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Primescan 2 can be used as a diagnostic aid by licensed dentists for detection of caries on visible tooth surfaces, proximal caries, and tooth cracks.

The Primescan 2 is an intraoral scanner that records and generates digital images to provide caries diagnosis support using additional light sources at 405 nm and 850 nm and an optical filter to filter out the excitation light. By illuminating the tooth with these two wavelengths, two diagnosis support modes are realized, the fluorescence mode and the near-infrared mode. The acquired 2D data from the scanner can be viewed in the software in a live stream video during acquisition. The images are also stored in the cloud platform software for later patient communication.

In fluorescence mode, the tooth (or teeth) are illuminated with UV light (405 nm). This stimulates an autofluorescence of the enamel in the green wavelength range. In addition, the red fluorescence is stimulated in carious areas on the teeth. All stimulated fluorescence responses are significantly weaker in terms of their light intensity compared to the back-reflected excitation light. For this reason, the excitation light is filtered out with the aid of an optical filter. The dental professional can use the 2D image data of the fluorescence response (live stream video) as additional information for caries diagnosis.

For near-infrared mode (NIR mode), the tooth or teeth are illuminated with 850 nm. Enamel is partially transparent in this wavelength. The illumination can therefore penetrate the tooth and is reflected by structural defects such as cracks and cavities, as well as from the dentin core. The reflected light is picked up by the 2D sensor of the scanner.

When used, a sleeve is placed over the distal end of the scanner. This sleeve is the only patient contacting component and is offered as either a single-use disposable or a multi-use sleeve that is reprocessed.

Here's the breakdown of the acceptance criteria and study information for the Primescan 2 device, based on the provided FDA 510(k) clearance letter:

Acceptance Criteria and Device Performance

The provided document does not explicitly state quantitative acceptance criteria or a specific table outlining them. However, it does mention that "in vivo bench tests demonstrated that Primescan-2 is effective as a diagnostic aid for occlusal caries using the fluorescence function and tooth cracks using the NIR function." This implies that the device met an unstated level of effectiveness for these diagnostic aids.

Since specific quantitative metrics (e.g., sensitivity, specificity, accuracy) are not provided in the summary, we cannot populate a detailed table with numerical acceptance criteria and performance outcomes.

Study Details

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

• Sample Size for Test Set: Not specified in the provided document.
• Data Provenance: The study was "in vivo bench tests," implying data was collected from living subjects. The country of origin and whether it was retrospective or prospective is not explicitly stated.

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

• Number of Experts: Not specified.
• Qualifications of Experts: Not specified.

4. Adjudication method for the test set

• Adjudication Method: Not specified.

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

• MRMC Study: Not mentioned in the provided document. The study described is "Performance Validation Testing of the Caries diagnostic Aid - In vivo bench tests demonstrated that Primescan-2 is effective as a diagnostic aid..." This describes standalone device performance rather than human-in-the-loop improvement.

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

• Standalone Performance Study: Yes, a standalone performance study was done. The document states: "Performance Validation Testing of the Caries diagnostic Aid - In vivo bench tests demonstrated that Primescan-2 is effective as a diagnostic aid for occlusal caries using the fluorescence function and tooth cracks using the NIR function." This indicates the device's ability to provide a diagnostic aid on its own.

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

• Type of Ground Truth: Not explicitly stated. For "in vivo bench tests" related to caries and tooth cracks, ground truth would typically be established through a combination of visual-tactile examination by experienced clinicians, potentially supplemented by radiography or even histology (though less common for a diagnostic aid). However, the document does not specify the method used here.

8. The sample size for the training set

• Sample Size for Training Set: Not applicable or not specified. This device appears to be a direct imaging and diagnostic aid rather than an AI/ML algorithm that requires a separate training set. The "diagnostic support" refers to the illumination and optical filtering techniques, not necessarily an AI algorithm trained on a dataset.

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

• Ground Truth for Training Set: Not applicable, as there's no indication of an AI/ML algorithm with a training set. The device operates on optical principles.

Key Observations and Limitations of Information:

• The provided 510(k) summary focuses highly on technological comparisons, safety, and regulatory compliance (electrical safety, biocompatibility, reprocessing, software, cybersecurity).
• While it mentions "Performance Validation Testing," it lacks specific quantitative results (e.g., sensitivity, specificity, accuracy, AUC) that are typically associated with diagnostic device clearances.
• The clinical study details, such as sample size, expert qualifications, and ground truth establishment methods for the performance validation, are not provided in this specific document. This information would typically be in a more detailed study report submitted to the FDA, but is summarized very broadly here.
• The device is described as providing "diagnostic support" using optical modes (fluorescence and NIR), rather than an explicit AI algorithm.

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The Midwest Motor Control Module includes a control unit, ports for three motors, an apex location port, and a peristaltic pump port. The motor ports are compatible with the Midwest Power Lux and Midwest Power Lux Implant.

The Midwest Power Lux electric micromotor is intended for use as a drive for rotating and oscillating straight and contra-angle hand pieces for endodontic and general dental purposes.

The Midwest Power Lux Implant motor is intended for use in implant placement and includes a closed system for delivery of sterile solution via peristaltic pump operation.

The apex locator supports the dentist in the determination of the working length during the endodontic treatment.

These motors are to be driven by the control unit. The control unit is an internal component of a dental delivery system.

The use of this product is intended exclusively for duly qualified dental practitioners.

This device is a system that includes a control module (internal component of a dental delivery system) that can operate up to three dental motors, an apex locator, and a peristaltic pump. The motors do not operate concurrently. The motors that can be attached include dental motors and dental implant motors. The motors included with this module in this subject system are the Midwest Power Lux and Midwest Power Lux Implant. Also included is the cable, file, and tip required for the operation of the apex location technology. The programming supports manual use of the apex locator as well as combined use of the locator with a motor. The included peristaltic pump and control allows for sterile solution irrigation when required.

