Search Results

FiteBac® CC OrthoSeal with K18 QAMS is a light cure primer intended to prepare the tooth surface prior to bonding orthodontic appliances to etched enamel.

The FiteBac® CC OrthoSeal is a 5% K18 Quaternary Ammonium Methacrylate (QAMS) functionalized, light cured orthodontic sealant used to prepare etched enamel for orthodontic bonding.

The provided text describes the 510(k) summary for the FiteBac® CC OrthoSeal device. Here's a breakdown of the requested information:

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

The document doesn't explicitly state "acceptance criteria" in a quantitative, pass/fail format for the device's performance characteristics. Instead, it categorizes performance testing, and the reported performance is described as being "acceptable" and not raising "any new issues of safety or effectiveness" in comparison to predicate devices. The primary performance characteristic mentioned is "Bond Strength Testing."

Ask a specific question about this device

The FiteBac® Cavity Cleanser is a 2% K21 QAS aqueous ethanolic solution intended for cleansing and moistening/re-wetting of cavity preparations.

The FiteBac® Cavity Cleanser is a 2% K21 Quaternary Ammonium Silane-functionalized (QAS) aqueous ethanolic solution intended for cleansing and moistening/re-wetting of prepared dental surfaces. It is recommended for use upon completion of tooth preparation or etching, prior to sealing dentinal tubules. Research has shown that FiteBac® Cavity Cleanser can not only remove debris in carious lesion preparations but can penetrate exposed dentin tubules allowing restorative adhesives to tightly bind to the prepared dentin surface. Clinical studies have not been conducted to demonstrate that this device results in improved clinical outcomes.

The provided document, a 510(k) premarket notification for the FiteBac® Cavity Cleanser, details the device's characteristics and compares it to predicate and reference devices to establish substantial equivalence. However, this document does not describe a study that involves human-in-the-loop performance, multi-reader multi-case studies, or AI assistance. The "Performance Testing" section only lists "Bond Strength Testing." The "Non-Clinical Testing" section lists "Biocompatibility" (Cytotoxicity and Sensitization).

Therefore, based on the provided text, I cannot provide information for many of the requested points, especially those related to AI model performance, expert ground truth establishment for a test set, MRMC studies, or training set details. The document focuses on establishing substantial equivalence through comparison of technological characteristics and non-clinical bench testing.

Here's a breakdown of what can be extracted and what cannot:

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

The document doesn't present "acceptance criteria" in the typical sense of a pre-defined performance threshold for a statistical study (e.g., AUC > X, sensitivity > Y%). Instead, it establishes substantial equivalence by demonstrating that the FiteBac® Cavity Cleanser has similar material properties and performs comparably in bench tests to legally marketed predicate and reference devices.

The "acceptance criteria" are implicitly met if the device demonstrates substantial equivalence to the predicate and reference devices in the evaluated characteristics. The "reported device performance" is essentially that it did achieve this equivalence in the listed non-clinical tests.

Important Note: The document explicitly states: "Clinical studies have not been conducted to demonstrate that this device results in improved clinical outcomes." This reinforces that the acceptance is based on non-clinical, bench-top equivalence, not clinical performance metrics.

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

• Test Set Sample Size: The document does not specify sample sizes for the bench tests (Bond Strength, Cytotoxicity, Sensitization). These are typically described in detailed study reports that are part of the 510(k) submission but are not fully reproduced in this summary letter.
• Data Provenance: The document does not specify the country of origin of the data. It's safe to assume the testing was conducted to support a US FDA submission, but the specific location of the labs isn't stated. The testing is retrospective in the sense that it evaluates the device's properties, not prospective patient outcomes.

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

• This question is not applicable to this document. The device is a "cavity cleanser," a chemical solution, not an AI diagnostic device that requires expert interpretation of images or other data to establish ground truth. The "ground truth" for chemical/physical properties is established by standardized laboratory methods and measurements, not by expert consensus.

