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Final cementation of ceramic, composite or metal inlays, onlays, crowns, bridges, 2-3-unit Maryland bridges and 3-unit inlay/onlay bridges (excluded for patients with bruxism or periodontitis); Final cementation of post and screws; Final cementation of ceramic, composite or metal restorations on implant abutments; Cementation of abutments made of Lava™ zirconium oxide ceramic.

Unicem HM in the Clicker™ dispenser is a dual-curing, self-adhesive resin cement for hand mixing. It contains bi-functional (meth)acrylate. The proportion of inorganic fillers is about 70% by weight; the grain size (D 90%) is about 12.5 um. The mixing ratio; based on volume, is 1 part base paste : 1 part catalyst. The cement is available in various shades.

Here's a breakdown of the acceptance criteria and the study details for the Unicem HM device, based on the provided 510(k) summary:

Acceptance Criteria and Device Performance

The device, Unicem HM, was compared to its predicate device, Unicem Aplicap, across several performance metrics. The acceptance criteria were established by relevant ISO and DIN standards.

Table 1: Acceptance Criteria and Reported Device Performance for Unicem HM

Summary of Device Performance against Acceptance Criteria:

Based on the table above, Unicem HM met all the specified limits for film thickness, working time, setting time, radiopacity, flexural strength (both dark and light cured), and compressive strength (both dark and light cured). For surface hardness, which had no specified numerical limit ("n.a."), the values are provided for comparison. The study concluded that Unicem HM is "safe and effective as as the predicate devices."

Study Details

The provided document describes a bench testing study comparing Unicem HM to a predicate device, Unicem Aplicap, and other predicate devices (Panavia F 2.0, Maxcem 2) were also referenced for substantial equivalence. This is not a clinical study involving human patients.

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

   • The document does not explicitly state the sample sizes (number of specimens tested) for each performance metric. It provides mean values and standard deviations (± values), which implies multiple samples were tested for each metric to calculate these statistics.
   • Data Provenance: The company submitting the 510(k) is 3M ESPE AG, based in Germany. Therefore, the data likely originated from Germany. The study is retrospective in the sense that the data appears to be from laboratory tests conducted to demonstrate compliance with standards for the premarket notification.

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

   • This question is not applicable (N/A) to this type of study. Ground truth, in the context of expert consensus, refers to clinical assessments or interpretations. As this is a bench testing study evaluating material properties against established standards, it does not involve expert readers establishing ground truth. The "ground truth" here is objective physical and chemical properties measured according to standardized methods.

3. Adjudication method for the test set:

   • N/A. Adjudication methods (like 2+1, 3+1) are used to resolve disagreements among human experts in clinical studies or image interpretation. This study involves objective measurements of material properties, not human interpretation, so no adjudication method was used.

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

   • No. This is not an MRMC study. It is a bench testing study for a dental cement, not a diagnostic device involving human readers or AI assistance.

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

   • No. This is not an algorithm or AI device. It is a material science study.

6. The type of ground truth used:

   • The "ground truth" in this context is based on established international standards (ISO and DIN) for dental materials. The device's performance was measured against these objective standards. Additionally, the performance of the predicate device serves as a benchmark for comparison to demonstrate substantial equivalence.

7. The sample size for the training set:

   • N/A. This is a material testing study, not a machine learning study, so there is no concept of a "training set."

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

   • N/A. As there is no training set for this type of study, this question is not applicable.

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Final cementing of all-ceramic, composite, or metal inlays, onlays, crowns and bridges; 2-3-unit Maryland bridges and 3-unit inlay/onlay bridges (excluded for patients with bruxism or periodontitis); Final cementing of posts and screws; Final cementation of all-ceramic, composite, or metal restorations on implant abutments.

Malta is a dual-curing, self-adhesive resin cement available in an automix syringe. It contains bi-functional (meth)acrylate. The proportion of inorganic fillers is about 70 % by weight; the grain size (D 90 %) is about 12.5 µm. The mixing ratio, based on volume, is 1 part base paste : 1 part catalyst paste. The two pastes are mixed by a static single use mixer attached to the syringe. Malta is available in various shades.