The provided FDA 510(k) Clearance Letter for the "Motor and Apex Module (MaAM)" (K251811) does not contain information about acceptance criteria or a study that proves the device meets specific performance criteria related to the apex locator's accuracy or the motors' performance in a clinical setting.

The document primarily focuses on regulatory approval, substantial equivalence to predicate devices, and general safety and performance testing. While it mentions the device supports "determination of the working length during the endodontic treatment" (for the apex locator) and drives "rotating and oscillating straight and contra-angle hand pieces for endodontic and general dental purposes" (for the motors), it does not provide the specific performance metrics (e.g., accuracy, precision, torque output, speed stability) for these functions, nor the studies that verified them.

The "Non-Clinical and/or Clinical Tests Summary & Conclusions" section explicitly states: "Not applicable (no clinical data necessary)." This indicates that the FDA clearance was based on non-clinical testing, primarily focused on safety, electrical compatibility, and adherence to established industry standards (ISO 14457 for dental motors, IEC 62471 for photobiological safety, and ISO 3964 for dental coupling dimensions).

Therefore, based solely on the provided document, I cannot generate the requested table and study details. The information about performance acceptance criteria, sample sizes, expert involvement, adjudication, MRMC studies, standalone performance, and ground truth establishment for clinical effectiveness is absent.

However, I can extract and present the information that is available in the document regarding testing:

Summary of Device Performance and Testing (Based on Available Information in K251811)

The provided 510(k) clearance letter for the Motor and Apex Module (MaAM) establishes substantial equivalence to predicate devices based on non-clinical testing. The document explicitly states "Not applicable (no clinical data necessary)", indicating that the clearance did not involve clinical studies assessing the device's functional performance in a patient setting, such as the accuracy of the apex locator or the clinical efficacy of the motors.

The testing highlighted in the document focuses on compliance with international standards and mechanical/electrical safety.

1. Table of Acceptance Criteria and Reported Device Performance

Given that clinical performance acceptance criteria and respective reported device performance data are not detailed in the provided document, the table below reflects the types of non-clinical testing mentioned and the general conclusion of meeting specifications.

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

• Sample Size: Not specified in the document. Testing was non-clinical (bench/laboratory).
• Data Provenance: Non-clinical (bench testing in a laboratory). Country of origin is not specified for the test data itself, but the applicant (Dentsply Sirona Inc.) is located in the United States. The testing was retrospective in the sense that it was conducted prior to the submission for clearance.

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

• Not applicable. The clearance was based on non-clinical, standard-driven testing. There was no clinical ground truth established by experts for performance assessment in a patient setting.

4. Adjudication Method for the Test Set

• Not applicable. No clinical test set or subjective assessment requiring adjudication (like image interpretation) was mentioned.

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

• No MRMC study was done. The document explicitly states "Not applicable (no clinical data necessary)". Therefore, no effect size of human readers improving with AI vs. without AI assistance can be reported. The device is not an AI-assisted diagnostic tool in the sense of image interpretation.

6. Standalone Performance (Algorithm Only)

• Not applicable. The device is a physical medical device (motors, control module, apex locator) and not an algorithm or AI software for standalone performance evaluation in a diagnostic context. Its "performance" refers to its physical and electrical operation within specified limits, not its diagnostic accuracy.

7. Type of Ground Truth Used

• Not applicable, for clinical performance. For the non-clinical tests, the "ground truth" was established by the specifications defined in the referenced ISO and IEC standards (e.g., a motor must achieve a certain speed, a coupling must fit, light emission must be within safety limits). There was no "expert consensus, pathology, or outcomes data" ground truth as would be used for diagnostic accuracy studies.

8. Sample Size for the Training Set

• Not applicable. This device is hardware with embedded control software; it is not a machine learning or AI model that requires a training set in the typical sense of algorithm training on data.

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

• Not applicable. As above, this device does not utilize a "training set" in a machine learning context.

In conclusion, the FDA 510(k) clearance for the MaAM (K251811) was granted based on non-clinical testing demonstrating conformance to relevant safety and performance standards for dental motors, photobiological safety, and dental coupling dimensions. The document explicitly states that no clinical data was necessary for this clearance, meaning functional performance (e.g., apex locator accuracy, motor clinical efficacy) in a patient setting was not assessed as part of this submission.

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MIS dental implant system is intended to be surgically placed in the bone of the upper or lower jaw arches to provide support for prosthetic devices, such as artificial teeth, in order to restore masticatory function. When a one-stage surgical procedure is applied, the implant may be immediately loaded when good primary stability is achieved and the occlusal load is appropriate.

Narrow implants (Ø3.30mm) are indicated for use in surgical and restorative applications for placement only in the mandibular central, lateral incisor and maxillary lateral incisor regions of partially edentulous jaws, to provide support for prosthetic devices such as artificial teeth. Mandibular central and lateral incisors must be splinted if using two or more narrow implants adjacent to one another.

The subject devices, MIS Implants, are supplied sterile and packaged together with a cover screw which can be connected to the implant during the initial healing period after implant placement.

The implants and cover screws are made of titanium alloy (Ti-6Al-4V ELI complying with standard ASTM F136-13 - Standard Specification for Wrought Titanium-6Aluminum-4Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant). The design and material of the implants and cover screws remain unchanged since most recently cleared 510(k).

The implants are also used with a wide range of previously cleared abutments which are sold separately.

