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• · Impression of inlay, onlay, crown, bridge, and veneer preparations
• · Functional impressions

The polyether impression material Permadyne consists of the two material components lightbodied consistency and heavy-bodied consistency. It's classified as impression materials (21 CFR 872.3660) because it's intended to reproduce the structure of a patient's teeth and qums. Permadyne is a hand mixed (base paste/catalyst paste) impression material used in one step technique. Thereby Permadyne – Light Bodied Consistency is used as wash material in combination with Permadyne – Heavy Bodied Consistency as tray material. The mixing ratio is 7 volumes base paste :1 volume catalyst paste.

Permadyne – Light Bodied Consistency is a light-bodied polyether impression material. The base paste is blueish colored and the catalyst paste reddish colored.

Permadyne - Heavy Bodied Consistency is a heavy-bodied polyether impression material. The base paste is salmon colored and the catalyst paste reddish colored.

The provided text describes a 510(k) summary for a medical device (Permadyne impression material) and focuses on demonstrating substantial equivalence to a predicate device rather than detailing a study that meets specific acceptance criteria for a novel AI/ML device. Therefore, much of the requested information (e.g., sample sizes for test sets, number of experts for ground truth, adjudication methods, MRMC studies, standalone performance, training set details) is not applicable or cannot be extracted from this document.

However, I can extract information related to the performance testing conducted to show equivalence.

Acceptance Criteria and Reported Device Performance

The device, Permadyne (reformulated), was tested against the requirements of ISO 4823:2015 Dentistry — Elastomeric Impression Materials. The reported performance indicates that the reformulated Permadyne fulfills the requirements of ISO 4823 and is similar to the predicate device (Permadyne K800031) for various physical and mechanical properties.

Study Details

The document describes in vitro testing to demonstrate that the reformulated Permadyne meets the requirements of the FDA-recognized standard ISO 4823. Additionally, a comparison was made to the predicate device (Permadyne K800031) for various physical and mechanical properties.

1. Sample size used for the test set and the data provenance: Not specified in the document. The tests are in-vitro, meaning they are laboratory tests, not clinical data from patients. The manufacturer is 3M Deutschland GmbH, located in Germany, suggesting data provenance from Europe. The study is an in-vitro performance test, making it a "prospective" test in the sense that the new device was created and then tested.
2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. For material science tests against an ISO standard, the "ground truth" is established by the standard's methodology and acceptance criteria, not by expert consensus on individual cases. Biocompatibility was assessed by a "board-certified toxicologist."
3. Adjudication method for the test set: Not applicable for material performance tests against a standard.
4. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This device is an impression material, not an AI/ML-driven diagnostic or assistive device.
5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an algorithm.
6. The type of ground truth used: The ground truth for performance avaluation of the impression material is defined by the ISO 4823:2015 standard, which specifies acceptable physical and mechanical properties for elastomeric impression materials. For biocompatibility, the ground truth is established by recognized international standards (ISO 10993 series, ISO 7405) and assessment by a board-certified toxicologist.
7. The sample size for the training set: Not applicable. This is not an AI/ML device requiring a training set.
8. How the ground truth for the training set was established: Not applicable.

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Use of Suglue 3 in Adhesive Mode with ADH19
·Final cementation of all-ceramic or metal Maryland bridges and 3-unit inlay/onlay bridges
·Final cementation of all-ceramic or composite veneers and occlusal veneers (tabletops)

Use of Suglue 3 in Adhesive Mode with ADH19 or in Self-Adhesive Mode

·Final cementation of all-ceramic, composite, or metal inlays and onlays, crowns, and bridges

·Final cementation of posts made of ceramic, glass fiber-reinforced composite or metal, and screws

·Final cementation of all-ceramic, composite, or metal restorations on implant abutments

Suglue 3 is a dual-curing universal cement that is used for both adhesive and self-adhesive cementation of indirect restorations and posts, whereas RelyX Unicem 2 Automix is a selfadhesive cement and RelyX Ultimate is an adhesive cement. New redox initiator system provides improved bond strength to tooth structure, especially dentin. Changed characteristics allow easier excess removal. Increased radioopacity facilitates clinicians to see the Suglue 3 in radiographs as well as tooth like fluorescence for an esthetic appearance, especially in the anterior region. Suglue 3 is used in combination with ADH19 (dental adhesive, product of 3M Deutschland GmbH) for adhesive cementation. ADH19 adhesive is self-etching. Optionally, the adhesive strength can be enhanced further through additional etching of the tooth structure with Scotchbond Universal Etchant (product of 3M Deutschland GmbH). Standard cases as well as post cementations can be solved securely and efficiently when Suglue 3 is used in selfadhesive mode.

The provided FDA 510(k) document details the clearance of a dental cement, Suglue 3. It primarily focuses on demonstrating substantial equivalence to predicate devices through comparisons of indications for use, composition, technology, and various physical and mechanical properties.

