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Rainbow 360 is a universal bonding agent intended to bond methacrylate-based restorative materials, cements and sealants to dentin, enamel, and various indirect restorative substrates. It can be used in a self-etch mode, selective etch mode or in a total-etch mode for both direct and indirect dental restorative procedures.

Direct Applications

• Light-cured, self-cured and dual-cured composite and compomer restorations.
• Composite/ceramic/metal repairs.
• Tooth preparation and root surface sealer.
• Cavity sealing for amalgam restorations.
• Light-cured or dual-cured core build-ups.
• Bonding of methacrylate-based fissure sealants.

Indirect Applications

• Cementation of veneers
• Cementation of porcelain, composite, and metal-based restorations
• Cementation of endodontic posts
• Cavity sealing as a pretreatment for indirect restorations.
• Prime metal, ceramic, and composite substrates/restorations.

The subject device, Rainbow 360, is a single-component universal dental adhesive intended for direct and indirect dental restorations. Rainbow 360 is formulated to provide reliable bond strengths with any etch technique, on all common substrates and in combination with any resin cements without auxiliary products (silane or metal primers) even in absence of light. Rainbow 360 is available in bottles for multiple uses and Unidose™ for single use. Rainbow 360 is intended for general population use by a dental professional.

The provided text describes the 510(k) summary for the "Rainbow 360" dental bonding agent. This document focuses on demonstrating substantial equivalence to a predicate device (ADH19 / 3M™ Scotchbond™ Universal Plus (K192961)) rather than proving the device meets specific acceptance criteria through a clinical study with human-in-the-loop performance, as might be done for an AI/ML-based diagnostic device.

Therefore, many of the requested criteria (e.g., expertise of ground truth adjudicators, MRMC study, training set details) are not applicable to this type of device submission, which relies on non-clinical performance and biocompatibility testing for substantial equivalence.

However, I can extract the relevant information regarding acceptance criteria and the non-clinical studies performed.

Here's a breakdown based on the provided text:

Key Takeaway: This 510(k) submission for a dental bonding agent relies on non-clinical performance data and biocompatibility testing to demonstrate substantial equivalence to a predicate device. It does not involve a study for an AI/ML-based device with acceptance criteria related to human-in-the-loop performance, ground truth establishment by experts, or MRMC studies.

1. Table of Acceptance Criteria and Reported Device Performance

The document states that "All test results met their acceptance criteria and support that the Rainbow 360 is appropriately designed for their intended use." However, it does not explicitly list the quantitative acceptance criteria for each test nor the specific reported performance values. It only states that the tests met the criteria.

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

• Sample Size: The document does not specify exact sample sizes for each non-clinical test (e.g., number of bond strength samples, number of biocompatibility specimens). It generally states that "Kerr conducted design verification performance testing".
• Data Provenance: Not explicitly stated regarding country of origin for test data, but it's a manufacturer's internal testing. The tests are purely non-clinical and conducted by the manufacturer, not clinical data from patients. The data would be prospective in the sense that the tests were specifically conducted for this submission.

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

• Not Applicable. This is a dental bonding agent validated through physical and chemical performance tests, not through expert-reviewed clinical imaging or diagnostic data requiring human ground truth.

4. Adjudication Method for the Test Set

• Not Applicable. There is no "ground truth" established by experts or adjudication needed for the non-clinical tests described. The tests are objective measurements (e.g., bond strength in megapascals, chemical composition analysis, biological interaction assessments).

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

• No. An MRMC study is relevant for AI/ML diagnostic tools where human readers interpret medical images. This device is a dental material, and its performance is assessed via non-clinical laboratory testing.

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

• Not Applicable. This is not an AI/ML algorithm. Its "performance" is its physical and chemical properties and biological safety.

7. The type of ground truth used

• For Bond Strength: The "ground truth" is the empirically measured force required to break the bond, compared against industry standards (ISO 29022).
• For Biocompatibility: The "ground truth" is the established biological safety criteria in recognized standards (ISO 10993 series, ISO 7405), and the results are evaluated against these criteria.
• For Shipping Performance: The "ground truth" is the ability to withstand simulated shipping conditions as defined by the standard (ASTM D4169).
• For Shelf-life: The "ground truth" is the maintenance of performance characteristics over time.

8. The sample size for the training set

• Not Applicable. This is a physical product, not an AI/ML model that requires a training set.

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

• Not Applicable. As above, no training set for an AI/ML model is involved.

