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For removal of subgingival calculi in periodontal pockets with periodontitis by closed or open curettage. Removal of subgingival calculi in periodontal pockets which have been affected by periodontitis, with open or closed curettage and using the detection function of the KEY Laser 1243.

This device represents the combination into one device of two previously cleared devices, the Diagnodent Laser Fluorescence Caries Detection Device with the KEY Laser III 1243.

Acceptance Criteria and Study for KEY Laser III 1243 US without Feedback, with Detect

Based on the provided 510(k) Summary (K073074), the KEY Laser III 1243 US without Feedback, with Detect is a combination of two previously cleared devices: the Diagnodent Laser Fluorescence Caries Detection Device and the KEY Laser III 1243. The acceptance criteria and "study" are focused on demonstrating that the performance of the individual components has not changed as a result of their combination and that the combined device meets established safety standards for laser and medical devices.

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not provide specific details on the sample size used for any in-vitro or bench testing. It only states "Laboratory testing has revealed..." and "bench, and in-vitro studies." The data provenance (e.g., country of origin, retrospective/prospective) is also not specified, as this was a premarket notification for a combination device, and detailed clinical study results are typically not required in the same way as for novel devices.

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

This information is not provided. The "ground truth" for this submission appears to be derived from the established performance and safety profiles of the individual predicate devices and the relevant industry standards. There is no mention of human expert evaluation in establishing ground truth for the "laboratory testing" or "bench/in-vitro studies."

4. Adjudication Method for the Test Set

Not applicable. There is no mention of a test set requiring adjudication in the context of human expert review. The "studies" were technical laboratory and bench tests against pre-defined performance and safety standards.

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 not an AI-assisted diagnostic tool for "human readers" in the typical sense that an MRMC study would be performed. It's a medical device with a laser for surgical procedures and a fluorescence detection function. The comparison is to predicate devices, not to human performance with or without AI.

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

This statement is partially applicable in that the device's functional integrity (laser operation, detection sensitivity) was assessed in isolation. The "laboratory testing" and "bench, and in-vitro studies" essentially evaluated the technical performance of the device components without necessarily considering a "human-in-the-loop" performance study for this type of submission. However, it's not an "algorithm only" device; it's a physical medical instrument. The "detection function" performance was evaluated in what could be considered a standalone manner from the surgical function, but both are physical components of the device.

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

The ground truth for this submission appears to be:

• Validated performance parameters of the predicate devices: The functionality of the detection and laser surgical components are compared to their previously cleared, individual versions.
• Established industry and regulatory standards: Compliance with various IEC, ISO, UL, VDE, ANSI, and 21 CFR standards for electrical safety, laser safety, and biocompatibility serves as the ground truth for safety and technical performance.

8. The Sample Size for the Training Set

Not applicable. This is not a machine learning or AI algorithm in the context of requiring a training set for model development. The device combines existing, cleared technologies.

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

Not applicable, as this device does not utilize a training set in the AI machine learning sense.

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Intra- and extra-oral surgery including incision, excision, hemostasis, coagulation and vaporization of soft tissue.
The GENTLEray 980 Diode Dental Laser System is intended for use in the following procedures: Frenectomy, Frenotomy, Biopsy, Operculectomy, Implant Recovery, Gingivectomy, Gingivoplasty, Gingival Troughing, Crown Lengthening, Hemostasis of Donor Site, Removal of Granulation Tissue, Laser-assisted Flan Singgry, Debridement of Deseased Epithelial Lining, Incisions and Draining of Abscesses, Tissue Retraction for Impressions, Papillectomy, Vestibuloplasty, Excision of Lesions, Leukoplakia, Exposure of Unerupted/Partially Erupted Teeth, Removal of Hyperplastic Tissues, Treatment of Aphthous Ulcers, Sulcular Debridement, Pulpotomy, Pulpotomy as an Adjunct to Root Canal Therapy, and Light Activation of Bleaching Materials.

The GENTLEray 980 Diode Dental Laser System is a portable instrument intended for ablating, incising, excising, and coagulating intraoral soft tissue (including the marginal and interdental gingiva) using a contact fiber optic delivery system.

The KaVo GENTLEray 980 Diode Dental Laser System's acceptance criteria and the study proving it meets these criteria are outlined through a comparison to predicate devices, focusing on technical specifications and intended use rather than direct performance metrics like sensitivity or specificity. This is a 510(k) submission, which primarily establishes substantial equivalence.