This document is a 510(k) clearance letter for dental implants, not an AI/software as a medical device (SaMD) submission. Therefore, it does not contain the information requested regarding acceptance criteria and study proving device meets acceptance criteria for an AI/SaMD product.

The document discusses dental implants and their physical and material characteristics, regulatory classifications, predicate devices, and performance testing for mechanical properties, sterility, and packaging. The "Performance Data" section specifically mentions "Hydrophilicity testing" for "wet-packed implants" and other physical tests, but none of these relate to AI/SaMD performance metrics like sensitivity, specificity, or reader studies.

Therefore, I cannot provide a table of acceptance criteria, sample sizes for test sets, expert qualifications, or details on MRMC studies, standalone performance, or ground truth establishment relevant to an AI/SaMD product based on the provided text.

The prompt asks for information that this type of medical device submission (dental implants) would not typically include.

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DS Core Diagnosis is a software product for use in dentistry for viewing and interacting with digital or digitized patient media as well as supporting the diagnosis of digital or digitized patient media. Intended users will be able to view and analyze different media types in one viewer.

The Panoramic Curve Proposal feature is intended for patients aged 12 years and older with permanent dentition.

DS Core Diagnosis is a cloud-based dental imaging software that provides access to dental media and images via an active internet connection. It is a medical device that can only be used in combination with the DS Core Platform. Classified as a Class II dental imaging software, DS Core Diagnosis allows users to view a variety of media types, including 2D and 3D images (e.g., bitewings, periapicals, panoramic, CBCT, etc.), as well as photos and documentation.

The software includes standard image viewing tools such as annotation, flip, rotate, contrast adjustment, brightness, and magnification.

DS Core Diagnosis also features a Machine Learning enabled panoramic curve proposal algorithm for a proposed panoramic curve of a CBCT scan along the dental arch, which can be adjusted and reviewed by the user. The architecture is a Convolutional Neural Network (CNN) model.

DS Core Diagnosis does not interact directly with patients or control any life-sustaining devices. The software does not perform diagnoses; instead, it provides tools to assist qualified clinicians in interpreting the displayed images and making informed decisions.

Here's an analysis of the acceptance criteria and the study proving the device meets them, based on the provided FDA 510(k) clearance letter for DS Core Diagnosis:

Acceptance Criteria and Reported Device Performance

Study Details

Based on the provided text, the following details about the studies can be extracted:

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

• PCPSR Evaluation:
  • Test Set Size (Dentsply Sirona & Third Party): 100 scans (specifically mentioned "99 of 100 scans considered 'successful'").
  • Data Provenance: A mix of "Dentsply Sirona Scans" and "Third Party" scans. Specific countries of origin are not detailed, but the inclusion of third-party scans suggests a broader dataset. The text does not explicitly state if it was retrospective or prospective, but given the nature of evaluating existing scans, it's highly likely to be retrospective.
• Clinical Evaluation:
  • Test Set Size: "a dataset made up of CBCT images". The exact number of cases or images in this dataset is not explicitly stated.
  • Data Provenance: Not explicitly stated, but would likely be retrospective CBCT images used for evaluation.

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

• PCPSR Evaluation: The text doesn't explicitly state that experts established ground truth for the PCPSR calculation directly. The success rate is described as whether "the proposed panoramic curve projection layer includes all teeth in the scan," which likely refers to an objective assessment based on the image content itself, possibly verified by a technical process rather than subjective expert consensus.
• Clinical Evaluation: "clinical experts assessed a dataset". The number of experts is not specified. Their qualifications are described as "clinical experts," implying dental professionals (e.g., dentists, oral and maxillofacial radiologists) but their specific experience levels (e.g., "radiologist with 10 years of experience") are not detailed.

4. Adjudication method for the test set:

• The text does not explicitly mention an adjudication method (like 2+1, 3+1). For the clinical evaluation, it states "experts assessed," which could imply independent assessment or consensus, but no specific method is described. For the PCPSR evaluation, the metric seems more objective and less prone to requiring adjudication in the same way.

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 where human readers' performance with and without AI assistance is compared is not explicitly described. The clinical evaluation focuses on the acceptability of the default AI-generated curve, not a comparison of expert performance with and without AI. It emphasizes that users retain full autonomy to adjust the curve.

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

• Yes, a standalone performance evaluation was done for the "Panoramic Curve Proposal" feature. The PCPSR evaluation directly assesses the algorithm's ability to propose a curve that includes all teeth, without human intervention in the proposal generation or acceptance. The "clinical evaluation" also assesses the default AI-generated panoramic image "without user modification."

7. The type of ground truth used:

• PCPSR Evaluation: The ground truth appears to be an objective determination of whether "all teeth in the scan" are included within the proposed panoramic curve. This would likely be established by a clear definition and potentially manual verification of tooth inclusion. It is closer to expert consensus if human verification was involved, but the description sounds more like an objective technical check.
• Clinical Evaluation: The ground truth for this aspect was established by expert consensus/assessment from "clinical experts" on the "clinical acceptability" (pass/fail) of the reconstructed panoramic images.

8. The sample size for the training set:

• The document does not provide any information about the sample size used for the training set for the Convolutional Neural Network (CNN) model.

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

• The document does not provide any information about how the ground truth for the training set was established. It only describes that the architecture is a Convolutional Neural Network (CNN) model.

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MIS Dental Implant System is intended to be surgically placed in the bone of the upper or lower jaw arches to provide support for prosthetic devices, such as artificial teeth, in order to restore masticatory function. When a one-stage surgical procedure is applied, the implant may be immediately loaded when good primary stability is achieved and the occlusal load is appropriate. Narrow implants (Ø3.3mm) are indicated for use in surgical and restorative applications for placement only in the mandibular central, lateral incisor and maxillary lateral incisor regions of partially edentulous jaws, to provide support for prosthetic devices such as artificial teeth. Mandibular central and lateral incisors must be splinted if using two or more narrow implants adjacent to one another. MIS LYNX short implants are indicated for delayed loading only.

