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ATLANTIS™ ISUS Implant Suprastructures are indicated for attachment to dental implants or abutments in the treatment of partially or totally edentulous jaws for the purpose of restoring chewing function.

ATLANTIS™ ISUS Implant Suprastructures are intended for attachment to a minimum of two (2) implants and are indicated for compatibility with the following implant and abutment systems:

Implants:
Biomet 3i Certain 3.25, 4/3 - Prevail 3/4/3, 4/3
Biomet 3i Certain 4.0, 5/4 – Prevail 4/5/4. 5/4
Biomet 3i Certain 5.0, XP 4/5 - Prevail 5/6/5, 6/5
Biomet 3i Certain 6.0, XP 5/6
BioHorizons Internal/Tapered 3.5, 4.5, 5.7
Camlog Screw-line Implant 3.3
Camlog Screw-line / Root-line Implant 3.8, 4.3, 5.0, 6.0
DENTSPLY Implants XiVE S 3.0, S 3.4, S 3.8, S 4.5, S 5.5
DENTSPLY Implants OsseoSpeed™ TX 3.0, 3.5/4.0, 4.5/5.0
DENTSPLY Implants Osseospeed™ Profile TX 4.5/5.0
DENTSPLY Implants Osseospeed™ EV 3.0, 3.6, 4.2, 4.8, 5.4
DENTSPLY Implants Osseospeed™ Profile EV 4.2, 4.8
Keystone Dental PrimaConnex SD 3.3/3.5
Keystone Dental PrimaConnex RD 4.0/4.1
Keystone Dental PrimaConnex WD 5.0
Keystone Dental Genesis 3.8, 4.5, 5.5/6.5
Nobel Biocare NobelActive NP 3.5 - RP 4.3, 5.0
Nobel Biocare NobelReplace NP-3.5 - RP 4.3 - WP 5.0 – 6.0
Straumann Bone Level 3.3 NC - 4.1, 4.8 NC
Straumann Standard Plus 3.5 NN
Straumann Standard / Standard Plus 4.8 RN – 4.8 WN
Zimmer Dental Tapered Screw Vent S-V 3.5/S-V 3.3, 3.7 / S-V 4.5/ S-V 4.5
Zimmer Dental Tapered Screw Vent 5.7

Abutments:
Biomet 3i Low Profile Abutment
DENTSPLY Implants ATIS Uni Abutment EV
DENTSPLY Implants ATIS UniAbutment 20°, ATIS UniAbutment 45°
DENTSPLY Implants ATIS Angled Abutment EV
DENTSPLY Implants ATIS Angled Abutment 20°
DENTSPLY Implants ANKYLOS Balance Base Narrow D4.2, Balance Base D5.5
DENTSPLY Implants XiVE MP 3.4, MP 3.8, MP 4.5, MP 5.5
DENTSPLY Implants XiVE TG 3.4, TG 3.8, TG 4.5
Nobel Biocare Multi-Unit Abutment RP
Straumann Bone Level Multi-Base Angled Abutment
Straumann Bone Level Multi-Base Abutment D3.5, D4.5
Straumann RN Abutment Level, WN Abutment Level
Straumann Screw-Retained Abutment 3.5, 4.6
Zimmer Dental Tapered Abutment

The ATLANTIS™ ISUS Implant Suprastructures include new implant and abutment interfaces of the predicate ISUS Implant Suprastructures, cleared in K122424.

The ATLANTIS™ ISUS Implant Suprastructures are patient-specific restorative devices that are intended to be attached to dental implants or abutments to facilitate prosthetic restoration in the treatment of partially and totally edentulous patients. The design of the subject device is derived from patient dental models and completed by DENTSPLY technicians using computer-assisted design (CAD) according to the clinician's prescription. The final CAD design of the ATLANTIS™ ISUS suprastructures are fabricated using computer-assisted manufacturing (CAM) to produce a customized, patient-specific device.

The subject ATLANTIS™ ISUS Implant Suprastructures are available in the same design types as cleared for the predicate ISUS Implant Suprastructures in K122424:

1. Bar Intended as a fixed supporting structure for a removable dental prosthesis.
2. Bridge Intended for direct veneering using dental ceramics or resin composites resulting in a fixed, screw-retained prosthesis.
3. Hybrid Intended as a fixed denture framework.

Screws are available for all compatible implant and abutments systems to screw the ATLANTIS™ ISUS Implant Suprastructures into the implant or onto the abutment.

