

Crucially, this document does not contain information about the device's specific performance metrics against pre-defined acceptance criteria from a human-in-the-loop or standalone study using a clinical test set. It discusses non-clinical performance testing related to removal from tooth surface after rinsing and brushing, and risk assessments/viral inactivation studies.

Therefore, I cannot provide a detailed answer to your request regarding acceptance criteria and the study proving the device meets them in the format you've requested for the following reasons:

• No Acceptance Criteria or Performance Data for Diagnostic Accuracy: The document does not specify quantitative acceptance criteria (e.g., sensitivity, specificity, AUC) for the device's diagnostic performance in identifying carious lesions. It states "Performance studies were conducted to demonstrate that the subject device has been removed from the tooth surface after rinsing, brushing with toothpaste containing sodium lauryl sulfate (SLS) and action of saliva," which relates to device residue, not diagnostic accuracy.
• No Clinical Study Details: There is no mention of a clinical test set, an MRMC study, standalone performance, the number of experts, adjudication methods, or how ground truth was established for diagnostic performance. The "Performance Data" section solely refers to non-clinical tests.
• No Training Set Information: The document is a 510(k) summary for a device (a liquid solution with staining agents), not an AI algorithm. Therefore, there is no concept of a "training set" in the context of machine learning.

The 510(k) process for this type of device (a diagnostic staining solution) typically relies on demonstrating substantial equivalence through:

1. Similar Indications for Use: As shown in the Indications for Use sections.
2. Similar Technological Characteristics: Explained in the "EQUIVALENCE TO MARKETED DEVICES" table, comparing the subject device to the predicate and reference devices in terms of formulation, application, detection method, etc.
3. Acceptable Non-Clinical Performance & Safety: This includes things like biocompatibility, shelf-life, and in this case, the ability of the stain to be removed post-use.

In summary, the provided text describes the regulatory clearance process for a chemical diagnostic aid, not a software/AI-driven medical device that would have specific diagnostic accuracy metrics and associated clinical study details as per your request.

If this were an AI/software device, the information you requested would typically be found in a clinical performance study report, which is usually part of the 510(k) submission but not always fully detailed in the public 510(k) summary.

Ask a specific question about this device

To aid the dental professional in visualization of carious lesions

The LumiCare™ device is an oral rinse solution containing starch-based particles tagged with fluorescein. A specific volume is swished in the mouth, followed by a water rinse and air drying of teeth prior to exposure of the teeth to a blue light source with an irradiance of 450 mW/cm2 and wavelength of 450-470 nm. The clinician completes the clinical examination by observing fluorescence through light orange filter accessories, including protective eyewear, to aid the visualization of dental caries.

Here's a breakdown of the acceptance criteria and the study information for the LumiCare™ Caries Detection Rinse, based on the provided FDA 510(k) summary:

1. Table of Acceptance Criteria and Reported Device Performance

The provided document does not explicitly state specific numerical acceptance criteria for sensitivity, specificity, or other performance metrics. Instead, it states that the device's performance was evaluated for "a high degree of reproducibility" and "performance comparable to the predicate device." Without explicit criteria, the table below reflects what was reported rather than pre-defined acceptance thresholds.

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

The document mentions "Sensitivity and Specificity testing was completed on extracted teeth using histologic reference standard..."

• Sample Size: The exact number of extracted teeth used for the test set is not specified in the document.
• Data Provenance: The document does not specify the country of origin. The data is retrospective in nature, as it was conducted on extracted teeth rather than live patients.

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

• Number of Experts: The document does not specify the number of experts used.
• Qualifications of Experts: The document does not specify the qualifications of the experts who established the ground truth (e.g., "histologic reference standard" implies histological analysis, typically performed by pathologists or histotechnicians, but specifics are missing).

4. Adjudication Method for the Test Set

The document does not describe an adjudication method for establishing the ground truth from the extracted teeth. It simply states "using histologic reference standard," which implies histological analysis was the definitive ground truth, not a consensus or adjudication among multiple reviewers of the device's output.

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

• No, an MRMC comparative effectiveness study was not done. The document explicitly states: "Clinical performance testing was not conducted." The "Simulated Use Testing" performed by clinicians on a manikin model with extracted teeth focused on "ease and effectiveness of use within the clinical workflow" rather than a comparative effectiveness of diagnostic accuracy against human readers with and without AI assistance.

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

The device is a "Caries Detection Rinse" that "aids the dental professional in visualization." This indicates it's a diagnostic aid for human interpretation, not an algorithm that performs analysis in standalone mode. Therefore, a standalone algorithm-only performance test is not applicable and was not reported. The "Sensitivity and Specificity testing" assessed the performance of the rinse itself in highlighting carious lesions, which then would be viewed by a human.

7. The Type of Ground Truth Used

The type of ground truth used for the sensitivity and specificity testing was histology ("histologic reference standard").