Crucially, this document does not describe acceptance criteria, a study proving device performance against such criteria in the context of an AI/ML device, or any of the specific AI/ML related questions posed (e.g., sample size for test set, ground truth experts, MRMC studies, standalone performance, training set details).

The document is for a medical device (dental cement) and does not involve AI or machine learning. Therefore, the requested information regarding AI/ML device performance and study design elements cannot be extracted from this text.

The information from the document related to general device performance studies is as follows:

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

   • The document does not provide a table of explicit acceptance criteria with specific thresholds for each performance metric. It rather states that "The results of Suglue 3 are comparable to RelyX Unicem 2 Automix, and RelyX Ultimate."
   • Reported performance (in comparison to predicate devices):
     • Excess removal forces (comparable)
     • Pull-out bond strength to endodontic post (comparable)
     • Shear bond strength to tooth structure (dentin and enamel), glass ceramic (feldspathic and lithium disilicate ceramics), zirconia, metals (gold, remanium, and titanium), and composites (comparable)
     • Film thickness (comparable)
     • Working time (comparable)
     • Flexural strength (comparable)
     • Water sorption (comparable)
     • Solubility (comparable)
     • Shade (comparable)
     • Color stability (comparable)
     • Radioopacity (comparable)
     • Compressive strength (comparable)

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

   • Not applicable as this is a physical dental cement, not an AI/ML device using a test set of data. The document does not specify sample sizes for the in vitro tests conducted.
   • Data provenance is not mentioned beyond the tests being "in vitro."

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

   • Not applicable. The "ground truth" here would refer to the measured physical and mechanical properties of the cement, established through standardized laboratory testing, not by expert interpretation of data.

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

   • Not applicable. This concept applies to human expert review of clinical data, not to physical property testing of a dental cement.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

   • Not applicable. This is for an AI/ML device, which Suglue 3 is not.

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

   • Not applicable. This is for an AI/ML device, which Suglue 3 is not.

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

   • For the physical and mechanical properties of the dental cement, the "ground truth" is established through direct measurement and testing methods, some of which are based on ISO standards (e.g., ISO 4049:2009, ISO 9917-1:2008).

8. The sample size for the training set:

   • Not applicable. There is no AI/ML model to train for this device.

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

   • Not applicable. There is no AI/ML model to train for this device.

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Direct Indications:
· Bonding for all methacrylate-based light-, dual-, and self-cure composite or compomer filling materials
·Root surface desensitization
· Bonding of methacrylate-based fissure sealants
· Protective varnish for glass ionomer fillings
·Repair of composite and compomer fillings
· Sealing of cavities prior to placement of amalgam restorations

Indirect Indications:
· Cementation of indirect restoration with Suglue 3 and other resin cements (follow applicable Instructions for Use)
· Bonding for all methacrylate-based light-, self-, and dual-cure core build-up materials and cements
· Cementation of veneers when combined with RelyX Veneer Cement
· Intraoral repair of composite restorations, porcelain fused to metal, and all-ceramic restorations without extra primer
•Sealing of cavities and preparation of tooth stumps prior to temporary cementation of indirect restorations

ADH19 is a one-component dental adhesive that is based on the chemistry of Scotchbond Universal (by 3M Deutschland GmbH, K110302, cleared as ADHESIVE EXL-759). It can be used in a self-etch mode, selective enamel etch mode or in a total-etch mode for both direct and indirect dental restorative procedures. It is intended to bond methacrylate-based restorative, cement and sealant materials to dentin, enamel, glass ionomer and various indirect restorative substrates (metals, glass ceramics, alumina and zirconia). The primary use will be with lightcured materials, however it will have the capability to also bond self- or dual-cure composite and cement materials. In contrast to Scotchbond Universal, no separate Dual Cure Activator will be necessary in this case.

The provided text describes the 510(k) premarket notification for a dental adhesive named ADH19, comparing it to a predicate device, Scotchbond Universal.

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

1. Table of acceptance criteria and the reported device performance

The document does not explicitly state formal "acceptance criteria" with specific numerical thresholds for performance. Instead, it describes a "substantial equivalence" claim based on comparisons to a predicate device. The primary performance metric mentioned throughout is shear bond strength.

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

The document states that "In vitro testing was conducted to show the performance of ADH19 compared to the predicate device Scotchbond Universal regarding shear bond strength..." However, the sample size used for the test set is not specified. The data provenance is also not specified (e.g., country of origin, retrospective or prospective). It is an in vitro study, meaning it was conducted in a lab environment.

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 in the context of this submission. The "ground truth" for in vitro shear bond strength tests is the measured strength itself, not an expert assessment. For biocompatibility, a "board-certified toxicologist" assessed the product, but this isn't about establishing ground truth for individual test cases.

4. Adjudication method for the test set

This is not applicable as the study described is in vitro testing of physical properties, not a clinical study involving human assessment that would require adjudication.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

There is no mention of an MRMC comparative effectiveness study or any AI component in this device submission. This is a dental material, not an AI-powered diagnostic device.

