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TrusFIL-Flow Flowable Composite Restorative is a visible light curing dental restorative material indicated for:

• Class III and V restorations
• Restoration of minimally invasive cavity preparations (including small, non stress-bearing occlusal restorations)
• Base/liner under direct restorations
• Repair of small defects in indirect restorations
• Pit and fissure sealant
• Undercut blockout
• Repair of resin and acrylic temporary materials

TrusFIL-Flow Flowable Composite Restorative is a visible light curing dental restorative material intended to restore carious lesions or structural defects in teeth in combination of a bonding agent and with or without other materials such as luting, etching agents, cavity liners, universal composites and others commonly used in a tooth restoration. The principal organic components are mixtures of dental methacrylate resins (Bis-GMA, TEGDMA, EBPADMA). The inorganic filler loading is about 46% by volume having particle size range of about 0.01 to 3 microns. It is packaged in syringes and single-dose capsules. Single-dose delivery is intended for single patient (single use) only to prevent cross-contamination between patients.
Available shades include opaque dentin shades and regular body shades. All shades are radiopaque.

The provided document is a 510(k) premarket notification for a dental restorative material, TrusFIL-Flow Flowable Composite Restorative. It aims to demonstrate substantial equivalence to a predicate device, not to prove the device meets acceptance criteria for an AI/algorithmic medical device, as implied by the user's request.

Therefore, the document does not contain the information needed to answer the user's questions about acceptance criteria and study details for an AI/algorithmic device. The document primarily focuses on physical and chemical properties, biocompatibility, and intended use for a conventional dental material.

Specifically, the following information is not available in the provided text:

• A table of acceptance criteria and reported device performance for an AI/algorithmic device. The "acceptance criteria" presented are pass/fail criteria for physical properties of a dental material according to ISO standards and FDA guidance, not for an AI.
• Sample size used for a test set or data provenance for an AI.
• Number of experts or their qualifications for establishing ground truth for an AI test set.
• Adjudication method for an AI test set.
• Information on Multi-Reader Multi-Case (MRMC) comparative effectiveness study or human reader improvement with AI assistance.
• Standalone performance for an algorithm only.
• Type of ground truth used (expert consensus, pathology, outcomes data, etc.) for an AI.
• Sample size for a training set for an AI.
• How ground truth for a training set was established for an AI.

The document explicitly states under "10. Clinical Performance Data": "Not applicable. Clinical performance testing has not been performed on the subject device." This further confirms that no clinical studies or AI performance evaluations, as requested, were conducted or reported here.

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Infinix™ Universal Composite:

• 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
  The addition of the QASi particles to the Infinix™ Universal Composite reduces demineralization, which is part of the caries-formation process.

Infinix™ Flowable Composite:

• Class III and V restorations
• Restoration of minimally invasive cavity preparations (including small, non-stress-bearing occlusal restorations)
• As base/liner under direct or indirect restorations
• Repair of small defects in aesthetic indirect restorations
• Pit and fissure sealant
• Blocking out of undercuts
• Repair of resin and acrylic temporary materials
  The addition of the QASi particles to the Infinix™ Flowable Composite reduces demineralization, which is part of the caries-formation process.

Infinix™ Bulk Fill Flow Composite:

• Base under Class I and II direct restorations
• Liner under direct restorative materials
• Pit and fissure sealant
• Restoration of minimally invasive cavity preparations (including small, non-stress-bearing occlusal restorations)
• Class III and V restorations
• Blocking out of undercuts
• Repair of small enamel defects
• Repair of small defects in esthetic indirect restorations
• Repair of resin and acrylic temporary materials
• As a core build-up where at least half the coronal tooth structure is remaining to provide structural support for the crown
  The addition of the OASi particles to the Infinix™ Bulk Fill Flow Composite reduces demineralization, which is part of the caries-formation process.

The Infinix™ Family of Dental Composites include the following light-cured, resinbased composite materials:

• Universal Composite
• Flowable Composite
• Bulk Fill Flow Composite
  Some of the silica-based filler particles (max 1.2% wt/wt of the total formulation) contained in all the Infinix™ composites are decorated with quaternary ammonium functional groups that are covalently bound to the filler particles' silica core via a silane linker (herein referred to as "QASi"). Following light induced polymerization, QASi particles (produced by Nobio) remain permanently entrapped within the composite restoration and destroy microorganisms by contact. As the cell membrane of microorganisms is negatively charged and the QASi particles have strong positive charges, microorganisms are electrostatically attracted to the positively charged cured material's surface resulting in disruption of their cell membrane and immediate microbial lysis.