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The SimpliShade Bulk Fill is indicated for:

• Direct placement of anterior and posterior restorations.
• Core build-ups.
• Repair of defects in restorations.

The SimpliShade Bulk Fill Flow is indicated for:

• Base/liner under Class I and Class II direct restorations.
• Pit and fissure sealant.
• Restoration of small cavities.
• Class III and V restorations.
• Blocking out undercuts.
• Small core build-ups.
• Repair of resin and acrylic provisional restorations.

SimpliShade™ Bulk Fill Composite is offered in two types of viscosities: the high viscosity formula will be branded as SimpliShade™ Bulk Fill; the low viscosity formula will be branded as SimpliShade™ Bulk Fill Flow.

SimpliShade Bulk Fill is an intra-oral, light-cured, esthetic, resin-based nanohybrid dental restorative that is designed for the placement of direct restorations. SimpliShade Bulk Fill is designed to be used after placement of a dental adhesive, such as a product from the Kerr OptiBond™ family. SimpliShade Bulk Fill is available in Unidose™ compules and syringe delivery systems that are suitable for occlusal surfaces. The product offers allows a technique in which a cavity up to 5 mm in depth can be filled and cured in a single increment. SimpliShade Bulk Fill is offered in one universal shade to optically blend with a range of VITA™ shade guide equivalents. This composite can be polished with a wide variety of polishing discs, rubber cups, and brushes.

SimpliShade Bulk Fill Flow is an intra-oral, light-cured, esthetic, resin-based nanohybrid dental restorative that is designed to be used as a base or liner in Class I and II restorations and must be overlayed with a composite resin to replace the occlusal surfaces. It is also suitable to be used on nonocclusal-contact surfaces, such as pit and fissures, core build-ups and Class III and V restorations. SimpliShade Bulk Fill Flow is available in Unidose™ compules and syringe delivery systems. The product allows a technique in which a cavity up to 4 mm in depth can be filled and cured in a single increment. SimpliShade Bulk Fill Flow is offered in one universal shade to optically blend with a range of VITAM shade guide equivalents. Once light cured, the composite can be finished and polished using conventional finishing and polishing instruments.

The provided text is a 510(k) Summary for dental resin materials. It describes the acceptance criteria and study proving the device meets these criteria, but it focuses on non-clinical performance and does not include information about clinical studies with human participants or AI-assisted performance analysis. Therefore, I cannot generate information related to multi-reader multi-case studies, effect size of AI assistance, or standalone algorithm performance, as these are not present in the document.

Here's a breakdown of the available information:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are primarily defined by adherence to international standards and internal benchmarks. The reported device performance indicates that the subject devices (SimpliShade™ Bulk Fill and SimpliShade™ Bulk Fill Flow) met these criteria.

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

The document does not specify the exact sample sizes (number of specimens tested) for each non-clinical test. It states that "Performance bench tests according to ISO 4049...have been conducted" and "Additional tests...have been performed." The data provenance is non-clinical laboratory testing, conducted by the manufacturer, Kerr Corporation, to demonstrate substantial equivalence to legally marketed predicate devices.

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

Not applicable. This is a non-clinical study involving material properties, not diagnostic interpretation by human experts.

4. Adjudication method for the test set

Not applicable. Ground truth for material properties is established through standardized testing procedures, not by human adjudication of observations.

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. This document describes the non-clinical performance of dental restorative materials. It does not involve AI, human readers, or clinical effectiveness studies in this context. The section "Clinical Performance Data" explicitly states: "Clinical data is not needed to characterize performance and establish substantial equivalence. The nonclinical test data characterize all performance aspects of the device based on well-established scientific and engineering principles. Clinical testing has not been conducted on the subject devices."

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

No. This document does not describe AI algorithm performance.

7. The type of ground truth used

The ground truth is established through physical and chemical property measurements according to established international standards (e.g., ISO 4049, ISO 10993 series) and internal company standards. This involves objective measurements rather than expert consensus, pathology, or outcomes data in a clinical sense.

8. The sample size for the training set

Not applicable. There is no mention of a training set as this is a non-clinical evaluation of material properties, not a machine learning model.

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

Not applicable. As there is no training set for a machine learning model, there is no ground truth established in that context.