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

This is not applicable as the device is a dental adhesive, not an algorithm.

7. The type of ground truth used

For the shear bond strength tests, the "ground truth" is the measured physical property (shear bond strength) obtained through standardized in vitro testing methods (e.g., ISO 29022: 2013).

For biocompatibility, the "ground truth" is established through assessment against recognized international standards (ISO 10993 series) and FDA guidance, with the conclusion made by a board-certified toxicologist.

8. The sample size for the training set

This is not applicable. The device is a dental adhesive, not an algorithm or AI model 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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· Impressions of inlay, onlay, veneer, crown, and bridge preparations

· Fixation and implant impressions

RAPID HB, MB and LB are especially suitable for taking impressions of single-unit and double-unit preparations.

Rapid HB, Rapid LB and Rapid MB are a group of polyether impression materials of heavy, light and medium consistency used by dental professionals individually or in combination. Rapid HB and Rapid MB are mixed in the Pentamix mixing device, while Rapid LB can be applied directly using the Garant dispenser.

Rapid HB is a heavy bodied hydrophilic impression material used in one step technique. Thereby Rapid HB is used in combination with the light consistency wash material Rapid LB. Rapid HB is reddish-violet colored.

Rapid LB is a light bodied hydrophilic impression material used in one step technique. Thereby Rapid LB is used in combination with the higher consistency tray material Rapid LB is apple green colored.

Rapid MB is a medium bodied hydrophilic impression material used in mono-phase technique (Rapid MB as syringing and as tray material) and in one step technique (Rapid LB as syringing and Rapid MB as tray material). Rapid MB is blueish-violet colored.

The provided document describes the 510(k) premarket notification for the dental impression materials Rapid HB, Rapid LB, and Rapid MB. It outlines the non-clinical testing conducted to demonstrate substantial equivalence to predicate devices, focusing on meeting ISO 4823 standards and comparative performance.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are primarily based on fulfilling the requirements of the FDA-recognized standard ISO 4823 and demonstrating similar performance to predicate devices. The document explicitly states: "In vitro testing was conducted to show that Rapid HB, Rapid LB and Rapid MB fulfils the requirements of FDA recognized standard ISO 4823." and "The results of Rapid LB and Rapid MB fulfill the requirements of ISO 4823 and are similar to Impregum Penta Soft Quick Step HB, Impregum Penta Soft Quick Step MB and Impregum Soft Quick Step LB."

The specific metrics tested and their performance relative to acceptance criteria are summarized below:

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

The document does not specify the exact sample sizes for the "in vitro testing" conducted for each physical and mechanical property. It only states that the testing was "in vitro." This implies the data provenance is from laboratory tests rather than human clinical data. The country of origin for the testing is not explicitly stated, but the submitter is "3M Deutschland GmbH" from Germany.

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. The study described is a non-clinical, in vitro performance study of dental impression materials against established standards and predicate devices, not a study involving human diagnostic interpretation or ground truth established by medical experts for a test set. The biocompatibility assessment was conducted by a "board-certified toxicologist."

4. Adjudication Method for the Test Set

This information is not applicable, as the study is a non-clinical performance and biocompatibility assessment, not a clinical study involving adjudication of human read data.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, an MRMC comparative effectiveness study was not done. The study focuses on the physical, mechanical, and biological properties of the impression material itself, not on the effectiveness of human readers using or interpreting data from the device.

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

This question is not applicable. The device is a dental impression material, not an AI algorithm or software. The performance assessment is inherently "standalone" in the sense that it evaluates the material properties directly.

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

For the non-clinical testing of physical and mechanical properties, the "ground truth" is defined by the requirements and methodologies outlined in the FDA recognized standard ISO 4823: Dentistry - Elastomeric Impression Materials, as well as the performance characteristics of the legally marketed predicate devices. For biocompatibility, the "ground truth" relies on the standards and guidance documents for biological evaluation of medical devices (ISO 10993 series and ISO 7405).

8. The Sample Size for the Training Set

This information is not applicable. There is no mention of a training set as this is a non-clinical performance study of a physical material, not a machine learning or AI model that requires training data.

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 and study.

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· Single crowns
· Bridges with a maximum of one pontic between two crowns
· Inlays, onlays, and veneers

XP202 zirconia blanks are used for the fabrication of esthetic zirconia restorations. The blanks are available in various heights and shades based on the Vita™ Classical shade guide. After sintering, restorations display a gradient shading and inherent fluorescence. The restorations are designed using dental CAD software and the data is converted into milling paths by CAM software. The blanks can be processed in milling units suitable for pre-sintered zirconia. Milled restorations must be final sintered in a furnace suitable for zirconia per the cycle designated for XP202.

The provided text pertains to the 510(k) premarket notification for the device XP202, a porcelain powder for clinical use (zirconia blanks for dental restorations). The document focuses on demonstrating substantial equivalence to predicate devices, rather than a detailed clinical study with human readers or a specific acceptance criteria table for performance metrics like sensitivity/specificity.