The provided text describes a dental cement product called "Malta" and its performance characteristics, comparing it to predicate devices to establish substantial equivalence for regulatory purposes. However, it does not contain information about a study involving an AI device or a comparative effectiveness study with human readers.

Therefore, I can only provide information related to the acceptance criteria and performance data for the dental cement "Malta," as well as details about the study that demonstrates this performance. Questions pertaining to AI, human readers, ground truth for AI, training sets for AI, or adjudication methods are not applicable based on the provided text.

Here's the information derived from the provided text regarding the dental cement Malta:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not specify the exact sample sizes used for each individual test or the specific data provenance (e.g., country of origin, retrospective/prospective) for these tests. It only states that "Biocompatibility testing was carried out." and presents performance data alongside predicate device data. These tests were likely conducted under controlled laboratory conditions to meet ISO standards.

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. The study is a laboratory-based performance evaluation of a dental material, not a clinical study requiring expert diagnosis or ground truth establishment in that typical sense. The "ground truth" here is the physical and mechanical properties of the material determined by standardized testing methods.

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

This question is not applicable. Adjudication methods typically apply to studies where human interpretation or classification is involved, such as medical imaging analysis. The presented data are objective measurements from laboratory 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 question is not applicable. The document describes a dental cement, not an AI device or a study involving human readers.

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

This question is not applicable. The document describes a dental cement, not an AI algorithm.

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

The "ground truth" in this context refers to the objectively measured physical and mechanical properties of the dental cement, established through standardized laboratory testing procedures defined by ISO (International Organization for Standardization) standards (e.g., ISO 4049:2000, ISO 9917:2001, ISO 2039-1:2000).

8. The sample size for the training set

This question is not applicable. There is no mention of a "training set" as this is not an AI or machine learning study.

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

This question is not applicable. There is no mention of a "training set" or "ground truth" in the context of an AI study. The performance data for Malta was established through direct measurement using recognized international standards.

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Final cementation of ceramic, composite or metal inlays, onlays, crowns, bridges, 2-3-unit Maryland bridges and 3-unit inlay/onlay bridges (excluded for patients with bruxism or periodontitis) Final cementation of post and screws Final cementation of ceramic, composite or metal restorations on implant abutments Cementation of abutments made of Lava™ zirconium oxide ceramic

Unicem Aplicap/Maxicap cements are dual-curing, self-adhesive resin cements available in two single dose delivery systems in capsules (K020256). They are used for the permanent cementation of indirect restorations made of ceramic, composite, or metal, and for posts and screws. Bonding and conditioning of the prepared tooth structure are not necessary with Unicem Aplicap™ and Maxicap™M. Unicem Aplicap™ and Unicem Maxicap™ release fluoride ions, and are available in various shades. Unicem Aplicap™ and Unicem Maxicap™ contain bifunctional (meth)acrylate.

The provided text is a 510(k) summary for a dental cement (Unicem Aplicap/Maxicap). It focuses on establishing substantial equivalence to predicate devices and expanding indications for use, primarily through comparison of performance data and biocompatibility testing. The document does not contain information on clinical studies that would involve acceptance criteria, test sets, ground truth establishment, or human reader performance as typically seen with AI/CADe devices.

Therefore, many of the requested details cannot be extracted from this specific document.

Here's an attempt to answer the questions based on the available information:

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

The document does not specify quantitative acceptance criteria or a direct performance table as would be found for an AI/CADe device. It generally states that "the comparison for performance data and indications for use shows that Unicem Aplicap™ /Maxicap™ is substantially equivalent to its predicate devices."

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

Not applicable. The submission is for a dental cement, not an AI/CADe device that uses a "test set" of clinical data in this manner. The "performance data" mentioned likely refers to physical and chemical properties of the cement, not clinical image data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable. Ground truth as typically understood for AI/CADe devices (e.g., expert consensus on medical images) is not relevant to this dental cement submission.