Here's the breakdown based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

For this 510(k) submission, the "acceptance criteria" are the specifications of the predicate devices. The "reported device performance" is the specifications of the proposed device, demonstrating equivalence. There are no explicit quantitative performance metrics like sensitivity, specificity, or AUC provided in this document as it's a laser device for surgical procedures, not a diagnostic tool.

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The KaVo Everest® C-temp is used in the manufacture of temporary dental prosthetics to be worn 12 months or less.

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

The provided 510(k) summary for the KaVo Everest® C-temp material primarily focuses on demonstrating substantial equivalence to predicate devices based on formulation, intended use, and general material classification rather than presenting a study for device performance against specific acceptance criteria. This class II dental material is evaluated through biocompatibility testing and standard compliance rather than a diagnostic performance study. As such, many of the requested categories related to medical device performance studies (e.g., sample size for test set, number of experts, MRMC studies, standalone performance) are not applicable or explicitly stated in this type of submission.

Below is an attempt to structure the available information as per your request, with explicit notes where information is not provided or not applicable due to the nature of the device and its regulatory submission.

Acceptance Criteria and Device Performance Study for KaVo Everest® C-temp

1. Table of Acceptance Criteria and Reported Device Performance

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

• Not Applicable/Not Provided: This submission focuses on material properties, biocompatibility, and substantial equivalence to legally marketed predicate devices rather than a diagnostic performance study with a test set of data samples. The "test set" in this context would refer to material samples used for the specified laboratory tests (biocompatibility, DIN IEC 60893 compliance), but specific sample sizes are not detailed in the summary. Data provenance would be from laboratory testing procedures by the manufacturer.

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

• Not Applicable: For a dental material cleared via substantial equivalence, ground truth as established by clinical experts for a diagnostic performance study is not relevant here. The "truth" is established by laboratory testing standards and comparison to predicate devices, verified by regulatory bodies.

4. Adjudication Method for the Test Set

• Not Applicable: As there is no diagnostic test set requiring human interpretation and consensus, no adjudication method (e.g., 2+1, 3+1) is relevant.

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 a submission for a dental material, not an AI-assisted diagnostic device. Therefore, an MRMC study is not relevant.

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

• Not Applicable: This is a dental material, not a standalone algorithm.

7. The Type of Ground Truth Used

• The "ground truth" for the KaVo Everest® C-temp is established by:
  • Laboratory Testing Results: Demonstrating biocompatibility and conformance to the DIN IEC 60893 standard.
  • Material Composition/Formulation: Comparison of the material's constituents to predicate devices deemed safe and effective.
  • Intended Use Alignment: Confirming the proposed use case (temporary dental prosthetics for 12 months or less) aligns with predicate devices and regulatory definitions.
  • Regulatory Classification: Conforming to the established classification for "Temporary Crown and Bridge Resin" (21 CFR 872.3770).

8. The Sample Size for the Training Set

• Not Applicable/Not Provided: This is not an AI/machine learning device that would require a "training set." The development process for a dental material would involve R&D and testing, but not in the context of a training algorithm.

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

• Not Applicable: As there is no training set for an algorithm, this question is not relevant.

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For use as an aid in the diagnosis of dental caries.

This submission is for a modification of a device system cleared under K983658, the DIAGNOdent® 2095. The modification is in the form of a new method of packaging the device, in the form of a pen-like device instead of the former electronic unit with a fiber optic probe.

The provided 510(k) summary for the KaVo DIAGNOdent® 2190 does not contain specific acceptance criteria or a detailed study report proving the device meets acceptance criteria. The document states that the conclusion of substantial equivalence is "based on indications for use, bench, invitro, and clinical studies, as well as EMC and electrical safety testing," but it does not provide the details of these studies or the performance metrics used.

Therefore, I cannot fulfill your request for detailed information on acceptance criteria, sample sizes, expert qualifications, or specific study designs as this information is not present in the provided text.

Based solely on the provided text, the following information is available:

1. Table of Acceptance Criteria and Reported Device Performance:

Not provided in the document. The document lists a comparison of general characteristics between the predicate (DIAGNOdent® 2095) and the new device (DIAGNOdent® 2190), indicating that for most aspects, the new device is "SAME" or has minor modifications (e.g., integrated probe, slightly different laser power, LCD numbers instead of LED numbers).