In addition to the introduction of the new interfaces of the ATLANTIS™ ISUS Implant Suprastructures, the product reference names of the compatible interfaces are adjusted in the indications for use for the currently marketed ATLANTIS™ ISUS Implant Suprastructures to better reflect the original manufacturer's product description.

The provided document describes a 510(k) premarket notification for a medical device, specifically the ATLANTIS™ ISUS Implant Suprastructures. This type of submission aims to demonstrate that a new device is as safe and effective as a legally marketed predicate device, rather than proving novel effectiveness. Therefore, the information provided focuses on demonstrating substantial equivalence through non-clinical testing and comparison to existing devices, rather than a clinical study establishing acceptance criteria in the traditional sense of AI performance metrics like sensitivity, specificity, or AUC.

Based on the document, here's a breakdown of the requested information:

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

Since this is a 510(k) for a dental implant component, the "acceptance criteria" are related to mechanical and material equivalence to predicate devices, and "device performance" refers to its ability to meet these engineering standards. There are no performance metrics like sensitivity or specificity.

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

This information is not applicable or not provided in the context of an AI device. This document is for a physical medical device (dental suprastructures). The testing performed is non-clinical, involving mechanical and dimensional analysis of device components themselves, rather than testing on a "test set" of patient data.

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 information is not applicable or not provided. "Ground truth" in the context of an AI device, established by experts, is not relevant here as this is a physical medical device. The "ground truth" for this device's performance would be the universally accepted engineering standards for dental prosthetics and the demonstrable properties of the materials and design.

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

This information is not applicable or not provided. Adjudication methods are typically used in clinical studies or for establishing ground truth in AI studies. The testing described is non-clinical performance data (mechanical design analysis, dimensional analysis, static and dynamic compression-bending testing).

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 information is not applicable or not provided. This is not an AI device, and therefore, an MRMC study comparing human readers with and without AI assistance is not relevant.

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

This information is not applicable or not provided. This is not an algorithm-only device.

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

The "ground truth" here is the established engineering standards for dental prosthetics. This includes:

• Mechanical standards: ISO 14801 Dentistry -- Implants -- Dynamic fatigue test for endosseous dental implants.
• Material standards: Properties of CPTi, CoCr, Ti-6Al-4V ELI, Ti-6Al-7Nb (as listed for abutment and screw materials).
• Biocompatibility: Demonstrated equivalence to the predicate device (K122424) which had prior biocompatibility testing.
• Design principles: Comparison to existing, legally marketed predicate devices to establish substantial equivalence in intended use and fundamental technology.

8. The sample size for the training set

This information is not applicable or not provided. As this is a physical device submission, there is no "training set" in the context of machine learning. The device's design is "derived from patient dental models and completed by DENTSPLY technicians using computer-assisted design (CAD) according to the clinician's prescription," and then fabricated using computer-assisted manufacturing (CAM).

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

This information is not applicable or not provided. There is no machine learning training set for this device. The "ground truth" for the CAD/CAM design process would be the clinician's prescription and the patient's dental models, which guide the creation of the patient-specific device.

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ATLANTIS™ ISUS implant suprastructures are indicated for attachment to dental implants or abutments in the treatment of partially or totally edentulous jaws for the purpose of restoring function.

ATLANTIS™ ISUS implant suprastructures are intended for attachment to a minimum of two (2) implants and are indicated for compatibility with the following implant and abutment systems:

Implants:

• 3i Internal Connection: D3.4, D4.1, D5, D6
• Friadent XiVE S: D3.0, D3.4, D3.8, D4.5, D5.5
• Nobel Biocare Active Internal: NP (3.5mm), RP (4.3mm, 5.0mm)
• Nobel Biocare Replace Select: NP (3.5mm), RP (4.3mm), WP (5.0mm) and Replace Select 6.0mm
• Straumann Bone Level: NC (3.3mm), RC (4.1mm, 4.8mm)
• Straumann NN (3.5mm), RN (4.8mm), WN (6.0mm)
• Zimmer Screw Vent: D3.5, D4.5, D5.7

Abutments:

• 3i Low Profile Abutment
• ANKYLOS Balance Base Abutment D5.5 and Narrow Abutment D4.2
• ASTRA TECH 20° and 45° UniAbutment
• Astra Tech UniAbutment EV 3.6
• Friadent XiVE MP D3.8, D4.5, D5.5
• Friadent XiVE TG D3.8,D 4.5, D5.5
• Nobel Biocare Multi-Unit Abutment RP: 4.0 mm
• Straumann Bone Level Angled Abutment: 4.0 mm
• Straumann Bone Level: Multi-Base Abutment D3.5, D4.5
• Straumann RN (4.8 mm), WN (6.5 mm)
• Zimmer Tapered Abutment: 4.5 mm