This document is a 510(k) Premarket Notification from the FDA regarding dental composites. It does not contain information about an AI/ML medical device. Therefore, I cannot provide details on acceptance criteria and study proving device meets criteria as requested in the prompt, as the provided text doesn't describe such a device or study.

The document discusses the substantial equivalence of the "Infinix™ Family of Dental Composites" to their predicate devices, emphasizing a new claim related to the reduction of demineralization due to the addition of QASi particles. The clinical performance section describes an in-situ clinical study comparing a composite with QASi particles to one without, focusing on mineral loss in enamel slabs. This study is for dental materials, not an AI/ML algorithm.

Therefore, I cannot fulfill the request as it pertains to an AI/ML device and its acceptance criteria, ground truth establishment, sample sizes for training/test sets, expert adjudication, or MRMC studies, because this information is not present in the provided text.

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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.

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TPH Spectra® ST Flowable Composite Restorative is indicated for:

• Direct restoration of cavities and lesions
• · Filling of defects and undercuts in crowns, inlays, and onlays
• Blockouts
• · Repair of defects
• · Pit and fissure sealants
• · Cementation of light transmissible indirect restorations

TPH Spectra® ST Flowable Composite Restorative is a visible light cured, radiopaque composite resin restorative material with flow characteristics that make it ideal for use in anterior and posterior teeth. The new device contains methacrylate-based resin, photo initiator, silanated inorganic filler and pigments. Available shades include opaque dentin shades, regular body shades and translucent enamel shades. TPH Spectra® ST Flowable Composite Restorative is applied to the tooth following use of a methacrylate-based dental adhesive and/or a cement, which bonds the restoration to the tooth structure. TPH Spectra® ST Flowable Composite Restorative is packaged in multi-use dispensing packages and pre-dosed Compula® Tips for intraoral dispensing.

The provided text is a 510(k) summary for the TPH Spectra® ST Flowable Composite Restorative. It describes the device, its indications for use, and a comparison to predicate devices to establish substantial equivalence. However, this document does not describe a study that uses a device to meet acceptance criteria in the context of diagnostic performance (e.g., sensitivity, specificity, AUC) or an AI algorithm's performance.

Instead, it pertains to a dental restorative material and its acceptance criteria are related to physical properties and biocompatibility as per established international standards for dental materials.

Therefore, I cannot provide the information requested in your prompt based on the given document, as it outlines the regulatory clearance process for a material rather than the performance evaluation of a diagnostic or AI-driven medical device.

Key points from the document indicating why it doesn't fit your request:

• Device Type: The device is a "Tooth Shade Resin Material" (flowable composite restorative), not a diagnostic device or an AI algorithm.
• Acceptance Criteria Focus: The criteria are related to material science (biocompatibility, compressive strength, flexural strength, radiopacity, water sorption, etc.) and adherence to ISO standards (ISO 4049:2009, ISO 10993-1, ISO 7405).
• No Clinical Performance Data: The document explicitly states, "No data from human clinical studies has been included to support the substantial equivalence of the proposed device TPH Spectra® ST Flowable Composite Restorative." This confirms there's no performance study in humans for diagnostic accuracy.
• No AI Component: There is no mention of an AI component or algorithm.

Therefore, I cannot populate the table or answer the specific questions about test set sample size, ground truth, expert qualifications, MRMC studies, or standalone performance, as these are not relevant to the evaluation described in the provided 510(k) summary.

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Indications for use:
*Class III and V restorations

• • Restoration of minimally invasive cavity preparations (including small, non stress-bearing occlusal restorations)
    *Base/liner under direct restorations
    *Repair of small defects in esthetic indirect restorations
    *Pit and fissure sealant
    *Undercut blockout
    *Repair of resin and acrylic temporary materials

Apoller Flow-Light Cure Flowable Composite is a low viscosity light activated flowable nanocomposite device. The device is comprised of a syringe with dispensing tips. It consists of methmethacrylate monomers, inorganic fillers and nanoparticles. Apoller Flow Light Cure Flowable Composite contains BisGMA, UDMA, TEGDMA, photo initiator, stabilizer and inorganic fillers including barium glass powder, strontium glass powder and nanosilica. The filler loading is about 56% by weight. The particle size varies from 0.03 to 1 micron. Apoller Flow Light Cure Flowable Composite series is packed in a plastic syringe with a bend metal injection needle heads for ease of usage, its model is Flowable and comes with Refill Syringe of 3.0g /syringe and 1.5 g /syringe. It is available in a variety of 15 tooth-colored shades.

