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TKO is a pink, flowable light cure composite gel for the creation of occlusal buildups (bite turbos) and as a retainer repar composite.

Intended for use in the creation of occlusal buildups (bite turbos) and as a retainer repair composite. It bonds to enamel, porcelain, acrylic and metal for duration of treatment externally communicating device that contacts tissue/bone/dentin.

TKO Composite Bite Turbo Gel is dispensed from a precision 3.5 gm LuerLoc syringe with tips.

The provided document is a 510(k) Premarket Notification from the FDA for a dental product called "TKO Composite Bite Turbo Gel." It outlines the device's characteristics, intended use, and a comparison with legally marketed predicate devices to establish substantial equivalence.

Here's an analysis of the acceptance criteria and the study proving the device meets them, based on the provided text:

Important Note: This document pertains to a medical device (dental resin) and not an AI/ML enabled device. Therefore, many of the requested criteria related to AI/ML device performance (e.g., MRMC studies, training set details, expert ground truth adjudication) are not applicable and thus not present in the document. The study described focuses on non-clinical, physical, and chemical performance testing to demonstrate substantial equivalence to existing predicate devices.

1. Table of Acceptance Criteria and Reported Device Performance

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Ultra SEP is a self etching primer intended to be used for the preparation of an enamel surface prior to bonding with a light cure orthodontic adhesive.

Ultra SEP is a self etching primer which can etch up to 6 teeth with a single drop. The material is dispensed from a bottle into a light impervious mixing well, and transferred to teeth by a saturated microbrush. Ultra SEP creates an ideal surface for a light cure paste to adhere teeth and brackets for orthodontic treatment.

Ultra SEP is used in combination with a light impervious mixing well (SEPW) and microbrushes (MB).

The provided text describes Reliance Orthodontic Products' Ultra SEP device and its substantial equivalence to a predicate device. Here's a breakdown of the acceptance criteria and the study information:

Acceptance Criteria and Reported Device Performance

The provided document describes non-clinical data and does not explicitly list numerical acceptance criteria with corresponding performance metrics like a typical clinical accuracy study. Instead, the "acceptance criterion" for the device appears to be demonstrating equivalence to the predicate device in terms of effectiveness and safety, and being found non-toxic.

The relevant section states: "Shear bond strength testing comparisons conducted between the Reliance Orthodontics Ultra SEP, the predicate device 3M Unitek Transbond™ Plus Self Etching Primer, and the reference Reliance Orthodontics S.E.P. demonstrate that the applicant device is equivalent to the legally marketed device in terms of effectiveness." and "Additionally, toxicity testing was conducted using an Oral Toxicity Test method and was found to be non toxic."

Study Information

1. Sample size used for the test set and the data provenance:
   The document mentions "shear bond strength testing comparisons" and "toxicity testing," but does not specify the sample sizes for these tests or the data provenance (e.g., country of origin, retrospective/prospective).

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
   This information is not applicable to the type of preclinical testing described (shear bond strength, toxicity, biocompatibility). These are laboratory tests evaluating material properties, not diagnostic or clinical performance requiring expert ground truth.

3. Adjudication method for the test set:
   This is not applicable as the tests are objective laboratory measurements, not subjective evaluations requiring adjudication.

4. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
   No, an MRMC comparative effectiveness study was not done. This device is a self-etching primer, not an AI-powered diagnostic tool. The study focuses on material properties.

5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
   No, this is not applicable. The device is a material, not an algorithm. The "standalone" performance here relates to its physical and chemical properties in laboratory settings.

6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
   For shear bond strength, the "ground truth" would be the measured bond strength values obtained through standardized laboratory testing methods, typically compared against industry standards or predicate device performance. For toxicity, the ground truth is the absence of toxic effects as determined by the specified oral toxicity test and biocompatibility standards.

7. The sample size for the training set:
   This concept is not applicable as this is a physical product (primer) undergoing non-clinical testing, not a machine learning algorithm that requires a training set.

