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Glazing of individually designed dental restorations from dental ceramics.

The CEREC SpeedGlaze Spray is used for coating dental restorations made from Sirona CAD/CAM materials. It is administered extra-orally and is indicated for crowns, inlays, onlays, partial crowns and bridges in the anterior and posterior tooth region.

The CEREC SpeedGlaze Spray is used to glaze dental restorations made from the Sirona CAD/CAM materials CEREC Zirconia, inCoris TZI C, CEREC Blocs C, CEREC Blocs C PC and CEREC Blocs C In. The spray meets the requirements of the ISO 6872:2008 "Dentistry - Ceramic materials". The product consists of a coated aluminum can cap, filled with a glaze and a valve and a spray nozzle, for applying the glaze. The CEREC Speed Glaze Spray is suitable for the coating of dental restorations from the Sirona CAD/CAM materials: CEREC Zirconia, inCoris TZI C, CEREC Blocs C, CEREC Blocs C PC and CEREC Blocs C In. The CEREC SpeedGlaze spray has to be administered extraorally.

It is indicated for the following parts of dentistry:

• crowns, inlays, onlays, partial crowns and bridges in the anterior and posterior tooth region.
  The product has 8 components as shown below:

1. Can: Aluminum monobloc spray can
2. Valve: For releasing the contents when engaged
3. Can cap PP - Polypropylene, Plastic
4. Spray nozzle: For spraying onto restoration
5. 14mm Glass balls For mixing of the components before spraying
6. Glaze Ceramic Silicate glass
7. Instruction for use Instructions for use document
8. Folding carton Package

The document describes the CEREC SpeedGlaze, a device used for glazing dental restorations, and its substantial equivalence to a predicate device (Nova Ceramic Spray Glaze). The information provided focuses on non-clinical performance data.

Acceptance Criteria and Device Performance:

Study Details:

The provided document describes non-clinical tests rather than a study with a test set of data as one might expect for an AI/device performance evaluation that applies to imaging or diagnostic devices. Instead, it describes laboratory-based performance testing of the physical, chemical, and biological properties of the CEREC SpeedGlaze.

1. Sample size used for the test set and the data provenance: Not explicitly an "imaging test set" in the traditional sense. The device itself (CEREC SpeedGlaze) and its components were subjected to various laboratory tests. The document does not specify the number of samples or batches tested for each property, nor does it mention data provenance (e.g., country of origin, retrospective/prospective).

2. 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 is based on established ISO and DIN standards for material properties, not expert interpretation of cases. The tests are laboratory-based measurements.

3. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable. The tests are objective measurements against defined standards.

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 a dental material (glaze), not an AI-assisted diagnostic or imaging system.

5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is a material testing, not an algorithmic performance evaluation.

6. The type of ground truth used (expert consensus, pathology, outcomes data, etc): The "ground truth" or reference for these performance tests are the requirements and methodologies stipulated in international standards such as ISO 6872, ISO 10993-5, and DIN 15169. For example, cytotoxicity is determined by meeting the criteria of ISO 10993-5, and bending strength by ISO 6872.

7. 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."

8. How the ground truth for the training set was established: Not applicable, as there is no training set.

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The dental treatment unit with accessories is intended to supply power to and serve as a base for dental devices and accessories. This product includes a dental chair. The dental treatment unit is intended for use in the dental clinic environment and is used by trained dentists and/or dental assistants.

The motors serve as drives for rotating and oscillating straight and contra-angle hand pieces in connection with a dental treatment unit. They are used for endodontic and general dental purposes.

The SPRAYVIT M multifunctional syringe is used for dental treatment with unheated air and heated water. It is also used to illuminate the preparation field.

The TENEO dental treatment unit is a dental operating system. The device includes a patient chair, foot control, dentist element, assistant element and a water unit. The unit may also include a dental operating light, and a monitor.

The provided text is a 510(k) Summary for the Sirona Dental Systems TENEO Dental Treatment Unit and Accessories. It focuses on demonstrating substantial equivalence to predicate devices, and as such, it does not contain the information requested about acceptance criteria and a study proving the device meets those criteria for software or AI performance.