ATLANTIS™ ISUS is a custom restorative device that is intended to dental implants or abutments to facilitate prosthetic restoration in the treatment of partially and totally edentulous patients. The design of the subject device is derived from patient dental models and completed by DENTSPLY technicians using computer-assisted design (CAD) according to the clinician's prescription. The final CAD design of ATLANTIS™ ISUS is fabricated using computer-assisted manufacturing (CAM) to produce a custom patient specific device.

ATLANTIS™ ISUS is available in four design types: Bar, Bridge, Hybrid, and 2 in 1. It also features Angulated Screw Access (ASA) allowing the screw-channel opening to be angled up to 30° off the implant/abutment axis.

The provided text describes a medical device called ATLANTIS™ ISUS, an implant suprastructure. The document is primarily a 510(k) premarket notification summary, which focuses on demonstrating substantial equivalence to predicate devices rather than providing detailed acceptance criteria and a study design for a new device.

Therefore, the document does not contain the detailed acceptance criteria and a study specifically designed to prove the device meets those criteria in the way one would for a new AI/software device. The information provided is for a physical medical device (dental implant suprastructure).

However, I can extract the information related to the device's "performance" characteristics and the testing performed to demonstrate its safety and effectiveness, which serves a similar purpose to acceptance criteria and performance data for this type of device.

Here's an interpretation based on the provided text, structured to align with your request for acceptance criteria and study information, noting the differences due to the nature of the device:

1. Table of Acceptance Criteria and Reported Device Performance

For this device, "acceptance criteria" are not framed as statistical thresholds for an AI algorithm's output, but rather as meeting specific physical and mechanical performance standards comparable to legally marketed predicate devices. The "reported device performance" refers to the results of non-clinical bench testing.

The following points refer to your specific questions, which are more tailored to AI/software validation studies. Given that this is a physical medical device submission (dental implant suprastructure), some of these questions are not directly applicable or the information is not present in the document.

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

• Sample Size: Not explicitly stated for the non-clinical tests (e.g., how many units were fatigue tested). It refers to "testing" in general.
• Data Provenance: Not applicable for non-clinical bench testing of physical devices. The testing was conducted as part of the submission package for FDA clearance.

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. "Ground truth" in this context would implicitly be the established engineering standards (like ISO 14801) and accepted dental restoration principles, not expert consensus on image interpretation or diagnosis.

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

• Not applicable for non-clinical bench testing. Performance is measured against physical specifications and standard test methods.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

• No. This is a physical dental implant suprastructure, not an AI/software device involving human readers.

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

• The performance assessment described is "standalone" in the sense that it's the physical device alone being subjected to tests. However, it's not an algorithm.

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

• For the non-clinical tests, the "ground truth" is based on:
  • International Standards: ISO 14801 (for dynamic fatigue testing).
  • Engineering Principles/Specifications: Performance against specified torque requirements, material properties, and dimensional compatibility.
  • Equivalence to Predicate Devices: The ultimate "truth" for 510(k) is demonstrating that the device is as safe and effective as a legally marketed predicate device.

8. The sample size for the training set

• Not applicable. This device is manufactured using CAD/CAM based on patient dental models and clinician prescriptions. There is no explicit "training set" in the machine learning sense. The "design" is based on established engineering principles and dental prosthetics knowledge, and the "manufacturing" is automated.

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

• Not applicable. There is no "training set" in the AI sense. The design process (CAD) uses patient-specific data to create a custom device according to pre-defined parameters and dental restoration best practices, rather than learning from a dataset.

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The ATLANTIS™ Crown is intended for use with an ATLANTIS™ Abutment and an endosseous implant to function as a substructure that also serves as the final restoration, in a partially or completely edentulous patient.

The ATLANTIS™ Crown is a patient-specific dental prosthetic component intended for use with an ATLANTISTM Abutment, abutment screw, and an endosseous implant to support a single-tooth prosthetic restoration. The ATLANTIS™ Crown is made of yttria stabilized zirconia powder (Y-TZP) and fabricated according to the clinician's prescription using CAD/CAM technology. The crown can be delivered as a full contour crown or as a cut-back substructure onto which porcelain will be added by the customer. The ATLANTIS™ Crown is finally cemented to the ATLANTIS™ Abutment.