8. How the ground truth for the training set was established:
   This concept is not applicable as there is no training set mentioned or required for this type of device and evaluation.

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GlassLok is intended for use as a dual cure glass ionomer band cement for use in an orthodontic or dental office.

GlassLok is intended for use as a dual cure glass ionomer band cement for use in an orthodontic or dental office. GlassLok can be used to bond molar bands to an enamel or metal substrate in a wet or dry field due to its hydrophilic properties. GlassLok is available in natural or blue shade (for easy disclosure at removal).

GlassLok is dispensed in a 2 part (powder and liquid) format with bottle dispensing. A 15cc and 25 cc liquid (in blue or natural shade) along with a 15gm or 100gm powder component will be available as separate components. A convenience kit will also be available in Blue or Natural shade in a starter or economy volume.

GlassLok powder is dispensed to a mixing pad using a measuring scoop and mixed with GlassLok liquid in a ratio of 2:1. The mixed GlassLok composite is then applied to the inside of an orthodontic band and applied to a properly prepared tooth structure. Working Time is 2 minutes and setting time is 5 minutes once the working time has expired. GlassLok can also be cured with a curing light for 20 seconds, if required for polymerization.

Associated accessories include a measuring scoop. Spatula and mixing pad.

Here's a breakdown of the acceptance criteria and the study that proves the device meets them, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Explanation of "Acceptance Met?": The document states that GlassLok demonstrated "similar or better performance" for shear bond strength and "similar results" for ISO 9917-2:2017 testing when compared to the predicate. For biocompatibility, it states the device "did not directly or through the release of material constituents produce adverse local or systemic effects; it is not carcinogenic or mutagenic, and will not produce adverse reproductive or developmental effects." This indicates the acceptance criteria were met.

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

• Sample Size for Test Set: The document does not explicitly state the sample size used for the shear bond strength testing or the ISO 9917-2:2017 testing.
• Data Provenance: The document does not specify the country of origin of the data. It also does not state whether the data was retrospective or prospective. Given the nature of a 510(k) submission for a new device, it would most likely be prospective, newly generated data for the purpose of the submission.

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

• The document describes laboratory performance testing (shear bond strength, ISO 9917-2:2017) and biocompatibility evaluations, not a study involving human interpretation where "ground truth" would be established by experts in the clinical sense (e.g., radiologists interpreting images).
• Therefore, this question is not applicable in the context of this device's evaluation as described. The "ground truth" here is objective physical and chemical measurements.

4. Adjudication Method for the Test Set

• As mentioned above, the primary evaluations were laboratory-based performance tests and biocompatibility assessments, not studies requiring expert adjudication of results.
• Therefore, this question is not applicable in the context of this device's evaluation as 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, an MRMC comparative effectiveness study was not done.
• This device, GlassLok, is a dental cement, not an AI-powered diagnostic or decision support tool. Therefore, the concept of "human readers improve with AI vs without AI assistance" is not relevant.

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

• No, a standalone algorithm performance study was not done.
• GlassLok is a physical dental material, not an algorithm or software.

7. The Type of Ground Truth Used

• For performance testing (shear bond strength, ISO 9917-2:2017): The ground truth was based on objective physical and mechanical measurements obtained through standardized laboratory test methods. The predicate device served as the comparative benchmark.
• For biocompatibility: The ground truth was established through biological evaluations and chemical characterization against established international standards (ISO 10993 and ISO 7405:2018), determining whether the material caused adverse biological reactions.

8. The Sample Size for the Training Set

• This is a medical device (dental cement), not a machine learning or AI model. Therefore, the concept of a "training set" in the context of AI development is not applicable. The device's performance is inherent to its material properties and manufacturing, not learned from data.

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

• As mentioned above, the concept of a "training set" is not applicable for this type of device. The characteristics and performance of GlassLok are determined through its chemical composition and physical properties, which are then verified through the performance data described.

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This Device is intended for use as a light cure, orthodontic adhesive.