The two additional implant size offerings which are being added to the predicate MIS LYNX Conical Connection Dental Implant System (K241692), and are the subject of this submission, consist of a standard platform, 4.20 mm diameter implant and a wide platform, 5.00 mm diameter implant, each available in a 6 mm length.

The proposed implant offerings, as their predicate K241692, are root-form, bone-level, self-tapping, two-piece, screw-type implants which are intended for one- or two-stage dental implant procedures and are used in the upper or lower jaw for supporting tooth replacement to restore chewing function.

Each implant offering is provided with a compatible cover screw based on the implant platform (standard and wide). The cover screws are identical to those cleared in K241692 and are intended to be used in a two-stage surgical procedure as temporary components to the proposed endosseous implant to allow healing of the soft tissue. The cover screw is screwed into the implant's internal thread and the gums are sutured over the cover screw. The cover screw's purpose is to let the osseointegration begin without any forces being applied to the implant. After a healing period, the cover screw is exposed and is then removed and replaced by either a healing cap or an abutment.

The implants and cover screws are manufactured from titanium alloy (Ti-6Al-4V ELI complying with standard ASTM F136-13 - Standard Specification for Wrought Titanium-6Aluminum-4Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant).

The proposed implants feature an outer profile which has a coronal section which is cylindrical and an apical section which is conical. The outer threads are designed so the implant has a self-drilling property. The implant's geometric design includes a dual thread feature and spiral channels (flutes) stemming from the apex. These spiral channels are designed to enable insertion torque reduction when applying reverse torque. The proposed implant design also includes circumferential grooves at the coronal area which are called "micro-rings". These horizontal micro-rings are designed to increase the BIC (Bone to Implant Contact) of the implant with the bone. The proposed implants feature a round (cylindrical) neck.

The proposed MIS LYNX Conical Connection Implants have a conical connection with an anti-rotation index of six positions and an internal thread for cover screws, screw-retained abutments and screwed healing caps. The implant-abutment connection surface of the proposed implants is anodized for color coding purposes to indicate the platform: purple for standard platform implants, and green for wide platform implants. The cover screws are also anodized for platform color coding.

The proposed implants are packaged in either a dry or wet package. Implants packaged in the wet packaging configuration are packaged in NaCl solution and are not anodized. The liquid environment is intended to maintain the super-hydrophilic (contact angle exhibited by water in contact with the surface is equal to zero degrees) property of the proposed dental implants until the implants are installed in patients.

This 510(k) clearance letter pertains to an Endosseous Dental Implant System, which is a physical medical device, not a software-driven AI device. Therefore, the concepts of acceptance criteria, study data, expert adjudication, MRMC studies, standalone algorithm performance, ground truth establishment for AI models, and training set sizes are not applicable to the information provided.

The document focuses on demonstrating substantial equivalence to predicate devices rather than proving performance against specific acceptance criteria in the context of an AI-driven system. The "acceptance criteria" here are implicitly the standards and performance levels demonstrated by the predicate and reference devices, as well as relevant ISO and ASTM standards.

Here's an analysis of the provided information, framed as closely as possible to your request, but acknowledging the device type:

Device: MIS LYNX Conical Connection Implant System

This device is an endosseous dental implant system, a physical medical device. The FDA clearance is based on demonstrating substantial equivalence to legally marketed predicate devices, not on the performance of an AI algorithm. Therefore, many of the requested fields related to AI model evaluation are not applicable.

Acceptance Criteria and Reported Device Performance

The acceptance criteria are generally understood to be compliance with relevant international and national standards for dental implants, and performance comparable to or exceeding established predicate/reference devices.

Table of Acceptance Criteria (Inferred from testing) and Reported Device Performance:

Regarding the other requested information (primarily relevant to AI/Software-as-a-Medical-Device):

2. Sample size used for the test set and the data provenance: Not applicable. The testing done was laboratory-based mechanical and MR safety testing, not evaluation of an AI model with a clinical test set. The implant dimensions analyzed for surface area were "smallest implant length (6 mm) and diameter (4.20 mm)" for proposed and reference devices. Pull-out testing and fatigue testing would have involved a number of physical samples per test, but specific quantities are not detailed in this summary.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth as typically understood for AI (e.g., expert labels on medical images) is not relevant here. The "ground truth" for mechanical testing is established by physical measurements and engineering principles.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This is a physical dental implant, not an AI assistance system for human readers.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): For mechanical properties, the "ground truth" is derived from established engineering test methods and their performance metrics (e.g., load at failure, cycles to failure). For MR safety, it's compliance with established safety limits for magnetic fields.

8. The sample size for the training set: Not applicable. There is no AI model or training set mentioned.

9. How the ground truth for the training set was established: Not applicable.

In summary: The provided document is an FDA 510(k) clearance letter for a conventional physical medical device (dental implant system). The evaluation and clearance process for such devices involve demonstrating safety and effectiveness by showing substantial equivalence to existing legally marketed devices, typically through non-clinical (laboratory) testing, materials characterization, and compliance with recognized standards. The concepts and terminology in your request are largely tailored to the evaluation of AI/Machine Learning-driven medical devices, which is not what this document addresses.

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The Dentsply Sirona Titanium Bases system is intended for use in partially or fully edentulous mandibles and maxillae in support of single cement-retained restorations.

For AT EV 3.0 S, AT TX 3.0 S, BH 3.0 S, and SB L 3.3 L titanium bases, the indication is restricted to the replacement of single lateral incisors in the maxilla and lateral and central incisors in the mandible.