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

• This question is not applicable for the same reason as point 3. Adjudication methods are used in reader studies (often for AI or imaging devices) to resolve discrepancies in human interpretations. This device's evaluation is based on objective laboratory measurements.

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 document pertains to a chemical dental product, not an AI-assisted diagnostic tool.

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

• No, this is not an AI algorithm. This question is not applicable.

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

• The "ground truth" for this device's evaluation is based on standardized laboratory measurements and accepted scientific principles for material properties, bond strength, and biocompatibility (cytotoxicity, sensitization). It is not based on expert consensus, pathology, or clinical outcomes data in the context of a diagnostic study.

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.

Ask a specific question about this device

The InfinixTM Universal Composite is indicated for:

• · Restorations in the posterior region (Class I and II)
• · Anterior restorations (Class III, IV)
• · Class V restorations (cervical caries, root erosion, wedge-shaped defects)
• · Veneering of discolored anterior teeth
• · Splinting of mobile teeth
• · Extended fissure sealing in molars and premolars
• · Repair of composite/ceramic veneers

Infinix™ Universal Composite is a packable (high viscosity) dental composite filling material, intended for direct anterior and posterior restorations, class V restorations, veneering of discolored anterior teeth, and repair of composite/ceramic veneers. The resin matrix of the Infinix™ Universal Composite contains Urethane dimethacrylate (UDMA), Bisphenol-a glycidyl dimethacrylate (Bis-GMA) and triethylene glycol dimethacrylate (TEGDMA). The inorganic filler of the Infinix™ Universal Composite is a mix of particles of alumino-silicate-based glasses, silica dioxide and pigments. A small percentage of the silica-based filler particles are covalently bound to quaternary ammonium residues (OASi), added to maintain the integrity of the restoration. The Infinix™ Universal Composite is provided in syringes (4 g) and in single-dose capsules (0.2 g) and is available in five shades (A1, A2, A3, B1 and translucent).

The provided document is a 510(k) Premarket Notification from the FDA for a dental resin material named "Infinix™ Universal Composite". This submission focuses on demonstrating substantial equivalence to a predicate device based on material properties and non-clinical testing. It does not describe a study involving algorithms, human readers, or image analysis for diagnostic purposes.

Therefore, most of the requested information regarding acceptance criteria, device performance in a diagnostic context, sample sizes for test/training sets, expert ground truth establishment, adjudication methods, MRMC studies, or standalone algorithm performance cannot be extracted from this document as it pertains to a different type of medical device and evaluation.

However, I can extract the non-clinical performance criteria and reported performance from the document.

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

The document lists various non-clinical tests performed on the Infinix™ Universal Composite to establish substantial equivalence to the predicate device, Tetric EvoCeram®, and compliance with ISO 4049 and FDA guidance. The acceptance criteria are implicitly those defined by these standards and guidance documents. The document states that the device "performs as intended based on the bench testing per ISO 4049 and FDA guidance document". Specific numerical results for "reported device performance" are not provided in this summary, but the general conclusion is that the device met these criteria.

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

This information is not applicable and not provided. The study pertains to non-clinical bench testing and biocompatibility assessments of a dental material, not a diagnostic device with test sets of patient data.

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 information is not applicable and not provided. Ground truth in the context of this device would relate to the physicochemical properties and biocompatibility of the material, not expert interpretation of diagnostic data.

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

This information is not applicable and not provided. Adjudication methods are relevant for expert review of human data, not for material property testing.

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 such study was done or is described. This device is a dental filling material, not an AI-powered diagnostic tool.

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

No such study was done or is described. This device is a dental filling material, not an algorithm.

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

The "ground truth" for this device's evaluation is based on established scientific and regulatory standards for material properties and biocompatibility as outlined in ISO 4049, ISO 10993, ISO 7405, and FDA guidance for dental composite resin devices. It's objective, quantitative measurements against these standards.

8. The sample size for the training set

This information is not applicable and not provided. There is no "training set" in the context of material property evaluation for a dental composite.

