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For use as an aid in the detection and localization of subgingival dental calculus.

This submission is for a modification of a device system cleared under K983658, the DIAGNOdent®. The modification is in the form of a new accessory probe tip which can be connected to the unmodified DIAGNOdent® electronics system. The probe tip is longer and more slender to allow for the periodontal use. In-vitro and preclinical studies have shown that that laser fluorescence is correlated with materials in calculi and concrements. The researchers identified the method of subgingival calculi detection to be a reproducible, objective method for assessing the root surface. Although the intensity of the detection was influenced by surrounding media, the differences between cementum and calculus was highly significant in media like air, electrolytic solution and blood.

The provide 510(k) summary does not contain sufficient information to describe the acceptance criteria and study that proves the device meets the acceptance criteria as requested. Specifically, the document mentions "in-vitro and preclinical studies" and "clinical studies" were conducted but does not provide details on the study design, sample sizes for test sets, data provenance, ground truth establishment, or specific performance metrics and their acceptance criteria.

Here's a breakdown of the information that is available and what is missing:

1. Table of Acceptance Criteria and Reported Device Performance:

• Acceptance Criteria: Not explicitly stated or quantified in the provided text.
• Reported Device Performance: The document only states that "in-vitro and preclinical studies have shown that that laser fluorescence is correlated with materials in calculi and concrements" and that "the method of subgingival calculi detection to be a reproducible, objective method for assessing the root surface." It also notes that "the differences between cementum and calculus was highly significant in media like air, electrolytic solution and blood." No specific metrics (e.g., sensitivity, specificity, accuracy, precision) or numerical results are provided for the device for the subgingival calculus detection.

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

• Sample Size: Not provided.
• Data Provenance: Not provided. The studies cited are general scientific papers, not necessarily the specific studies conducted for this 510(k) submission.

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

• Not provided.

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

• Not provided.

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 mentioned. The device is for direct detection, not AI assistance for human readers.

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

• The device is a "Laser Fluorescence Caries Detection Device" (specifically, a periodontal probe accessory). It functions as a diagnostic tool that provides a reading, which a human then interprets. The summary doesn't describe an "algorithm only" performance study in the way AI would be evaluated. However, the in-vitro and preclinical studies would likely represent a standalone assessment of the device's ability to detect calculus. Specifics are lacking.

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

• Implied for the in-vitro studies that the "ground truth" would be the known presence of calculus in the samples tested. For preclinical studies, it would likely be confirmed by expert visual inspection or other established diagnostic methods. However, the specific method is not explicitly stated.

8. The sample size for the training set:

• Not applicable as this is not described as an AI/machine learning device requiring a training set. The device operates on direct physical principles (laser fluorescence).

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

• Not applicable.

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For acquiring, viewing, handling, and storage of dental color images and radiographs.

KaVo ERGOcom®/ERGOcam® system consists of four main components:

• The ERGOcom® Video control box.
• One of two versions of the ERGOcam® Cameras: The ERGOcam® 3 of the ERGOcam® 4 camera.
• A video display, flat panel color from 15 to 19" with touch screen control.
• A PC compatible computer with the KaVo Device Interface System Software installed. The Device Interface System has the following components:
  • 1. CCCDIS. The CCCDIS software is used to administer and configure the software components in the KaVo Device Interface System. The CCCDIS acts as the interface of the KaVo Device Interface System with third party applications
  • ERGOcam Control The ERGOcam Control software is used to configure individual parameters of the ERGOcam 4
  • ERGOcom Control The ERGOcom Control software is used for the PC-assisted status display, configuration and service support of the ERGOcom 3.
  • ERGOvideo Control The ERGOvideo Control software is used for generating and displaying video imaging data created with ERGOcom 2 / ERGOcom 3 andERGOcam 3 / ERGOcam 4
  • ERGOcam Viewer The ERGOcam Viewer is used for demonstrating the use of the ERGOvideo Control, ERGOcam Control and ERGOcom Control. The ERGOcam Viewer is used to store and administer imaging data that have been generated with the software components referred to above.
  • VirtualCom2 VirtualCom2 is used to convert the foot starter and camera cradle signals from ERGOcom 3 to a format that is compatible with ERGOcom 2. These signals are only used to control program modules within a practice management software that allows the recording of images with a KaVo intraoral camera, thereby meeting the interface specification for the serial interface of ERGOcom 2

The intraoral camera emits video signals which generate an image of the area under inspection (the patient's oral cavity for instance) on a screen or other visual display medium. The generated image is used for the patient's information and to support the diagnosis.

The provided text is a 510(k) summary for the KaVo ERGOcom®/ERGOcam® Dental Image Management System. It states that the device is substantially equivalent to a predicate device (DentalEye 2, K012439) and does not contain detailed information about specific acceptance criteria, performance studies, or efficacy claims in the way a clinical study report would.