Therefore, I cannot populate the table or answer the specific questions about acceptance criteria, study details, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth establishment.

The document primarily discusses:

• Intended Use and Device Description: What the device does and its components.
• Technological Characteristics Comparison: A detailed table comparing the TENEO device to two predicate devices (C8+ and A-DEC 200) across various features like dentist element, assistant element, chair, water unit, and general characteristics. This comparison is to establish substantial equivalence.
• Performance Data (General): It mentions a "clinical assessment has been conducted for the TENEO by a dentist," that a "test concept along with the acceptance criteria have been provided," and that "Additional information concerning system and component tests and traceability analysis has been provided." It also references sterilization and biocompatibility tests, and compliance with various international and national performance standards (ISO, AAMI, IEC, EN, DIN) related to dental units, biocompatibility, risk management, electrical safety, usability, software lifecycle, photobiological safety, and sterilization.

However, it does not provide the actual acceptance criteria values or the specific results of a study demonstrating fulfillment of those criteria in a quantitative manner. It certainly does not mention anything related to AI, machine learning, or algorithms.

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The INTEGO Family of Dental Treatment Units with accessories is intended to supply power to and serve as a base for dental devices and accessories. Each unit includes a dental chair. The units are intended for use in the dental clinic environment and are used by trained dentists and/or dental assistants.

The MOTOR BL ISO E is used to drive rotating and oscillating straight and contra-angle handpieces in connection with the dental treatment units for endodontic and general dental purposes.

The SPRAYVIT E multifunctional syringe is used for dental treatment with unheated air and unheated water. The SPRAYVIT E multifunctional syringe is also used to illuminate the preparation field.

The INTEGO family dental treatment unit is a dental operating system. INTEGO and INTEGO pro dental treatment units constitute the INTEGO Family. These are the successors of C8+. Components and functional principles are taken over or widely derived from this C8+. The units include a patient chair, foot control, dentist element and a water unit. The units may also include an assistant element, a cuspidor a dental operating light, and a monitor.

The design concept of the INTEGO treatment unit is similar to commonly available treatment units.

The dimensions of the components, their movements and shapes are designed for ergonomic treatment; i.e. the dentist and, where applicable, the assistant can perform their treatments in a healthy working posture.

Surfaces are smooth to enable easy cleaning and disinfecting. This simplifies, in line with detachable parts and barriers as well as simple maintenance routines, efficient infection control.

The operating concept is designed to make treatments easy and intuitive to prevent mal-operations and provide an unimpeded workflow. Depending on the selected foot control and user interface version, a significant portion of functions can be operated hands-free to improve infection control and treatment workflow.

Styling and colors were selected under aesthetic aspects.

The provided text is a 510(k) Summary for the Sirona Dental Systems INTEGO Family and Accessories. It focuses on demonstrating substantial equivalence to predicate devices rather than presenting a study with acceptance criteria and device performance in the way a clinical study for a novel device would.

Therefore, many of the requested elements (like sample size, number of experts, adjudication method, MRMC studies, standalone performance with metrics like AUC, sensitivity, specificity, ground truth type for test/training sets) are not applicable in this regulatory context, as it's a submission for a Class I device based on substantial equivalence, not a new high-risk device requiring extensive clinical validation.

However, I can extract information related to the device's adherence to relevant standards and its demonstrated equivalence.

Here's a breakdown of the available information:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are implicitly defined by the device's compliance with various national and international standards. The "Reported Device Performance" is stated by the manufacturer to be substantially equivalent to the predicate devices and compliant with these standards. Since this is a substantial equivalence submission, specific numerical performance metrics (e.g., sensitivity, specificity, accuracy) are not provided in the document for the device itself against a specific acceptance criterion.

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. This document describes a 510(k) submission for a Class I dental operative unit, not a device requiring clinical performance testing with test sets in the typical sense (e.g., for diagnostic accuracy). The evaluation is primarily based on compliance with recognized consensus standards and comparison of technological characteristics to predicate devices.

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

• Not Applicable. See point 2. The evaluation relied on "an evaluation using relevant literature and a critical appraisal of the Dental Treatment Unit and accessories by a medical professional." The number and specific qualifications of this medical professional are not detailed.

