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• Bonding of direct composite, Polyglas® and compomer restorations .
• Bonding of indirect laboratory-fabricated ceramic, Polyglas and composite . restorations (inlays, onlays, veneers and crowns)
• 0 Treatment of hypersensitive tooth regions

iBond Total Etch is an improved light-component adhesive for use in adhesive restorative dentistry and was developed within the scope of the project IBTE on the base of an ethanol solution of light-activated, adhesive resins The material is characterized by the following properties in detail

• The material has been developed for the adhesive bonding of plastic filling materials (e g ♥ composites, comporner, Polyglas ) to dental hard substance and laboratory-fabricated restorations (e g ceramics)
• With IBOND Total Etch, priming, bonding and desensitizing can be done in one step .
• Before using IBOND Total Etch, the dental hard substance is conditioned with iBOND Etch 35 Gel (etch&rinse)
  In its unpolymenzed state, the adhesive matenal is workable smilar to current products Cross linking reaction is initiated with light curing (QTH, LED) devices customary in dental technology Cross-Iniking of the methacrylate monomers occurs very fast, ensurng reliable curing of the adheswe layer
  Thus, a highly cross-linked material results, fully complying with the mechanical requirements for a dental adhesive matenal

1. Table of Acceptance Criteria and Reported Device Performance:

The provided document does not explicitly state quantitative acceptance criteria or a dedicated performance table for iBOND Total Etch. Instead, it relies on comparative evaluations and conformity to established standards for dental materials.

2. Sample Size for Test Set and Data Provenance:

The document does not specify a sample size for any "test set" in the context of an algorithmic or AI-based device. This document describes a traditional medical device (dental adhesive) and its evaluation.

There is no data provenance information (country of origin, retrospective/prospective) for a "test set" as this type of study design is not applicable to the evaluation described.

3. Number of Experts and Qualifications for Ground Truth:

The document mentions an "expert" for the clinical evaluation who states a positive risk-benefit ratio. However, it does not specify the number of experts used to establish ground truth or their specific qualifications (e.g., number of years of experience, specific medical specialty).

4. Adjudication Method for Test Set:

An adjudication method is not applicable to the evaluation described in this document, as it is not an AI/algorithmic device requiring consensus on diagnostic labels from a test set.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

A MRMC comparative effectiveness study was not conducted as this is not an AI-assisted device. The document describes a dental adhesive material.

6. Standalone (Algorithm Only) Performance Study:

A standalone performance study was not conducted as this is not an AI/algorithmic device.

7. Type of Ground Truth Used:

The "ground truth" for this device's evaluation is primarily based on:
* Biocompatibility testing results against established international standards (DIN EN ISO 10993).
* Laboratory-measured physical properties of the material compared to established products.
* Clinical evaluation based on scientific data and technical results, assessed for safety and effectiveness in its intended use, likely drawing upon existing literature and expert judgment.
* Risk analysis outcomes according to DIN EN ISO 14971.

8. Sample Size for Training Set:

The document does not mention a training set as this is not an AI/algorithmic device.

9. How Ground Truth for Training Set Was Established:

This information is not applicable as there is no training set for an AI model. The evaluation of this device relies on standard medical device testing and clinical evaluation processes, not machine learning model training.

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CutterSil Activator Universal Plus paste and liquid are used as a catalyst to induce polymerization of the CutterSil base paste which is used for all inlay, crown and bridge, partial and edentulous impressions.

Hardener Universal Plus (Liquid and Paste) (identical with Activator Universal Plus, Liquid and Paste) is the catalyst of the two component condensation curing silicone dental impression material Cuttersil (hardener and base paste and hardener are mixed before use according to the instruction of use.

Here's an analysis of the provided text regarding the acceptance criteria and study for the Hardener Universal Plus:

Device: Hardener Universal Plus (Liquid and Paste)

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not explicitly state the numerical sample size for the test set regarding the physical properties or biocompatibility. It states that "test data" was used (Section 4) and that the biocompatibility was "verified" and "documented in a Biological Evaluation Report" (Section 3).

Data Provenance: The manufacturer, Heraeus Kulzer GmbH, is based in Dormagen, Germany. The evaluations mention compliance with European medical device legislation (Medical Device Directive 93/42/EWG) and international standards (EN ISO), suggesting the data originates from studies conducted or accepted within the European context. The document itself is a 510(k) Summary, which is a submission to the US FDA, so the data is being presented for US regulatory review. The type of data appears to be retrospective in the sense that the studies (biocompatibility, physical properties) were completed prior to this submission.