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Nexus Universal Self-Cure is a bonded resin cementation of indirect restoration of indirect restorations including veneers, inlays, onlays, crowns, bridges, posts, and the cementations to implant abutments. Nexus Universal Self-Cure can be used for the cementation of ceramic, porcelain, resin, metal-based, zirconia, and CAD/CAM block materials. Nexus Universal Self-Cure can also be used for the adhesive bonding of amalgam restorations and as a core build-up material.

Nexus Universal Self-Cure, manufactured by Kerr Corporation, is a two-component, auto-mixing, dual-cure bonded resin cement consisting of catalyst and base paste at a 4:1 ratio, packaged into a syringe extruded out with an automix tip prior to use. The cement is designed to simplify cementation of restorative substrate such that product can be used with adhesive/bonding agents without the need to light-cure the adhesive/bonding agent on the tooth structure and to eliminate the need for primer treatment on the substrate prior to cement applications. Nexus Universal Self-Cure will be available in various shades.

The provided document is a 510(k) summary for a dental cement (Nexus Universal Self-Cure), which is a device used for restorative dentistry. The document focuses on demonstrating substantial equivalence to a predicate device (Suglue-10) through technological characteristics, performance testing, and biocompatibility.

It does not describe a study involving an AI/Medical Device that processes images or requires human expert adjudication for ground truth, Multi-Reader Multi-Case (MRMC) studies, or the performance of an algorithm. The context of the original request seems to be geared towards diagnostic or assistive AI devices, whereas this document pertains to a physical dental material.

Therefore, many of the requested items (e.g., sample size for test set, data provenance, number of experts, adjudication method, MRMC study, standalone performance, ground truth for training set, training set sample size, how ground truth was established) are not applicable to this type of medical device submission.

However, I can extract the relevant information regarding acceptance criteria and performance as presented for this dental material.

Acceptance Criteria and Device Performance (Dental Cement - Nexus Universal Self-Cure)

The acceptance criteria here are established by comparing the performance of the proposed device (Nexus Universal Self-Cure) to a legally marketed predicate device (Suglue-10) and relevant ISO standards. Substantial equivalence is demonstrated by showing that the new device performs "similar to" or "at least as good as" the predicate, or meets established standard thresholds.

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't explicitly state "acceptance criteria" values independently but presents a comparative table (Table 5.1) where the predicate's performance serves as a de facto benchmark for the subject device to achieve substantial equivalence. The "Subject" values are the reported device performance. ISO standards provide the basis for the criteria.

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

• Sample Size: The document does not specify the exact sample sizes (number of tests/specimens) used for each performance test (e.g., film thickness, flexural strength, shear bond strength). It refers to "various tests" and "the data analyzed from the various tests."
• Data Provenance: The tests are non-clinical performance tests conducted by the manufacturer, Kerr Corporation, in a laboratory setting. The country of origin of the data is not explicitly stated but is implied to be within the US, given the submission to the FDA. The tests are retrospective in the sense that they were completed prior to the 510(k) submission. They are laboratory bench tests, not clinical retrospective/prospective studies on patients.

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

• Not Applicable. This is a physical dental material, and the "ground truth" is established through standardized laboratory testing (bench testing) against ISO standards and comparison to a predicate device, not through human expert interpretation of images or clinical outcomes that require expert consensus or adjudication.

4. Adjudication Method for the Test Set:

• Not Applicable. See point 3. Testing involves objective measurements of material properties, not subjective interpretations requiring adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and the effect size of how much human readers improve with AI vs without AI assistance:

• Not Applicable. This is not an AI-assisted diagnostic or imaging device. No human-in-the-loop study was performed.

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

• Not Applicable. This is a physical dental cement; there is no algorithm. The "standalone" performance refers to the intrinsic material properties measured in lab tests.

7. The Type of Ground Truth Used:

• Bench Test Results / ISO Standards / Predicate Device Performance: The "ground truth" for the performance evaluation is derived from the results of standardized non-clinical (bench) tests according to ISO standards (e.g., ISO 1641, ISO 1041, ISO 7405, ISO 29022, ISO 14971, ISO/TS 16506, ISO 10993-1, ISO 11405). The measured properties of the new device are directly compared to the established properties of the predicate device and the thresholds set by these international standards.

8. The Sample Size for the Training Set:

• Not Applicable. This device is a physical product, not an AI model that requires a training set.

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

• Not Applicable. This device is a physical product, not an AI model that requires a training set or corresponding ground truth for training.