The provided FDA 510(k) summary for the "Apoller Flow Light Cure Flowable Composite" describes its substantial equivalence to a predicate device, "Filtek™ Supreme Ultra Flowable Restorative." The document outlines various performance aspects but primarily focuses on demonstrating equivalence to the predicate device rather than establishing specific acceptance criteria for the new device and then proving it meets those criteria with a standalone study. Instead, it compares the new device's properties to existing standards and the predicate device.

Here's an attempt to extract the requested information based on the provided text. It's important to note that many of the specific details regarding study design, sample sizes for test/training sets, expert qualifications, and adjudication methods (which are typical for AI/software device studies) are not present in this type of submission for a dental composite. This document focuses on material properties and biocompatibility.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are implicitly that the "Apoller Flow Light Cure Flowable Composite" performs comparably to the "Filtek™ Supreme Ultra Flowable Restorative" predicate device and meets relevant ISO standards. The performance is reported in terms of various physical properties and biocompatibility, demonstrating equivalence.

• Depth of cure (mm): Compared, results demonstrate substantial equivalence.
• Flexural Strength (MPa): Compared, results demonstrate substantial equivalence. |
  | | | - Water sorption (µg/mm³): Compared, results demonstrate substantial equivalence.
• Water solubility (µg/mm³): Compared, results demonstrate substantial equivalence.
• Shade Color stability after irradiation and water sorption: Compared, results demonstrate substantial equivalence. |
  | | | - Radio-opacity (mm): Compared, results demonstrate substantial equivalence. |
  | Biocompatibility | Substantially equivalent to predicate device per ISO 7405, ISO 10993-1, -3, -5, -11 | Concluded to be substantially equivalent to the primary predicate device based on comparative test report. |
  | Technological | Equivalent to predicate device | - Intended Use: Equivalent
• Method of Polymerization: Equivalent (Light Cured)
• Chemical composition: Equivalent (Glass filled Methmethacrylate monomer resins, Nanoparticle) |
  | | | - Mechanical/physical properties: Equivalent (Low viscosity, Flowable)
• Application process and use: Similar
• Camphorquinone / amine photoinitiator system: Equivalent |
  | | | - Methacrylate-based resin matrix: Equivalent
• Silane treated fillers: Equivalent
• Bonded with permanent dental adhesive: Equivalent |

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

The document does not specify exact sample sizes for the "comparison testing" of physical properties. These would typically be determined by the specific ISO standards (e.g., ISO 4049) applied to dental materials, which involve a certain number of specimens for each test. The data provenance is from non-clinical performance testing conducted by the manufacturer (SINO-DENTEX CO., LTD., Changchun, China). The data is retrospective in the sense that it was generated for the purpose of the 510(k) submission, not as part of an ongoing prospective study.

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 to this type of device and submission. Dental composite materials do not typically involve expert review for "ground truth" in the same way an AI diagnostic image analysis device would. The "ground truth" for material properties is established through standardized laboratory testing (e.g., ISO 4049).

4. Adjudication method for the test set

This information is not applicable. There is no adjudication process involving multiple human readers for validating the performance of a dental material.

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

An MRMC study was not done. This type of study is relevant for AI-powered diagnostic devices involving human interpretation, not for dental composite materials.

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

This information is not applicable. The device is a dental material, not an algorithm.

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

The "ground truth" for the performance claims (physical properties, biocompatibility) is based on standardized laboratory testing methods (e.g., ISO 4049 for physical properties; ISO 7405, ISO 10993-1, -3, -5, -11 for biocompatibility). The performance of the new device is then compared against that of the predicate device and the requirements of these standards.

8. The sample size for the training set

This information is not applicable. The device is a physical material, not a machine learning algorithm that requires a training set.

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

This information is not applicable. As the device is a physical material, there is no training set or ground truth in the context of machine learning.

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Pulpdent Solo Flowable Composite with MCP is a fluoride, calcium and phosphate-releasing flowable composite used by dental professionals as a restorative, base and liner.