Therefore, much of the requested information regarding clinical study design, human reader performance, and detailed statistical analysis of AI performance is not available in the provided text. The evaluation is primarily based on in vitro testing and comparison to recognized standards and predicate devices' properties.

Here's the information that can be extracted or inferred from the document:

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

The document states that in vitro testing was conducted to show that XP202 fulfills the requirements of FDA recognized standard ISO 6872: "Dentistry Ceramic materials" and compares its performance (flexural strength, chemical solubility, linear thermal expansion) to predicate devices. It concludes that "The results of XP202 are similar to Katana STML. The difference between XP202 and Lava Plus are their flexural strength and is addressed by limiting the indications to three unit bridges according ISO 6872."

Since a specific table of acceptance criteria with numerical values is not explicitly presented in the document, here's a conceptual representation based on the text:

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

• Sample Size: Not explicitly stated for the in vitro tests. The document mentions "in vitro testing", but not the number of samples or items tested.
• Data Provenance: The tests are "in vitro testing", meaning conducted in a laboratory setting. The origin of the raw materials (zirconia blanks) would be from 3M Deutschland GmbH, Germany.

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 as the 'ground truth' for this device is established through in vitro measurements against recognized material standards (ISO 6872), not through expert interpretation of clinical images or data with human-in-the-loop.
• For biocompatibility, a "board-certified toxicologist" assessed the product, implicitly establishing "ground truth" for safety from a toxicological perspective.

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

• Not applicable, as this refers to adjudication of discrepancies in expert readings, which is not part of the described in vitro material 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, an MRMC comparative effectiveness study was not done. This device is a material (porcelain powder/zirconia blank) used for dental restorations, not an AI-powered diagnostic or assistive tool for human readers.

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

• No, this is not relevant. The device is a material, not an algorithm. Its performance is evaluated through material properties in a laboratory setting, not through an algorithm's standalone performance.

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

• For the performance testing, the ground truth is established by physical and chemical measurements of material properties (flexural strength, chemical solubility, linear thermal expansion) as defined by the ISO 6872 standard for dentistry ceramic materials.
• For biocompatibility, the ground truth is established by compliance with ISO 10993 series standards and FDA guidance on biological evaluation of medical devices, assessed by a board-certified toxicologist.

8. The sample size for the training set

• Not applicable. This device is not an AI algorithm and therefore does not have a "training set."

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

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

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• Linings for single-surface and multiple-surface composite fillings
• Core build-up prior to crown placement
• Primary tooth fillings
• Stress bearing Class I restorations with at least one additional support outside of the filling area
• Stress bearing Class II restorations when the isthmus is less than half of the intercuspal distance and with at least one additional support outside of the filling area
• Cervical fillings, if aesthetics is not the prime consideration
• Single-surface and multiple-surface temporary fillings
• Fissure sealing

Ketac Universal Aplicap is a radiopaque glass ionomer restorative delivered in capsules used for bulk fillings. It can be applied without lining; releases fluoride ions and is available in various shades corresponding to the Vita™ Classical color system.

The provided text describes the 510(k) premarket notification for the "Ketac Universal Aplicap" dental cement and its substantial equivalence to a predicate device, "Equia." The text details various performance criteria, comparisons, and biocompatibility studies. However, it does not explicitly outline "acceptance criteria" as pass/fail thresholds against which the device performance is measured in a structured table or clinical study with patient outcomes. Instead, it compares the performance of Ketac Universal Aplicap to the predicate device and relevant ISO standards.

Based on the provided text, here's an attempt to extract and synthesize the requested information, acknowledging that some specific details (like direct acceptance criteria with pass/fail values, sample sizes for all tests, detailed expert qualifications, and specific multi-reader multi-case study results) are not fully present for an AI-based device, as this document pertains to a dental cement:

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

The document does not provide a formal table of "acceptance criteria" with defined pass/fail thresholds. Instead, it compares the performance of Ketac Universal Aplicap against the predicate device (Equia) and relevant ISO standards. The "Comparison" column implicitly acts as an assessment of whether the performance is considered acceptable or substantially equivalent.

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

The document does not explicitly state the sample sizes for the "test set" (i.e., for the in vitro physical and mechanical properties comparison). For biocompatibility, it states "assessed by a board-certified toxicologist" but doesn't mention sample sizes of biological tests.

Regarding data provenance, the studies are described as "in-house testing" for some parameters (working time, setting time, compressive strength), and comparisons are made against ISO standards. The submitter is "3M Deutschland GmbH" in Germany, implying the data generation origin. The studies are in vitro evaluations of material properties, not clinical trials with patient data, so "retrospective or prospective" does not directly apply in the usual clinical sense.