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The KaVo KEY Laser Models 1243+ and 1242 are intended for the incision, excision, cutting, ablation, and vaporization of soft tissue in oral and maxillofacial surgery and dentistry. This includes the following: Surgery (oral and dental) on soft tissue Aphthae (herpes, decubitus) Incision for drainage of abscesses Frenectomy, incision on frenulum of the cheek Excision of fibromas and flap fibromas Gingivectorny in the case of hyperplasias of the gingiva or excision of hyperplasias Preprosthetic surgery, flabby alveolar ridge, vestibuloplasty, exposure of implants, hyperplasias, epulides, papillomas, fibromatoses, benign growths Removal of diseased or inflamed tissue in the periodontal pocket (sulcular debridement) Tooth preparation to obtain access to the root canal Pulpotomy Pulp Extirpation Pulpotomy as an adjunct to root canal therapy Root canal debridement and cleaning. The KaVo KEY Laser Models 1243+ and 1242 are intended for ablation and vaporization of hard tissue in dentistry. The uses include: Removal of carious tissue Enamel Etching Cavity preparation Removal of subgingival calculi in periodontal pockets with periodontitis by closed or open curretage.

The KaVo KEY Laser 1243+ is an erbium laser which emits its energy at 2.94 microns. The laser consists of a cabinet, foot switch, fiber optic and hand pieces, and a software controlled user/laser interface.

The provided documentation describes the KaVo KEY Laser 1243+ and KaVo KEY Laser 1242, which are erbium lasers intended for various dental procedures, including the removal of subgingival calculus. The acceptance criteria and supporting study are specifically detailed for this indication.

Here's an analysis of the provided information:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: The document does not explicitly state the sample size for the clinical study. It refers to it as a "well-controlled clinical study."
• Data Provenance: Not explicitly stated (e.g., country of origin, specific clinics). The study was a "well-controlled clinical investigation" with a "2-year follow-up." It can be inferred to be prospective due to the follow-up period and objective criteria measurement at specific intervals.

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

• Number of Experts: Not specified.
• Qualifications of Experts: Not specified. The study measured "objective criteria" at various time points, suggesting quantitative evaluation rather than subjective expert consensus for the primary outcome.

4. Adjudication Method for the Test Set

• Not specified. The mention of "objective criteria were measured and recorded" suggests quantitative measurement rather than an adjudication process typically used for subjective assessments.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance

• No. This study is for a medical laser device, not an AI-assisted diagnostic tool. Therefore, an MRMC study related to human reader improvement with AI assistance is not applicable.

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

• Yes, in a sense. The device (KaVo KEY Laser 1242) itself performs the treatment (removal of subgingival calculus), and its performance was evaluated against a control group (mechanical removal). While a clinician operates the device, the study assesses the device's effectiveness in achieving the therapeutic outcome.

7. The Type of Ground Truth Used

• The ground truth for the clinical study was established through objective criteria measured over a 2-year follow-up period. These criteria were used to compare the laser's performance to mechanical removal for subgingival calculus.
• Additionally, SEM examination provided ground truth for surface damage, and laboratory cell adhesion tests provided ground truth for biocompatibility.

8. The Sample Size for the Training Set

• Not applicable/Not specified. This is a medical device study, not an AI model requiring a distinct "training set." The in vitro, in vivo, and clinical studies serve to validate the device's performance.

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

• Not applicable. See point 8.

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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 In eXam Intraoral X-ray device is to be used exclusively within dentistry as an extraoral source of x-rays.

The KaVo In eXam Intraoral Dental X-Ray System is an extraoral source of x-rays for imaging of the dento-maxilofacial area. The KaVo In eXam Intraoral Dental X-Ray System is comprised of the following main components: X-ray tube head, Yoke with user interface capabilities, Articulated arm, Horizontal arm, Electronic control unit, Wall mount, Cone. The power supply is regulated to provide a fixed 70kVp, and the x-ray target current is fixed at 7mA. Predefined exposure times may be selected directly through the control or yoke switchpads. The range of expsure time is 0.012 through 1.88 seconds.

I am sorry, but the provided text does not contain the detailed information necessary to answer your request about the acceptance criteria and the study that proves the device meets them. The document is a 510(k) summary for the KaVo In eXam Intraoral Dental X-Ray System, issued by the FDA in 2005.

While it mentions "Performance testing to meet product specifications" and "Effective clinical image exposures" as demonstrations of safety and effectiveness, it does not provide:

• A table of acceptance criteria and reported device performance.
• Details on sample size, data provenance, number of experts, adjudication methods, or specific ground truths for any studies.
• Information about multi-reader multi-case comparative effectiveness studies or standalone algorithm performance.
• Sample size or ground truth establishment for a training set.

The document primarily focuses on establishing substantial equivalence to predicate devices based on indications for use, similar materials, design, operational, and functional features, rather than presenting a detailed study proving specific acceptance criteria.

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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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