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Direct restoration of Class I, II, III and V cavities (ideally Class I and II), base or liner, core build-ups.

DenMat Bulk Fill is a tooth shaded, radiopaque, dual-cured (auto-cure with light-cure acceleration) composite that offers an unlimited depth of cure in a single application without multiple layers and lightcuring when allowed to self-cure. DenMat Bulk Fill has the handling properties of a low viscosity or "flowable" composite that allows for adaptation to the prepared cavity walls. DenMat Bulk Fill is also ideal for core buildups, and any application where light transmission is inadequate. It is provided in multiple shades.

This a medical device for tooth restoration, not an AI/ML device. Thus, the questions surrounding AI/ML device performance are not applicable.

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

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

The document does not specify exact sample sizes for each performance test. It refers to "Non-clinical performance evaluations" and "DenMat internal testing methods." There is no information regarding the country of origin of the data or whether it was retrospective or prospective.

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):

This is a non-AI/ML medical device submission. The concept of "ground truth" established by experts, as typically applied in AI/ML studies (e.g., radiologists interpreting images), is not relevant here. Performance criteria are based on established international standards for dental materials (e.g., ISO 4049).

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

Not applicable, as this is a non-AI/ML medical device submission. Adjudication methods are typically used in clinical trials involving human readers or evaluators, which is not the primary mode of evaluation for this materials-based device.

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, as this is a non-AI/ML medical device submission.

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

Not applicable, as this is a non-AI/ML medical device submission.

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

The "ground truth" for this device's performance is based on well-established international standards for dental materials (e.g., ISO 4049:2019, ANSI/ADA Standard No. 27-2016, ISO 7491:2000) and internal testing methods. For biocompatibility, it's based on ISO 10993 series of standards. These standards define the acceptable physical, chemical, and biological properties for these types of materials.

8. The sample size for the training set:

Not applicable, as this is a non-AI/ML medical device submission. There is no concept of a "training set" for this type of device.

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

Not applicable, as this is a non-AI/ML medical device submission.

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1. Direct restorations of anterior or posterior teeth (Class I - Class V)
2. Diastema closures
3. Intraoral repairs of fractured crowns/bridges

nuance® UNIVERSAL is a Class II medical device, under Classification 21 CFR 872.3690. Product Code EBF. intended to be used as a composite tooth restorative. The device falls within the scope of guidance document, "Dental Composite Resin Devices -Premarket Notification [510(k)] Submissions. According to the applicable FDA recognized consensus standard, ISO 4049 - "Dentistry - Polymer-based restorative materials, this device is classified as Class 2: materials whose setting is affected by the application of energy from an external source, such as blue light or heat (Group 2). nuance® UNIVERSAL is used in direct restorations of anterior or posterior teeth. They are polymerizable dental monomer resins that are chemically-cured when exposed to dental curing lights. It is used to form a durable, aesthetic restoration. It is a higher viscosity material to be used where mechanical strength is a primary importance. nuance® UNIVERSAL may be appropriate for dental Class I, II, III, IV and V type restorations. nuance® UNIVERSAL is packaged in a 4 gram single-barrel syringe, a 0.35 gram singules, and offered in 11 shades listed below:

This document details the 510(k) submission for Nuance UNIVERSAL, a light-curable dental restorative material. The submission aims to prove substantial equivalence to a predicate device, CLEARFIL MAJESTY Posterior, rather than establishing acceptance criteria and proving performance through a clinical study as would be done for novel or high-risk devices.

Therefore, many of the requested details, such as sample size for test/training sets, number of experts for ground truth, adjudication methods, MRMC studies, or standalone algorithm performance, are not applicable to this type of device submission, which relies on bench testing against recognized standards and comparison to a legally marketed predicate device with a history of safe use.