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Direct Bonding Applications

• Light-cured composite and compomer restorations. .
• . Composite/ceramic/metal repairs.
• o Cavity sealing for amalgam restorations.
• Sealing of hypersensitive and/or exposed root surfaces. .
• . Core build-ups (self-cured, light-cured, or dual-cured).

Indirect Bonding Applications

• Veneers. .
• . Self-cure, dual-cure, light-cure resin cements and core buildup materials.
• Porcelain, ceramic (including zirconia-based, lithium disilicate-based and . alumina-based), composite, and metal-based (including precious and non-precious metal inlays, onlays, crowns, bridges.
• . Endodontic posts.
• Cavity sealing as a pretreatment for indirect restorations. .

OptiBond eXTRa Universal is a two-component universal adhesive system including a PRIMER and an ADHESIVE. The OptiBond eXTRa Universal PRIMER provides effective etching to enamel and dentin without the need for a separate phosphoric acid etch, thus simplifying the bonding procedure (self-etch technique). OptiBond eXTRa Universal is compatible with total etch and selective etch techniques. The OptiBond eXTRa Universal ADHESIVE is 15% filled with 0.4 micron barium glass to help reinforce bond strength.

The provided document describes the FDA 510(k) premarket notification for the device "OptiBond eXTRa Universal". This document focuses on demonstrating substantial equivalence to a predicate device, rather than providing detailed acceptance criteria and a study design to meet those criteria as would be typical for an AI/ML device.

However, based on the non-clinical performance data and the comparison table, we can infer the acceptance criteria and the "study" (bench testing) that proves the device meets (or is substantially equivalent to) those criteria.

Here's the breakdown:

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

Since this is a substantial equivalence submission for a dental bonding agent and not an AI/ML device, the "acceptance criteria" are implied by demonstrating performance similar to the predicate device. The primary performance metric mentioned is shear bond strength to various substrates, which would have implicit targets aligned with the predicate's known performance.

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

The document does not specify the exact sample size for the shear bond strength testing. It states: "Bench testing was conducted on a variety of self-cure or dual-cure resin cements and core-build up materials." and "OptiBond eXTRa Universal has been tested for its shear bond strength against a variety of materials (including enamel, dentin, and common substrates) in all etching modes."

• Sample Size: Not explicitly stated. The phrase "a variety of" implies multiple samples per test condition.
• Data Provenance: The testing appears to be retrospective (conducted by the manufacturer, Kerr Corporation, likely in a lab environment). The country of origin for the data is not specified, but the manufacturer is based in Orange, California, USA.

The document also mentions these relevant standards for testing:

• ISO 10993-1: 2009 Biological Evaluation of Medical Devices
• ISO 10993-3:2003 Biological Evaluation of Medical Devices- Part 3: Tests for Genotoxicity, Carcinogenicity, and Reproductive Toxicity
• ISO 10993-5:2009 Biological Evaluation of Medical Devices- Part 5: Tests for in Vitro Cytotoxicity
• ISO 10993-6:2007 Biological Evaluation of Medical Devices- Part 6: Tests for Local Effects after Implantation
• ISO 10993-10:2010 Biological Evaluation of Medical Devices- Part 10: Tests for Irritation and Skin Sensitization
• ISO 14971:2007 Risk Management
• ISO 29022:2013* Dentistry Adhesive-Notched Edge Sheer Bond Strength Test - Testing of Adhesion to Tooth Structure

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 as the device is a dental bonding agent, not an AI/ML device requiring expert ground truth for image interpretation or diagnosis. The "ground truth" for its performance is derived from standardized physical and chemical tests (e.g., measuring bond strength, cytotoxicity).

4. Adjudication method for the test set

This is not applicable as there is no expert adjudication process for this type of device and its performance testing. Performance is measured objectively through lab tests.

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. This is not an AI/ML device, and no MRMC study was conducted. There is no human-in-the-loop performance with this product.

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

This is not applicable. This is not an AI/ML device.

7. The type of ground truth used

The "ground truth" for this device's performance is established through objective laboratory measurements based on international standards for dental materials and biocompatibility:

• Shear bond strength values: Measured using standardized methods (e.g., ISO 29022).
• Biocompatibility test results: Measured as per ISO 10993 standards (e.g., cytotoxicity, genotoxicity, irritation).
• Chemical composition compatibility: Verified through material science and chemical analysis.

8. The sample size for the training set

This is not applicable. This is a physical medical device (dental bonding agent), not an AI/ML algorithm that requires a 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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Aluminum Chloride impregnated retraction material are for the temporary retraction of the gingival margins and hemostasis procedures. The Retraction Cord is place the gingival tissues for a short period prior to making an impression or for other restorative procedures.