Pulpdent Solo Flowable Composite with MCP is a light-cured, radiopaque, glass-filled resin with MCP (modified calcium phosphate filler) that releases calcium and phosphate ions into the oral environment and which may be formulated to release fluoride ions. Solo Flowable Composite with MCP contains no Bisphenol A, no BisGMA and no BPA derivatives. It is available in tooth shades, has low solubility, low water sorption and high physical properties.

This document is a 510(k) summary for a dental product, Pulpdent Solo Flowable Composite with MCP. It primarily focuses on demonstrating substantial equivalence to predicate devices rather than providing a detailed study proving performance against acceptance criteria for a new AI/software device.

Therefore, the requested information (acceptance criteria, study details, sample sizes, expert qualifications, adjudication, MRMC, standalone performance, ground truth, training set size, etc.) is not available in the provided text as it pertains to a medical device's premarket notification, not an AI/software study.

The document describes the device, its intended use, and compares its physical and chemical properties to two predicate devices to demonstrate that it is substantially equivalent and safe for market introduction. There is no mention of an algorithm, AI, or software development.

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• Class III and V restorations o
• Restoration of minimally invasive cavity preparations (including small, non stress-bearing occlusal restorations)
• Base/liner under direct restorations .
• Repair of small defects in esthetic indirect restorations ●
• Pit and fissure sealant ●
• . Undercut blockout
• Repair of resin and acrylic temporary materials o

Nanova™ Flowable Dental Composite is a methacrylate based, low viscosity, visible-light activated, radiopaque, flowable composite. This device is available in syringe and ampule packaging. Nanova™ Flowable Dental Composite is available in a variety of tooth colored shades. Nanova™ Flowable Dental Composite contains methacrylate resins, photo-initiator, and inorganic filler material. Inorganic filler loading is approximately 60% by weight.

When irradiated by light, the methacrylate functionalities of the resins and surface-treated fillers undergo, in conjunction with the photo-initiator system, a light-induced polymerization to form a hard composite that is bonded to the tooth structure with a permanent dental adhesive.

Nanova™ Flowable Dental Composite formulation is based off of several FDA cleared commercially available flowable dental composites. The formulation was modified to improve physical properties, such as flexural strength, and handling properties. As a result of the reformulation, a biocompatibility assessment was developed for Nanova™ Flowable Dental Composite using standard risk assessment techniques and consideration of FDA & internationally recognized guidelines, including ISO 10993 Parts 3, 5, 6, 10 and 11.

The document describes the Nanova™ Flowable Dental Composite, a dental material. The acceptance criteria and supporting studies are detailed, primarily through comparison with a predicate device and non-clinical performance testing.

Here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for "Nanova™ Flowable Dental Composite" are largely established by demonstrating its substantial equivalence to a legally marketed predicate device (Filtek Supreme Ultra Flowable Restorative K100235) and by meeting established international and ADA standards for dental materials.

Specific quantitative values for performance (e.g., exact flexural strength in MPa) are not provided in this summary, but the document confirms that the device meets or exceeds the standards or predicate device performance for these properties.

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

The document does not specify the sample sizes used for the individual non-clinical performance tests (e.g., number of specimens for flexural strength, depth of cure). It lists the types of tests performed.

The data provenance is from non-clinical benchtop testing performed by Nanova Biomaterials, Inc. and potentially external labs for GLP studies, but specific country of origin for all data is not explicitly stated. The submission is from Nanova Biomaterials, Inc. in Columbia, Missouri, USA. The studies are retrospective as they were conducted to support the 510(k) submission.

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

This information is not applicable as the studies are entirely non-clinical (benchtop and biocompatibility). There is no "ground truth" derived from expert consensus on patient data. The ground truth for performance is the specified standards (e.g., ISO, ADA) and comparison to the predicate device. For biocompatibility, it's defined by the ISO 10993 series.

4. Adjudication Method for the Test Set

This is not applicable as there is no human interpretation or subjective assessment of the test results that would require adjudication in the context of clinical or image-based studies. The results are quantitative measurements against established standards.

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 is not applicable. The device is a dental restorative material, not an AI-powered diagnostic or assistive tool. No MRMC study was performed.

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

This is not applicable. The device is a physical dental material, not an algorithm.