The system comprises three parts:

• Abutment Block material (CEREC Cercon 4D Abutment Block)
• Titanium Base (TiBase)
• CAD/CAM system

The TiBase is recommended for use with two-piece hybrid abutments and hybrid abutment crowns, used in conjunction with endosseous dental implants.

The proposed Dentsply Sirona Titanium Bases system are connected to Dentsply Sirona or third-party dental implants to facilitate the prosthetic dental restoration of edentulous areas of the oral anatomy. The proposed TiBase components are assembled (through extraoral cement bonding) with the patient specific CEREC Cercon 4D Abutment Block (K234018), to form the complete, two-piece CAD/CAM Titanium Base system abutments. The bottom half of the abutment is the TiBase component, which interfaces with the implant system-specific geometry, while the top half of the abutment is the abutment block material that is milled to form either an abutment crown or a meso-structure (the latter is subsequently finished with a crown). The TiBase component therefore serves as the "platform" on which the customized milled abutment crown or the meso-structure is bonded to, forming the complete CAD/CAM Titanium Base system abutment. The completed CAD/CAM Titanium Base system abutment is attached to the dental implant with an abutment screw.

The TiBase system is part of a workflow that includes CAD/CAM software cleared in predicate device, K193408, CAD/CAM system with CEREC Chairside Software, and reference device, K200191, CAD/CAM System with inLab Software, and the abutment crown and meso-structure material cleared in reference device, K234018.

The TiBase components are made of the same material as the predicate device (K193408) TiBases, which is titanium alloy Ti6Al4V, complying with ASTM F136-13. While the lower part connects to the implant system, the upper part consists of a tapered, cylindrical center post which is designed to receive the abutment crown or meso-structure to complete the finished CAD/CAM abutment.

The TiBase components come in small and large sizes depending on the diameter size of the connecting implant. A notch feature on the cylindrical part of the upper portion (i.e. rotational reference and lock) ensures that there is only one position to mount either a scanbody or the abutment crown/meso-structure.

The TiBase component center post includes a through-channel through which a corresponding abutment screw is inserted to allow retention of the finished abutment to the implant. The abutment screw, made of the same Titanium material, when assembled with the proposed TiBase component, is located in the internal geometry of the titanium base and does not seat in the finalized abutment crown/meso-structure.

The minimum/maximum design specification limits are as follows:

• Maximum angulation for the Zirconia top-half material: 20˚
• Minimum wall thickness of the Zirconia top-half material: 0.5 mm
• Gingival heights of the TiBase component: 1, 2, 3 mm
• TiBase component post height (i.e., length above the gingival height): ≥ 4 mm

This document is a 510(k) clearance letter for the Dentsply Sirona Titanium Bases system, which specifies its indications for use and compares it to predicate and reference devices to demonstrate substantial equivalence. It does not describe the specific acceptance criteria and detailed study results that prove the device meets those criteria in a format applicable to AI/ML software performance studies.

The document details the technical aspects of the dental implant components and their mechanical testing for safety and performance (e.g., fatigue testing), biocompatibility, reprocessing validation, and MR compatibility. However, it does not involve the types of performance metrics, test set characteristics, or ground truth establishment typically associated with AI/ML device evaluations.

Therefore, for aspects related to AI/ML device performance (like accuracy metrics, expert review, MRMC studies, standalone performance), the answer is "Not applicable" or "Not provided" as this is a traditional medical device clearance, not an AI/ML software clearance.

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

1. Table of Acceptance Criteria and Reported Device Performance

The document describes several non-clinical tests that the device was subjected to and that it "met acceptance criteria" or "showed similar results" to reference devices. However, the specific quantitative acceptance criteria (e.g., "fatigue strength must be > X N") and the exact reported quantitative performance values achieved by the Dentsply Sirona Titanium Bases system are not explicitly stated in this clearance letter. The letter generally refers to compliance with standards.

For example, for fatigue testing, it states: "The TiBases systems were subjected to fatigue testing per the following requirements and showed similar results when compared to the reference devices (K213961, K241485)" and refers to ISO 14801:2016 and FDA Special Controls Guidance. It does not provide the numerical results or the specific acceptance mechanical load values. The same applies to MR testing, reprocessing, and biocompatibility.

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

• Sample Size: Not explicitly stated in terms of the number of unique devices/tests in the provided text. The fatigue testing mentions "the proposed device performs as well as the reference devices (K213961, K241485)," implying a comparison and potentially new tests for the specific new TiBases. However, specific counts are not given.
• Data Provenance: The studies are non-clinical (laboratory tests) rather than human patient data. Therefore, "country of origin" and "retrospective/prospective" are not applicable in the context of patient data. The tests were performed to demonstrate compliance with international standards (ISO, ASTM) and FDA guidance.

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

• Not Applicable (N/A). This is a mechanical/material device clearance, not an AI/ML software evaluation based on expert-labeled data. The "ground truth" for these tests refers to the objective results conforming to engineering and material science standards (e.g., a device either fractures at a certain load or it doesn't, a material is biocompatible or not).

4. Adjudication method for the test set

• Not Applicable (N/A). Adjudication methods like 2+1 or 3+1 are used for resolving discrepancies in expert labeling for AI/ML ground truth, which is not relevant here.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done

• No. This is not an AI/ML software device that involves human interpretation of medical images.

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

• Not Applicable (N/A). This is a physical device, not an algorithm. The "software system verification" refers to confirming that the CAD/CAM software correctly integrates the design parameters for the physical components, not an AI algorithm's standalone diagnostic performance.