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

Not applicable.

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

Not applicable.

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

Not applicable.

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

Not applicable in the context of clinical image interpretation. For dental cements, "ground truth" would likely refer to established physical and chemical properties and their compliance with relevant international standards, which are not detailed here beyond a general statement of "biocompatibility testing."

8. The sample size for the training set

Not applicable. This is not an AI/CADe device, and therefore does not have a "training set" in the machine learning sense.

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

Not applicable.

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All indications for displacement of the marginal gingiva and to provide for a dry sulcus when the periodontium is healthy.

CoSP2, manufactured by 3M ESPE, is a retraction paste for the displacement of marginal gingiva and to provide for a dry sulcus. Any suitable, commonly available dispensers, e.g., the Capsule Applicator, manufactured for 3M ESPE, can be used for application of the retraction paste. The paste is applied directly from the retraction capsule into the sulcus. A CoSP2 retraction capsule may not be used on more than one patient.

I am sorry, but based on the provided text, there is no information about a study that proves the device meets specific acceptance criteria in the way you've outlined for AI/ML device evaluation.

The provided document is a 510(k) summary for a medical device called "CoSP2," which is a retraction paste used in dentistry. The document focuses on demonstrating substantial equivalence to predicate devices, not on proving performance against a set of quantitative acceptance criteria through a specific performance study as would be typical for an AI/ML device.

Here's why I cannot fulfill your request based on the given text:

• Type of Device: CoSP2 is a physical dental paste, not an AI/ML device or software. Therefore, the evaluation methodology and criteria are fundamentally different.
• Safety and Effectiveness Claims: The document states, "In this 510(k) premarket notification chemical composition, performance data (e.g. extrusion force, flow resistance, and rinsing time), and indications for use of CoSP2 have been compared to its predicate devices." and "To provide evidence for safety biocompatibility testing was carried out. The results show that CoSP2 is a safe device." It concludes: "In summary, it can be concluded that safety and effectiveness requirements for CoSP2 are completely met."
• "Performance Data" Context: The "performance data" mentioned (extrusion force, flow resistance, and rinsing time) are physical properties of the paste, not clinical efficacy or diagnostic accuracy metrics related to AI.
• No "Acceptance Criteria" Table: There is no table of acceptance criteria or reported device performance metrics in the way you've requested (e.g., sensitivity, specificity, AUC) for an AI/ML device.
• No ML-Specific Study Information: The document does not mention anything about:
  • Sample sizes for test sets (beyond general product testing).
  • Data provenance for clinical images/data.
  • Number or qualifications of experts establishing ground truth.
  • Adjudication methods.
  • Multi-reader multi-case (MRMC) studies or comparative effectiveness with human readers.
  • Standalone AI algorithm performance.
  • Types of ground truth (e.g., pathology, outcomes data).
  • Training set sample size or how its ground truth was established.

In essence, the 510(k) submission for CoSP2 focuses on demonstrating that the device is as safe and effective as existing legally marketed predicate devices, primarily through comparison of chemical composition, physical performance characteristics, and biocompatibility testing. It doesn't involve the kind of performance study or acceptance criteria relevant to an AI/ML diagnostic or assistive device.

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CAD/CAM veneering for anterior and posterior single crowns made of Lava Frame Zirconia, manufactured with Lava Design Software and the accordingly released Lava milling machine.

Elegant is classified as Porcelain powder for clinical use (21 C.F.R. § 872.6660). Elegant is used for production of glass ceramic veneers for 3M ESPE Lava™ Frame Zirconia frameworks.

Elegant consists of 4 glass ceramic blocks (E1 - E4), from which the veneer is milled. Each ceramic block is available in the two sizes S and M. The veneer is then fused to the Zirconia framework via color-coordinated fusion porcelain (D1 - D10). For smaller adjustments to the restoration, corrective porcelains (CR1 - CR4) can be used. For the tooth colors A4, B4, C3, C4, and D4, the basic shades ("Shade" A - D) must be used. The individual stains S1 (White), S2 (Lemon Yellow), S3 (Orange), S4 (Violet), S5 (Blue), S6 (Dark Brown), and glaze are used for individualization. For the mixing of the fusion porcelain powder and the corrective porcelain, modelling liquid is available; also, for stains and glaze, stain/glaze liquid is available.