Therefore, the following information is not available in the provided document:

• A table of acceptance criteria and reported device performance (beyond basic system specifications and functional equivalence).
• Sample sizes used for test sets.
• Data provenance (country of origin, retrospective/prospective).
• Number and qualifications of experts for ground truth establishment.
• Adjudication method for the test set.
• Results of a multi-reader multi-case (MRMC) comparative effectiveness study.
• Results of a standalone (algorithm-only) performance study.
• The type of ground truth used (expert consensus, pathology, outcomes data, etc.) for performance evaluation of clinical effectiveness.
• Sample size for the training set.
• How ground truth for the training set was established.

The document focuses on demonstrating substantial equivalence to a previously cleared device (DentalEye 2, K012439) based on intended use and technological characteristics, rather than presenting performance data from a clinical efficacy study.

Here's what can be extracted regarding how the device meets the acceptance criteria (which, in this context, are primarily about substantial equivalence and safety standards):

1. Acceptance Criteria and Reported Device Performance (Summary based on Substantial Equivalence Comparison):

The "acceptance criteria" here are implicitly defined by the characteristics and performance of the predicate device (DentalEye 2, K012439) and compliance with safety standards. The study/justification provided is a comparison table and a statement of compliance.

2. Study/Evidence Proving Acceptance:

The "study" described is a comparative analysis for substantial equivalence to a predicate device (DentalEye 2, K012439) and testing for compliance with relevant safety standards.

Key evidence provided:

• Comparison Table: A detailed side-by-side comparison of the KaVo ERGOcom®/ERGOcam® system with the predicate device (DentalEye 2) across various technical and functional specifications.
• Statement of Compliance: A declaration that the system has been "thoroughly tested to IEC/UL/CSA standards including electrical safety and electromagnetic compatibility and has been found to comply with those standards."
• Conclusion of Substantial Equivalence: A statement that "In all important respects, the KaVo ERGOcom®/ERGOcam® Dental Image System is substantially equivalent to one or more predicate systems, including the one named above."

Since this is a 510(k) submission primarily demonstrating substantial equivalence for an image management system without claims of diagnostic aid or advanced clinical performance, the following information is not applicable or not provided in the document:

• Sample size for the test set and data provenance: No clinical test set data is presented for efficacy. The "test set" implicitly refers to the physical device undergoing safety and compatibility testing.
• Number of experts and qualifications for ground truth: Not applicable for this type of submission focused on substantial equivalence of an image management system.
• Adjudication method for the test set: Not applicable.
• MRMC comparative effectiveness study: Not applicable, as no claims are made about human reader improvement with AI assistance.
• Standalone (algorithm only) performance: Not applicable, as this is an image management system with human-in-the-loop operation.
• Type of ground truth used: Not applicable for establishing clinical efficacy, as none is measured or reported.
• Sample size for the training set: Not applicable, as this is not an AI/machine learning device with a "training set" in the typical sense.
• How the ground truth for the training set was established: Not applicable.

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The KaVo RONDOflex® plus 360 Handpiece is intended for the: preparation for fissure sealing by cleaning, opening, and extending the fissures; creation of micro-mechanical retention for adhesive restorations on enamel and dentine with subsequent acid etch technique; preparation-of small carious defects; removal of deep discolorations in the enamel; cleaning and removal of adhesive residues from bridges, crowns, etc.; and, preparation of adhesive surfaces of brackets.

This submission is for a modification of a device system cleared under K002708, KaVo Corund Handpiece 2013. The modification is in the form of adding dental water to the stream.

The RONDOflex plus 360 is an air abrasion system in which alumina particles are accelerated to high speed in an air jet in order to remove material from the tooth surface.

The provided text describes a 510(k) summary for the KaVo RONDOflex® plus 360 Handpiece, which is a modification of an existing device. The device is being submitted for substantial equivalence to predicate devices, and as such, the "acceptance criteria" discussed are largely related to demonstrating that the modified device performs as safely and effectively as the predicate devices, with no new questions of safety or effectiveness.

Here's an analysis based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Since this is a 510(k) submission for a modified device seeking substantial equivalence, the "acceptance criteria" are implicitly met by demonstrating that the new device shares the same indications for use and has comparable technical characteristics (e.g., abrasive material, sterilization methods) to the predicate devices. The "reported device performance" is essentially that it operates within the specified technical data and its indications for use are the same as the primary predicate.

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

The document does not explicitly mention a "test set" in the context of clinical trials or specific performance testing against ground truth. The submission is based on comparison to predicate devices and internal validation studies. There is no information provided about the sample size for these internal validation studies or their data provenance (e.g., country of origin, retrospective/prospective).

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

Not applicable. This 510(k) submission primarily relies on demonstrating substantial equivalence to predicate devices through technical comparisons and internal validation. There is no mention of a ground truth established by experts for a specific test set.

