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DuoCem is indicated for:

• permanent cementing of crowns, inlays, onlays (ceramic, metal, composite)
• permanent cementing of root posts of all types

Not Found

The provided text is a 510(k) premarket notification letter from the FDA regarding a dental cement called DuoCem. It determines substantial equivalence for the device based on its indications for use.

Crucially, the provided text does not contain any information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert involvement. This document is a regulatory approval letter, not a scientific study report.

Therefore, I cannot answer the requested questions with the given input.

To answer those questions, I would need a different document, such as:

• A clinical study report
• A performance testing report
• A premarket notification (510(k)) summary that includes detailed performance data.

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BRILLIANT EverGlow Bleach (BL), A1/B1, A2/B2, A3/D3, A3,5/B3, C2/C3, A4/C4 are indicated for:

• Direct filling of class I, II, III, IV and V cavities
• Cementation and repair of composite and ceramic restorations (e.g. COMPONEER)

BRILLIANT EverGlow Translucent (Trans) and Bleach Translucent (BL Trans) are indicated for:

• Shape and color corrections to enhance the individual esthetics
• Reconstruction of incisal edges
• Cementation and repair of composite and ceramic restorations (e.g. COMPONEER)

Not Found

This document is a 510(k) clearance letter from the FDA for a dental material called BRILLIANT EverGlow. It does not contain information about acceptance criteria or a study proving that a device meets acceptance criteria.

The information provided describes:

• The FDA's decision that the BRILLIANT EverGlow material is "substantially equivalent" to legally marketed predicate devices.
• The regulation number and name for the material (21 CFR 872.3690, Tooth shade resin material).
• The intended uses for the BRILLIANT EverGlow material, which are direct filling of various classes of cavities, as well as cementation and repair of composite and ceramic restorations.

Therefore, I cannot fulfill your request to describe acceptance criteria and a study proving a device meets acceptance criteria based on the provided text, as it concerns a dental material's substantial equivalence to existing products, not a device study with the requested metrics.

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Fill-Up! is indicated for - direct restoration of class I and II cavities - cavity lining - first layer for class I and II cavities - core build-ups

Not Found

The provided document is a 510(k) clearance letter from the FDA for a dental material (Fill-Up!), not a study describing the acceptance criteria and performance of a device. Therefore, I cannot extract the requested information regarding acceptance criteria, study details, sample sizes, expert qualifications, or ground truth from this document.

The letter merely states that the device is substantially equivalent to legally marketed predicate devices for the indicated uses. It does not contain any performance data, study designs, or statistical analyses typically found in a clinical or performance study report.

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The BioSonic Suvi ultrasonic scaler is intended for use in dental applications such as supra and subgingival scaling, periodontal therapy, endodontic procedures, cavity preparation, and restorative dentistry.

The BioSonic Suvi Air Polisher is intended for use in the cleaning, surface preparation and polishing of teeth by the projection of water, air and dental powders onto the tooth surface. The device removes dental plaque, soft deposits, and surface stains from pits, grooves, interproximal spaces or smooth surfaces of teeth. The BioSonic Suvi Air Polisher is also indicated for the nonsurgical removal of subgingival plaque in pockets up to 5 mm after initial periodontal treatment.

The BioSonic Suvi Piezoelectric Scaler and Air Polisher (BioSonic Suvi) is a combination scaler and polisher device for use in dental care. It combines the functions of an ultrasonic scaler and dental air polisher into a single device.

The scaler is used for removal of tartar or calculus on teeth and other dental work where ultrasonic vibration is beneficial. The polisher unit is used for removal of plaque, cleaning discolored teeth and other dental work where air polishing is beneficial.

The BioSonic Suyi will be offered in (4) four different models. These are the BioSonic Suvi Premier, BioSonic Suvi Premier Plus, BioSonic Suvi Elite and the BioSonic Suvi Elite Plus. The Premier and Premier Plus are scalers only. The Elite and Elite Plus are combination scaler and polisher units

The Premier and Plus versions differ in whether they include a standard tap water supply attachment or an optional medicament dispenser system. The standard tap water versions connect directly to a tap water supply using a hose connection. The medicament dispenser system provides either medicine or clean water using a medicament bottle which connects to the side of the unit.

The medicament versions utilize an internal air compressor to pressurize the medicament. During use, compressed air forces fluids from the bottle, through the hose, to the hand piece and the tip/nozzle. Thus medication can be provided if desired.