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

This question is more pertinent to clinical studies or AI/diagnostic device evaluations where "expert ground truth" is established for patient cases. For this dental cement, the "ground truth" for material properties is established through standardized (e.g., ISO, P/L acid-base cements, Adhesives Notched Edge Sheer Bond Strength) or in-house mechanical and chemical testing methods.

For biocompatibility, the assessment was performed by "a board-certified toxicologist." The exact number (e.g., one or a team) is not specified.

4. Adjudication method for the test set

Adjudication methods (like 2+1, 3+1) are typically used in clinical studies or expert reviews of ambiguous cases, particularly for AI diagnostic devices. This document describes material science testing and comparisons to predicate devices and standards, not a process that would involve human adjudication of results in that manner. The "comparison" is based on objective measurements and established chemical/physical principles.

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. These studies are specific to diagnostic devices, particularly those involving human interpretation (readers) and AI assistance, to assess changes in diagnostic performance. This document is for a dental cement.

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

This question is not applicable. The device is a dental cement, not an algorithm.

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

The "ground truth" for the performance comparisons comes from:

• Standardized Test Methods: Adherence to, or comparison against, ISO standards (e.g., ISO 9917-1 for dental cements).
• Predicate Device Performance: Direct measurement and comparison of properties against a legally marketed predicate device (Equia).
• Clinical Literature Review: For bonding strength to dentin, "a clinical literature review showed that a performance in the range of Ketac Universal Aplicap are clinically sufficient." This implies that existing clinical evidence for similar materials and their performance is considered a form of "ground truth" for clinical sufficiency.
• Toxicological Assessment: For biocompatibility, a board-certified toxicologist's assessment based on international standards forms the ground truth for safety.

8. The sample size for the training set

This is not applicable as the device is a dental cement, not an AI model requiring a training set.

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

Not applicable, as there is no training set for a dental cement.

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· Professional cleaning of teeth: Removal of subgingival and supragingival plaque-biofilm and stains

· Professional cleaning of teeth including patients with dentin hypersensitivity

· Treatment of dentin hypersensitivity by blockage of the dentin tubules

· Can also be used in the presence of fixed orthodontic devices (brackets), restorative and prosthetic materials, and implants

· For maintenance in periodontitis therapy after completion of initial treatment - when using standard devices - for gingival pockets up to 5 mm in depth

· For maintenance in perimplantitis therapy after completion of initial treatment - when using standard devices - for gingival pockets up to 5 mm in depth

Clean & More is classified as airbrush (21 C.F.R. § 872.6080) because it is a powder to be used with air polishing devices in the professional tooth cleaning.

Clean & More is a prophylactic powder for gentle and professional sub- and supragingival cleaning of teeth, including the removal of plaque-biofilm and stains, using commercially available air polishing devices.

Clean & More is a glycine based air polishing powder containing functionalized tri-calcium phosphate, a substance which blocks open dentin tubules on the tooth surface, thereby contributing to a reduction in dentin hypersensitivity.

Here's an analysis of the acceptance criteria and study information for the "Clean & More" device, based on the provided document:

The document (K151748) describes a 510(k) premarket notification for "Clean & More," a prophylactic powder for professional tooth cleaning. The primary purpose of the submission is to demonstrate substantial equivalence to predicate devices, rather than establishing de novo acceptance criteria. Therefore, the "acceptance criteria" for the device are largely implied by its performance being equivalent to the predicate devices and demonstrating safety and efficacy for its stated Indications for Use.

1. Table of Acceptance Criteria and Reported Device Performance

Given that this is a 510(k) summary demonstrating substantial equivalence, formal, quantitative acceptance criteria are not explicitly stated in the same way they would be for a direct performance claim against a specific standard. Instead, the "acceptance criteria" are implied by the requirement for the new device to perform equivalently to its predicate devices in various aspects.

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

• Clinical Study Test Set:
  • Sample Size: A total of 40 subjects were enrolled.
  • Data Provenance: The document does not explicitly state the country of origin for the clinical study. It was conducted "according to ISO 14155:2011 - Good Clinical Practice (GCP)," which suggests international standards were followed. It is a prospective study, as subjects were enrolled, treated, and followed up at specific intervals (10 days, 4 weeks, 3 and 6 months).
• Non-Clinical (In vitro) Test Set:
  • Sample Materials: Bovine enamel, composite materials, bovine dentin, zirconia surfaces, and titanium surfaces.
  • Data Provenance: Not specified, but generally in vitro studies are conducted in a controlled lab environment. This data is prospective in the sense that the experiments were designed and executed to test the device.

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

• Clinical Study:
  • Dentin Hypersensitivity: Ground truth for hypersensitivity was "predetermined hypersensitivity on at least two teeth determined by air blast and tactile scoring." The document does not specify the number or qualifications of the experts (e.g., dentists, hygienists) who performed these initial assessments or subsequent evaluations.
• Non-Clinical (In vitro) Studies:
  • The "ground truth" for these studies is the experimental measurement and comparison to the predicate device's performance. Experts would include the researchers conducting the tests and analyzing the data, but no specific number or qualifications are provided.