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

• Toxicological Expert Opinions: "In addition toxicological expert opinions are carried out to assess possible risks..." (Section 3). The number of experts is not specified, nor are their specific qualifications (e.g., years of experience, specific board certifications).
• Clinical Evaluation Expert: "...expert stated for hardener D B90/3 that the benefits overweight the possible risks if the product is applied according to the instruction for use." (Section 5). The number of experts is referred to in the singular ("expert"), and no specific qualifications are provided.

4. Adjudication Method for the Test Set

The document does not describe any specific adjudication method for establishing ground truth from multiple expert opinions (e.g., 2+1, 3+1). It refers to "expert opinions" (plural) for toxicology and a singular "expert" for the clinical evaluation conclusion. This suggests a potential lack of formal adjudication for consensus if multiple individual opinions were initially present.

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 section is not applicable. The device described is a dental impression material hardener. It is a material, not an AI-powered diagnostic or assistive device that would involve human "readers" or an MRMC study.

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

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

7. The Type of Ground Truth Used

• Physical Properties: The ground truth for physical properties was established by testing against established international standards (EN ISO 4823) and functional specifications. These standards define measurable parameters and acceptable ranges.
• Biocompatibility: The ground truth for biocompatibility was established by testing according to EN ISO 10993-1, which involves a series of standardized tests to assess biological responses.
• Toxicological Evaluation: Ground truth was established through toxicological expert opinions and risk assessments.
• Clinical Evaluation: Ground truth was established by an expert's conclusion based on evaluated data, clinical evaluation, and technical results, weighing benefits against risks. This leans towards expert consensus/opinion based on available evidence.

8. The Sample Size for the Training Set

This information is not provided and is likely not applicable in the typical sense of machine learning "training sets" as this is a material science and biocompatibility assessment, not an AI/algorithm development. The "training" in this context would refer to the development and formulation of the hardener itself, which is not quantified by a sample size in this document.

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

As with point 8, this is not explicitly stated or readily applicable in the context of this device type. The "ground truth" for the development (or "training") of a material like this would involve iterative testing and refinement based on desired physical properties, handling characteristics, and biocompatibility, continuously measured against industry standards and internal specifications.

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Direct restorations of Black classes I V. ●
Direct composite veneers .
Shape corrections of teeth .
Temporary splinting of teeth loosened by trauma or periodontal disease .
. Indirect restorations (inlays, veneers)
. Restoration of primary teeth
Core build-up .
Temporary repairs of composite and ceramics (in combination with a suitable . repair system)

An improved light curing dental filling composite was developed within the scope of the project NEUN on the base of customary radical cross linking (meth)-acrylate monomers and dental glass fillers. The material is characterized by the following properties in detail:

• The material is a light curing nano hybride composite. .
• . The monomer matrix included is a particularly low-shrink mixture of polyether and urethane monomers preponderantly.
• A special TCD backbone monomer makes the excellent mechanical properties and the low . shrinkage possible. (TCD = tricyclodecane)
• . The composite material does not contain any Bis-GMA monomer making it toxicologically advantageous, as no Bisphenol-A can be released.
• The filler contained is a mixture of various particle size fractions of a customary, radiopaque dental . alass.
• The composite material contains non-agglomerated nano particles cross-linking to the polymer . network.
• . The material has a pasty consistency and can be applied plastically into the cavity. It is hardly sticky, packable, can be moulded, cured by blue light and polished with common systems.
• . Handling is comparable with customary light curing dental composite materials. For deeper cavities layering technique is recommended.
  In its unpolymerized state, the composite material is plastically workable (pliable) similar to current products. Using a special initiator system reduced the sensitivity to ambient light. Cross-linking reaction is initiated with light curing devices (QTH, LED) customary in dental technology. Radical cross-linking of the (meth)- acrylate monomers occurs very fast, ensuring complete curing of a layer with a thickness of over 2 mm in an irradiation time of 20 seconds.
  Thus, a highly cross-linked composite material results, fully complying with the mechanical requirements for a dental filling material in the Black classes I, II, III, IV and V according to the international standard EN ISO 4049.