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

• Not Applicable. See point 2.

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 an AI/CADe/CADx device. No MRMC study was performed.

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

• Not Applicable. This is not an algorithmic device in the AI sense.

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

• Not Applicable in the traditional clinical validation sense. The "ground truth" for this type of submission is the established performance and safety demonstrated by predicate devices and the requirements set forth in the referenced consensus standards.

8. The sample size for the training set

• Not Applicable. This is not an AI/machine learning device that uses a "training set."

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

• Not Applicable. See point 8.

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The contra-angle handpieces are used to hold and drive burr instruments for the purposes of rotary processing. The handpieces are intended for dental applications in endodontics and for root canal measurement and are used by trained dental personnel in dental practices and laboratories. The T1 Spray is intended to be used to clean and lubricate dental handpieces.

Endo 6:1 is a contra-angle handpiece which is adapted to dental electric motors or dental air motors with the ISO 3964 interface. It is reusable and it does not have a fiber optic light system.
T1 LINE ENDO 6 L contra-angle handpiece is equipped with a fiber optic light system. It is also adapted to dental electric motors or dental air motors with the ISO 3964 interface. It is reusable.
SIRONiTi APEX contra-angle handpiece is adapted to dental electric motors with the ISO 3964 interface. It is reusable. SIRONiTi APEX is equipped with a torque limitation function. Once a set torque has been reached, a gold plated magnetic coupling prevents jamming of the file in the root canal by retro-rotation.
T1 Spray is the lubricant used for maintenance and cleaning of the drive channels of the handpieces.

The provided text is a 510(k) Summary for dental handpieces. This document focuses on demonstrating substantial equivalence to predicate devices based on design, function, and performance standards, rather than proving a device meets specific acceptance criteria based on clinical study performance of an AI-powered device.

Therefore, many of the requested categories for AI/clinical study performance (such as sample size for test/training sets, data provenance, number of experts for ground truth, adjudication methods, MRMC studies, standalone performance, and how ground truth was established) are not applicable to the information contained in this type of submission.

The document does not describe the acceptance criteria and a study proving the device meets those criteria in the context of an AI-powered medical device and its performance against a specific clinical outcome. Instead, it demonstrates compliance with recognized performance standards for dental handpieces.

However, I can extract the relevant information regarding the performance standards and a general conclusion of equivalency:

1. Table of Acceptance Criteria and Reported Device Performance:

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

• Not applicable for a 510(k) submission of this type of device. The compliance is based on meeting engineering and biocompatibility standards, not on clinical performance evaluations with a specific test set of patients/data. The "study" mentioned is conformity to existing standards, which implicitly involves testing the device against those standards.

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

• Not applicable. Ground truth in the context of clinical performance is not established here. The document mentions "An evaluation using relevant literature and a critical appraisal of the handpieces by a medical professional have been performed," but this is for overall assessment, not for establishing ground truth on a specific test set for an AI algorithm.

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:

• No. This is not an AI-powered device.

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

• No. This is not an AI-powered device.

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

• Not applicable. For this type of device, "ground truth" relates to the device successfully meeting the specifications outlined in the various ISO/DIN/AAMI standards (e.g., sterilization effectiveness, biocompatibility, mechanical performance as per ISO 14457).

8. The sample size for the training set:

• Not applicable. This is not an AI-powered device.

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

• Not applicable. This is not an AI-powered device.

Summary of the study that proves the device meets the acceptance criteria (from the text):

The device's performance is demonstrated through its compliance with a list of recognized national and international performance standards (listed in the table above). These standards cover aspects such as mechanical performance, biocompatibility, risk management, sterilization, labeling symbols, and quality management systems. The document states: "The Sirona Dental System T1 LINE Endo 6 L, ENDO 6:1 and SIRONiTi Apex contra-angle handpieces comply with the following performance standards." Additionally, "An evaluation using relevant literature and a critical appraisal of the handpieces by a medical professional have been performed." This implies that testing and evaluation against these standards were conducted to ensure the devices meet the specified requirements for safety and performance. The conclusion drawn is that "Based on a comparison of intended use, indications, principal of operations, features and technical data, the Sirona Dental Systems T1 LINE ENDO 6 L, ENDO 6:1 and SIRONiTi APEX are similar in design and function to the Predicate Devices. Therefore, the subject device is substantially equivalent to the predicate device."