This device is a light-cure orthodontic adhesive intended for bonding brackets and appliances to a tooth surface. This device will bond to any enamel, porcelain, composite or metal tooth surface that has been properly conditioned. This device will be available in push syringe or tips for preferences in dispensing.

The provided text describes a 510(k) submission for the "Quantum LB" orthodontic adhesive. The study aims to demonstrate substantial equivalence to a predicate device, Transbond XT.

Here's an analysis of the acceptance criteria and the study presented:

Quantum LB Orthodontic Adhesive - Acceptance Criteria and Study Details

1. Acceptance Criteria and Reported Device Performance

The core acceptance criterion for the Quantum LB device, as per the provided summary, is similar performance to the predicate device (Transbond XT) in shear bond strength. No specific numerical thresholds are given for this similarity, but the summary states it was achieved.

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The Pontic Paint is intended for use as a light cure coloring agent of thermoplastic aligners.

The Pontic Paint is a light cure coloring agent for thermoplastic aligners. The Pontic Paint is formulated in a viscosity that is easily mixed and bonds chemically to a typically difficult to adhere to surface, a thermoplastic aligner now common in the dental industry. This paint, upon polymerization, is in Vita Shades A1. A2, and Bl allowing the appearance of a realistic tooth under the thermoplastic aligner thereby making a missing tooth situation appear aesthetically pleasing to the patient undergoing orthodontic treatment using clear aligner systems. The light cure property of the paint allows the user to determine the polymerization time required by simply exposing the adhesive to an LED light source until set. The Pontic Paint will be marketed in a jar for ease of mixing and application with a brush.

The provided text describes a 510(k) summary for a medical device called "Pontic Paint." However, the document does not contain any information about acceptance criteria, device performance results, or a study to prove the device meets acceptance criteria.

The document primarily focuses on:

• Identifying the applicant (Reliance Orthodontic Products, Inc.)
• Describing the device ("Pontic Paint" - a light-cure coloring agent for thermoplastic aligners)
• Stating its intended use and population
• Identifying the predicate devices (Flowtain™ and Plastic Conditioner)
• The FDA's decision of substantial equivalence.

Therefore, I cannot provide the requested information in the tables or bullet points because it is not present in the provided text.

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The CLEAR ALIGNER ADHESIVE is intended for use as an orthodontic bonding adhesive for brackets and appliances to thermoplastic aligner surfaces.

The Clear Aligner Adhesive is a light cure, orthodontic adhesive for metal, composite and porcelain brackets and appliances to bond to a thermoplastic aligner. The Clear Aligner Adhesive is formulated in a viscosity that flows easily from the syringe and bonds chemically to a typically difficult to adhere to surface. a thermoplastic aligner now common in the dental industry. This adhesive, upon polymerization, is clear and virtually indistinguishable from the thermoplastic aligner thereby making it aesthetically pleasing to the patient. The light cure property of the adhesive allows the user to determine the polymerization time required by simply exposing the adhesive to an LED light source until set. The Clear Aligner Adhesive will be marketed in a push syringe for dispensing.

The provided text describes a medical device called "Clear Aligner Adhesive" and its 510(k) submission for premarket notification. The information pertains to the adhesive's composition, intended use, and a comparison to a predicate device. However, the document does not contain information about acceptance criteria or specific studies that would typically be described for a diagnostic AI/ML device approval (e.g., sensitivity, specificity, clinical endpoints, reader studies).

Therefore, I cannot provide a detailed answer to your request in the format specified. The information about sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, training set sizes, and ground truth establishment for a diagnostic AI/ML device is not present in the provided text.

The document primarily focuses on establishing substantial equivalence for a physical medical adhesive based on its technical characteristics and an assessment of shear bond strength and cytotoxicity.

Here's what can be extracted from the provided text about the device:

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

The document doesn't explicitly list quantitative "acceptance criteria" for regulatory approval in the typical sense for an AI/ML device. Instead, it compares the new device's properties to a predicate device and reports on specific tests.