The provided text describes a new dental filling composite named NEUN and its evaluation for regulatory clearance. Here's a breakdown of the acceptance criteria and the study performed, based only on the provided information:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are primarily based on established international standards for dental restorative materials.

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

The document does not explicitly state the sample size for any specific test set in the context of clinical or physical property evaluation. It refers to "in-vitro tests" for physical properties and "clinical studies" and a "clinical investigation report" for clinical evaluation.

• Physical Properties: "All important properties were proved with in-vitro tests." No sample size is given.
• Biocompatibility: "The biological compatibility... was verified in accordance with the international standard." "A certified laboratory has confirmed the prototype of NEUN meets the requirements of the DIN EN ISO 10993 standard." No specific sample size or data provenance (e.g., country of origin, retrospective/prospective) for the biocompatibility testing is provided, beyond the mention of a "laboratory prototype" and a "prototype from the production."
• Clinical Evaluation: "Based on the results of the clinical studies..." No sample size or data provenance is detailed for the clinical studies mentioned. The clinical evaluation followed MEDDEV 2.7.1.

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

• Biocompatibility: The evaluation was conducted by a "certified laboratory." The "benefit/risk-relation has to be judged as positive" and was "discussed in a Biological Evaluation Report." No specific number or qualifications of experts involved in establishing ground truth for biocompatibility were explicitly stated, beyond the implicit expertise of a certified laboratory.
• Clinical Evaluation: "Therefore, a positive risks versus benefits ratio can be stated by the Expert for NEUN..." This indicates at least one "Expert" was involved in the clinical evaluation. No specific qualifications (e.g., "radiologist with 10 years of experience") are provided for this expert.

4. Adjudication Method for the Test Set

The document does not explicitly mention any adjudication method (e.g., 2+1, 3+1) for establishing ground truth in any of the evaluations (biocompatibility, physical properties, or clinical evaluation).

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

No, the document does not mention a Multi Reader Multi Case (MRMC) comparative effectiveness study. The evaluation focuses on the performance of NEUN against established standards and competitor materials, not on human readers' improvement with or without AI assistance.

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

This device is a dental composite material, not an AI algorithm. Therefore, the concept of "standalone (algorithm only without human-in-the-loop performance)" does not apply to this device. The physical and clinical evaluations are about the material itself.

7. The Type of Ground Truth Used

• Biocompatibility: Ground truth was established based on compliance with the DIN EN ISO 10993 standard and the toxicological assessment results from the certified laboratory.
• Physical Properties: Ground truth was established by compliance with the EN ISO 4049 standard and comparison with "best competitor materials" and "registered and commercially available products" via "in-vitro tests."
• Clinical Evaluation: Ground truth for clinical performance and safety was assessed through a "clinical evaluation in accordance with MEDDEV 2.7.1," which likely involved evaluating scientific data, clinical research, and technical results against established clinical benefits and potential risks, leading to an expert's conclusion on the benefit/risk ratio. This would typically be based on clinical outcomes and safety data and expert judgment.

8. The Sample Size for the Training Set

The document does not refer to a "training set" as this is a dental material, not a machine learning model.

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

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

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Retention Flow Opaque is a light curing, transparent component for filling undercut areas in retentions.

Not Found

I am sorry, but based on the provided text, I cannot provide the requested information. The document is an FDA 510(k) clearance letter for a dental device called "Retention Flow Opaque." It confirms the device's substantial equivalence to a predicate device but does not contain any details about:

• Acceptance criteria or reported device performance metrics.
• Specific studies (e.g., test set sample size, data provenance).
• Ground truth establishment details (number of experts, qualifications, adjudication method, type of ground truth).
• Whether MRMC or standalone performance studies were conducted, or any associated effect sizes.
• Training set details (sample size or ground truth establishment).

The letter primarily focuses on regulatory approval and compliance.

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OSTEOPAL® V bone cement is indicated for the treatment of pathological fractures of the vertebral body due to osteoporosis, cancer, or benign lesions using a vertebroplasty or balloon kyphoplasty procedure.

Osteopal® V is an acrylic cement for use in vertebroplasty and kyphoplasty. It is formed from powder and liquid by exothermic polymerization.

This 510(k) summary for Osteopal® V, a PMMA bone cement, does not contain the kind of study information requested.