This document describes a 510(k) premarket notification for the ATLANTIS™ Crown, a patient-specific dental prosthetic component. The information provided heavily focuses on comparing the proposed device to predicate devices to establish substantial equivalence, rather than detailing a specific clinical study with acceptance criteria for a novel device.

Therefore, it is important to note that the input document does NOT describe the acceptance criteria and a study that proves the device meets those acceptance criteria in the typical sense for an AI/ML device.

Instead, the document demonstrates that the ATLANTIS™ Crown is substantially equivalent to a legally marketed predicate device based on its intended use, technological characteristics (material, design, manufacturing), and non-clinical performance data (flexural strength, fracture toughness, chemical solubility, radioactivity concentration, and coefficient of thermal expansion).

Here's an analysis based on the available information, addressing the requested points where possible, and noting where information is not present in the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state "acceptance criteria" in the context of a performance study for the ATLANTIS™ Crown as a new device with novel performance claims to be evaluated. Instead, it relies on demonstrating that the ATLANTIS™ Crown meets the established performance characteristics of its predicate devices and complies with relevant standards.

Regarding the remaining points:

The provided document is a 510(k) summary for a medical device (ATLANTIS™ Crown) which is a physical product, not an AI/ML diagnostic or assistive tool. Therefore, many of the requested points related to AI/ML device studies (sample sizes for test/training sets, data provenance, number/qualifications of experts, adjudication methods, MRMC studies, standalone performance, ground truth types) are not applicable and are not found in this document.

Specific responses to the remaining points based on the understanding that this is not an AI/ML device document:

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): Not applicable. This document reports non-clinical material characterization data (flexural strength, fracture toughness, etc.) against established standards (ISO, ASTM), not a clinical trial with a test set of patient data.
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. "Ground truth" in the context of clinical or diagnostic AI/ML studies is not relevant here. Material properties are measured against physical standards.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable. Material testing involves scientific measurement and comparison to quantitative standards, not expert adjudication.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This is a physical prosthetic device, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable. This is a physical prosthetic device.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc): Not applicable in the AI/ML sense. The "ground truth" for material properties is the defined limits and test methods of international standards like ISO 6872.
8. The sample size for the training set: Not applicable. There is no "training set" as this is not an AI/ML model.
9. How the ground truth for the training set was established: Not applicable. There is no "training set" or corresponding ground truth establishment process.

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The ATLANTIS™ Abutment is 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 prosthesis can be cemented or screw retained to the abutment. The 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 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 attachmentretained by friction fit to the abutment. The abutment screw is intended to secure the ATLANTIS™ Conus Abutment to the endosseous implant.

ATLANTIS™ Abutment for NobelActive 3.0 is compatible with the NobelActive 3.0 implant.

ATLANTISTM Abutment for NobelActive 3.0 is provided in three designs: ATLANTISTM Abutment for NobelActive, ATLANTIS™ Crown Abutment for NobelActive and ATLANTISTM Conus Abutment for NobelActive. All are patient specific fabricated abutments using CAD/CAM technology. Each abutment is designed according to prescription instructions from the clinician to support a screw-retained. cement-retained or friction fit prosthesis.

The coronal portion of the ATLANTIS™ abutment can be fabricated as a conventional abutment for prosthesis attachment (ATLANTIS™ Abutment or ATLANTISTM Conus Abutment) or fabricated as a single tooth final restoration onto which porcelain is added (ATLANTISTM Crown Abutment). The implant/abutment interface is compatible with the NobelActive 3.0 implant.

ATLANTISTM Abutment for NobelActive 3.0 has an internal connection and is provided for implant platform diameter Ø3.0 mm. The abutment diameter ranges from 3.3 to 13 mm, the maximum abutment height is 15 mm above implant interface and the minimum abutment height is 4 mm above the transmucosal collar. The abutment is provided straight and up to 30° of angulation.

Here's an analysis of the provided text regarding the acceptance criteria and study for the ATLANTIS™ Abutment for NobelActive 3.0.

Important Note: The provided document is a 510(k) premarket notification for a medical device (dental implant abutment). These types of submissions typically focus on demonstrating substantial equivalence to existing legally marketed devices, rather than establishing completely new performance criteria or conducting extensive effectiveness studies for a novel AI algorithm. Therefore, many of the requested categories related to AI performance, ground truth, and expert evaluation are not applicable to this type of traditional medical device submission.