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The X-ray system creates data for digital exposures in the maxillofacial area and in subareas for dentistry, including pediatric dentistry, for hard-tissue diagnostics within ENT medicine, and for carpus exposures.

The device comprises image receptors for cephalometric exposures, 2D panoramic radiographs and 3D volume exposures. The combination of sensors in the device varies depending on the installed options and the regions of interest can be altered. The technology behind this is collimation and different start- and end angles of exposure. These allow for a reduced dosage depending on the program selected. This function is available with some volume, cephalometric and panoramic programs.

Class I laser beam light localizers aid in the positioning of a patient's head which may be fixed through the use of bite blocks and adjustable forehead and temple supports.

From the obtained exposures, reconstructed images can be viewed. The reconstructed 3D volumes, simulated projection exposures and panoramic/cephalometric data can be conveyed to SIDEXIS (an FDA approved Sirona software for acquisition, administration, analysis, diagnosis, presentation and transfer of image data for medical/dental use) and stored in the SIDEXIS database.

An operator control panel allows for height adjustment, selection of mode and program, and indication of machine states. A separate handheld push-button serves for exposure release and an optional remote control is available.

The provided text describes a 510(k) premarket notification for the "ORTHOPHOS SL" dental X-ray system. The document focuses on demonstrating substantial equivalence to predicate devices rather than providing detailed acceptance criteria and a study proving the device meets them in the context of an AI/algorithm-driven device.

Therefore, many of the requested items (e.g., acceptance criteria table, sample size for test set, number of experts for ground truth, adjudication method, MRMC study, standalone performance, training set details) are not applicable or not present in this type of regulatory submission for a conventional medical imaging device without explicit AI involvement.

Based on the provided text, here's the information that can be extracted:

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

• Not applicable for an AI device. This document is for a traditional X-ray system. The "acceptance criteria" discussed are largely related to meeting established X-ray performance standards and demonstrating substantial equivalence to predicate devices. Specific quantitative performance metrics for diagnostic accuracy (e.g., sensitivity, specificity, AUC) against a defined ground truth, as would be expected for an AI device, are not detailed.
• The study focuses on demonstrating that the device's technical specifications and image quality are comparable to predicate devices and comply with relevant international standards.

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

• Test Set Sample Size: "test phantoms" were used for evaluating exposure programs. "Sample clinical images" were provided. No specific numerical sample size for either is given.
• Data Provenance: Not specified beyond "test phantoms" and "sample clinical images." It does not mention country of origin or whether clinical data was retrospective or prospective.

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)

• "Oral Surgeon reports" were provided with the sample clinical images, "asserting the general diagnostic quality of the images."
• Number of Experts: Not specified.
• Qualifications: "Oral Surgeon" is mentioned as the expert type, but no specific experience level is provided.

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

• None explicitly mentioned. The "Oral Surgeon reports" seem to imply a singular assessment rather than an adjudicated consensus process.

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 document is for a conventional X-ray system, not an AI-assisted diagnostic tool, so improvement of human readers with AI assistance is not applicable.

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

• Not applicable. This is a hardware X-ray device, not a standalone algorithm.

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

• For technical testing, "test phantoms" were used.
• For clinical images, "Oral Surgeon reports asserting the general diagnostic quality" served as a form of expert assessment of image quality, not necessarily a definitive "ground truth" for specific disease presence/absence.

8. The sample size for the training set

• Not applicable; no training set mentioned. This is a conventional X-ray system, not an AI model that undergoes training.

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

• Not applicable; no training set mentioned.