4. Adjudication Method for the Test Set

• Clinical Study: Not explicitly stated. The determination of "predetermined hypersensitivity" and subsequent assessment of "incidence and degree of dentinal hypersensitivity" would imply a clinical evaluation, but no multi-reader adjudication method (like 2+1 or 3+1) is mentioned. "Air blast and tactile scoring" are common methods, and typically, the assessing clinician's findings serve as the "ground truth" for that individual.
• Non-Clinical (In vitro) Studies: Not applicable in the same way as clinical adjudication. Data analysis of measurements and observations (e.g., Keyence microscope observation, statistical evaluation) would be the method to determine "truth."

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

• No, an MRMC comparative effectiveness study was not explicitly done or mentioned.
  • The clinical study focused on the effectiveness of Clean & More in reducing dentin hypersensitivity in a cohort of patients. It describes the device's performance, not a comparison of human readers with and without AI assistance.
  • The non-clinical studies were direct comparisons of material properties and performance between the new device and its predicate, not involving human readers' diagnostic accuracy.

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

• Yes, in spirit, the clinical and non-clinical studies can be considered standalone performance for the device itself.
  • The in vitro tests directly assessed the physical and chemical performance of the Clean & More powder. This is an "algorithm only" type of test in the sense that it's the device's inherent performance being measured.
  • The clinical study evaluated the direct effect of the Clean & More treatment on patients' dentin hypersensitivity relief. This is the "standalone" performance of the therapeutic intervention itself; it's not assessing a diagnostic algorithm or a human reader's interpretation.

7. The Type of Ground Truth Used

• Clinical Study: The ground truth for dentin hypersensitivity was established by expert clinical assessment (air blast and tactile scoring) of pre-existing hypersensitivity and subsequent changes after treatment. This effectively represents a clinical outcome and patient-reported state (pain level).
• Non-Clinical (In vitro) Studies: The ground truth was based on objective laboratory measurements of physical properties (e.g., surface roughness, abrasion levels, plaque removal efficiency) using scientifically accepted methods and instrumentation.

8. The Sample Size for the Training Set

• The document does not explicitly mention a "training set" because this product is a physical dental device (prophylactic powder), not a software algorithm that requires machine learning training data. The studies conducted are for performance validation, not for training an AI model.

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

• As there is no mention of a "training set" in the context of an AI/ML algorithm for this device, this question is not applicable. The device's formulation and design would be based on prior scientific research and development, not on a machine learning training process.

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Fabrication of temporary crowns, bridges, inlays, onlays, and veneers
Fabrication of long-lasting temporary restorations .
. Lining material for prefabricated temporary crowns made of composite (e.g., ProtempTM Crown) and metal (e.g., Iso-Form crowns)

SuPro 100 is classified as temporary crown and bridge resin (21 C.F.R. § 872.3770, Class II device). As its predicate device TempXN28 (K073296, by 3M Deutschland GmbH - Germany), SuPro 100 is a composite material based on multifunctional methacrylates esters, therefore, both TempXN28 and SuPro 100 as two-component system have filling material-like properties. As TempXN28, Supro 100 will be available in Garant™ mixing and dispensing system (by 3M Deutschland GmbH, Germany).

This is a 510(k) summary for a dental temporary restorative material, SuPro 100. The document focuses on demonstrating substantial equivalence to a predicate device (TempXN28) rather than providing detailed acceptance criteria and a study report in the format typically seen for AI/ML-driven medical devices.

Therefore, many of the requested elements (e.g., sample size for test/training sets, data provenance, number of experts, adjudication methods, MRMC studies, standalone performance, type of ground truth for AI) are not applicable to this type of regulatory submission because it is for a physical dental material, not a software device or AI algorithm.

However, I can extract the acceptance criteria (in terms of performance comparisons) and summarize the "study" (i.e., the physical and mechanical testing performed).

Acceptance Criteria and Device Performance for SuPro 100

The acceptance criteria for SuPro 100 are based on demonstrating "substantial equivalence" to the predicate device, TempXN28 (K073296), in terms of physical and mechanical properties, as well as biocompatibility and indications for use. The "study" refers to the series of laboratory tests conducted on SuPro 100 and TempXN28 to compare their performance.

1. Table of Acceptance Criteria and Reported Device Performance

Summary of "Acceptance Criteria" for Substantial Equivalence:
The implied acceptance criterion is that SuPro 100 must either demonstrate comparable performance or, ideally, superior performance in key mechanical and physical properties while maintaining similar handling characteristics (like setting time within a functional range), biocompatibility, and intended uses as the predicate device. For several key mechanical properties (flexural strength, e-Modulus, tensile strength, surface hardness), SuPro 100 showed higher values, which is considered an improvement. For other properties, it was "comparable" or "similar." Faster setting time is a characteristic difference. Lower compression strength and compression at break were noted, but the overall conclusion was still substantial equivalence, likely because other reinforcing properties were improved.