The document is a premarket notification for a medical device (bone cement) that is claiming substantial equivalence to a predicate device (Osteopal®) based on a change in a material characteristic (higher zirconium dioxide content for better X-ray contrast and lower viscosity). Therefore, the provided text describes the device, its intended use, and its comparison to a predicate device but does not include any studies related to its performance in terms of diagnostic accuracy or clinical effectiveness, which would typically involve acceptance criteria and performance data.

Specifically, the requested information elements are not present because this is a 510(k) submission for a physical device that is not an AI/ML diagnostic tool, and thus does not involve "acceptance criteria and reported device performance" in the way that an AI model would be evaluated.

Therefore, I cannot provide the requested information from the given text.

Here's why the specific questions cannot be answered:

1. A table of acceptance criteria and the reported device performance: This document is about a material (bone cement) and its physical characteristics, not a diagnostic device with performance metrics like sensitivity or specificity.
2. Sample size used for the test set and the data provenance: There is no "test set" in the context of an AI/ML algorithm being evaluated.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
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.
8. The sample size for the training set: Not applicable.
9. How the ground truth for the training set was established: Not applicable.

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PALAMED® G is indicated for use in the second stage of a two stage revision for total joint arthroplasty after the initial infection has been cleared.

PALAMED® G is an acrylic bone cement for use in orthopedic surgery. It is formed from powder and liquid by exothermic polymerization. It secures the fixation of the grafted artificial joint improving the transfer of forces at the interface implant - bone.

This document is a 510(k) premarket notification for a medical device (Palamed® G bone cement), not a study report or clinical trial. Therefore, it does not contain the structured information typically found in a study describing acceptance criteria and device performance based on a specific study.

The document primarily focuses on establishing "substantial equivalence" to a predicate device (PALACOS® R BONE CEMENT), meaning it asserts that the new device is as safe and effective as a legally marketed device.

Here's a breakdown of why the requested information is not available in this document:

• No Acceptance Criteria or Reported Device Performance Table: The document does not present a table of specific acceptance criteria (e.g., mechanical strength thresholds, elution rates, etc.) nor does it report detailed performance metrics for Palamed® G against such criteria. The comparison is made at a higher level, stating "Palamed® G performs very similar to Palacos R."
• No Specific Study Details (Sample Size, Data Provenance, Experts, Adjudication, MRMC, Standalone Performance, Ground Truth for Test or Training Sets): Since this is a 510(k) summary focusing on equivalence, it does not describe a clinical study or a detailed technical performance study with the granularity you've requested.
  • There is no mention of a specific test set sample size, data provenance, number or qualifications of experts, or adjudication methods for establishing ground truth.
  • No MRMC comparative effectiveness study is described. The concept of "human readers improving with AI" is not applicable here as Palamed® G is a bone cement, not an AI-powered diagnostic device.
  • The document does not describe a "standalone" algorithm performance study for the same reason – it's a physical device, not an algorithm.
  • The type of ground truth used (e.g., pathology, outcomes data) is not discussed because no such study is presented.
  • There is no information on a training set sample size or how ground truth was established for a training set, as the device is not machine-learning based.

What the Document DOES provide related to performance:

• Comparison to Predicate Device: "Palamed® G is similar to Palacos R except for the additional gentamicin sulphate and a lower initial viscosity. Palamed® G performs very similar to Palacos R." This is the core "proof" of performance in a 510(k) – that it's equivalent to an already approved device.
• Intended Use: The cement is indicated for use in the second stage of a two-stage revision for total joint arthroplasty after the initial infection has been cleared. This defines the clinical context in which its performance is relevant.
• Reference to another 510(k): "See also K030904 (PALAMED)." This implies that some data or comparison for a similar device (PALAMED, without the 'G' perhaps) was submitted previously, and this submission might leverage or build upon that.

In summary, this document is a regulatory submission for substantial equivalence, not a detailed technical or clinical study report. It doesn't contain the granular information about acceptance criteria and study methodologies that you are seeking. To find such information, one would typically need to review the full 510(k) submission (which is usually much more extensive than the summary provided) or any associated pre-clinical or clinical study reports that were conducted to support the safety and effectiveness claims.

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PALACOS® LV + G is indicated for use in the second stage of a two stage revision for total joint arthroplasty after the initial infection has been cleared.

Palacos® LV + G is an acrylic bone cement for use in orthopedic surgery. It is formed from powder and liquid by exothermic polymerization. It secures the fixation of the grafted artificial joint improving the transfer of forces at the interface implant - bone.