8. The Sample Size for the Training Set

The document does not mention a training set in the context of an algorithm or machine learning model. The LumiCare™ Caries Detection Rinse is a chemical diagnostic aid, not an AI/ML-based device that requires a training set.

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

As there is no mention of a training set for an algorithm, this question is not applicable.

Ask a specific question about this device

A visual aid for the identification of carious dentin.

Vista Dyes are colored agents that when applied to the suspected carious areas of the tooth stains the carious dentin. The method of operation and placement of Vista Dyes are similar to that of the primary predicate and reference device, Caries Finder (K955445) and Pulpdent Snoop (K964430), respectively. A drop of the dye is applied to the carious dentine, rinsed with water and air dispersed. The stained carious tissue is then removed with a low speed rotary bur. The process may be repeated until there are no more stainable tissues in the carious cavity.

The device described is "Vista Dyes", a caries detection device. Based on the provided text, there is no detailed study provided that presents specific acceptance criteria and device performance metrics in a quantitative manner. The submission primarily relies on demonstrating substantial equivalence to predicate devices (Caries Finder and Pulpdent Snoop) based on identical indications for use, technological characteristics, and methods of application, rather than presenting a performance study with specific acceptance criteria.

The document states: "Clinical performance is not deemed necessary to support the substantial equivalence of the proposed device." Therefore, there is no information about acceptance criteria, reported device performance, sample size, ground truth establishment, or expert involvement for a performance study.

However, based on the information provided, we can infer some aspects of what would typically be considered "acceptance criteria" through the comparative analysis with predicate devices.

Here's an analysis of the provided information in response to your questions:

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

No explicit quantitative acceptance criteria or reported device performance (e.g., sensitivity, specificity) were provided in the document. The substantial equivalence argument serves as the "acceptance criteria" here, meaning that the device's characteristics must be sufficiently similar to the predicate devices to not raise new questions of safety or effectiveness.

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

Not applicable. No clinical or performance test set was described.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable. No clinical or performance test set requiring expert ground truth was described.

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

Not applicable. No clinical or performance test set was 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

Not applicable. This device is a dye, not an AI-assisted device, and no MRMC study was performed.

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

Not applicable. This device is a dye, not an algorithm.

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

Not applicable. No performance study requiring ground truth was conducted or described. The safety and effectiveness are established by substantial equivalence to legally marketed predicate devices, implying that the known performance characteristics of the predicate devices implicitly serve as a "ground truth" for what is acceptable.

8. The sample size for the training set

Not applicable. This is not an AI/ML device, so there is no training set.

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

Not applicable. This is not an AI/ML device, so there is no training set or associated ground truth establishment.

Summary of Acceptance Criteria and Performance (Inferred from Substantial Equivalence):

• Blue Dye: 99% distilled water, 1% methylene blue dye. Differs from primary predicate (which uses propylene glycol) but is equivalent to reference device (Pulpdent Snoop). |
  | Physical Properties | Colored aqueous liquid. Identical to predicate. |
  | Chemical Properties | 1% dye concentration. Identical to predicate. |
  | Intended Use | Same target population and anatomical site. Identical to predicate. |
  | Packaging Configuration | - Dropper bottles: Identical to predicate.
• Prefilled 1.2mL syringes: Additional configuration, deemed not to raise new concerns as it simplifies application and is common in dentistry. |
  | Sterility | Non-sterile. Identical to predicate. |
  | Shelf-Life | 3 years. Based on accelerated testing and ongoing real-time aging. Identical to predicate. |
  | Prescription/OTC Use | Prescription use only. Identical to predicate. |
  | Biocompatibility | Confirmed via literature review, LD50 analysis of constituents, existing FDA data, and longstanding use of predicate without significant adverse events (MAUDE database). |
  | Safety and Effectiveness | Demonstrated through substantial equivalence to legally marketed predicate devices, with no new questions of safety or effectiveness raised by minor differences. |

In essence, the "study" for Vista Dyes was a substantial equivalence comparison demonstrating that its characteristics are similar enough to existing, legally marketed devices that it does not require new clinical performance data.

Ask a specific question about this device

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.

Ask a specific question about this device

DiscovRED™ is indicated for use to detect carious dentine.

The product, DiscovRED™, is classified into the Caries Detection Device category of CFR 21, Section 872.1740.

DiscovRED™, as well as the Predicate Device, Caries Detector, is a red dye agent that when applied to the suspected carious areas of the tooth stains the carious dentine.

DiscovRED™ is a caries detector. Both devices have a two year shelf-life.

DiscovRED™ is for Prescription Use only and not over-the-counter use.