Here's the information that is available based on the provided text, structured as closely as possible to your request, with explicit notes for inapplicable sections:

Device: Nuance UNIVERSAL (Light-Curable Dental Restorative Material)

Study Focus: Substantial Equivalence to Predicate Device (CLEARFIL MAJESTY Posterior)

Type of Study Conducted: Bench Testing against ISO 4049 (Dental - Polymer-based restorative materials) and biocompatibility testing. This is not a clinical study involving human patients or an AI/algorithm-based device.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are derived from the ISO 4049 standard, and the reported performance is compared against these and the predicate device.

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

• Sample Size for Test Set: Not explicitly stated in terms of the number of samples for each test (e.g., how many specimens for flexural strength). The testing was conducted according to the ISO 4049 standard, which specifies the number of samples required for each test. This is bench testing, not a clinical test set from patient data.
• Data Provenance: The data comes from in vitro (bench) testing performed by the manufacturer, Den-Mat Holdings, LLC. The location of the testing facility is not specified, but the company is based in Lompoc, California, USA. The data is prospective in the sense that the tests were performed to generate data for this submission.

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

• Not Applicable. This device is a material, and its performance is evaluated through physical and chemical property testing against an international standard (ISO 4049) and comparison to a predicate device. Ground truth is established by objective measurements based on the standard, not expert consensus on interpretations of images or clinical outcomes.

4. Adjudication Method for the Test Set

• Not Applicable. See point 3. Testing involves objective measurements, not subjective assessment requiring adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and effect size.

• No. This is not an AI/imaging device requiring an MRMC study. It is a dental restorative material.

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

• Not Applicable. This device does not involve an algorithm or AI.

7. The type of ground truth used

• Objective measurement against an international standard (ISO 4049) and comparative data to a legally marketed predicate device.
• Additionally, Biocompatibility was demonstrated through:
  • Substantial equivalence to the predicate device, citing materials with a long history of safe use in dentistry.
  • Specific in vitro cytotoxicity testing (ISO 10993 Part 5), with the conclusion "the test article was not considered to have a cytotoxic effect (no reactivity)."

8. The Sample Size for the Training Set

• Not Applicable. This is not an AI/machine learning device that requires a training set. The device formulation is based on established dental material science principles and minor modifications to an existing predicate device.

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

• Not Applicable. See point 8.

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nuance® FLOW is intended to be used as a composite tooth restorative.

nuance® FLOW is recommended for the following types of applications:

1. Direct restorations of anterior or posterior teeth
2. Cavity base/liner
3. Intraoral repairs of fracture crowns/bridges

nuance® FLOW is a Class II medical device intended to be used as a composite tooth restorative. According to the applicable FDA recognized consensus standard, ISO 4049-"Dentistry- Polymer-based restorative materials", this device is classified as Class 2: materials whose setting is affected by the application of energy from an external source, such as blue light or heat (Group 2). nuance® FLOW is DenMat's Flowable for use in direct restorations of anterior or posterior teeth. They are polymerizable dental monomer resins that are chemically-cured when exposed to dental curing lights. It is used to form a durable, esthetic restoration. It is a lower viscosity material that allows it to be used when ease of application and thinner layers are needed. nuance® Flow may be appropriate for dental Class I, III, IV and V type restorations where maximum mechanical strength and wear resistance is not required. A small amount of fluoride (.5-.7%) is included to minimize likelihood of secondary caries. nuance® FLOW is packaged in a 1 mL single• barrel syringe and offered in 8 shades: A1, A2, A3, A3.5, B1, B2, BL1 and BL2.

This document describes the 510(k) premarket notification for the nuance® FLOW dental restorative material, and its substantial equivalence to the predicate device LC FLOWFILL.

Here's an analysis based on your request:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not specify the exact sample sizes used for each test performed on nuance® FLOW or LC FLOWFILL. It only states that "Testing results indicate that nuance® FLOW was as effective and performs as good as the predicate device."

The data provenance is not explicitly stated in terms of country of origin or retrospective/prospective. However, given that it's a 510(k) submission to the FDA, it is expected that the tests were conducted according to recognized international standards (ISO 4049) which implies controlled laboratory settings. The document also mentions "Scientific literature have been evaluated to support the use of similar products for the same indications," suggesting some reliance on existing published data.