7. The type of ground truth used

• For mechanical (fatigue) testing: Compliance with ISO 14801:2016 and FDA guidance, meaning the physical behavior of the device under specified loads.
• For MR testing: Compliance with ASTM standards, meaning objective measurements of displacement, torque, and image artifacts.
• For software verification: Conformation that design parameters are correctly implemented in CAD/CAM software.
• For reprocessing and biocompatibility: Compliance with ISO standards and FDA guidance, meaning objective evaluations of sterility and biological response.

8. The sample size for the training set

• Not Applicable (N/A). There is no AI/ML model involved; therefore, no training set.

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

• Not Applicable (N/A). There is no AI/ML model involved; therefore, no training set.

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The Atlantis Abutment and Atlantis Abutment Milling are intended for use with an endosseous implant to support a prosthetic device in a partially or completely edentulous patient. It is intended for use to support single and multiple tooth prosthesis, in the mandible or maxilla. The Atlantis Abutment screw is intended to secure the Atlantis Abutment to the endosseous implant.
The Atlantis Crown Abutment is intended for use with an endosseous implant to function as a substructure that also serves as the final restoration, in a partially or completely edentulous patient. The Atlantis Abutment screw is intended to secure the Atlantis Crown Abutment to the endosseous implant.
The Atlantis Conus Abutment is intended for use with an endosseous implant to support a prosthetic device in partially or completely edentulous patients. It is intended for use to support a removable multiple tooth prosthesis, in the mandible or maxilla. The prosthesis is an attachment- retained by friction fit to the abutment. The Atlantis Abutment screw is intended to secure the Atlantis Conus Abutment to the endosseous implant.
The Atlantis Healing Abutment is intended for use with an endosseous implant for temporary use during soft tissue healing after one-stage or two-stage surgeries. The Atlantis Abutment screw is intended to secure the Atlantis Healing Abutment to the endosseous implant.

Atlantis® Abutment in Titanium refers to the following abutments that are the subject of this 510(k):

• Atlantis® Abutment,
• Atlantis® Crown Abutment,
• Atlantis® Conus Abutment, and
• Atlantis® Healing Abutment.

The Atlantis® Abutments in Titanium are patient-specific dental abutments that are intended for attachment to dental implants in the treatment of partially or totally edentulous jaws for the purpose of restoring chewing function. The design of the Atlantis® Abutments in Titanium is derived from patient dental models and is completed by Dentsply Sirona using computer-assisted design (CAD) technology according to the clinician's prescription. The final CAD design of the Atlantis® Abutment in Titanium is fabricated using computer-assisted manufacturing (CAM) to produce a customized, patient-specific device. Design and fabrication of the Atlantis® Abutment in Titanium is completed in internal Dentsply Sirona manufacturing facilities.

Alternatively, the CAD design, according to the clinician's prescription, can be performed by a laboratory or clinician in an FDA cleared abutment design software (3Shape Abutment Designer Software, K151455) within the design envelope of the Atlantis® Abutments which is codified in the validated and locked design library of the cleared software. Fabrication of the Atlantis® Abutment is then completed in internal Dentsply Sirona manufacturing facilities.

The Atlantis® Abutment in Titanium serves as a connection of the prosthetic construction and the endosseous implant. The lower part of the abutment is designed to fit with the specific implant geometry it is compatible, and the upper part design is according to the patient's specific anatomy. The Atlantis® Abutment in Titanium, including the Conus abutments and Healing abutments, are available in Titanium or Gold-shaded Titanium (titanium nitride layer applied using PVD (Physical Vapor Deposition)). The Crown Abutment is only available in Titanium.

The Atlantis® Abutment design envelope became the basis for the other more specific designs that make up the Atlantis® Abutments in Titanium. The Atlantis® Abutment is intended for use with an endosseous implant and for single tooth restoration.

The Atlantis® Crown Abutment in Titanium incorporates a design that is a combination of an abutment and an anatomically accurate crown to constitute the final finished device. It functions as a substructure that also serves as the final abutment, in a partially or completely edentulous patient.

The Atlantis® Conus abutment supports a removable prosthesis (bridges and overdentures) which is retained by friction fit to the abutment. The abutment connects to the prosthesis via caps embedded in the prosthesis.

The Atlantis® Healing Abutment is used with the compatible implants for temporary use during soft tissue healing after one-stage and two-stage surgeries. It is designed based on the planned final Atlantis® Abutment or Atlantis® Crown Abutment, using the same emergence profile as those abutments to achieve an aesthetic outcome during the soft tissue healing phase.

Unless otherwise noted in this summary, the design envelope has remained unchanged from the previously cleared systems. Parameters such as gingival height and abutment diameter are dependent on the different implant system compatibilities.

The provided document is an FDA 510(k) clearance letter for Atlantis® Abutments in Titanium. This document indicates that the device has received clearance and is considered substantially equivalent to previously marketed devices. However, it is not a clinical study report and therefore does not contain the detailed information typically found in a study that proves a device meets acceptance criteria derived from a clinical trial.

Specifically, the document primarily focuses on non-clinical testing (e.g., MRI compatibility, biocompatibility, reprocessing, and CAD/CAM software validation) to support a labeling change and the substantial equivalence to predicate devices. It explicitly states:

• "8. Clinical Tests Summary and Conclusion: Not applicable. There are no clinical tests submitted, referenced, or relied on in the 510(k) for a determination of substantial equivalence."

Therefore, I cannot extract the requested information (Acceptance Criteria Table, Sample Size, Data Provenance, Ground Truth Experts, Adjudication Method, MRMC Study, Standalone Performance, Ground Truth Type, Training Set Size, Training Set Ground Truth Establishment) from this document as it pertains to a clinical study proving device performance against acceptance criteria.