For the production of an Elegant restoration, the Lava™ Frame Zirconia framework and the corresponding Elegant veneer are virtually designed on the screen with the Lava™ Design Software. The milling for both parts takes place in the accordingly released Lava™ milling machine with special milling cutters. Subsequently the Lava™ Frame Zirconia framework is shaped and then sintered in the Lava™ sintering furnace. All of the above-mentioned Lava products are manufactured by or for 3M ESPE.

This document is a 510(k) Summary for the device "Elegant," a porcelain powder for clinical use in dental restorations. It focuses on establishing substantial equivalence to predicate devices, rather than a traditional clinical study with acceptance criteria for device performance in terms of diagnostic accuracy or similar metrics.

Therefore, many of the requested elements pertaining to acceptance criteria and performance studies are not directly applicable or available in this type of submission, as it's not a clinical performance study evaluating outcomes like sensitivity or specificity. Instead, the "study" is a comparison to predicate devices, and the "acceptance criteria" are the demonstration of substantial equivalence.

Here's an interpretation based on the provided text:

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

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

• Not applicable in the context of this 510(k) summary. This document does not describe a clinical performance study with a test set of patient data. The "test" for a 510(k) is typically a comparison of device characteristics (chemistry, performance, indications) to existing devices. If any physical or mechanical properties were tested, the sample sizes would refer to experimental batches of materials, not a "test set" of patient data. The manufacturer is based in Germany.

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)

• Not applicable. This submission does not involve a diagnostic decision-making process requiring expert ground truth for a test set. The "ground truth" here is regulatory acceptance of equivalence based on the provided technical data and comparisons to predicate devices, reviewed by FDA officials.

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

• Not applicable. There is no "test set" or adjudication of diagnostic findings described. The FDA's review process internally involves multiple reviewers, but this is a regulatory review, not a clinical adjudication.

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

• Not applicable. This device is a material for dental restorations, not an AI software or diagnostic tool that assists human readers.

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

• Not applicable. This device is a material, not an algorithm.

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

• The "ground truth" for this 510(k) submission is the established characteristics and regulatory acceptance of the predicate devices. The new device's data (chemistry, performance, indications) is compared against these known, legally marketed predicates to demonstrate substantial equivalence.

8. The sample size for the training set

• Not applicable. This device is a material, not a machine learning model, so there is no training set.

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

• Not applicable. As there is no training set, this question is not relevant.

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Color staining and glazing of glass ceramic restorations made from 3M ESPE's Glass Ceramics "Jolly".

Bellus Shading Kit contains stain pastes, a glazing paste, and a liquid which can be used to thin the pastes. The pastes serve solely for the color staining and glazing of the surfaces of restorations made from "Jolly" glass ceramic blocks, manufactured for 3M ESPE.

This 510(k) premarket notification for the Bellus Shading Kit does not contain the detailed study information or acceptance criteria typically found for medical devices.

The filing primarily focuses on demonstrating substantial equivalence to predicate devices, particularly regarding safety (biocompatibility) and intended use, rather than presenting a performance study with specific acceptance criteria.

Therefore, most of the requested information cannot be extracted from the provided text. I will explain why each section cannot be answered from the document.

1. Table of acceptance criteria and reported device performance:

• Cannot be provided. The document states "To provide evidence for safety biocompatibility testing was carried out. The results show that Bellus Shading Kit is a safe device." However, it does not specify any quantitative acceptance criteria for biocompatibility nor does it report specific performance metrics for color staining and glazing. The assessment relies on the comparison of chemistry, performance data, and indications for use with predicate devices, implying qualitative rather than quantitative performance comparison.