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

This information is not applicable and not provided for the reasons stated above.

Ask a specific question about this device

The Novidia™ Bulk Fill Flow Composite is indicated for:

• 1. Base under Class I and II direct restorations
• 2. Liner under direct restorative materials
• 3. Pit and fissure sealant
• 4. Restoration of minimally invasive cavity preparations (including small, non-stress-bearing occlusal restorations)
• 5. Class III and V restorations
• 6. Blocking out of undercuts
• 7. Repair of small enamel defects
• 8. Repair of small defects in esthetic indirect restorations
• 9. Repair of resin and acrylic temporary materials

10. As a core build-up where at least half the coronal tooth structure is remaining to provide structural support for the crown

Novidia™ Bulk Fill Flow Composite is a low viscosity, visible-light activated, radiopaque, flowable composite indicated for minimally invasive cavity preparations as well as various other indications. The resin matrix of the Novidia™ Bulk Fill Flow Composite contains Urethane dimethacrylate (UDMA), Bisphenol-a glycidyl dimethacrylate (Bis-GMA) and triethylene glycol dimethacrylate (TEGDMA). The inorganic filler of the Novidia™ Bulk Fill Flow Composite is a mix of particles of alumino-silicate-based glasses, silica dioxide and pigments. A small percentage of the silica-based filler particles are covalently bound to quaternary ammonium residues (QASi), added to maintain the integrity of the restoration. The Novidia™ Bulk Fill Flow Composite is provided in syringes (2 g) and in single-dose capsules (0.2 g) and is available in two shades (A2 and A3).

The provided text describes a 510(k) premarket notification for a dental device, "Novidia™ Bulk Fill Flow Composite." The information focuses on demonstrating substantial equivalence to a predicate device ("Filtek™ Bulk Fill Flowable Restorative") primarily through non-clinical performance testing (bench testing and biocompatibility assessments).

Therefore, the requested information regarding acceptance criteria and the study that proves the device meets the acceptance criteria will reflect this focus on non-clinical, in vitro performance, rather than clinical study data involving human readers or AI algorithms.

Here's a breakdown based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for Novidia™ Bulk Fill Flow Composite are implicitly aligned with the performance characteristics of its predicate device, Filtek™ Bulk Fill Flowable Restorative, as well as the requirements of the ISO 4049:2009 standard for polymer-based restorative materials.

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

The document does not specify the exact sample sizes (e.g., number of specimens tested for flexural strength) for the non-clinical bench tests. However, it indicates that testing was conducted "per ISO 4049 and FDA guidance document 'Dental Composite Resin Devices - Premarket Notification [510(k)] Submissions'." These standards and guidance documents typically specify minimum sample sizes for material properties testing.

The data provenance is from non-clinical laboratory testing performed to support the 510(k) submission. No specific country of origin for the testing lab is mentioned, but the submitter, Nobio Ltd., is based in Kadima, Israel. This is retrospective in the sense that the testing was completed prior to the submission for regulatory clearance.

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

This question is not applicable in the context of this 510(k) submission. The "ground truth" for the device's performance is established by objective, standardized laboratory measurements against established international standards (ISO 4049:2009) and FDA guidance, not by expert consensus or human interpretation of images/data for diagnostic purposes.

4. Adjudication Method for the Test Set

Not applicable. This device is a material, and its performance is evaluated through physical and chemical property testing, not through human adjudication of diagnostic outcomes.

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 dental restorative material, not an AI-assisted diagnostic or imaging device. No MRMC study was performed or is relevant. The document explicitly states: "Animal and clinical performance data was not included." and "Clinical studies demonstrating that the presence of QASi in this device improves clinical outcomes have not been conducted."

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

Not applicable. This is not an algorithm or AI device.

7. The Type of Ground Truth Used

The "ground truth" for this device's performance is based on objective, standardized measurements of its physical, chemical, and biological properties as defined by:

• International standards (e.g., ISO 4049:2009 for polymer-based restorative materials, ISO 10993 for biocompatibility).
• FDA guidance documents for dental composite resin devices.
• Comparison to the established performance characteristics of the legally marketed predicate device.