7. The Type of Ground Truth Used

The ground truth used for evaluating the Nanova™ Flowable Dental Composite is primarily:

• Established industry standards: ISO 4049:2009 (E) for properties like flexural strength, depth of cure, water sorption/solubility; ADA specification 27 for compressive strength.
• Comparison to a legally marketed predicate device: Filtek Supreme Ultra Flowable Restorative (K100235) for various technical and performance characteristics.
• Biocompatibility standards: ISO 10993 Parts 3, 5, 6, 10 and 11.

There is no pathology, outcomes data, or expert consensus on clinical cases described in this summary for establishing ground truth.

8. The Sample Size for the Training Set

This is not applicable. The device is a physical material, not a machine learning model, therefore there is no "training set."

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

This is not applicable as there is no training set for this type of device.

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• Base under Class I and II direct restorations
• Liner under direct restorative materials
• Class III and V restorations
• Undercut Blockout
• Minimally invasive cavities (including small non stress-bearing occlusal restorations)
• Tunnel preparations
• Repair of small enamel defects
• Repair of small defects in esthetic indirect restorations
• Repair of resin and acrylic temporary materials

The new Bulk Fill Flowable Composite manufactured by Septodont Louisville is a low viscosity, radiopaque flowable composite which sets upon exposure to a high-intensity blue light source. After polymerization, it exhibits low stress on the bond with the tooth, and it has a high polymerization conversion. This high degree of polymerization is achieved with short curing times and creates improved physical and mechanical properties. The new Bulk Fill Flowable Composite is packaged in single dose capsules and syringes. The shades offered with Bulk Fill Flowable Composite are: A1, A2, A3, A3.5.

The provided text is a 510(k) summary for a dental device, "Bulk Fill Flowable Composite." This type of document is for regulatory clearance and focuses on demonstrating substantial equivalence to predicate devices based on indications for use, technological characteristics, and performance data from bench tests. It is not a study that proves the device meets specific acceptance criteria in the context of an AI/ML medical device.

Therefore, I cannot extract the requested information (acceptance criteria table, sample sizes for test/training sets, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth details) because this document does not describe such a study for an AI/ML device.

Instead, the document focuses on:

1. Bench testing: Physical tests conducted according to ISO 4049:2009 for properties like Depth of Cure, Conversion, Compressive Strength, Diametral Tensile Strength, Microhardness, Volume Shrinkage Stress, Water Absorption, and Solubility.
2. Biocompatibility testing: Following ISO 10993-1:2009 and ISO 7405:2008.
3. Comparison to predicate devices: Demonstrating similar indications for use and technological characteristics.

Here's a summary of what information is available related to performance and testing, but it does not fit the requested format for an AI/ML device study:

1. Table of Acceptance Criteria and Reported Device Performance: This document does not provide a table of acceptance criteria or specific numerical performance results for the listed physical tests. It only states that the device "was tested following" the ISO standards and that the data "evaluate the performance... in comparison with its predicates." The conclusion is that the device is "substantially equivalent" and "biocompatible and safe for its intended use."

2. Sample size used for the test set and the data provenance: Not applicable in the context of an AI/ML device test set. The document refers to "bench testing" of the "Bulk Fill Flowable Composite" itself. No specific sample sizes for these bench tests are mentioned, nor is data provenance in the sense of patient data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth as typically understood for AI/ML performance evaluation (e.g., expert labels on images) is not relevant to this bench testing.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: 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: Not applicable. This device is a dental material, not an AI/ML diagnostic or assistive tool.

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 the physical properties, the "ground truth" would be the standard scientific measurements themselves as defined by the ISO 4049:2009 standard. For biocompatibility, it would be the results against the criteria in ISO 10993-1:2009 and ISO 7405:2008.

8. The sample size for the training set: Not applicable. This device is not an AI/ML model that requires training data.

9. How the ground truth for the training set was established: Not applicable.

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UFill Bulk Fill Posterior Flowable Composite is indicated for use (i) in fillings with layer thicknesses up to 4mm in Class I and II cavities, (ii) in cavity lining- as a first (bottom layer) in Class I and II cavities.

UFill Bulk Fill Posterior Flowable Composite is a light cure radiopaque posterior composite for use in the Bulk-Fill Technique. The flowable viscous material is suitable for filling layers of up to 4mm in thickness and as a cavity lining (bottom layer) for both Class I and II restorations. Placed in a unit dose needle capsule containing 0.25g of material, the device is delivered by a standard dental unit-dose tip applicator dispenser gun, and offered in a universal dentin shade that is formulated and manufactured without Bis-GMA, HEMA, or TEG-DMA.