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

• Cannot be provided. The document does not describe a clinical or performance test set. It mentions "biocompatibility testing," but no details about the sample size, study design (retrospective/prospective), or data provenance are given.

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

• Cannot be provided. No test set or ground truth establishment process is described in the document.

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

• Cannot be provided. No test set or adjudication method 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:

• Cannot be provided. This device is a dental material (porcelain powder for clinical use), not an AI-powered diagnostic or therapeutic device. Therefore, a MRMC study or AI assistance is not applicable.

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

• Cannot be provided. This device is a dental material, not an algorithm.

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

• Cannot be provided. No specific ground truth methodology is described as there isn't a performance study in the document. The primary "truth" being established is substantial equivalence to predicate devices based on safety and intended use.

8. The sample size for the training set:

• Cannot be provided. No training set is applicable or described for this type of device.

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

• Cannot be provided. Not applicable.

In summary, the provided 510(k) pertains to a dental material (porcelain powder) and follows a substantial equivalence pathway, not a performance study with explicit acceptance criteria and detailed study results typical of more complex medical devices or software. The emphasis is on demonstrating that the device is safe and performs similarly to already legally marketed predicate devices, primarily through biocompatibility testing and a comparison of intended use and composition.

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Impressions for inlay, onlay, crown, and bridge restorations
Functional impressions
Fixation impressions
Implant impressions

PECD-01 and PECD Quick-01 are polyether tray impression materials of medium-bodied consistency. They are designed to be used in 3M ESPE's mixing, dosing and dispensing device, Garant™.

The provided text is a 510(k) summary for a dental impression material (PECD-01 and PECD Quick-01). As such, it focuses on demonstrating substantial equivalence to predicate devices rather than providing detailed acceptance criteria and study results in the manner typically found for a diagnostic device.

Therefore, many of the requested details about acceptance criteria, study methodologies, and performance metrics (especially those related to clinical accuracy, human reader performance, or ground truth derivation from pathology/outcomes data) are not present in this document. The safety and effectiveness are primarily established through biocompatibility testing and by demonstrating that the new device has the same fundamental scientific technology and intended use as the predicates, and that performance data are comparable.

Here's a breakdown of the information that can be extracted or inferred based on the provided text, and where information is missing:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present specific numerical acceptance criteria or detailed performance metrics. The primary "acceptance criteria" presented is substantial equivalence to the predicate devices based on chemistry, performance data, and indications for use.

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. The document refers to "biocompatibility testing" and "performance data" without detailing the number of samples or tests conducted.
• Data Provenance: Not explicitly stated. The submitting company is 3M ESPE AG, based in Germany. It is reasonable to infer the testing was likely conducted in Germany or a location affiliated with the manufacturer, but this is not explicitly mentioned. No information on retrospective or prospective studies.

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)

• Not applicable / Not specified. This type of study (e.g., involving expert consensus for ground truth) is typically associated with diagnostic devices, not material science evaluations of dental impression materials for 510(k) submission where "substantial equivalence" is the primary goal.

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

• Not applicable / Not specified. Adjudication methods are relevant for studies involving human interpretation or subjective assessments, which are not detailed for this material science submission.

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 is not a diagnostic device or an AI-assisted tool. Therefore, an MRMC comparative effectiveness study is not relevant and was not performed.

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

• No. This is a material, not an algorithm.

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

For biocompatibility testing, the "ground truth" would be established by standardized toxicological and biological tests according to relevant ISO standards (e.g., ISO 10993 series), comparing results against established safety limits or predicate device performance. For "performance data" (e.g., physical properties), the ground truth would be established by standard test methods (e.g., ISO 4823 for dental elastomeric impression materials) measuring specific properties and comparing them to predicate devices or industry standards. The document does not specify these standards or the exact "ground truth" used beyond stating "biocompatibility testing" and "performance data" were conducted.

8. The sample size for the training set

• Not applicable / Not specified. This is not a machine learning or AI device that requires training data.

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

• Not applicable / Not specified. This is not a machine learning or AI device.