As part of a tissue management procedure, Styptin, Hemogin-L, Hemodettes, and GingiGEL are aluminum chloride containing astringent/ hemostatic solutions and gels that are intended to be supplied with gingival retraction cord or cotton pellets that are either pre-impregnated or for end-user impregnation by soaking the cords or cotton pellets in these solutions. The aluminum chloride impregnated retraction material is then packed into the sulcus to temporarily displace gingival tissue to expose the sub-gingival margins and control sulcular seepage and hemorrhage for impression taking and other restorative treatments. The supplied retraction material is available as an aqueous aluminum chloride solution or gel and either unit-dose 2"-pieces of braided cotton cord, braided cotton-polyester cord, or unit-dose cotton pellets.

The provided document is a 510(k) Pre-market Notification from the FDA for dental retraction materials (Styptin, Hemogin-L, Hemodettes, and GingiGEL Aluminum Chloride Impregnated Retraction Cord/Materials). This type of document is focused on demonstrating substantial equivalence to existing legally marketed devices, rather than establishing acceptance criteria and conducting studies to prove performance against those criteria in the way one might for a novel device or software.

Therefore, much of the requested information regarding detailed acceptance criteria and a specific study proving the device meets those criteria (especially clinical performance, AI/ML specific details like sample sizes for training/test sets, expert adjudication, or MRMC studies) is not applicable or not present in an FDA 510(k) summary for this type of device.

Here's a breakdown of what information can be extracted or inferred from the document based on your request:

1. Table of Acceptance Criteria and Reported Device Performance

Formal acceptance criteria, as in numerical thresholds for accuracy, sensitivity, or specificity commonly seen for diagnostics, are not presented for this device. Instead, the "acceptance criteria" are implied through demonstration of substantial equivalence to predicate devices, focusing on shared intended use, indications for use, fundamental technological characteristics, and safety profiles. Performance is primarily assessed through non-clinical testing and comparison of characteristics.

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The Demi Ultra is a Light Emitting Diode (LED) visible light curing device used for the polymerization of light-cured materials by dental professionals.

The Demi Ultra is a Light Emitting Diode (LED) visible light curing device used for the polymerization of light-cured materials by dental professionals. The Demi Ultra consists of a handpiece, LED light curing attachment, and charging dock. The aluminum and plastic molded handpiece contains two (2) ultracapacitors (electric double-layer capacitors), printed circuit boards containing the electronics and user interface buttons, receptacle for retaining the LED light curing attachment, and receptacle for interfacing with the charging dock. The LED light curing attachment contains the curing LED, clear lens and two (2) copper head spreaders, all over molded in plastic. The charging dock contains printed circuit boards containing electronics to support charging the handpiece and built-in LED radiometer functionality. For the handpiece, a digital circuit and microprocessor is utilized to control three (3) different curing modes (5, 10 and 20 seconds). Each mode specifies LED curing output and optional audible beep timing. The handpiece uses one button to activate the LED curing output and another to select the curing time mode. For the charging dock, a digital circuit and microprocessor is utilized to monitor the charging of the handpiece ultracapacitors, as well as respond to light at the radiometer input by illuminating lights on a radiometer meter. Demi Ultra is required to be used with an FDA cleared barrier sleeve.

The provided text describes a 510(k) premarket notification for a dental light-curing device called Demi Ultra. The submission asserts substantial equivalence to a previously cleared predicate device, the Demi Ultra (K123468).

Here's an analysis of the acceptance criteria and the study information based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state "acceptance criteria" in a quantitative format for specific performance metrics that the device needs to meet. Instead, it lists performance tests that were conducted and compares the technological characteristics of the proposed device to a predicate device. The core argument for acceptance is substantial equivalence to the predicate device.

The document explicitly states: "The nonclinical performance testing demonstrates that the Demi Ultra performs as well as the predicate device Demi Ultra." This implies that the acceptance criteria for these tests were to demonstrate comparable performance to the predicate and compliance with relevant standards.

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

The document does not provide details on specific sample sizes for the performance tests (e.g., number of cure samples for depth of cure, number of units for charge/run time). The data provenance is not explicitly stated beyond the fact that the tests were performed by Sybron Dental Specialties as part of their product lifecycle and design validation. It is implied to be prospective testing for the proposed device.