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 tests are bench tests based on an international standard (ISO 4049), not clinical evaluations requiring expert interpretation of results for ground truth.

4. Adjudication method for the test set

This information is not applicable as the tests are objective, quantitative measurements against a standard, not subjective interpretations requiring 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

There was no MRMC comparative effectiveness study and no mention of AI assistance. This device is a dental restorative material, not an AI-powered diagnostic tool.

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

This question is not applicable as the device is a physical dental material and not an algorithm.

7. The type of ground truth used

The ground truth used for performance evaluation is based on the objective measurement criteria defined in the ISO 4049 standard for "Dentistry – Polymer-based restorative materials." This standard sets specific quantitative thresholds for various material properties.

8. The sample size for the training set

This information is not applicable as the device is a chemical material, not a machine learning algorithm that requires a training set.

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

This question is not applicable as the device is a chemical material, not a machine learning algorithm.

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tenure@4G is recommended for the following types of applications:

1. All routine direct and indirect resin composite bonding

2. Porcelain, ceramic veneers, amalgams, precious and semi-precious metals bonding

3. Indirect gold, porcelain and ceramic inlays and onlays bonding

4. Desensitization of root or dentin prior to impressions or temporaries

5. Preparation desensitization of crown prior to impressions or temporaries

tenure * 4G is DenMat's next generation of its popular Tenure MPB System with greater bond strength and sensitivity control. It is a 40 generation multi-purpose, self-cure adhesive system for bonding any resin restorative to all intraoral surfaces. They are polymerizable dental monomer resins that are chemically-cured with the reaction initiated when the two parts are mixed together. These polymers form strong leak and stain resistant bonds between the dental surface and restorations placed over them.

This document is a 510(k) premarket notification for the "tenure®4G" resin tooth bonding agent. It evaluates the device's substantial equivalence to predicate devices (ALL-BOND 2 and Tenure MPB) based on intended use, indications for use, chemical components, safety, and technological characteristics.

Here's an analysis of the provided information concerning acceptance criteria, device performance, and the study details:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for this device are implicitly tied to demonstrating substantial equivalence to the predicate devices, particularly in terms of shear bond strength. While explicit numerical acceptance criteria (e.g., "must achieve at least X psi") are not stated, the study aims to show that the tenure®4G performs "as good as or even better than the predicate devices."

Conclusion from Table: For Porcelain and Enamel, tenure®4G demonstrates higher mean bond strength than ALL-BOND 2, and for Enamel and Dentin, it shows higher mean bond strength than Tenure MPB. For Porcelain, its mean bond strength is slightly lower than Tenure MPB but falls within the standard deviation. Overall, the results support the claim that tenure®4G performs "as good as or even better than" the predicate devices.

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

The document mentions "Results of shear bond testing indicate that tenure®4G was as effective and performs as good as or even better than the predicate devices." However, it does not explicitly state the sample size used for the shear bond testing. The data provenance is not specified beyond being "tested in the lab using R&D test protocols." It is likely retrospective data collected for this submission. The country of origin of the data is not mentioned but can be inferred to be related to the submitter, DenMat Holdings, LLC, which is based in Lompoc, California, U.S.A.

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

This type of study (comparative performance of a dental bonding agent) does not involve experts establishing ground truth in the same way clinical diagnostic studies do. The "ground truth" here is the objective measurement of shear bond strength, which is a physical property determined through laboratory testing methods, not expert consensus or interpretation. Therefore, this information is not applicable.

4. Adjudication Method for the Test Set

As the "test set" involves objective laboratory measurements of shear bond strength rather than subjective assessments requiring expert adjudication, this information is not applicable.

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

This document describes the performance of a dental bonding agent, an in-vitro material, not a diagnostic imaging device or an AI application. Therefore, an MRMC comparative effectiveness study involving human readers and AI assistance is not applicable to this submission.