The method of operation and placement of DiscovRED™ is similar to that of the Predicate Device, Caries Detector. A drop of the detector is applied to the carious dentine, rinsed with water and air dispersed. The stained carious tissue is then removed with a low speed rotary bur. The process may be repeated until there are no more stainable tissues in the cavity.

DiscovRED™ and the Predicate Device do not involve chemical reactions.

DiscovRED™ and the Predicate Device do not use any power-assisted devices such as optical light emitting or electrical energy forms.

This document describes a medical device, DiscovRED™, and its substantial equivalence to a predicate device, Caries Detector. However, it does not contain information about specific acceptance criteria, a study demonstrating the device meets those criteria, or details regarding sample sizes, ground truth establishment, or expert involvement for such a study.

The provided text is a 510(k) summary and FDA clearance letter, which focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than providing detailed performance study results against predefined acceptance criteria. Instead, it highlights similar technological characteristics, intended use, and safety profiles to the predicate.

Therefore, the requested details for the table and subsequent points cannot be extracted from the given information. The document serves as a regulatory filing for market clearance based on equivalence, not a performance study report.

Ask a specific question about this device

A visual aid for the identification of infected carious dentine.

Not Found

I am sorry, but the provided text does not contain the detailed study information needed to describe the acceptance criteria and the study that proves the device meets them. The document is a 510(k) clearance letter from the FDA for the SEE-IT™ Caries Detector, stating that the device is substantially equivalent to a legally marketed predicate device.

The letter mentions the device's regulation number, regulation name, regulatory class, and product code, but it does not include:

1. A table of acceptance criteria and reported device performance.
2. Details about sample sizes, data provenance, ground truth establishment, or expert qualifications.
3. Information on adjudication methods or multi-reader multi-case (MRMC) studies.
4. Data regarding standalone algorithm performance.
5. Training set details.

Therefore, I cannot fulfill your request for these specific details based on the provided text.

Ask a specific question about this device

Caries Indicator is indicated for the following applications: Designed to be used to help identify caries in dentin.

Not Found

This FDA letter confirms substantial equivalence for a Caries Indicator device (K030807), but it does not contain any information about acceptance criteria or a study proving the device meets said criteria.

The letter is a regulatory document affirming that the device is substantially equivalent to a legally marketed predicate device, allowing it to be marketed. It does not include performance data or details of clinical studies.

Therefore, I cannot provide the requested information based on the provided text.

Ask a specific question about this device

CARIES DETECTOR is indicated for the following applications: Detection of carious dentin

This product is classified into Caries Detection Device, CFR 21 Section 872. 1740. Two of the predicate devices listed in section 3 operate by means of applying dyes to teeth to stain areas of decay. They do not involve chemical reactions, nor use electrical current or optical instruments. The methods of operation of these devices is similar to that of plaque disclosing agents in that they stain the affected areas.

The provided text is a 510(k) summary for the "CARIES DETECTOR" device by Kuraray Medical Inc. It explicitly states that the submission is for an alteration of the name and address of the manufacturer and not to intend other changes to the device itself.

It further clarifies that the "technological characteristics, chemical ingredients and safety of this device are completely the same as CARIES DETECTOR manufactured by Kuraray Co., Ltd. (K951813)."

This means that a new study to prove device performance or establish new acceptance criteria was not conducted for this specific 510(k) submission (K012733). The substantial equivalence is based on the predicate device (K951813), which presumably had its performance proven at the time of its own clearance.

Therefore, the requested information regarding acceptance criteria and the study proving the device meets them cannot be directly extracted from this document for K012733, as no such new study was performed for this submission. The document relies on the previous clearance of the predicate device.

To answer your request, one would need to refer to the original 510(k) submission for the predicate device, K951813 (CARIES DETECTOR by Kuraray Co., Ltd.), if that information is publicly available.

Based solely on the provided text for K012733:

1. Table of acceptance criteria and the reported device performance:

   • No new acceptance criteria or reported device performance studies are included in this 510(k) summary for K012733, as it is a manufacturer name/address change and not a device modification. The device is stated to be "completely the same" as the predicate K951813.

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

   • Not applicable to this 510(k) submission, as no new performance study was conducted.

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

   • Not applicable to this 510(k) submission, as no new performance study was conducted.

4. Adjudication method:

   • Not applicable to this 510(k) submission, as no new performance study was conducted.

5. Multi-reader multi-case (MRMC) comparative effectiveness study:

   • No MRMC study was conducted or reported in this 510(k) submission.

6. Standalone performance study:

   • No standalone performance study was conducted or reported in this 510(k) submission for K012733.

7. Type of ground truth used:

   • Not applicable to this 510(k) submission, as no new performance study was conducted.

8. Sample size for the training set:

   • Not applicable to this 510(k) submission, as it is a dye-based caries detection device and typically does not involve algorithm training in the context of AI.

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

   • Not applicable to this 510(k) submission.

Ask a specific question about this device