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

This information is not provided. The performance tests (e.g., depth of cure, irradiance) are objective measurements based on standards, not expert interpretation of data points.

4. Adjudication Method for the Test Set

This information is not provided. Given that the tests are objective physical measurements, a traditional adjudication method for subjective assessments would not be applicable.

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

No, an MRMC comparative effectiveness study was not done. This type of study typically assesses the impact of a device (often AI-driven) on human reader performance, which is not applicable to a dental light-curing device.

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. The Demi Ultra is a physical medical device, not an AI/software algorithm, so this type of study is irrelevant.

7. The Type of Ground Truth Used

For the performance tests, the "ground truth" would be the physical measurements obtained from testing the device against established international and national standards (ISO 10650:2015, ANSI/ADA 48-2:2010, ISO 10993, IEC 60601). For instance, the "ground truth" for depth of cure would be the actual measured depth under standardized conditions.

8. The Sample Size for the Training Set

This information is not applicable. The Demi Ultra is a hardware device, not an AI/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 there is no training set for this type of device.

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GingiKnit+, GingiBraid+, GingiBraid+ Shortcut, and UniBraid+ impregnated Aluminum Potassium Sulfate Retraction Cord are for the temporary retraction of the gingival margins and hemostasis procedures. The Retraction Cord is placed in the sulcus to displace the gingival tissues for a short period prior to making an impression or for other restorative procedures.

Dental retraction materials are used to aid in creating accurate impressions of subgingival margins by temporary gingival displacement, and control of sulcular seepage and hemorrhage. Cords are impregnated with Aluminum Potassium Sulfate. The braided GingiBraid+ and the knitted GingiKnit+ are made of cotton fiber with a different color strand running through the cord for identification of the diameter. Retraction Cords have a yellow background color for medicament identification. The usage is inherently of transient nature. Typical exposure time is less than five minutes. The braided and knitted cord configurations are available in different sizes to fit the sulcus.

This document describes Kerr Corporation's dental retraction cords (GingiKnit+, Gingibraid+, Gingibraid+ Shortcut, and Unibraid+ impregnated Aluminum Potassium Sulfate Retraction Cord) and their substantial equivalence to a predicate device.

Here's an analysis of the acceptance criteria and supporting studies, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not describe a clinical test set in the traditional sense for evaluating the device's performance against specific acceptance criteria for diagnostic accuracy or detection. This is a 510(k) submission focused on substantial equivalence to a predicate device.

• Test Set for Non-Clinical Performance Data: The sample sizes for the Stability, Cutting Test, Water Contact Test, and Biocompatibility testing are not specified in the provided text.
• Data Provenance: Not explicitly stated for the non-clinical tests. However, the standards used (ISO 10993-1: 2009 and ISO 10993-5:2009) are international standards. This type of testing is generally performed in laboratory settings.

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

This information is not applicable as the document describes non-clinical performance and substantial equivalence, not a study evaluating human interpretation or a diagnostic device where ground truth would be established by experts.

4. Adjudication Method for the Test Set

This information is not applicable for the reasons stated above.

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. This device is a dental retraction cord, not an AI software or diagnostic imaging device. No MRMC study was conducted or is relevant to this submission.

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

This information is not applicable. This is a physical medical device, not an algorithm.

7. The Type of Ground Truth Used

For the non-clinical tests mentioned:

• Biocompatibility: The ground truth is established by the specified ISO standards (ISO 10993-1 and ISO 10993-5), which define acceptable biological responses and methodology.
• Other Non-Clinical Tests (Stability, Cutting, Water Contact): The "ground truth" or acceptance criteria for these tests would likely be internal specifications derived from the predicate device's performance or industry standards, ensuring the device functions as intended and safely. Specific criteria are not detailed in the provided text.

8. The Sample Size for the Training Set

This information is not applicable. This is a physical medical device, not a machine learning model, so there is no "training set."

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

This information is not applicable for the reasons stated above.

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GingiKnit+, GingiBraid+, and Shortcut with GingiBraid+ Non-Impregnated Retraction Cord are for the temporary retraction of the gingival margin. The Retraction Cord is placed in the sulcus to displace gum tissue for a small period of time in dental procedures.