The provided text is a 510(k) summary for PALACOS® LV + G bone cement. This document does not describe a study involving an algorithm or device performance in the context of diagnostic accuracy, image analysis, or similar applications where acceptance criteria and performance are typically measured with metrics like sensitivity, specificity, or AUC.

Instead, this 510(k) focuses on demonstrating substantial equivalence to a legally marketed predicate device (OSTEOPAL® K030903 and PMA P810020) for a medical device (bone cement). The primary "acceptance criteria" here is substantial equivalence to the predicate, with the main difference being the addition of gentamicin.

Therefore, many of the requested elements for describing an AI/algorithm study (such as sample size for test set, data provenance, number of experts, adjudication method, MRMC study, standalone performance, training set sample size, how ground truth for training was established) are not applicable to this type of regulatory submission.

However, I can extract the relevant information from the provided text regarding the device and its claimed equivalence.

Here's an interpretation of the request based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

For a 510(k) of a bone cement, "acceptance criteria" typically refer to demonstrating that the new device is as safe and effective as a predicate device. This is often done by comparing technological characteristics and, if applicable, performance in terms of mechanical properties or elution rates for antibiotic-loaded cement.

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

• Sample Size: Not applicable. This summary does not describe a clinical study with a "test set" in the context of an algorithm's performance. The review is based on a comparison of the device's characteristics to a predicate.
• Data Provenance: Not applicable. The submission is from Heraeus Kulzer GmbH, Germany.

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

• Not applicable. This is not a study assessing diagnostic accuracy or expert-adjudicated ground truth.

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

• Not applicable.

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

• Not applicable. This device is bone cement, not an AI or imaging diagnostic tool.

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

• Not applicable.

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

• Not applicable for this type of device and submission. The "ground truth" for the 510(k) process is the predicate device's established safety and effectiveness.

8. The sample size for the training set

• Not applicable.

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

• Not applicable.

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• Bonding of direct composite restorations (including Polyglas® and Compomer)
• Bonding of direct composite restoration with a light-curing luting cement:
• Bonding of indirect restoration in combination with a light-curing luting cement: Porcelain, Polyglas®, and composite restorations (inlays, onlays, veneers, crowns).
• Sealing hypersensitive areas of teeth.

Not Found

The input document does not contain information about the acceptance criteria or a study that proves the device meets the acceptance criteria. The document is a 510(k) premarket notification letter from the FDA to Heraeus Kulzer, Incorporated, regarding clearance for their "iBond™ Next Generation" resin tooth bonding agent. It outlines the regulatory classification, general controls, and indications for use of the device.

Therefore, I cannot extract the requested information from the provided text.

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Activator for light-induced intraoral polymerization of resin dental pit and fissure sealant, restorative materials, bonding , or luting materials.

Not Found

The provided document is a 510(k) clearance letter from the FDA for a dental curing light, the Translux® Power Blue. It states that the device is substantially equivalent to legally marketed predicate devices. However, this document does not contain any information regarding acceptance criteria or the study that proves the device meets specific performance criteria.

The 510(k) clearance process primarily focuses on demonstrating substantial equivalence to pre-existing, legally marketed devices. While manufacturers typically conduct internal testing to ensure their devices meet performance and safety standards, the FDA 510(k) summary (which is generally a separate document from the clearance letter itself) would contain details about such studies and acceptance criteria if they are deemed necessary for demonstrating substantial equivalence.

Therefore, I cannot provide the requested information based on the text you've provided. The document focuses on regulatory clearance, not detailed performance studies or specific acceptance criteria for the device itself.

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PALACOS G is indicated for use in the second stage of a two stage revision for total joint arthroplasty after the initial infection has been cleared.

Palacos® G is an acrylic bone cement for use in orthopedic surgery. It is formed from powder and liquid by exothermic polymerization. It secures the fixation of the grafted artificial joint improving the transfer of forces at the interface implant - bone.

The provided text is a 510(k) summary for a medical device called PALACOS® G, which is a bone cement. This document describes the device, its intended use, and its equivalence to a predicate device.

However, it does not contain any information regarding acceptance criteria, device performance studies, sample sizes, ground truth establishment, expert qualifications, adjudication methods, MRMC studies, or standalone performance. This type of information is typically found in the clinical or performance data sections of a 510(k) submission, which are not present in this summary.

Therefore, I cannot provide the requested table or detailed study information based on the provided text.

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