The information from the document that is relevant to non-clinical testing and device characteristics is provided below.

Non-Clinical Testing and Device Characteristics from the 510(k) Clearance Letter

While a clinical study proving performance against acceptance criteria is not presented, the document does describe the non-clinical tests performed to support the device's safety and effectiveness and its substantial equivalence to predicate devices.

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

Since this is a 510(k) clearance notice based on substantial equivalence and non-clinical testing, there isn't a direct "acceptance criteria table" in the traditional sense of a clinical trial's performance endpoints. However, the document outlines standards and guidance documents used as criteria for the non-clinical tests, and the stated conclusion is that the device meets these requirements.

• ASTM F2213-17: Measurement of magnetically induced torque
• ASTM F2119-07 (2013): Evaluation of MR image artifacts from passive implants
• ASTM F2503-20: Marking medical devices for MR safety
• FDA guidance: "Testing and Labeling Medical Devices for Safety in the Magnetic Resonance (MR) Environment" (October 10, 2023) | MR Conditional. Testing included in reference device (K221094) supports labeling update.
  The proposed Atlantis® Abutments in Titanium meet the requirements. |
  | Biocompatibility | - ISO 10993-1:2018: Biological evaluation of medical devices – Part 1
• ISO 10993-5:2009: Cytotoxicity testing | Biocompatibility assessment was performed and no new questions regarding biocompatibility are raised. Cytotoxicity testing was performed. |
  | Reprocessing (Sterilization Drying Time) | - ANSI/AAMI/ISO 17665-1:2006/(R)2013, Annex D
• ANSI/AAMI/ISO 14937:2009/(R)2013, Annex D (Approach 3)
• AAMI TIR12:2020
• ANSI/AAMI/ISO TIR17665-2:2009
• FDA guidance: "Reprocessing Medical Device in Health Care Settings: Validation Methods and Labeling" | Reprocessing testing was performed to validate the proposed drying time for steam sterilization. The sterilization drying time validation followed the FDA guidance and relevant standards. |
  | CAD/CAM Software Validation & Verification (Atlantis® Abutment Milling) | To ensure that the same design limitations/constraints present in the 3Shape Atlantis® Abutment library match those in the internal CAD system, and that the design parameters cannot be exceeded. | Software validation was performed and confirmed that the additional option of using the 3Shape design module for design of Atlantis® Abutments does not raise new questions of safety and performance as it was confirmed that the locked design library has the same design limits as the internal VAD software. |
  | Mechanical Performance (Fatigue Testing) | - ISO 14801:2016: Implants – Dynamic loading test for endosseous dental implants
• FDA Guidance: Root-form Endosseous Dental Implants and Endosseous Dental Abutments – Class II Special Controls Guidance Document. | The internally documented and proposed modifications did not affect the performance of the devices and no new fatigue testing was needed. The abutments continue to meet the requirements. |

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

• Sample Size for Non-Clinical Tests: Not explicitly stated as numerical sample sizes (e.g., 'n=X implants'). The testing refers to meeting standard requirements (e.g., ASTM, ISO guidelines), which imply specific numbers of test units, but these are not provided in this summary document.
• Data Provenance: The testing was conducted by Dentsply Sirona (the manufacturer) and references previous FDA clearances (K numbers) and established standards. The data is part of the 510(k) submission to the FDA. The provenance of specific raw data (country of origin, retrospective/prospective) is not detailed in this summary.

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):

• Not applicable. This document does not describe a process for establishing ground truth using human experts for the purpose of validating an AI/software device's diagnostic performance against human readers. The validation activity for the software (Atlantis® Abutment Milling) was to ensure its design limitations mirrored the internal CAD system and did not fall outside acceptable parameters.

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

• Not applicable. This is not a clinical study involving human interpretation or adjudication of findings.

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. The document explicitly states: "Clinical Tests Summary and Conclusion: Not applicable. There are no clinical tests submitted, referenced, or relied on in the 510(k) for a determination of substantial equivalence." Therefore, no MRMC study was conducted or reported.

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

• The "software validation" for "Atlantis® Abutment Milling" is a form of standalone performance evaluation for the CAD capabilities. It confirms that the software's design outputs (e.g., abutment geometry) from the 3Shape Abutment Designer Software conform to the established design envelope and limitations of Dentsply Sirona's internal CAD system (Virtual Abutment Design - VAD). This is a technical validation of the algorithm's design capability, not a diagnostic performance study.

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

• For the MR Safety testing, the ground truth or "reference standard" is the physical behavior of the device under MR conditions, measured against established ASTM standards and FDA guidance.
• For Biocompatibility, the ground truth is the biological response, evaluated against ISO standards.
• For Reprocessing, the ground truth is the effectiveness of sterilization and drying, validated against AAMI/ISO standards and FDA guidance.
• For CAD/CAM Software Validation, the "ground truth" for the 3Shape software is the "validated and locked design library" and "design limitations" of Dentsply Sirona's internal VAD software, ensuring the external software produces designs within the company's approved specifications.
• For Mechanical Performance (Fatigue Testing), the ground truth is the structural integrity and durability under dynamic loading, evaluated against ISO standards and FDA guidance.

8. The sample size for the training set:

• Not applicable. This is not an AI/ML device that requires a "training set" in the context of supervised learning for diagnostic tasks. The software referred to (3Shape Abutment Designer Software) is a CAD software for design, not a machine learning model for prediction or classification.

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

• Not applicable, as there is no "training set" in the machine learning sense described in this document. The "ground truth" for the CAD software's validation was its adherence to the manufacturer's established design rules and limitations.

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Permanent obturation of root canals of the secondary dentition in combination with root canal points.