GingiKnit+, GingiBraid+, and GingiBraid+ ShortCut Non-Impregnated Retraction Cord are dental retraction materials used to aid accurate impressions of sub-gingival margins by temporary gingival displacement, control sulcular seepage and control hemorrhage. Non-impregnated retraction materials are to be used in combination with an astringent/hemostatic solution of choice. The usage is inherently of transient nature. Typical exposure time is less than five minutes. The non-impregnated retraction materials consists only of braided or knitted cotton yarn soaked with an aqueous surfactant solution and then dried to facilitate absorption of medicament containing retraction solution of dentist's choice into the cotton cord. The braided and knitted cord configurations are available in different sizes to fit the sulcus.

This document describes the premarket notification (510(k)) for GingiKnit+, GingiBraid+, and Shortcut with GingiBraid+ Non-Impregnated Retraction Cord. It does not contain information about the acceptance criteria or a study proving the device meets those criteria in the context of device performance metrics like sensitivity, specificity, or accuracy.

The document focuses on demonstrating substantial equivalence to a predicate device (Quicknit Cord, K131799) based on shared technological characteristics, intended use, and indications for use, rather than presenting a performance study against specific acceptance criteria for a new clinical claim or diagnostic capability.

Therefore, many of the requested elements for a study demonstrating acceptance criteria cannot be extracted from this document, as it is a 510(k) submission for a medical device regulatory clearance, not a clinical performance study with acceptance criteria.

However, I can extract information related to the non-clinical performance data provided, which serves as evidence for safety and substantial equivalence.

Here's a breakdown of what can be extracted:

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not provide a table of acceptance criteria with corresponding performance metrics for a clinical study in the typical sense (e.g., sensitivity, specificity, accuracy). Instead, it presents non-clinical performance data and states that Biocompatibility meets requirements of ISO 10993.

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

• Test Set Sample Size: Not applicable. No clinical test set is described as this is a non-clinical evaluation for substantial equivalence.
• Data Provenance: Not applicable for a clinical test set. The non-clinical tests (Cutting Test, Water Contact Test, Biocompatibility) would have been conducted in a laboratory setting, likely by the manufacturer or a contract research organization.

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

• Not applicable. No clinical test set with ground truth established by experts is described.

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

• Not applicable. No clinical test set is 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, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This device is a dental retraction cord, not an AI-powered diagnostic device.

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

• Not applicable. This is not an AI algorithm.

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

• Not applicable for a clinical ground truth. For the non-clinical tests, the "ground truth" would be the specifications and requirements defined by the referenced ISO standards.

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. This is not a machine learning or AI device.

Summary of what the document does provide regarding "proof" of meeting criteria:

The document asserts that the device meets safety and effectiveness requirements by demonstrating substantial equivalence to a legally marketed predicate device (Quicknit Cord, K131799). This demonstration relies on:

• Non-clinical performance data: "Cutting Test, Water Contact Test and Biocompatibility testing" were performed.
• Compliance with standards: The non-clinical performance testing utilized ISO 10993-1:2009 (Biological evaluation of medical devices) and ISO 10993-5:2009 (Tests for in Vitro Cytotoxicity). The document explicitly states that the "Biocompatibility meets requirements of ISO 10993".
• Comparison to Predicate: A comparison table (Table 8.1) highlights the similarities between the proposed device and the predicate in terms of intended use, indications for use, material composition (both primarily cotton, non-impregnated), product code, classification, and material compatibility. The key differences noted (e.g., configurations, presence of a surfactant in the proposed device) are argued to "not raise new questions of safety and effectiveness."
• No Clinical Performance Data: The document explicitly states, "Clinical performance testing has not been performed for GingiKnit+, GingiBraid+, and GingiBraid+ ShortCut Non-Impregnated Retraction Cord." This is common for 510(k) submissions where substantial equivalence can be established through non-clinical data.

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The EndoVac™ Pure System is intended for the delivery and evacuation of endodontic irrigation solutions and removing debris of injured or necrotic pulp tissue during root canal procedures.

The EndoVac Pure™ system builds on the EndoVac System and presents a unique way to irrigate during root canal treatments. The system is an apical negative pressure system that draws fluid apically by way of evacuation, reducing the risk of apical irrigant extrusion during root canal procedures. The vacuum is routed through the system and controlled independently through the dental chair vacuum system. The fluid delivery is controlled by peristaltic pumps. The pumps are driven by Printed Circuit Board Assemblies (PCBA) and controlled by Field Programmable Gate Array (FPGA) configuration files.