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The turbines of the T1 / T2 / T3 Turbine family are intended for the

• Preparation of cavities and crowns
• Removal of carious material
• Removal of fillings
• Processing of tooth and restoration surfaces
• Reducing hard tooth structure

The Sirona Dental Systems T1 / T2 / T3 turbine family consists of air powered, high speed handpieces. The handpieces are reusable, ergonomically shaped and include (T1 and T2 Turbines) a fiber optic light system. The water delivery geometry includes 4 pair of water / air spray nozzles just below the head with one way retraction valves to prevent the ingress of external water or air, when the spray system is shut down. The devices are sterilizable in an autoclave. The turbines are provided in three variants: control, boost and mini.

In addition, the turbines are compatible with the following quick-coupling:

• Sirona R coupling
• Sirona F coupling
• Sirona B coupling
• KaVo coupling
• W&H coupling
• NSK MachLite coupling
• NSK QD-J coupling

This document is a 510(k) summary for a dental device, specifically the Sirona Dental Systems T1 / T2 / T3 Turbine family. Due to the nature of the device (a dental handpiece) and the regulatory submission (510(k)), the "acceptance criteria" and "study that proves the device meets the acceptance criteria" are discussed in the context of demonstrating substantial equivalence to predicate devices, rather than through formal clinical trials with specific performance metrics such as sensitivity, specificity, or accuracy, which are typical for diagnostic or AI-driven devices.

Here's a breakdown based on the provided text, addressing your questions where applicable and noting where the information is not relevant to this type of device submission:

1. Table of Acceptance Criteria and Reported Device Performance

For this type of device, the "acceptance criteria" are predominantly compliance with recognized international standards and demonstration of similar technological characteristics and performance to predicate devices. The "reported device performance" is a comparison of these characteristics to the predicate devices.

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

This is not applicable to this type of device submission. The submission is for a mechanical dental handpiece, and its performance is evaluated through engineering tests, compliance with standards, and comparison of technical specifications to legally marketed predicate devices, not through a "test set" of patient data or clinical cases.

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

This is not applicable to this type of device submission. There is no concept of a "ground truth" derived from expert consensus for a mechanical dental handpiece in the way it would be for an AI diagnostic device. The ground truth, in a technical sense, would be defined by engineering specifications and material properties, validated through laboratory testing.

4. Adjudication Method for the Test Set

This is not applicable to this type of device submission. There is no "test set" requiring adjudication in the context of a mechanical handpiece's 510(k) 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

This is not applicable to this device. It is a traditional mechanical dental handpiece, not an AI-assisted diagnostic or therapeutic device. Therefore, no MRMC study, AI integration, or human reader improvement metric is relevant.

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

This is not applicable. The device is a mechanical dental handpiece; there is no algorithm, AI, or software component that operates in a standalone manner.

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

For this device, the "ground truth" is established through adherence to international standards (ISO 14457, 1797, 9168, 21531), engineering specifications, and validation through laboratory performance testing related to sterilization, device effectiveness, and biocompatibility. There is no patient-specific "ground truth" in the clinical sense mentioned (pathology, outcomes data, expert consensus). The performance is measured against objective, quantifiable physical and sterile conditions.

8. The Sample Size for the Training Set

This is not applicable to this device. There is no "training set" as it is not an AI/ML device.

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

This is not applicable to this device. There is no "training set."

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SIDEXIS 4 is software that offers functions for the acquisition, administration, analysis, diagnosis, presentation and transfer of digital or digitized image data, e.g. X-ray images or video recordings, for medical use, predominantly in dentistry.

SIDEXIS 4 combines the two Sirona products GALAXIS and SIDEXIS XG and now integrates 2D and 3D functions. New functions have been implemented (e.g. comparison of two volumes, comparison of two 2D projections).

The provided documentation for Sirona Dental Systems SIDEXIS 4 does not contain information on acceptance criteria or a study proving that the device meets specific performance criteria.