Regarding the study proving the device meets criteria, the document states:

"Clear Aligner Adhesive was tested and compared to Reliance Orthodontic Products, Inc. Flowtain in conjunction with Plastic Conditioner for Shear Bond Strength. Testing resulted in highly increased bond strength values for the Clear Aligner adhesive when compared to the use of Flowtain with a Plastic conditioner. Clear Aligner Adhesive has been tested for cytotoxicity via the ISO 10993-5 elution test method and showed no evidence of causing cell lysis or toxicity."

The following information cannot be provided from the given text:

• 2. Sample size used for the test set and the data provenance: Not mentioned.
• 3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable/mentioned for this type of device and submission.
• 4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable/mentioned.
• 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/ML device.
• 6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
• 7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): For Shear Bond Strength, the "ground truth" would be the measured force. For cytotoxicity, it would be the cellular response observed in the lab. These are not clinical "ground truths" in the diagnostic sense.
• 8. The sample size for the training set: Not applicable for this type of device.
• 9. How the ground truth for the training set was established: Not applicable.

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Light Bond is intended for use as an orthodontic bracket adhesive.

Pad Lock® is intended for use as a fluorescing, light cure Orthodontic Bracket Adhesive.

Light Bond and Pad Lock are light cure, orthodontic bracket adhesives available in a variety of viscosities for bonding to metal, ceramic and composite surfaces. Both Light Bond and Pad Lock are available in fluoride and non-fluoride formulas and come in syringe style or tip dispensing.

In addition, Pad Lock fluoresces to ease clean-up of flash for the user.

The provided document is a 510(k) summary for orthodontic bracket adhesives (Light Bond™ and Pad Lock®). It is not a study report for an AI-powered device. Therefore, I cannot extract information about acceptance criteria or a study proving that an AI device meets acceptance criteria, as an AI device is not described in this document.

The document discusses the substantial equivalence of the Light Bond™ and Pad Lock® products to a predicate device (QUICK CURE, K001048), focusing on their intended use and mechanical/physical properties as orthodontic bracket adhesives.

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L.C.R." is a flowable, light-cure orthodontic adhesive intended to be used within an orthodontic, dental or pediatric dental office for the bonding of lingual retainers, creation of occlusal buildups and for the retention of thermo-plastic aligners.

L.C.R."" is a light-cure orthodontic adhesive that is flowable and a highly filled resin in order to provide durability. These properties make it ideal for bonding lingual retainers, creating occlusal buildups and for the retention of a thermoplastic aligner.

L.C.R is available in push syringe, luer-lok syringe or tips for preferences in dispensing.

This document is a 510(k) summary for a medical device called L.C.R.™, a light-cure orthodontic adhesive. The primary purpose of this submission is to demonstrate substantial equivalence to a legally marketed predicate device, Flowtain™.

Here's an analysis of the acceptance criteria and the study information provided, structured according to your request:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Flexural Strength & Depth of Cure: The document states "L.C.R.™ was tested and compared to Flowtain™ for Flexural Strength and Depth of Cure via ISO 4049:2009(E) test method." While the standard ISO 4049:2009(E) specifies methodology, the exact sample size used for this specific study is not explicitly mentioned in the provided text.
• Compressive Strength: "five replicates" were conducted for the Compressive Strength Test.
• Oral Toxicity: "a 10 Mouse, 7 Day Method (Solid)" was used.
• Data Provenance: The document does not specify the country of origin of the data or whether the studies were retrospective or prospective. Given the nature of material property testing, these would typically be laboratory-based prospective studies.

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

There is no mention of experts being used to establish a "ground truth" in the traditional sense of clinical outcome assessment for the performance tests (Flexural Strength, Depth of Cure, Compressive Strength, Oral Toxicity). These are objective, quantitative laboratory measurements.

For the "Bonding of Lingual Retainers" and "Bonding of Thermoplastic Aligners" properties, the descriptions ("Successful bond," "Adhesive created retentive surface") suggest qualitative assessments, but no information about experts or their qualifications is provided.