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

This document pertains to a dental bonding agent and not a software algorithm. Therefore, "standalone (algorithm only without human-in-the-loop performance)" is not applicable.

7. The Type of Ground Truth Used

The "ground truth" for this performance study is objective laboratory measurements of shear bond strength. This is determined through physical testing protocols in a lab setting, not through expert consensus, pathology, or outcomes data in a clinical sense.

8. The Sample Size for the Training Set

This submission is for a medical device (dental bonding agent), not a machine learning algorithm. Therefore, there is no concept of a "training set" in this context. The chemical formulation and manufacturing processes are developed through research and development, and the performance is validated through testing, not by training a model on data.

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

As there is no "training set" for this device, this question is not applicable.

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The Sapphire Plus STM 3W Diode Laser is intended for use in dental intraoral soft tissue general, oral maxilla-facial and cosmetic surgery. It is intended for ablating, incising, excising, vaporizing and coagulation of soft tissues using a fibre optic delivery system. Indications include excision and incision biopsies; hemostatic assistance; treatment of apthous ulcers; frenectomy; frenotomy; gingival incision; gingivectomy; gingivoplasty; incising and draining abscesses; operculectomy; oral papillectomy; removal of fibromas; soft tissue crown lengthening; sulcular debridement (removal of diseased or inflamed soft tissue in the periodontal pocket); tissue retraction for impression; and vestibuloplasty.

The Sapphire Plus STM Laser is a plug-in option for the Sapphire Plus Light Source Unit. The Sapphire Plus Light Source Unit contains a xenon arc lamp that, depending on which handpiece is attached, has been cleared for use as either a Curing/Whitening attachment (K081287) or as an adjunct for visual oral tissue examination (K073483). In both cases, these two attachments use different portions of the broad-spectrum xenon arc light's emissions to perform their clinical functions.

Like the other two attachments for the Sapphire Plus Light, the Sapphire Plus STM Laser also plugs into the Sapphire Plus Light. Unlike the other two attachments, however, when the Sapphire Plus STM Diode Laser is attached to the Sapphire Plus Light, only low-voltage DC current -not visible light -- is sent to the Laser. The Sapphire Plus STM Diode Laser is comprised of two basic parts: the control box ("control module") with microprocessor and user interface, and the Laser Handpiece containing the working and aiming beam laser diodes and the laser ON/OFF switch. The Control Module interface allows selection of mode (continuous wave or pulsed) and laser output, provides visual indications of power settings and of the unit's status, and features the unit's footswitch jack and operating key switch and the Emergency STOP button. The Laser Handpiece is found at the end of a six foot long power/communications cord that is plugged into the Control Module's light guide port. The Handpiece houses the 808 ± 5nm laser working beam diode and the 640 ± 10nm aiming beam diode and control board, optics and heat sink, on/off switch, and the disposable fiberoptic tip assembly. An optional footswitch is available that plugs into the control module and can be used to activate the laser working beam instead of the handpiece on/off actuator. The Sapphire Plus STM Laser is powered by a 15W, 5 VDC rechargeable lithium-ion battery that receives its energy from the Sapphire Plus Light Source Unit.

The information provided discusses the substantial equivalence of the Den-Mat Holdings Sapphire Plus STM 3W Diode Laser to predicate devices, focusing on non-clinical performance and a review of existing literature for similar devices. There isn't information present to fill all sections of the requested table.

Here's the information that can be extracted from the provided text:

1. Table of acceptance criteria and reported device performance

The acceptance criterion for laser output accuracy is that the output should vary by less than ± 20% of the setting, as per IEC 60601-2-22.

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

The document indicates that the Sapphire Plus STM Diode Laser was tested "side-by-side against one of the predicate devices". However, it does not specify the sample size for this comparison.

The data provenance is from non-clinical comparative performance testing conducted by Den-Mat Holdings, LLC, which would be considered prospective for the specific device being tested. No external data provenance like country of origin for a 'test set' in a clinical study is provided.