Here's an analysis of the provided text regarding the acceptance criteria and study information for the EndoVac Pure device:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of "acceptance criteria" with direct performance metrics alongside the reported performance of the EndoVac Pure. Instead, it details various "performance tests were conducted as part of design verification" and then provides a comparison table (Table 7.1) outlining technological characteristics between the proposed EndoVac Pure and its predicate device. This comparison implicitly serves as evidence of meeting performance requirements by demonstrating similarity to a legally marketed device.

Therefore, the table below is constructed by interpreting the "Technological Characteristics Non-Clinical Performance Data" section and the "Predicate and Proposed Device Comparison Table" (Table 7.1) as the reported performance, and the fact that these tests were conducted as "design verification" implies they met established internal acceptance criteria for substantial equivalence to the predicate.

Study Proving Device Meets Acceptance Criteria

The study primarily relies on non-clinical performance testing and a comparison to a legally marketed predicate device (EndoVac® Apical Negative Pressure Irrigation System K140685) to demonstrate substantial equivalence. The document explicitly states: "The EndoVac Pure™ and the predicate EndoVac System (K140685) perform the same function, which is a method to deliver irrigant, rinse and evacuate during root canal procedures. The following performance tests were conducted as part of design verification:" followed by a list of tests.

The conclusion further reinforces this: "The proposed EndoVac Pure™ is substantially equivalent to the predicate Endo Vac System (K140685) based on design, performance, biocompatibility testing, and the intended use."

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

The document does not explicitly state specific sample sizes for each non-clinical performance test. It lists the types of tests conducted (e.g., Flow Rate Delivery, Suction Flow Rate, Biocompatibility, Sterilization, etc.) but not the number of units or datasets used for each.

The data provenance is from non-clinical performance testing, presumably conducted internally by Sybron Dental Specialties. There is no information provided about country of origin of data (apart from the manufacturer being in Orange, CA). The studies are inherently prospective with respect to the device's design verification.

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

This information is not applicable as the evaluation is based on non-clinical performance testing against engineering specifications and comparison to a predicate device. There is no mention of human experts establishing "ground truth" for the performance tests in the context of diagnostic accuracy or clinical outcomes.

4. Adjudication Method for the Test Set

This information is not applicable for non-clinical performance testing. Adjudication methods (like N+1 consensus) are typically used in clinical studies where expert reviewers evaluate cases and make subjective judgments, which is not the nature of the tests performed here.

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

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. The document explicitly states: "Clinical performance testing has not been performed for EndoVac Pure™" in section 8.

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

This question is not applicable as the device is a physical dental system, not an algorithm or AI software. There is no "standalone" algorithm performance to evaluate. The device's performance is inherently tied to its use by a human operator within a clinical procedure.

7. The Type of Ground Truth Used

The "ground truth" for the non-clinical performance tests was established by engineering specifications, accepted industry standards (e.g., ISO, IEC), and the performance characteristics of the legally marketed predicate device. For instance, flow rates were expected to fall within a specified range, and biocompatibility tests were conducted according to ISO standards.

8. The Sample Size for the Training Set

This information is not applicable. The EndoVac Pure is a physical medical device, not an AI or machine learning model that requires a training set.

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

This information is not applicable for the same reason as point 8.

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P1145, a nanohybrid dental restorative, is indicated for direct placement in all cavity classes in anterior and posterior teeth. Additional indications include: repair of enamel defects, repair of provisionals, repair of porcelain restorations, minor occlusal build-ups, core build-ups and incisal abrasions.

P1145 is a light-cured, esthetic, resin-based nanohybrid dental restorative designed for direct placement in both anterior and posterior restorations. It is designed to be used after placement of a dental adhesive. Once placed, the composite can be easily sculpted to the desired shape, and after curing, can easily be finished and polished to achieve a highly esthetic restoration.

The provided text is a 510(k) premarket notification for a dental restorative device (P1145 Dental Restorative). It describes the device, its intended use, and argues for its substantial equivalence to a predicate device (Herculite Ultra).

However, the document does not describe acceptance criteria for an AI/algorithm-based device, nor does it detail a study proving such a device meets acceptance criteria.

The "Non-Clinical Performance Data" section refers to tests for a conventional dental material (mechanical strength, polishability, water sorption, etc.) against established standards like ISO 4049:2009. These are physical and chemical property tests for the restorative material itself, not performance metrics for an AI or algorithm.

Therefore, I cannot extract the information required for the prompt as it pertains to an AI/algorithm-based device and its performance study. The document is about a physical dental material, not a digital diagnostic or prognostic tool.

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