8. The Sample Size for the Training Set

Not applicable. This is not a machine learning or AI device that requires a training set.

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

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

Ask a specific question about this device

The Novidia™ Flowable Composite is indicated for:

1. Class III and V restorations
2. Restoration of minimally invasive cavity preparations (including small, non-stress bearing occlusal restorations)
3. As base/liner under direct or indirect restorations
4. Repair of small defects in esthetic indirect restorations
5. Pit and fissure sealing
6. Blocking out of undercuts
7. Repair of resin and acrylic temporary materials

Novidia™ Flowable Composite is a low viscosity, visible light activated, radiopaque, flowable composite indicated for minimally invasive cavity preparations as well as various other indications. The resin matrix of the Novidia™ Flowable Composite contains Urethane dimethacrylate (UDMA), Bisphenol-a glycidyl dimethacrylate (Bis-GMA) and triethylene glycol dimethacrylate (TEGDMA). The inorganic filler of the Novidia™ Flowable Composite is a mix of particles of alumino-silicate-based glasses, silica dioxide and pigments. A small percentage of the silica-based filler particles are covalently bound to quaternary ammonium residues (OASi), added to maintain the integrity of the restoration. The Novidia™ Flowable Composite is provided in syringes (2 g) and in single-dose capsules (0.2 g) and is available in three shades (A1, A2 and A3).

The provided text describes a 510(k) submission for a dental device, the Novidia™ Flowable Composite. The document focuses on demonstrating substantial equivalence to a predicate device, rather than providing a detailed clinical study proving acceptance criteria for a new AI/medical image analysis device. Therefore, much of the requested information regarding acceptance criteria, study details, and AI-specific metrics is not available in the provided text.

However, I can extract and structure the available information regarding performance data, which in this case refers to non-clinical testing.

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

The document outlines a series of non-clinical (bench) tests performed on the Novidia™ Flowable Composite. For several key physical properties, it states that the device was tested according to ISO 4049:2009 standards, which would implicitly define the acceptance criteria, as the statement of "performing as intended" implies meeting these standards. However, the specific numerical acceptance criteria (e.g., minimum flexural strength value) are not explicitly stated in the text, nor are the precise numerical results for the Novidia™ Flowable Composite.

Biocompatibility Testing:

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

• Test Set Sample Size: Not specified for any of the bench tests.
• Data Provenance: The document does not specify the country of origin for the data or whether it was retrospective or prospective. Given these are bench tests rather than clinical studies, these terms are less applicable.

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

• This information is not applicable and not provided. The data comes from physical/chemical bench testing, not expert interpretation of medical images or conditions.

4. Adjudication method for the test set:

• This information is not applicable and not provided. Adjudication is relevant for clinical or image-based studies where multiple readers interpret data.

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 information is not applicable and not provided. The device is a dental material, not an AI or medical image analysis device. No MRMC study was conducted.

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

• This information is not applicable and not provided. The device is a dental material, not an AI or algorithm.

7. The type of ground truth used:

• The "ground truth" for the non-clinical performance and biocompatibility data is established by objective measurements and standardized protocols (e.g., ISO 4049, ISO 10993, ISO 7405 benchmarks for material properties and biological responses). For the "Preservation of Surface Integrity" test, the ground truth was the measured surface roughness under microbial challenge.

8. The sample size for the training set:

• This information is not applicable and not provided. This is a material science submission, not an AI/machine learning submission, so there is no concept of a "training set."

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

• This information is not applicable and not provided, as there is no training set mentioned or implied.

In summary, the provided document describes the substantial equivalence of a dental material based on its physical, chemical, and biological properties evaluated through non-clinical bench testing. It does not contain information relevant to AI/medical image analysis device evaluation criteria such as clinical study design, expert consensus, or reader performance metrics.

Ask a specific question about this device