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

• Sample Size: Not explicitly stated in the 510(k) summary. For physical and mechanical tests of materials, established dental material standards (e.g., ISO) typically specify minimum sample sizes for each test type (e.g., n=5 or n=10 per group). Given the reference to ISO standards, it is highly likely that suitable sample sizes were used in accordance with those standards.
• Data Provenance: The tests were conducted by 3M Deutschland GmbH in Germany. This is a prospective testing of the manufactured material.

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 material testing submission, not a diagnostic device involving expert interpretation of data or images. The "ground truth" for material properties is established through standardized laboratory measurements and physical tests referencing ISO standards.

4. Adjudication method for the test set:

• Not Applicable. See point 3.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

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

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

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

7. The type of ground truth used:

• Objective Material Property Measurements: The "ground truth" for the performance comparisons comes from direct laboratory measurements of physical, mechanical, and chemical properties of the material, as defined by international standards (e.g., ISO 179-1, ISO 527-1, ISO 4049, ISO 9917 for physical/mechanical; ISO 7405, ISO 10993 series for biocompatibility).

8. The sample size for the training set:

• Not Applicable. This is a physical material, not an AI/ML model. There is no concept of a "training set" in this context. The formulation of the material and its properties are developed through R&D (research and development) processes.

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

• Not Applicable. See point 8. The "ground truth" for material development is based on scientific principles of polymer chemistry and material science to achieve desired properties.

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• Removal of subgingival and supragingival plaque; can also be used in the presence of permanent orthodontic apparatus (brackets) and implants
• For maintenance in periodontitis therapy after completion of initial treatment, for gingival pockets up to 5 mm in depth only
• For maintenance in periimplantitis therapy after completion of initial treatment, for gingival pockets up to 5 mm in depth only
  Calculi and tartar cannot be removed with Clinpro Prophy Powder.

Clinpro TM Prophy Powder is classified as airbrush (21 C.F.R. § 872.6080) because it is a powder to be used with air polishing devices in the professional tooth cleaning. As the predicate devices Air-N-Go® Perio Powder (K110379) and Air-Flow® Perio Powder (K092289), Clinpro Prophy Powder is a glycine based air polishing powder to be used with air polishing devices in the professional tooth cleaning.

The provided text is a 510(k) summary for a dental device (Clinpro Prophy Powder) and does not describe acceptance criteria for a study or a study proving that a device meets such criteria in the format requested.

The document primarily focuses on demonstrating substantial equivalence to predicate devices based on indications for use, performance characteristics, and biocompatibility. It does not contain a typical "acceptance criteria" table or details of a clinical study designed to quantitatively prove the device meets specific performance thresholds with a defined "test set" or "training set" as would be expected for a diagnostic or AI-based device.

Here's an breakdown of why the requested information cannot be extracted from the provided text, and what information is available:

Information NOT available in the document:

• A table of acceptance criteria and the reported device performance: The document compares characteristics to predicate devices but does not list specific numerical acceptance criteria (e.g., Sensitivity > X%, Specificity > Y%) or quantifiable performance metrics like a standalone study would.
• Sample size used for the test set and the data provenance: There is no mention of a specific test set, its size, or its origin.
• Number of experts used to establish the ground truth for the test set and the qualifications of those experts: No information about expert adjudication for a test set.
• Adjudication method for the test set: Not applicable as no specific test set or expert review process is described.
• 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: This is a dental powder, not an AI diagnostic device. MRMC studies are not applicable.
• If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable for this device type.
• The type of ground truth used (expert consensus, pathology, outcomes data, etc.): While it mentions "in vitro and in vivo studies" and "clinical literature review," it doesn't specify a rigorous ground truth establishment process for a performance study.
• The sample size for the training set: Not applicable for this type of submission.
• How the ground truth for the training set was established: Not applicable.

What the document does provide, in relation to device evaluation:

The evaluation conducted for this 510(k) submission primarily relies on:

• Comparison to predicate devices: The manufacturer argues "substantial equivalence" based on similar materials, indications for use, and a literature review of glycine-based air-polishing powders.
• Biocompatibility testing: This was carried out against "FDA & internationally recognized guidelines."
• In vitro and in vivo investigations: The document states that "Results of in vitro and in vivo investigations using Clinpro Prophy Powder and glycine based air-polishing powder (i.a.) published in numerous literature show that Clinpro Prophy Powder is substantially equivalent to the predicate device with regard to the performance of the product." However, it does not provide details of specific studies, their methodologies, sample sizes, or numerical results.
• Clinical literature review: The document states, "The overall conclusion, based also on the clinical literature review, is that Clinpro Prophy Powder is suitable and safe for its intended use."