The "studies" described are primarily non-clinical engineering tests to ensure mechanical integrity and compatibility with the predicate device.

Acceptance Criteria and Reported Device Performance

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: Not explicitly stated in the summary. For mechanical testing (ISO 14801), devices are typically tested in small batches to statistical significance or to demonstrate compliance with a specific load rating. The exact number of abutments tested is not provided.
• Data Provenance: The "Non-Clinical Performance Data" section (Section 7) describes testing performed by DENTSPLY International, Inc., the manufacturer/submitter, and references predicate devices. This would be considered prospective testing conducted specifically for this 510(k) submission or in support of prior predicate device approvals. The country of origin of the data is implied to be within the company's testing facilities, likely in the US as the submitter is a US company.

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

• N/A. This device is a physical medical device (dental abutment), not an AI algorithm that requires expert annotation for ground truth. The "ground truth" for its performance is established through quantitative mechanical testing and engineering analyses against defined standards (like ISO 14801).

4. Adjudication Method for the Test Set

• N/A. Adjudication methods (like 2+1, 3+1) are relevant for human evaluation processes, especially in clinical trials or AI performance evaluations involving multiple readers. This is a physical device undergoing mechanical and engineering tests, not an interpretive task.

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

• N/A. This is not an AI-powered diagnostic or assistive device. It is a physical dental implant abutment.

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

• N/A. This is a physical dental implant abutment, not an algorithm.

7. The Type of Ground Truth Used

• For Mechanical Strength & Compatibility: The "ground truth" is defined by engineering standards and specifications (e.g., ISO 14801, material properties, dimensional tolerances, fit with the corresponding implant). Performance is measured against these objective standards.
• For Biocompatibility & Sterility: The "ground truth" is derived from established regulatory standards and validated testing protocols (e.g., ISO 10993 for biocompatibility, ISO 11137 or AAMI standards for sterility assurance levels).

8. The Sample Size for the Training Set

• N/A. This is not an AI algorithm that requires a training set. The design of the ATLANTIS™ Abutment is based on CAD/CAM technology, but the "training" in this context refers to the manufacturing process, not machine learning.

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

• N/A. As there is no AI training set, this question is not applicable. The design and manufacturing process for the CAD/CAM abutment are governed by engineering principles and quality control, not ground truth derived from annotated data.

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Used for ultrasonic procedures:

• All general supra and subgingival scaling applications .
• Periodontal debridement for all types of periodontal diseases .

The Cavitron Touch™ Ultrasonic Scaling System is an ultrasonic scaling unit that is used in all general supra and subgingival scaling applications and periodontal debridement for all types of periodontal diseases. The Cavitron Touch™ Ultrasonic Scaling System includes a digital touch screen interface and Bluetooth technology. This device is equipped with the Tap-On™ Wireless Foot Pedal with Tap-On™ technology.

The provided text describes a medical device, the Cavitron Touch™ Ultrasonic Scaling System, and its substantial equivalence to a predicate device, the Cavitron® RF Ultrasonic Scaler System with Sterimate Handpiece (K052334). However, the document does not contain specific acceptance criteria or a study proving the device meets those criteria with quantitative performance metrics for the reasons listed below for each criterion. This is a 510(k) submission, which focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than undergoing a de novo clinical trial with explicit acceptance criteria for efficacy.

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

1. Table of acceptance criteria and the reported device performance

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

• The document does not specify sample sizes for any test sets related to performance characteristics (e.g., number of units tested, duration of tests).
• The data provenance is internal testing performed by DENTSPLY International Inc. (Section 7, "Internal specification and testing"). Country of origin is not specified but the company is based in York, Pennsylvania, USA. The testing would be prospective in nature for a new device design.

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 submission focuses on engineering and performance verification against existing standards and internal specifications, not on establishing ground truth for diagnostic or clinical interpretation using expert readers.

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

• Not applicable. As the "ground truth" and "expert" roles are not relevant in this type of engineering and performance verification submission, there is no adjudication method 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

• No, an MRMC comparative effectiveness study was not done. This device is an ultrasonic scaler; it is a tool used by dental professionals, not an AI-powered diagnostic system that assists human readers in case interpretation. The document explicitly states "No data from human clinical studies has been included to support the substantial equivalence of the Cavitron Touch™ Ultrasonic Scaling System" (Section 9, page 9).

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

• Not applicable. This device is an ultrasonic scaler. Its function is to perform ultrasonic scaling procedures, which inherently involves a human operator (a dental professional). It is not an algorithm that functions in a standalone capacity without human intervention.