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

There is no mention of experts or ground truth establishment for the non-clinical comparative performance data presented. This section primarily focuses on technical specifications and output accuracy comparisons.

4. Adjudication method for the test set

No adjudication method is described as the available information pertains to non-clinical technical comparisons, not clinical trials requiring expert 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 was performed or mentioned. The device is a surgical laser, not an AI-powered diagnostic tool, so this type of study is not relevant to its evaluation in this document.

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

A standalone study of the device's technical performance was done. The "NON-CLINICAL COMPARISONS Comparative Performance Data" section describes measurements of the device's output accuracy (variance from set power), which is a standalone assessment of its functional precision.

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

For the technical performance comparison, the "ground truth" used was the device's own set output parameters. The measured output was compared against these set values to determine accuracy, relative to the international standard IEC 60601-2-22.

The document also references a body of literature showing the safety and effectiveness of 808 nm diode lasers in general. This literature would consist of various study types (meta-reviews, clinical studies, in vitro studies, animal studies), implying diverse forms of "ground truth" (e.g., clinical outcomes, histological findings, expert assessment, etc.) but these are for the predicate devices and the general class of lasers, not specifically for establishing a ground truth for the new Sapphire Plus STM 3W Diode Laser's performance.

8. The sample size for the training set

No training set is mentioned. The document describes a medical device (laser), not an AI algorithm that requires training data.

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

Not applicable, as there is no training set mentioned for this device.

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The Sapphire ST Portable Diode Laser is intended for use in dental intraoral soft tissue general, oral maxilla-facial and cosmetic surgery. It is intended for ablating, incising, excising, vaporizing and coagulation of soft tissues using a fiber optic delivery system. Indications include excision and incision biopsies; hemostatic assistance; treatment of apthous ulcers; frenectomy; frenotomy; gingival incision and excision; gingivectomy; gingivoplasty; incising and draining abscesses; operculectomy; oral papillectomy; removal of fibromas; soft tissue crown lengthening; sulcular debridement (removal of diseased or inflamed soft tissue in the periodontal pocket); tissue retraction for impression; vestibuloplasty, and light activation of bleaching materials for teeth whitening, laser-assisted bleaching /whitening of teeth.

The Sapphire ST Portable Diode Laser is comprised of three basic parts: the control box ("control module") with microprocessor and user interface for selection of mode (continuous wave or pulsed) and laser output to provide visual indications of power settings and of the unit's status, and features the unit's power ON/OFF switch, footswitch jack and key switch; the second component is the corded laser handpiece that houses the laser working beam and aiming beam diodes and control board, optics and harat sink, on/off switch, and the disposable fiberoptic tip assembly. An optional footswitch is available that plugs into the control module and can be used to activate the laser working beam instead of the handpiece on/off actuator. Electrical power is taken from the AC/DC Power Supply that plugs into a standard electrical outlet and charges a 15W, 5 VDC lithium-ion battery that generates 4 amps used to drive the diode laser.

The provided text describes the Den-Mat Holdings Sapphire ST Portable Diode Laser, a medical device. Here's an analysis of the acceptance criteria and study as requested:

Acceptance Criteria and Device Performance

Study Details:

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

   • The document mentions "Measurements of the output of the subject device's working beam ranging from 0.1 to 3.0W output in Continuous Wave and Pulse modes were shown to vary..." However, it does not specify a numerical sample size for the test set (i.e., how many measurements were taken or how many devices were tested).
   • The data provenance is not explicitly stated (e.g., country of origin, retrospective or prospective). It describes internal testing of the device against predicate devices.

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

   • Not applicable. This study is a technical performance comparison of laser output accuracy against a predefined standard (IEC 60601-2-22), not a clinical study requiring expert ground truth in the traditional sense of medical image or diagnosis evaluation.

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

   • Not applicable. See point 2. The performance data is objective measurement of physical output, not subjective human assessment needing 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:

   • Not applicable. This document is for a laser surgical instrument, not an AI-powered diagnostic or assistive device that would involve human readers or AI assistance.