The provided document describes the "UFill Bulk Fill Posterior Flowable Composite" and its substantial equivalence to a predicate device. However, it does not contain information about acceptance criteria or a study that uses human experts to establish ground truth for a test set, nor does it discuss AI or machine learning. The device is a dental restorative material, and the performance testing mentioned is physical testing per ISO 4049-2009.

Therefore, I cannot provide the requested information. The document focuses on demonstrating substantial equivalence based on material composition, intended use, and physical properties, not on diagnostic performance or human-AI interaction.

The information present in the document is limited to:

• Device Description: A light-cure radiopaque posterior composite for bulk-fill technique.
• Predicate Device: 3M-Filtek Bulk Fill Flowable Restorative (K120453).
• Indications for Use: Fillings with layer thicknesses up to 4mm in Class I and II cavities, and as a cavity lining (bottom layer) in Class I and II cavities.
• Technological Characteristics: UDMA and BDDMA as resin components, silanized strontium aluminum boron silicate glass and silanized silica fillers (approx. 77% by weight), light-activated cure.
• Performance Testing: "Physical testing per ISO 4049-2009, Dentistry -- Polymer-based restorative materials was conducted with all criteria for success satisfied."
• Safety Testing: Evaluated per AAMI/ANSI/ISO 10993-1:2009.
• Risk Management: Evaluated per ISO 14971:2007.

The comparison table outlines characteristics like intended use, basic material composition, method of cure, delivery system, shade, depth of cure, and performance characteristics (radiopaque, flowable, compliant to ISO 4049).

None of these sections address AI, expert evaluations, ground truth establishment with human experts, MRMC studies, or standalone algorithm performance.

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OptiFlow II Flowable Composite, LC is intended for use as:

• Repair of minimally invasive cavity (including non-stress bearing areas)
• Pit and fissure sealant
• Class III-V restorations
• Repair of porcelain restorations
• Repair of ceramic/composite veneers

OptiFlow II Flowable Composite, LC is a light cure resin-based flowable restorative dental composites. The restorative is packaged in capsules and syringes. The fillers are a combination of radiopaque inorganic fillers and advanced nano-silicas with an average particle size of 0.7 microns to produce a loading approximately 57% by weight (40% by volume). All shades have a radiopacity of 200%.

The available text describes the 510(k) summary for OptiFlow II Flowable Composite, LC, a dental material. The submission focuses on demonstrating substantial equivalence to a predicate device through physical tests.

Here is the information structured according to your request, with a note where the information is not provided in the text:

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

The document states that the device was evaluated for Flexural Strength, Young's Modulus, Compressive Strength, Diametral Tensile Strength, and Rockwell Hardness and compared to the predicate device. However, the specific acceptance criteria (e.g., minimum values or range for each test) and the reported device performance (the actual numerical results for OptiFlow II and the predicate) are not included in this summary. It only states that the device is "substantially equivalent."

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

The document mentions "data from bench testing" but does not specify the sample size used for these tests. It also does not indicate the provenance (e.g., country of origin, retrospective or prospective) of this test data. Bench testing is typically conducted in a laboratory setting.

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

This document describes physical, bench-top testing of a dental material. It does not involve human interpretation or subjective assessment by experts for establishing ground truth in the way an AI diagnostic device would. Therefore, this question is not applicable to the provided context.

4. Adjudication method for the test set

Since this is bench testing of physical properties and not an expert-driven assessment, no adjudication method (like 2+1 or 3+1) was used.

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 done, as this submission is for a dental material and not an AI-assisted diagnostic device involving human readers.

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 dental material, not an algorithm.

7. The type of ground truth used

The "ground truth" in this context is the measured physical properties (Flexural Strength, Young's Modulus, Compressive Strength, Diametral Tensile Strength, and Rockwell Hardness) of the materials being tested. These are quantitative measurements derived from standardized laboratory tests.

8. The sample size for the training set

This is a physical material, not an AI model, so there is no training set in the typical sense. Physical properties are inherent to the material formulation and manufacturing process, not "trained" on data.

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

As there is no training set for a physical material, this question is not applicable.

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