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

• Not applicable/Not explicitly defined in the clinical sense. For a device like an ultrasonic scaler, "ground truth" for non-clinical performance would relate to engineering specifications, safety standards (e.g., electrical safety, electromagnetic compatibility), and functional requirements (e.g., power output, water flow, touch screen responsiveness). The closest to "ground truth" would be the standards themselves (e.g., AAMI ANSI ES 60601-1, IEC 60601-1-2) and the internal specifications against which the device was tested.

8. The sample size for the training set

• Not applicable. This device is not an AI/machine learning system that requires a "training set" in the conventional sense. The development likely involved iterative design and testing, but not a formally defined "training set" for an algorithm.

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

• Not applicable. As there is no training set for an AI/ML algorithm, the concept of establishing ground truth for it does not apply.

Summary of Study Type:

The document describes non-clinical performance data (Section 7, page 9) which includes:

• Verification of design
• Ultrasonic scaling performance
• Function of the device
• Adherence to international standards (AAMI ANSI ES 60601-1, IEC 60601-1-2)
• Guidance for software validation (FDA - Guidelines for the Content of Premarket Submissions for Software Contained in Medical Devices- Software Validation)
• Internal specification and testing for handpiece operation, autocycle operation, touch screen/user interface, and radio frequency distance for the wireless foot pedal.

This type of submission relies on demonstrating that the new device is as safe and effective as a legally marketed predicate device through engineering and performance testing, rather than through extensive clinical trials with explicit performance metrics and acceptance criteria for patient outcomes.

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Anchorage of dentures retained by taper friction and supported by ANKYLOS® implants. Immediate loading of an implant supported prosthesis in an edentulous mandible supported by 4 ANKYLOS® implants of at least 11mm in length and placed interforaminally.

The ANK YLOS® SynCone Abutiment 5° is an endosseous dental implant abutment which provides a platform for prosthetic restoration in conjunction with ANKYLOS™ implants. The subject device incorporates an abutment head with a 5° conical taper and is provided in angulations of 0° 7.5° 15° 22.5° and 30° and with gingival heights ranging from J.5mm . 4.5mm. The abutment is connected to the corresponding iniblant. by a central screw which mates with the internal thread of the implant. The abuiment and the abutment screw are machined from Titanium Alloy (Ti6AL4V ELI) conforming 10 ASTM F136 (Standard Specification for Wrought Titannum-6 Aluminim-4 Vanadium ELI (Extra Low Interstitial' Alloy for Surgical Implant Applications). The tapered SynCone® 5° caps which anchor the SynCone® abutment on the fixed denture are made of Gold Alloy of Titanium conforming to ASTM F67 (Standard Specification for Unalloyed Titanium, for Surgical Implant Applications). The SynCone® abutments feature a reatining screw design which allows for the rotation of the abutment head after attachment to the implant in order to achieve rotational alignment for all of the abutments used in the prosthetic restoration.

Here's an analysis of the provided text regarding the acceptance criteria and supporting studies for the ANKYLOS® SynCone® Abutment 5°:

Acceptance Criteria and Study Details for ANKYLOS® SynCone® Abutment 5°

Based on the provided 510(k) summary, the device's acceptance criteria and the studies performed focus on demonstrating substantial equivalence to predicate devices. The primary criteria revolve around material composition, design, and performance characteristics compared to existing, legally marketed products.

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not explicitly state the specific numerical sample sizes for the test sets in the non-clinical performance data (fatigue testing, pull force testing). It mentions "Representative fatigue testing" and "Pull force testing."

The data provenance is non-clinical bench testing, meaning it's laboratory-generated data, not from human subjects. Therefore, country of origin and retrospective/prospective designations for human data are not applicable here.

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

This section is not applicable. The ground truth for this type of submission (demonstrating substantial equivalence through non-clinical bench testing) is defined by established international standards (like ISO 14801) and direct comparison to the performance characteristics of legally marketed predicate devices. It does not involve expert adjudication of human clinical data.

4. Adjudication Method for the Test Set

This section is not applicable as the evaluation relies on objective measurements from bench testing following established standards and direct comparison to predicate device performance. No human adjudication of results is described.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done

No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic devices where human readers interpret medical images or data. The ANKYLOS® SynCone® Abutment 5° is a dental implant abutment, and its evaluation for this 510(k) submission relied on non-clinical performance data.