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

   • Not applicable. See point 4.

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

   • The "ground truth" for the performance evaluation in this context is the international standard IEC 60601-2-22, which specifies that laser output should vary by less than ± 20% of the setting. The measurements taken from the device were compared against this objective standard.

7. The sample size for the training set:

   • Not applicable. This device is a hardware laser instrument, not a machine learning or AI model that requires a training set.

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

   • Not applicable. See point 7.

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The Sapphire PAC Light is a source of illumination for curing dental restorative materials and is a source of illumination for tooth whitening activities performed in dentistry.

The Sapphire Supreme Plasma Arc Dental Curing Light consists of a xenon plasma arc light source (lamp), power supply with user interface controls, and a light guide with a priol-type handpiece with user interface compls. The light from the xenon arc lamp is transmitted through optical litters that largely eliminate unnecessary ultraviolet (UV), visible, and infrared (IR) wavelengths into the proximal end of the light guide, where it is conducted through a fiber-optic bundle and focused through a removable tip at the light guide. Controls on both the light source and the handpiece activate the lamp and time of exposure. The Sapphire PAC Light safely and effectively transmits blue light at wavelengths and with sufficient intensity to initiate photopolymerization of light-cured dental restorative naterials. Ultraviolet (UV) and infrared (IR) blocking filters are placed between the xenon arc lamp and the light guide. The wavelength of the blue light transmitted by the device is chosen to cure all common dental photoinitiators; its irradiant intensity is powerful enough to initiate rapid polymerization while not so strong as to be a thermal hazard.

The provided document is a 510(k) summary for a dental curing light, not an AI software or diagnostic device. Therefore, much of the requested information regarding AI-specific criteria (like expert adjudication, MRMC studies, training/test set details, and ground truth for AI models) is not applicable.

However, I can extract the relevant information regarding performance testing and acceptance criteria as described for this medical device.

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

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

The document does not specify a "test set" in the context of data used for algorithm validation as it's not an AI device. Instead, it refers to the physical device undergoing performance testing. The sample size for the device testing (e.g., how many units were tested) is not explicitly stated. The provenance of this physical testing data would be "in-house" or "laboratory testing" conducted by the manufacturer (Den-Mat Holdings, LLC).

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

Not applicable. This device is a physical product (dental curing light), not an AI algorithm requiring expert consensus for ground truth. Its performance is validated against established industry standards and physical measurements.

4. Adjudication method for the test set

Not applicable. This is not an AI algorithm requiring 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

Not applicable. This is not an AI device.

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

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

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

The "ground truth" for this device's performance is established by conformance to recognized industry standards (ANSI/ADA Specification No. 48, Visible Light Curing Units (2004)) and normalized standards for electromagnetic compatibility and safety characteristics of medical equipment. This involves objective physical measurements and technical evaluations rather than human expert interpretation of data.

8. The sample size for the training set

Not applicable. This is not an AI device that requires a training set.

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

Not applicable. This is not an AI device that requires a training set.

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The Sapphire O/E oral examination light is intended for use by a dentist or qualified health-care provider as an adjunct to traditional oral examination by white light to enhance the visualization of oral mucosal abnormalities that may not be apparent or visible to the naked eye, such as oral cancer or pre-malignant dysphasia. Sapphire O/E oral examination light is further intended to be used by a surgeon to help identify diseased tissue around a clinically apparent lesion and thus aid in determining the appropriate margin for surgical excision.

Not Found

The provided text primarily focuses on the FDA's regulatory decision regarding the Sapphire™ O/E Oral Examination System and does not contain the detailed information required to describe the acceptance criteria and the study that proves the device meets those criteria.

The document is a 510(k) premarket notification approval letter, indicating that the device has been deemed substantially equivalent to a predicate device. It defines the device's indications for use but does not delve into the specific performance studies, acceptance criteria, or statistical details of those studies.

Therefore, I cannot provide the requested information based on the given input. The document is a regulatory approval notice, not a study report.

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