4. Adjudication Method for the Test Set

Not applicable. The reported tests are primarily objective laboratory measurements rather than subjective assessments 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 device is an orthodontic adhesive, not an AI software or imaging interpretation tool that would involve human readers or MRMC studies.

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

Not applicable, as this is a physical medical device (an adhesive), not an algorithm.

7. The Type of Ground Truth Used

The "ground truth" for the performance characteristics (Flexural Strength, Depth of Cure, Compressive Strength) is based on objective, quantitative measurements obtained through standardized laboratory test methods (e.g., ISO 4049:2009(E)). For oral toxicity, the ground truth is established by the observed biological response in the mouse model. For bonding efficacy, the "successful bond" or "retentive surface" acts as a qualitative ground truth.

8. The Sample Size for the Training Set

Not applicable. This is a physical product, not a machine learning model, so there is no training set in the AI sense. The development of the adhesive likely involved internal R&D tests, but these are not described as a "training set."

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

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

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Flowtain™ is a flowable, light-cure orthodontic adhesive intended to be used within an orthodontic, dental or pediatric dental office for the bonding of lingual retainers and splinting materials, creation of archwire stops and indirect bonding of orthodontic brackets. Flowtain™ can also be used for the retention of thermoplastic aligners.

Flowtain™ LV is a lower viscosity, flowable light cure orthodontic adhesive intended to be used for indirect bonding of orthodontic brackets.

Flowtain™ is a light-cure orthodontic adhesive with a low modulus of elasticity that is flowable. This low modulus of elasticity makes it ideal for bonding lingual retainers, splinting materials and for indirect bonding of brackets. Thixotropic design properties of Flowtain™ also make it highly polishable which allows it to be used for comfortable archwire stops and as an aid for retention of a thermoplastic aligner.

Flowtain™ LV is a low viscosity version of the Flowtain™ product used primarily for indirect bonding of brackets.

Both are available in push syringe or tips for preferences in dispensing.

The provided text describes the 510(k) summary for "Flowtain™ and Flowtain™ LV," orthodontic adhesives. It primarily focuses on demonstrating substantial equivalence to predicate devices rather than defining and proving acceptance criteria for a novel AI or software device. As such, many of the requested categories for AI/software device evaluation are not directly applicable or explicitly stated in the document.

However, I can extract and infer information relevant to the device's performance evaluation as presented:

Acceptance Criteria and Study for Flowtain™ and Flowtain™ LV

The acceptance criteria for Flowtain™ and Flowtain™ LV relate to demonstrating comparable performance, specifically in shear bond strength, to the legally marketed predicate device, 3M Unitek Transbond™ Supreme LV. The study aimed to show similar performance between the new devices and the predicate device.

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size and Data Provenance

• Sample Size for Test Set: Replicates of 5 for Flowtain™, Flowtain™ LV, and Transbond™ Supreme LV. (Total of 15 samples for shear bond strength testing, assuming 5 replicates for each of the three products).
• Data Provenance: Not explicitly stated, but the testing method ("in-vivo performance test method") suggests biological or simulated biological conditions. The manufacturer is based in Itasca, Illinois, USA, implying the study was likely conducted in the USA. The study design (comparison against a predicate device) is typical for a 510(k) submission. It's a retrospective comparison against a known predicate device's performance data or a prospective comparative study where both were tested simultaneously under the same conditions. Given the phrasing "tested against," it implies a comparative study.

3. Number of Experts and Qualifications for Ground Truth

• Not applicable for this type of device. The assessment of shear bond strength is a quantitative mechanical test, not dependent on expert interpretation or ground truth established by human experts in the way an image analysis or diagnostic AI would require.

4. Adjudication Method

• Not applicable for this type of device. Adjudication methods like 2+1 or 3+1 are used for expert consensus on qualitative assessments (e.g., medical image interpretation). Shear bond strength is a physical measurement.