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

This section is not applicable. The device is a physical medical device (an implant abutment), not an algorithm or AI system. Its performance is inherent in its physical and mechanical properties, evaluated through bench testing, not through an algorithm's output.

7. The Type of Ground Truth Used

The ground truth used for verifying the device's performance is established engineering and material science standards and metrics, and direct comparative performance against legally marketed predicate devices.

Specifically:

• ISO 14801: Dynamic fatigue test for endosseous dental implants.
• ASTM F136 and ASTM F67: Standard specifications for titanium alloys, defining acceptable material properties.
• Performance of predicate devices: The established and accepted performance of the ANKYLOS SynCone® Abutinents 4º and 6° (K041509) and Angled ANKYLOS® Balance Base Abutments (K122268) serve as the benchmark for equivalence.

8. The Sample Size for the Training Set

The concept of a "training set" is not applicable here. A training set is used in machine learning to teach an algorithm. This submission is for a physical medical device, not an AI/ML algorithm.

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

This section is not applicable for the same reasons as point 8.

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MTM® Clear-Aligner is indicated for the treatment of anterior tooth malocclusions in patients with permanent dentition (i.e. all second molars). Utilizing a series of incremental minor tooth movements (torque, tipping, rotation and bodily movement), MTM® Clear-Aligner sequentially positions teeth by way of continuous gentle force.

MTM® Clear-Aligner is a system of plastic aligners fabricated in an orthodontic appliance laboratory. The formed aligners contain force points and spaces necessary for tooth movement by way of continuous gentle force. As the aligner is positioned on any particular tooth, the presence of the force points loads the polymeric shell material. The stored energy thus imparted into the elastomeric material of the aligner slowly dissipates over time as the bone underlying the tooth physiologically responds to the forces. After the entire series of aligners are produced by the MTM® Service Center for the prescribed case, they are shipped to the dental practitioner. Each individual aligner moves the patient's teeth in small increments from their original state to a final state.

This submission for the MTM® Clear-Aligner is a 510(k) premarket notification, which demonstrates substantial equivalence to a predicate device rather than providing extensive clinical study data to meet specific acceptance criteria for novel devices. Therefore, much of the requested information regarding clinical studies and detailed performance metrics (like effect sizes for MRMC studies, standalone performance with AI, sample sizes for training/test sets, and expert details for ground truth) is not applicable or not provided in this type of submission.

The core of this submission revolves around demonstrating that the new device (MTM® Clear-Aligner) is substantially equivalent to a previously cleared predicate device (MTM® Clear Aligner In-Office). The acceptance criterion here is "substantial equivalence" based on technological characteristics, indications for use, and safety/performance.

Here's the breakdown of the available information:

1. Table of Acceptance Criteria and Reported Device Performance

Since this is a substantial equivalence submission, the "acceptance criteria" are effectively the characteristics of the predicate device that the new device must match or be demonstrably as safe and effective as. The "reported device performance" is a comparison to those characteristics.

Device Performance Claim: The MTM® Clear-Aligner is substantially equivalent to the predicate device because it shares the same indications for use, intended use, fundamental technological characteristics, and materials. The use of commercially available software is addressed by "performance qualification" of that software.

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

• Sample Size: Not applicable. No dedicated 'test set' in the context of a new clinical study is described for this 510(k) submission.
• Data Provenance: The submission relies on "All non-clinical performance data was included in the predicate submission, premarket notification K123925." A "clinical evaluation was performed utilizing the predicate device MTM® Clear Aligner In-Office cleared under K123925" which collected safety and performance data. This data would be retrospective relative to this current application but was originally prospective for the predicate device. No new human clinical data was included in this submission.

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

• Not applicable. There is no new clinical study with a test set requiring expert-established ground truth for this submission. The submission references data from the predicate device's clinical evaluation.

4. Adjudication Method

• Not applicable. No new clinical study requiring adjudication is mentioned.

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

• No. An MRMC comparative effectiveness study was not done for this submission. The submission explicitly states "No new human clinical data has been included in this premarket notification." The study focuses on demonstrating substantial equivalence, not comparative effectiveness of human readers with/without AI assistance.

6. Standalone Performance (Algorithm only without human-in-the-loop performance)

• Not directly applicable in the terms of typical AI/ML algorithm evaluation. The device involves the use of "commercially available dental software to create digital images and 3D overlays of the patient's dentition." A "performance qualification of the commercially available software utilized in the processing steps of the subject MTM® Clear-Aligner has been included to support substantial equivalence." This "performance qualification" would be the closest analogue to a standalone performance evaluation, but specifics of that qualification (metrics, data, etc.) are not provided in this document as it refers to a software component rather than the device as a whole.