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The Lava™ system is intended for CAD/CAM fabrication of all-ceramic dental restorations. The system is used for the manufacturing of inlays, onlays, veneers, crowns and bridges.

Lava™ Frame and Lava™ Frame Shade are intended for the manufacturing of abutments.

The titanium connection for the abutment must meet the following dimensions:

• Overall cementation surface > 30 mm²
• Height of the head of the titanium interface from the shoulder > 2.8 mm

The following systems fulfill the above described specifications:

Co. Alitec Dental GmbH: Camlog Titanium base for Ceramic abutment. Abutment ø ≥ 4.3 mm

• Co. Alltec Dental GmbH: Camlog Titanium-base for Ceramic-abutment - Abutment a ≥ 4.3 mm

• Co. Dentsply Friadent GmbH: Friadent Cera Base

• Co. Neoss GmbH: Neo Link Neoss Mono Abutment Titanium; Neo Link Neoss Multi Abutment Titanium; Neo Link Neoss Mono Aesthetic Abutment Titanium; Neo Link Neoss Multi Aesthetic Abutment Titanium; Matrix Abutment Hex - Regular Mono Titan; Matrix Abutment Hex - Regular Multi Titan; Matrix Abutment Hex - Narrow Mono Titan; Matrix Abutment Hex - Narrow Multi Titan; Matrix Abutment C-Lect - Regular Mono Titan; Matrix Abutment, C-Lect - Regular Multi Titan; Matrix Abutment C-Lect - Narrow Mono Titan; Matrix Abutment C-Lect - Narrow Mono Titan; Matrix Abutment ST - Mono Titan; Matrix Abutment ST - Mono Titan

Lava™ abutment made from Lava™ Frame zirconia mill blanks and dyed with Lava™ Frame Shade is classified as cndosseous dental implant abutment (21 C.F.R. § 872.3630) because it is a prosthetic component directly connected to the endosseous dental implant and is intended for use as an aid in prosthetic rehabilitation.

Lava™ Frame and Lava™ Frame Shade are parts of the Lava™ system (K011394). Lava™ Frame Zirconia mill blanks are used for the fabrication of frameworks for allceramic restorations. The frameworks for onlays, inlays, veneers, crowns and bridges are designed and manufactured by CAD/CAM technology, whereas the CAM fabricated Lava™ Abutments made from Lava™ Frame Zirconia mill blanks will be designed by means of a traditional wax up technique. The wax up will be scanned (Lava™ Scan, K062493) and milled without any further design step in the CNC milling unit Lava™ Form. After milling, the abutments are dyed with one of the 7 Lavat 10 Frame Shade dyeing liquids as required to achieve the desired tooth color, then sintered. The dyed abutments are sintered using the specialized program of the Lava™ Therm sintering furnace.

The wax up designed abutment will be cemented to a titanium interface which will be subsequently screwed into the respective implant (e.g. Camlog, Altatec Biotechnologies).

The provided text is a 510(k) Summary and FDA clearance letter for a dental device called "Lava™ Frame, Lava™ Frame Shade." This document describes the device and its intended use, but it does NOT include any information about acceptance criteria, device performance studies, sample sizes, expert ground truth, or adjudication methods.

Therefore, I cannot fulfill your request for that specific information based on the text provided. The document focuses on demonstrating substantial equivalence to a predicate device rather than providing a detailed study report of a device's performance against specific acceptance criteria.

The 510(k) summary only states: "In summary, it can be concluded that safety and effectiveness requirements for Laya™ Frame and Lava™ Frame Shade for the fabrication of abutments are completely met." This is a general statement of compliance, not a report on specific performance metrics or studies.

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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 and metal.

TempXN28 is a temporary crown and bridge resin intended to make a temporary prosthesis, such as a crown or bridge, for use until a permanent restoration is fabricated. Temporary crown and bridge resin is designated at 21 C.F.R § 872.3770 as a Class II device.
Like Protemp™ 3 Garant™, TempXN28 is available in the proven Garant™ mixing and dispensing system.