Topics of "studies evaluated to substantiate performance and safety":

• Removal of subgingival bacterial load in supportive periodontal therapy
• Root debridement
• Use on contaminated implant material
• Professional oral hygiene treatment of patients with orthodontic appliances (effects on plaque index (PI) and gingival bleeding)
• Gingival tissue effects
• Abrasiveness of air-polishing

In conclusion, this document describes a 510(k) submission for a dental prophy powder asserting substantial equivalence to existing devices, supported by general statements about in vitro/in vivo studies and a clinical literature review, rather than a detailed report of a specific device performance study with predefined acceptance criteria.

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• Impressions for the production of temporary restorations .
• . All types of preliminary impressions
• . Impressions of the opposing jaw
• Impressions for orthodontic models .

Flash AR and Flash AR Quick are classified as impression materials (21 C.F.R. § 872.3660) because they are devices intended to reproduce the structure of a patient's teeth. As the predicate devices Flash AR Penta™ and Flash AR Penta™ Quick (K131404), Flash AR and Flash AR Quick are medium-bodied (ISO Type 2) consistency A-silicone impression materials for all kinds of preliminary impressions. Like Flash AR Penta™ and Flash AR Penta™ Quick, Flash AR and Flash AR Quick are two component (base paste/catalyst) vinyl polysiloxane impression materials to be used for impressions, where typically alginates are used. Whereas Flash AR Penta™ and Flash AR Penta™ Quick are designed to automatically be mixed and dispensed in all versions of Pentamix™ devices of 3M Deutschland GmbH and the mixing ratio for both materials is base paste:catalyst, 5:1 (by volume), Flash AR and Flash AR Ouick will be delivered in Garant™ cartridges (50 ml plastic cartridges) and can be mixed and extruded using the Garant™ dispenser manufactured by 3M Deutschland GmbH with the mixing ratio for both materials of base paste:catalyst, 1:1 (by volume).

The provided text describes a 510(k) premarket notification for two dental impression materials, Flash AR and Flash AR Quick. The study presented focuses on demonstrating substantial equivalence to predicate devices rather than the performance of an AI/ML powered device. Therefore, many of the requested categories (such as sample size for test set, number of experts for ground truth, MRMC study, standalone study, and training set details) are not applicable to this submission.

Here's an analysis of the available information:

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

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

• Sample Size for Test Set: Not specified in the provided text. The study references "Test results according to ISO 4823" and "Biocompatibility testing," but does not detail the sample sizes for these tests.
• Data Provenance: The tests were conducted to establish substantial equivalence to predicate devices manufactured by 3M Deutschland GmbH, Germany. The actual location of the testing is not explicitly stated, but given the company's location, it is likely that the studies were performed in Germany or under the purview of a German entity. The exact nature (retrospective or prospective) of the physical/mechanical and biocompatibility testing is not specified, but typically these types of studies for product equivalency are laboratory-based and controlled.

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 as the submission is for a dental impression material, not an AI/ML powered device requiring interpretation by experts to establish ground truth. Substantial equivalence was based on physical, mechanical, chemical, and biocompatibility testing against ISO standards and predicate devices.

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

• This information is not applicable as the submission is for a dental impression material. Ground truth in this context is established through objective physical, mechanical, chemical, and biological tests, not through expert consensus requiring adjudication.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

• This information is not applicable as the submission is for a dental impression material and does not involve AI or human readers.

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

• This information is not applicable as the submission is for a dental impression material and does not involve an algorithm or AI.

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

• The "ground truth" for the device's performance was established through:
  • Objective physical and mechanical property measurements: Conducted according to ISO 4823, comparing working time, intra-oral setting time, consistency, and other properties.
  • Chemical composition analysis: To ensure similarity with predicate devices.
  • Biocompatibility evaluations: Performed in consideration of FDA and internationally recognized guidelines.
• The primary "ground truth" for the submission's goal was the established performance and safety of the predicate devices (Flash AR Penta™ and Flash AR Penta™ Quick), against which substantial equivalence was demonstrated.

8. The sample size for the training set

• This information is not applicable as the device is not an AI/ML powered device and therefore does not have a "training set."

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

• This information is not applicable as the device is not an AI/ML powered device and therefore does not have a "training set" or ground truth for it.

Summary of the Study Proving Acceptance Criteria:

The study proving the device meets the acceptance criteria is a substantial equivalence evaluation comparing the new devices (Flash AR and Flash AR Quick) to their predicate devices (Flash AR Penta™ and Flash AR Penta™ Quick). This evaluation involved:

• Performance testing: According to ISO 4823, focusing on physical and mechanical properties such as working time and intra-oral setting time. The new devices reportedly had the "same" working and intra-oral setting times as their respective predicates.
• Chemical composition comparison: Demonstrating similarity to the predicate devices.
• Biocompatibility evaluations: Performed under FDA and international guidelines, concluding that the materials are biocompatible for their intended use.
• Indications for Use comparison: Establishing that the new devices share the same intended uses as the predicate devices.

The conclusion of the study was that Flash AR and Flash AR Quick are substantially equivalent in safety and effectiveness to the predicate devices, thereby meeting the necessary criteria for regulatory clearance.

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