The provided document is a 510(k) summary for the BioSonic Suvi Piezoelectric Scaler and Polisher. It focuses on demonstrating substantial equivalence to a predicate device rather than presenting a detailed study proving the device meets specific acceptance criteria through a clinical or non-clinical performance study with defined metrics.

Therefore, many of the requested details about acceptance criteria, sample sizes, expert involvement, and ground truth establishment for a performance study are not available in this type of regulatory submission. The document primarily describes the device, its intended use, and compares it to a legally marketed predicate device.

However, I can extract the information that is present and indicate where the requested information is not provided.

1. Table of Acceptance Criteria and Reported Device Performance

Missing Information:

• Specific quantitative or qualitative acceptance criteria beyond compliance with the listed standards.
• Detailed performance metrics (e.g., scaling efficiency, polishing effectiveness, plaque removal percentage, etc.) are not provided. The document focuses on safety and general functional equivalence.

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

Not applicable/Not provided. This document describes non-clinical testing for compliance with general safety and EMC standards, and a comparison to a predicate device for substantial equivalence. It does not refer to a test set in the context of a clinical performance study involving human or biological samples. The testing appears to be bench testing.

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

Not applicable/Not provided. There is no mention of experts establishing ground truth for a test set in the context of a clinical/performance study.

4. Adjudication Method for the Test Set

Not applicable/Not 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

Not applicable/Not provided. This device is a medical instrument (scaler and polisher), not an AI-powered diagnostic or assistive technology for human readers. Therefore, an MRMC study related to AI assistance is not relevant or described.

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

Not applicable/Not provided. This device is a physical instrument for dental procedures, not an algorithm.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

Not applicable/Not provided. For the non-clinical testing, the "ground truth" would be the successful demonstration of compliance with the specified IEC and EN standards, which are engineering and safety standards, not clinical ground truth.

8. The Sample Size for the Training Set

Not applicable/Not provided. This device is not an AI/ML algorithm that requires a training set.

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

Not applicable/Not provided. This device is not an AI/ML algorithm.

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SoloCem is indicated for

• permanent cementation of root posts of all types
• permanent cementation of crowns, bridges, inlays, onlays
• permanent cementation of implant abutments

Not Found

I am sorry, but the provided text is a 510(k) premarket notification approval letter from the FDA for a dental cement called SoloCem. This document focuses on the regulatory approval process and does not contain detailed information about specific acceptance criteria for a device's performance, nor does it describe a study proving the device meets particular criteria.

Therefore, I cannot extract the requested information such as a table of acceptance criteria, device performance, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, or training set details.

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• -restoration therapy for caries
• -optimisation of old restorations
• -tooth fractures
• -extending incisors
• -malpositioned teeth
• -tooth discoloration, incorrect shading
• -anatomical malformation
• -diasteme
• -attrition, abrasion, erosion
• -cosmetic correction

COMPONEER are polymerised, radio-opaque composite shells

This document is a 510(k) premarket notification decision letter from the FDA regarding a dental device called COMPONEER. It does not contain information about the acceptance criteria or a study proving the device meets said criteria for an AI/ML powered medical device.

The document states that the device is "substantially equivalent" to legally marketed predicate devices, which is a regulatory determination based on comparing the new device to existing ones, rather than through a study with specified acceptance criteria for algorithm performance.

Therefore, I cannot extract the requested information from this document.

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TempoSIL 2 is indicated for

• temporary cementation of provisional restorations
• temporary cementation of provisional restorations on implant abutments
• temporary cementation of final crown and bridges
• temporary cementation of final crowns and bridges on implant abutments

Not Found

I am sorry, but based on the provided text, there is no information about the acceptance criteria or a study that proves the device meets any acceptance criteria.

The document is a 510(k) premarket notification letter from the FDA to Coltene/Whaledent AG for a dental cement called "Temposil 2". It states that the device is substantially equivalent to legally marketed predicate devices. The letter primarily focuses on regulatory compliance, outlining the requirements for marketing the device under the Federal Food, Drug, and Cosmetic Act.

The document includes:

• The trade/device name: Temposil 2
• Regulation Number and Name: 872.3275, Dental Cement
• Regulatory Class: II
• Product Code: EMA
• Date of FDA review and receipt of the notification.
• A confirmation of substantial equivalence.
• A list of general controls and additional controls the device may be subject to.
• Contact information for various FDA offices.
• The Indications for Use statement for TempoSIL 2.

