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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.

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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.

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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.

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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.

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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.

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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.

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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.

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CARIES INDICATOR PLUS ( CARIES STAIN ) is indicated for detection of caries through the staining of the outer layer of carious dentin.

Not Found

This document is a 510(k) summary for the American Dental Products Caries-Detector Plus. It states that the product's efficacy is comparable to or better than other brands on the market, as shown by third-party testing. However, it does not provide detailed information about the acceptance criteria, the specific study conducted, or any of the other information requested in the prompt.

Therefore, I cannot provide the requested information based on the given text. The document is too high-level and lacks the specific details about the study design, sample sizes, ground truth establishment, or expert involvement.

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Caries detection Device

The Oral Potential Meter aids the dental professional in detecting potential caries. Meaurements above 10 millivolts, 1 microamp and 0.01 microwatts x seconds indicates a need for the dental professional to look at potentially carious leasions by also using other means, such as direct exploration, radiographs, etc. The OPM aids in determing potentially active caries and can not detect mineralized caries that have no potenial energy. Remineralized teeth are no longer considered carious.

The OPM is a device that measures and displays voltage and conducts through caries related to metallic restorations in the oral cavity. The dentist may be able to, on visual exam, detect caries at the margins or with x-ray under a restoration with these readings. It also provides a power measurement (energy or joules) integrated over a measured period of time and displays it. The meter has two probes that are used to make the measurements. One is a reference probe, Red, with push-button switch to turn on the meter and initiate the measurements. The other is used as the primary input, Black to the meter's electronics

This appears to be a 510(k) clearance letter from the FDA for an Oral Potential Meter (OPM) device, not a detailed study report. Therefore, much of the requested information about acceptance criteria, study design, and performance metrics cannot be directly extracted from the provided text. The document primarily focuses on the device's intended use and FDA's determination of substantial equivalence.

However, I can extract the following based on the information provided:

1. Table of Acceptance Criteria and Reported Device Performance:

The document describes the "Indications For Use" and provides specific thresholds for the OPM readings that indicate a need for further examination by a dental professional. These thresholds act as the de facto acceptance criteria for the device's output, informing the user when to consider a "potential caries."

Note: The document does not provide a separate "Reported Device Performance" section in the sense of accuracy, sensitivity, or specificity against a reference standard. Instead, it describes what the device measures and how those measurements should be interpreted by a dental professional. The device's "performance" is its ability to provide these measurements.

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

• Sample Size for Test Set: Not specified. The document is a regulatory clearance letter, not a clinical study report.
• Data Provenance: Not specified.

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 or implied. The OPM is a diagnostic aid, not an AI-assisted reader system.

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

• Standalone Performance Study: Not mentioned or implied. The device is explicitly stated to "aid the dental professional" and requires the professional to "look at potentially carious lesions by also using other means." This indicates human-in-the-loop performance is integral to its intended use, rather than a standalone algorithm.

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

• Type of Ground Truth: Not specified in the provided text. The device's indications for use rely on the dental professional using "other means, such as direct exploration, radiographs, etc." to confirm caries. This suggests that existing clinical diagnostic methods would serve as the ultimate ground truth.

8. The sample size for the training set:

• Sample Size for Training Set: Not specified.

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

• Ground Truth for Training Set: Not specified.

Summary based on the provided text:

The provided document is an FDA 510(k) clearance letter for the Oral Potential Meter (OPM). It outlines the device's intended use and the specific measurement thresholds (10mV, 1µA, 0.01 microwatts x seconds) that signal a need for further dental professional investigation of potential caries. These thresholds serve as the practical "acceptance criteria" for the device's output. However, the document does not include details about specific studies, sample sizes, ground truth establishment, expert qualifications, or detailed performance metrics against a reference standard that would typically be found in a clinical study report. The FDA's clearance is based on a determination of "substantial equivalence" to a predicate device, which implies that the device's performance aligns with established clinical utility for this type of diagnostic aid.

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For use as a color-indicator of caries demineralized dentin. The water-soluble dye differentiates between dentin infected by caries and uninfected demineralized dentin and serves as a guide for the dentist-user in conservative caries removal during restoration.

CARIES STAIN may be described as a water-soluble solution of dye in solvent that selectively stains carious, infected dentin. It differentiates between non-remineralizable and remineralizable dentin to serve as a guide for conservative caries removal while maintaining as much vital tooth structure as possible.

The provided text is a 510(k) summary for a dental product called "CARIES STAIN," which is a caries indicator/detector. It describes the product's intended use and lists equivalent devices, but it does not contain any information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, or multi-reader multi-case studies.

Therefore, I cannot fulfill most of your request as the necessary data is not present in the provided document.

Here's what can be extracted based on the information given, and an explanation of why other parts cannot be answered:

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

• Cannot be provided. The document describes the product and its intended use but does not present any performance data or acceptance criteria.

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

• Cannot be provided. This information is not present in the 510(k) summary.

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)

• Cannot be provided. This information is not present in the 510(k) summary.

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

• Cannot be provided. This information is not present in the 510(k) summary.

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

• Cannot be provided. The device is a "water-soluble solution of dye in solvent," not an AI-powered device. Therefore, an MRMC study with AI assistance is not applicable and not mentioned.

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

• Cannot be provided. As noted above, this is a chemical staining solution, not an algorithm. Therefore, "standalone" algorithmic performance is not applicable or discussed.

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

• Cannot be provided. The document does not describe any studies with ground truth. The device itself is intended to help differentiate between carious and uninfected dentin to guide conservative caries removal. The "ground truth" in clinical practice would be the actual state of the dentin, likely confirmed by visual, tactile, and potentially histological examination during the procedure. However, the document does not detail how this was established for any regulatory study.

8. The sample size for the training set

• Cannot be provided. There is no mention of a training set as this is a chemical product, not a machine learning model.

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

• Cannot be provided. Not applicable (see point 8).

The 510(k) summary focuses on the product description, its intended use, and its substantial equivalence to other existing devices, which is the primary purpose of a 510(k) application. It does not typically include detailed clinical study protocols, performance data, or ground truth establishment methods in the way a more comprehensive clinical trial report would.

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