AH Plus Endodontic Sealer is a two-component paste-paste permanent root canal sealer based on epoxyamine resin. It is available in two delivery forms: AH Plus Endodontic Sealer in tubes, for an easy manual mix, or as AH Plus Jet Endodontic Sealer double-barrel syringe with a disposable mixing tip for intraoral use, offering a more precise, convenient, and faster procedure. It functions as part of the endodontic treatment, allowing for restoration of tooth integrity. It adapts closely to the walls of the prepared root canal and presents permanent sealing ability and radiopacity. AH Plus Endodontic Sealer does not stain teeth.

This document is a 510(k) summary for the AH Plus Endodontic Sealer. It primarily focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study proving device performance against specific acceptance criteria in the context of an AI-powered diagnostic device.

Therefore, many of the requested categories for AI/digital health devices are not directly applicable or are not explicitly detailed in this type of submission for a traditional medical device like an endodontic sealer.

However, I can extract the information related to performance testing as described for this device, specifically those aspects that function as "acceptance criteria" for the device's physical properties.

Acceptance Criteria and Study for AH Plus Endodontic Sealer (K243546)

1. Table of Acceptance Criteria and Reported Device Performance

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

This information is not provided in the document. The document describes non-clinical bench testing, not a clinical study involving patients or data provenance in that sense.

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)

This is not applicable as the ground truth for the performance tests (radiopacity, solubility, etc.) is established by the physical and chemical properties measured against the ISO standard, not by expert interpretation.

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

This is not applicable. The "test set" here refers to samples of the device material undergoing physical and chemical tests, not diagnostic cases 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

This is not applicable. This is a submission for an endodontic sealer, which is a physical material, not an AI-powered diagnostic device. No human reader or AI assistance is involved.

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

This is not applicable. This device is not an algorithm or software.

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

The "ground truth" for the performance tests is the specified limits and methodologies defined within the ISO 6876:2012 standard for dentistry-root canal sealing materials. For biocompatibility, the ground truth is adherence to the specified ISO 10993 series and USP standards.

8. The sample size for the training set

This is not applicable. This is a physical medical device, not an AI model. There is no concept of a "training set."

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

This is not applicable.

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· Lucitone Digital Print™ 3D Denture Base is a light-cured resin indicated for the fabrication of denture bases including full and partial dentures* and implant overdentures.
· Lucitone Digital IPN™ 3D Premium Tooth is a light-cured resin intended for printing denture teeth. Lucitone Digital Value™ 3D Economy Tooth & Trial Placement is intended for use as:
· Printing resin for fabricating removable dentures for try-in and evaluation prior to fabrication of the final denture.*
· Printing resin for fabricating a temporary denture.
· Printing resin for fabricating denture teeth in full arches and segments that will subsequently be fused into a denture base.
· Printing resin for fabricating provisional crowns, bridges.**
• Lucitone Digital Fuse™ Step 1 – 3D Tooth Conditioning Agent is indicated for use in enhancing the bond of denture teeth to denture base and denture base to denture base.
· Lucitone Digital Fuse™ Step 2 - 3D Denture Bonding Resin is utilized as an aid in bonding denture teeth to denture base as well as repair using traditional techniques.
· Lucitone Digital Fuse™ Step 3 – Total 3D Sealer is a light-cured sealant that produces a smooth, glossy surface finish on the denture.
*Partial and full dentures are replacement for patients with missing teeth.†
**For instructions on printing provisional crowns and bridges with Lucitone Digital Value reference Section G in IFU
+Statement added for EU MDR alignment.

Lucitone Digital Value™ (LDV) 3D Economy Tooth & Trial Placement, which is part of the Lucitone Digital Print™ Denture (LDPD) System, is a methacrylate-based resin system which is used to fabricate dental prostheses using an additive printer and computer aided design and computer aided manufacturing (CAD/CAM) technologies.

I am sorry, but the provided text does not contain the detailed information necessary to answer your request about acceptance criteria and the study that proves the device meets them. The document is an FDA 510(k) summary for a dental device (Lucitone Digital Print Denture™ System) that describes the device, its indications for use, and a few performance tests.

Specifically, the following information is not present in the text:

• A comprehensive table of acceptance criteria and reported device performance. While some performance metrics are listed (Flexural Strength, Flexural Modulus, Water Sorption, Water Solubility), these are general and not presented as specific acceptance criteria with corresponding performance test results. For example, for "Flexural Strength," it only states "≥50 MPa" as the acceptance criterion, but it does not report the actual performance value obtained for the subject device.
• Sample size used for the test set and data provenance. The document only mentions "In all instances, the subject device functioned as intended and all test results observed were as expected," without providing details about the test set.
• Number of experts used to establish ground truth and their qualifications.
• Adjudication method.
• If a multi-reader multi-case (MRMC) comparative effectiveness study was done, or the effect size of human improvement with AI assistance. This device is a denture system, not an AI or diagnostic tool, so an MRMC study is highly unlikely to be relevant.
• If a standalone (algorithm only without human-in-the-loop performance) study was done. This is not applicable to a physical dental device.
• The type of ground truth used. This is not applicable in the context of a physical materials performance study.
• Sample size for the training set. This is not applicable as it's not an AI model.
• How the ground truth for the training set was established. This is not applicable as it's not an AI model.

The document mainly focuses on demonstrating substantial equivalence to a predicate device through non-clinical performance data (material properties) and biocompatibility, rather than a clinical study evaluating diagnostic or treatment efficacy that would typically involve test sets, ground truth, and expert adjudication. The "Performance Data" section explicitly states, "Clinical and Pre-clinical testing were not necessary to demonstrate equivalence."

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