The provided text is a 510(k) Summary for a dental material (TempXN28) and not a study describing the performance of an AI/ML powered device. As such, the requested information pertaining to AI/ML device acceptance criteria, study design, and performance metrics (e.g., sample size for test set, ground truth establishment, MRMC studies, standalone performance) is not available in the given document.

The document discusses the safety and effectiveness of the dental material TempXN28 by demonstrating its substantial equivalence to predicate devices (Protemp™ 3 Garant™, Luxatemp Fluorescence, and Sinfony).

Here's what can be extracted and what cannot:

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

• Acceptance Criteria: Not explicitly stated as quantifiable metrics for a software/AI device. For this dental material, acceptance criteria would typically involve biocompatibility, mechanical properties (e.g., flexural strength, wear resistance), polishability, color stability, and ease of use, all within acceptable ranges or comparable to predicate devices.
• Reported Device Performance: The document generally states: "To provide evidence for safety biocompatibility testing was carried out. The results show that TempXN28 is a safe device. The comparison for chemistry, performance data and indications for use shows that TempXN28 is substantially equivalent to the predicate devices."
  • No specific performance values (e.g., strength in MPa, fill rate, etc.) are provided in this summary.

The following questions cannot be answered from the provided text as they relate to AI/ML device evaluation, which is not the subject of this 510(k) summary:

2. Sample size used for the test set and the data provenance.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts.
4. Adjudication method for the test set.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, and the effect size.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.).
8. The sample size for the training set.
9. How the ground truth for the training set was established.

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• All classes of fillings (according to Black) with lightcuring composite or compomer
• Cementation of indirect restorations made of composite or compomer, ceramic, and metal using RelyX™ ARC, manufactured by 3M ESPE
• Core build-ups made of light-curing composite
• Root surface desensitization
• Repair of composite or compomer fillings
• Repair of restorations veneered with composite or ceramic
• Bonding orthodontic appliances to teeth for orthodontic treatment

Uno is classified Resin Tooth Bonding Agent (21 C.F.R. § 872.3200) because it is a device intended to be painted on the interior of a prepared cavity of a tooth to improve retention of restorative materials (compomer and composite restorative material). Like Adper Prompt L-Pop, 3M ESPE's well-known and well-established resin bonding agent, Uno offers the advantages of a simplified bonding procedure, eliminating the need for a separate etching step. Thus it reduces both possible errors during application and post-operative sensitivity. Additionally, it saves the dentist valuable chair time. Being based on methacrylate chemistry itself, Uno is well suited for bonding methacrylate based composites to dentin and enamel. Uno is also indicated to seal sensitive root surfaces as is Adper Prompt L-Pop. Furthermore, Uno is suited to bond orthodontic appliances to teeth for orthodontic treatment as is Prompt L-Pop. Like Adper Prompt L-Pop, Uno will be available in single dose applicators and in a vial version.

This document pertains to a 510(k) summary for a dental adhesive product called "Uno" and does not contain information about the acceptance criteria or a study proving its performance against such criteria in the context of an AI/ML device.

The provided text describes a "Resin Tooth Bonding Agent" and its substantial equivalence to predicate devices, focusing on its chemical composition, intended use (bonding restorative materials, sealing root surfaces, bonding orthodontic appliances), and biocompatibility.

Therefore, I cannot provide the requested information, such as:

• A table of acceptance criteria and reported device performance: This document is for a physical dental adhesive, not an AI/ML device.
• Sample size, data provenance, number of experts, adjudication method, MRMC studies, standalone performance, type of ground truth, training set size, or ground truth establishment for a test set: These concepts are relevant to the evaluation of AI/ML devices, not a resin tooth bonding agent.

The document states, "To provide evidence for safety biocompatibility testing was carried out. The results show that Uno is a safe device." This is the extent of any "study" mentioned, and it only addresses biocompatibility for safety, not performance against specific clinical efficacy metrics. The primary mechanism for clearance is demonstrating "substantial equivalence" to existing, legally marketed predicate devices.

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