There is no mention of:

1. A table of acceptance criteria and reported device performance.
2. Sample sizes for a test set or data provenance.
3. Number and qualifications of experts for ground truth establishment.
4. Adjudication methods.
5. Multi-reader multi-case (MRMC) comparative effectiveness studies.
6. Standalone algorithm performance studies.
7. Type of ground truth used.
8. Sample size for the training set.
9. How ground truth for the training set was established.

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The PerFect® TCS II is intended to cut or remove soft tissue or to control bleeding during dental and periodontal surgical procedures in the oral cavity.

PerFect® TCS II is an electrosurge unit designed to appeal to both the new and experienced user of electrosurgery. PerFect® TCS II can simplify and enhance the results of a variety of everyday procedures performed by virtually every dentist, including the control of bleeding, gaining access to caries and aesthetic contouring of gingiva.

The PerFect® TCS II is an AC-powered device consisting of a controlled power source and a set of cutting and coagulating electrodes. The radio-frequency energy used by PerFect® TCS II is able to sever and coagulate tissue because it focuses the heat energy at the small, active electrode. While the active electrode remains cold, sufficient heat energy is generated in its path to sever and coagulate effectively.

The high-frequency energy focused at the active electrode returns to the electrosurge through the large dispersive electrode, which is placed on the back of the dental chair against the patient's back during use. The PerFect® TCS II has two output modes: "Cut" and "Coag." The operator can adjust the intensity of these modes. When the power output is adjusted properly, the electrode cuts without resistance, permitting an extraordinary degree of control and precision.

The PerFect® TCS II is designed to use the Strobex (predicate) handpiece electrodes. These handpiece electrodes have not changed in biocompatibility materials (stainless steel) or in the manufacturing process. In addition performance testing was conducted by UL that included functional testing of electrodes sterilized twenty times via the recommended cycle.

Here's an analysis of the acceptance criteria and supporting study for the PerFect® Tissue Contouring System II, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

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

The provided documentation does not specify a discrete "test set" sample size for a clinical or in-vitro study involving patient data or images. The performance testing primarily focused on engineering and electrical safety standards compliance rather than a typical clinical evaluation with a test set of cases.

The provenance of data is therefore not applicable in the usual sense of clinical trial data. The compliance testing was performed by Underwriters Laboratories Inc. Melville Division in the USA.

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

This information is not applicable as the study described is primarily an engineering and electrical safety compliance assessment, not a clinical study requiring expert labeling or adjudication of medical cases.

4. Adjudication Method

This information is not applicable for the same reason as point 3.

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

No, an MRMC comparative effectiveness study was not conducted. The submission focuses on demonstrating substantial equivalence through technical and safety performance, not on comparing reader performance with and without AI assistance. The device is an electrosurgical unit, not an AI-powered diagnostic tool.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

No, a standalone algorithm performance study was not conducted. The device is a physical electrosurgical unit, not an algorithm.

7. The Type of Ground Truth Used

The "ground truth" for this device's evaluation was primarily defined by:

• Recognized International and National Electrical Safety Standards: Such as IEC 60601-1, IEC 60601-2-2, EN55011, EN60601-1-2, CAN/CSA C22.2 series. Compliance with these standards served as the basis for safety and performance "truth."
• Predicate Device Performance: The functional capabilities and safety profile of the Strobex Ultron Electrosurge Unit (K850666) served as the benchmark for demonstrating "equally effective" performance.
• Functional Testing Results: The ability of electrodes to maintain function after repeated sterilization cycles.

8. The Sample Size for the Training Set

This information is not applicable. The PerFect® TCS II is an electrosurgical unit, not a machine learning model, so there is no concept of a "training set" in this submission.

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

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

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ParaPost ParaCore automix 5ml is indicated for core build-ups and cementation of posts

Not Found

The provided text is a 510(k) premarket notification letter from the FDA to Coltene/Whaledent AG regarding their device, ParaPost ParaCore Automix 5ml. This document primarily focuses on the FDA's determination of substantial equivalence to a predicate device and provides regulatory guidance.

It does not contain any information about acceptance criteria for device performance, study details, sample sizes, data provenance, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth establishment.

Therefore, I cannot fulfill your request for a table of acceptance criteria and reported device performance or other study-related details based on the provided text.

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