Here's a breakdown of why this information is missing based on the provided text:

• Section 7. PHYSICAL AND PERFORMANCE CHARACTERISTICS: States "Not applicable." This indicates that no specific performance characteristics or acceptance criteria were defined or tested in the context of a 510(k) submission that typically focuses on substantial equivalence.
• Section 10. Clinical Testing: States "Clinical tests have not been performed." This explicitly indicates that no clinical studies were conducted to assess the device's performance against clinical endpoints or acceptance criteria.
• Section 9. Non-clinical Testing: Mentions that "The SIDEXIS 4 system functions have been tested" and "Additional tests with technicians and physicians have been performed to compare images from SIDEXIS XG/GALAXIS with SIDEXIS 4." While this indicates some testing, it doesn't describe quantitative acceptance criteria or a formal study to prove performance. The nature of these tests appears to be focused on functional equivalence and user perception rather than quantifiable performance metrics.
• Section 11. Conclusion: States that the device is deemed "safe and effective to perform its intended use and is substantially equivalent to the predicate devices" based on a comparison of intended use, indications, principle of operation, features, and technical data. This reinforces that the submission relies on substantial equivalence rather than meeting specific performance criteria.

Therefore, since the device's approval seems to be based on substantial equivalence to predicate devices (SIDEXIS XG, GALAXIS, Cybermed OnDemand3D) rather than meeting predefined performance criteria through a specific study, the requested information cannot be extracted from this document.

Summary of missing information:

1. Table of acceptance criteria and reported device performance: Not provided.
2. Sample size for the test set and data provenance: Not applicable as a formal performance test set and study were not conducted.
3. Number of experts used to establish ground truth and their qualifications: Not applicable.
4. Adjudication method for the test set: Not applicable.
5. Multi-reader multi-case (MRMC) comparative effectiveness study: Not conducted.
6. Standalone (algorithm only) performance study: Not conducted, as the device is a PACS system with image viewing capabilities, not an AI algorithm with standalone performance metrics.
7. Type of ground truth used: Not applicable.
8. Sample size for the training set: Not applicable (this is an imaging system, not an AI model that undergoes training).
9. How ground truth for the training set was established: Not applicable.

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Classic sintering

• Framework and reduced crowns in the anterior and posterior tooth region
• Bridge frameworks in the anterior and posterior tooth region with max. 2 pontics
• Crown caps in the anterior and posterior region
• Cone and telescoping crowns

Speed sintering

• Framework and reduced crowns in the anterior and posterior tooth region
• Bridge frameworks in the anterior and posterior tooth region with max. 2 pontics and up to 9 units
• Crown caps in the anterior and posterior region
• Cone and telescoping crowns

Super speed sintering

• Framework and reduced crowns with a maximum wall-thickness of 2 mm

The inCoris ZI are blocks of various sizes from which custom made dental restorations are grinded using Sirona CAD/CAM system. inCoris ZI ceramics constitute blocks comprised of zirconia ceramics (ZrO2). The blocks are initially manufactured in a partially sintered state; then, they are individually processed to specification, and finally, densely sintered. One end plane of a block is mounted to a metal carrier that is inserted in the spindle's clamping chuck of the grinding machine. The blocks are available in different colors.

The Sirona Dental Systems inCoris ZI is a dental ceramic block made of zirconia (ZrO2) used to grind custom dental restorations. The device is a material, not an AI/ML device, and therefore the standard AI/ML evaluation metrics are not applicable.

Here's a breakdown of the provided information:

Acceptance Criteria and Device Performance (Physical and Chemical Properties)

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CEREC Blocs C In are indicated for the fabrication of veneers and of crowns in anterior teeth and in premolars that have not been endodontically treated, using the Sirona CAD/CAM system.

CEREC Blocs C In is an industrially manufactured, silicate glass ceramic block used to produce crowns and veneer. The block consists of an inlying, highly-chromatic dentine core and an overlying translucent enamel layer. It is grinded to custom made dental restorations using Sirona CAD/CAM systems. The block is initially manufactured in a sintered state; then, is individually processed to specification. One end plane of a block is mounted to a metal carrier that is inserted in the spindle's clamping chuck of the grinding machine.

CEREC Blocs C In are available in several colors and additional bleach color. The dental restorations obtain their individual color appearance by stain and glaze firing.

Here's an analysis of the provided text regarding acceptance criteria and the supporting study for the CEREC Blocs C In device:

Based on the provided 510(k) summary, the device is a dental material (porcelain powder) for fabricating restorations, not an AI/ML device. Therefore, many of the typical AI/ML study components (like sample size for test set, experts for ground truth, MRMC studies, standalone performance, training set details) are not applicable.