4. Adjudication Method for the Test Set

Not applicable. As there is no mention of an external test set requiring expert ground truth, no 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. This device is an air abrasion handpiece for dental procedures, not an AI-assisted diagnostic or therapeutic tool for which MRMC studies would typically be conducted.

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

Not applicable. This is a physical medical device (handpiece), not an algorithm or AI system.

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

The term "ground truth" as typically used in the context of AI or diagnostic device evaluation is not directly applicable here. The device's safety and effectiveness are established by:

• Comparison to legally marketed predicate devices: The "ground truth" implicitly relies on the established safety and effectiveness of the predicate devices cleared by the FDA.
• Internal validation studies: These studies would typically verify that the device meets its design specifications and performs as intended, likely using engineering and performance metrics relevant to an air abrasion device (e.g., consistency of abrasive flow, pressure, sterilization efficacy). The specific nature of these "internal validation studies" (what they tested and how performance was measured) is not detailed in the provided text.

8. The Sample Size for the Training Set

Not applicable. There is no mention of a "training set" as this is not an AI/machine learning device.

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

Not applicable. As there is no training set mentioned, no ground truth establishment for a training set is relevant.

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The KaVo Everest® ZH-Blank is used in the manufacture of dental prosthetics.

The KaVo Everest® ZH-Blank is a pre-formed material for use by dental laboratories in filling orders/prescriptions for dental prosthetics

Here's an analysis of the provided text regarding the acceptance criteria and supporting study for the KaVo Everest® ZH-Blank:

Based on the provided 510(k) summary, the device is a material for dental prosthetics, and its clearance process differs significantly from a typical AI/software-as-a-medical-device (SaMD) study focusing on diagnostic or prognostic performance. Therefore, many of the requested categories (like MRMC studies, expert ground truth, sample sizes for training/test sets) are not applicable or not explicitly detailed in this type of submission.

Here's a breakdown of the requested information based on the provided text:

Acceptance Criteria and Device Performance for KaVo Everest® ZH-Blank

The submission for the KaVo Everest® ZH-Blank is based on demonstrating substantial equivalence to predicate devices and adherence to the classification for porcelain powders, rather than on specific quantitative performance metrics typically seen for diagnostic devices.

1. Table of Acceptance Criteria and Reported Device Performance

• Comparable chemical composition and physical properties to legally marketed predicate devices (KaVo Everest Z-Blank, KaVo Everest G-Blank, Vita inCeram Zirconia). | The claim of substantial equivalence is based on comparisons of formulations of the KaVo device to legally marketed predicates. The submission concludes the material is substantially equivalent to cited legally marketed predicates. |
  | Intended Use Equivalence:
• Used in the manufacture of dental prosthetics, consistent with predicate devices. | The claim of substantial equivalence is based on comparisons of intended uses of the KaVo device to legally marketed predicates. The device is intended for use in the manufacture of dental prosthetics. |
  | Regulatory Identification Compliance:
• Conforms to the FDA's identification for porcelain powders for clinical use (21 CFR 872.6660). | The submission is based on the IDENTIFICATION of porcelain powders in 21 CFR 872.6660. The device is classified as a Class II medical device under this regulation with product code EIH. |
  | Safety and Effectiveness:
• No new questions of safety or effectiveness are raised compared to predicate devices. | The FDA letter implicitly confirms this by granting substantial equivalence, stating the device is subject to general controls and does not require PMA. |

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

• Not applicable / Not specified. This device is a material, not a diagnostic algorithm. Therefore, there is no "test set" in the context of an AI/SaMD performance evaluation. The substantial equivalence argument relies on comparing material specifications and intended use.

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

• Not applicable. There is no "ground truth" establishment in the traditional sense for this type of material submission, as it's not a diagnostic device.

4. Adjudication Method for the Test Set

• Not applicable. No test set or expert adjudication was performed as part of this submission type.

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 submission is for a dental material (a physical product), not an AI/SaMD system designed to assist human readers.

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

• Not applicable. This submission is for a dental material, not a standalone algorithm.

7. The Type of Ground Truth Used

• Implicitly "regulatory compliance" and "material property comparison." For this type of submission, the "ground truth" is that the material's formulation and intended use correspond to those of legally marketed predicate devices and the relevant FDA regulation for "Porcelain Powder for Clinical Use." There isn't an "expert consensus," "pathology," or "outcomes data" ground truth in the typical diagnostic sense.

8. The Sample Size for the Training Set

• Not applicable / Not specified. As this is a material submission based on substantial equivalence, there is no "training set" in the context of an AI/SaMD and no data used for machine learning model development.

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

• Not applicable. There is no training set or associated "ground truth" for this type of device submission. The "truth" is established through documented material specifications and their comparison to established predicate devices and regulatory definitions.

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