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

• No MRMC study was done. This type of study is relevant for AI systems that assist human readers in tasks like medical image interpretation. Flowtain™ and Flowtain™ LV are orthodontic adhesive materials, not AI systems.

6. Standalone Performance Study (Algorithm Only)

• Not applicable. This relates to AI algorithms. The performance of the adhesive materials was evaluated directly through mechanical testing.

7. Type of Ground Truth Used

• Mechanical Test Results / Physical Property Measurement: The "ground truth" for shear bond strength is the objective measurement obtained from a standardized mechanical test. For toxicity, it's based on toxicology testing.

8. Sample Size for Training Set

• Not applicable. This device is a physical product (orthodontic adhesive), not a machine learning model, so there is no "training set."

9. How Ground Truth for Training Set was Established

• Not applicable. As there is no training set for an AI model, this question is irrelevant to the described device.

Summary of the Study:

The study detailed in the 510(k) summary for Flowtain™ and Flowtain™ LV involved in-vivo performance testing to assess shear bond strength. This testing was conducted using an indirect bonding procedure for replicates of 5 for Flowtain™, Flowtain™ LV, and the predicate device, 3M Unitek Transbond™ Supreme LV. The results indicated that the new adhesives achieved "similar performance" to the predicate device, thereby meeting the implied acceptance criterion for substantial equivalence in this critical mechanical property. Additionally, Flowtain™ was explicitly tested and proven to be non-toxic.

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LED PRO SEAL® is intended to seal enamel surfaces around orthodontic brackets.

LED PRO SEAL® is a fluoride containing light cure filled surface sealant provided in a light impervious bottle dispenser. Upon delivery of one drop of LED PRO SEAL to a mixing pad, a thin coat of LED PRO SEAL is applied to a prepared enamel surface using a brush applicator and light cured for a minimum of 20 seconds with any halogen, plasma arc or cordless light capable of a 440-490 NM wavelength.

The provided document describes the 510(k) summary for the LED PRO SEAL® dental sealant. This submission seeks to demonstrate substantial equivalence to a predicate device, not through an AI/ML study, but through traditional laboratory testing of material properties. Therefore, many of the requested fields related to AI/ML specific studies will be marked as "Not Applicable".

Here's a breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Study Proving Device Meets Acceptance Criteria:

A series of comparative tests were conducted between LED PRO SEAL® and the predicate device, original PRO SEAL® (K021503). These tests included:

• Shear bond strength
• Compressive strength
• Flexural strength
• Cumulative fluoride release
• Depth of cure

The document states that these comparisons "demonstrate that the applicant device is equivalent to the legally marketed device in terms of effectiveness."

Additionally, for biocompatibility, a Cytotoxicity Study using the ISO 10993-5 Agarose Overlay Method (Solid) was performed. The LED PRO SEAL® was found to cause "mild cell lysis or toxicity (generating grade 2 for mild reactivity)" and "met the requirements of ISO10993-5 for a grade 2 material showing evidence that the product is safe to use."

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

• Sample size: Not explicitly stated in the provided text for the material property tests.
• Data provenance: The tests were conducted internally by Reliance Orthodontic Products, Inc., comparing their new device to their own predicate device. The country of origin of the data is implied to be USA given the company's location. The study is prospective in nature as it tests the newly developed device.

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

• Not Applicable: This type of medical device submission (dental sealant) relies on objective laboratory measurements of material properties and biological tests, not expert interpretation of images or clinical outcomes that would require a ground truth established by human experts in the context of an AI/ML study.

4. Adjudication method for the test set

• Not Applicable: See explanation for item 3.

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/ML device requiring human reader assessment. It's a dental material.

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

• Not Applicable: This is not an AI/ML device.

7. The type of ground truth used

• Not Applicable: For material properties, the "ground truth" is established by the objective measurements obtained from standardized testing methods (e.g., measuring force for bond strength, chemical analysis for fluoride release, cell viability for cytotoxicity). For the purpose of regulatory submission, the performance of the predicate device acts as the benchmark ("ground truth" for comparison).

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.

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