The acceptance criteria provided are in relation to the physical and chemical properties of the material itself, and the "study" demonstrating compliance is non-clinical testing and comparison to predicate devices.

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: Not specified. Standard material testing usually involves a sufficient number of samples to achieve statistical significance for each property test, but the exact number isn't detailed in the summary.
• Data Provenance: The tests are non-clinical, likely lab-based measurements performed by the manufacturer, Sirona Dental Systems GmbH, in Germany. The data is prospective in the sense that the tests were performed on newly manufactured blocks to characterize their properties.

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

Not applicable. This device is a material, not a diagnostic or AI/ML device that requires human expert ground truth. The "ground truth" for material properties is established by recognized international standards (e.g., ISO 6872, ISO 10993-1) and objective physical and chemical testing.

4. Adjudication method for the test set

Not applicable. This is a material properties test, not a subjective assessment 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

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

The ground truth for the physical and chemical properties of the CEREC Blocs C In is based on:

• International Standards: Specifically, ISO 6872: 2008 ("Dentistry -- Ceramic materials") for bending strength and overall ceramic material compliance, and ISO 10993-1: 2009 for biocompatibility.
• Predicate Device Characteristics: Comparison to the known characteristics and performance of the legally marketed predicate devices (Vita's Vitablocs® and Wieland Dental + Technik's Press X Zr) to demonstrate substantial equivalence.

8. The sample size for the training set

Not applicable. This is not an AI/ML device; there is no "training set."

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

Not applicable. This is not an AI/ML device. The "ground truth" for the material's development would be established through principles of material science, engineering, and manufacturing processes aimed at achieving desired physical and chemical properties and clinical performance.

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Devices of the GALILEOS family consist of an x-ray system that uses a cone beam with a rotational sequence, providing two dimensional images and three dimensional volume reconstructions of the head area, which includes ENT and dentomaxillofacial areas, for use in planning and diagnostic support in adult and pediatric care.

Devices of the GALILEOS family comprise a package of PC software modules to expand SIDEXIS capabilities to handling 3D data. This includes 3D reconstruction, storage, retrieval, viewing and processing of 3D-image data.

The GALILEOS family is an extraoral source dental X-ray system intended to produce Xrays for obtaining three dimensional volume reconstructions of the teeth, jaw, and the head area, which includes ENT and dentomaxillofacial areas, for use in planning and diagnostic support in adult and pediatric care.

The GALILEOS family device generates a conical x-ray beam that rotates around the patient's head within a certain angle.

The device comprises an image receptor for 3D volume exposure with an adjustable diaphragm. Three volume regions are defined through this. Class I laser beam light localizers serve to position the patient's head that may be fixed through bite block and adjustable forehead and temple supports.

From the obtained exposures a three dimensional image is reconstructed and can be viewed as well as panoramic/cephalometric images. The constructed 3D volume and simulated projection exposures as well as panoramic/cephalometric data are conveyed to SIDEXIS and stored in the SIDEXIS data base.

An operator control panel allows height adjustment, selection of mode and program, and indicates machine states.

A separate handhold push-button serves for exposure release An optional remote control is available.

The provided text describes a 510(k) submission for the Sirona Dental Systems GALILEOS family of devices but does not include any acceptance criteria or details of a study demonstrating the device meets such criteria.

The submission states:

• "Nonclinical Testing" involved system functions testing, which "covers the requirements from the function specification, the risk/hazard analysis and the functionality of the equipment from the user's perspective." Additionally, "The exposure programs have been tested utilizing test phantoms. The tests evaluate the equality of exposures of proposed GALILEOS family and predicate device GALILEOS."
• "Clinical Testing": "Clinical tests have not been performed."

Therefore, I cannot provide the requested information regarding acceptance criteria and a study proving the device meets them because this information is not present in the provided text. The submission relies on demonstrating substantial equivalence to a predicate device, as highlighted by the conclusion: "Based on a comparison of intended use, indications, construction materials, principle of operation, features, and technical data, the Sirona Dental GALILEOS family and the new member GALILEOS Comfort" is safe and effective to perform its intended use and is substantially equivalent to the predicate devices."

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