7. Type of Ground Truth Used

• For the performance data referenced from the predicate device, it's implied that the "safety and performance data regarding DENTSPLY aligner materials and force points to demonstrate the ability of the MTM® Clear-Aligner technology to achieve sequential incremental minor tooth movement" would be based on clinical outcomes (e.g., actual tooth movement, patient comfort, treatment success rates as assessed by dental practitioners). However, the details are not provided in this document.

8. Sample Size for the Training Set

• Not applicable. This submission does not describe the development or training of a new AI/ML model for which a training set would be used. The software mentioned is "commercially available dental software" which likely means a pre-existing package not developed by DENTSPLY for this specific submission, and its internal training data is not part of this document.

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

• Not applicable, as there's no description of a training set for a new AI/ML model in this submission.

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The ISUS Implant Suprastructures are indicated for attachment to dental implants or abutments in the treatment of partially or totally edentulous jaws for the purpose of restoring chewing function. The ISUS Implant Suprastructures are intended for attachment to a minimum of two (2) implants.

ISUS Implant Suprastructures are indicated for compatibility with the following implant and abutment systems:

Implants:

• Nobel Biocare Replace Select: NP (3.5mm), RP (4.3mm), WP (5.0mm), and Replace Select 6.0mm
• Nobel Biocare Active Internal: NP (3.5mm), RP (4.3mm, 5.0mm)
• Zimmer Screw Vent: D3.5, D4.5, D5.7
• Straumann: NN (3.5mm), RN (4.8mm), WN (6.0mm)
• Straumann Bone Level: NC (3.3mm), RC (4.1mm, 4.8mm)
• 31 Internal Connection: D3.4, D4.1, D5, D6
• Friadent XiVE S: D3, D3.4, D3.8, D4.5, D5.5

Abutments:

• ASTRA TECH 20° and 45° UniAbutment
• ASTRA TECH UniAbutment EV: 3.6
• ANKYLOS Balance Base Abutment D5.5 and Narrow Abutment D4.2
• Nobel Biocare Multi -Unit Abutment RP: 4.0 mm
• Zimmer Tapered Abutment: 4.5mm
• Straumann RN(4.8mm), WN (6.5 mm)
• Straumann Bone Level: Multi-Base Abutment D3.5, D4.5
• Straumann Bone Level Angled Abutment:4.0 mm
• 3I Low Profile Abutment
• Friadent XiVE MP D3.8. D4.5. D5.5
• Friadent XiVE TG D3.8, D4.5, D5.5

The ISUS Implant Suprastructures are metallic dental restorative devices which are intended for attachment by screw retention to dental implants to aid in the treatment of partially and totally edentulous patients for the purpose of restoring chewing function. The ISUS system consists of the Suprastructure devices themselves as well as retention screw accessories which facilitate their attachment to the dental implants.

The design of the ISUS Implant Suprastructures is derived from models of patient dentition which are produced by the dental professional using standard dental techniques. The dental models are converted to digital representations by DENTSPLY to facilitate DENTSPLY's Computer Aided Design (CAD) and Computer Aided Manufacturing (CAM) of the customized, patient-specific ISUS Implant Suprastructure.

The ISUS Implant Suprastructures consist of three (3) device types:

• Bars Intended to act as a supporting structure to facilitate attachment of removable dental prostheses.
• Bridges - Intended for direct veneering using dental ceramics or resin composites resulting in a fixed, screw-retained prosthesis.
• Hybrids Intended as a metallic substructure to which finished dentures are bonded to form a fixed prosthesis.

The ISUS Implant Suprastructures are manufactured in versions composed of titanium and cobalt-chromium alloy and feature customized designs derived from individual patient dental impressions.

The provided 510(k) summary for the ISUS Implant Suprastructures indicates that no human clinical study was performed to support substantial equivalence. Therefore, the device does not have acceptance criteria or a study proving that it meets those criteria, as understood in terms of clinical performance metrics.

Instead, the submission relies on non-clinical performance data and comparison to predicate devices to demonstrate substantial equivalence.

Here's a breakdown of the requested information based on the provided document, reflecting the nature of this 510(k) submission:

1. Table of Acceptance Criteria and Reported Device Performance

Since no clinical study with acceptance criteria was conducted, this table will reflect the non-clinical tests performed and their conformity to established standards or comparison to predicate devices.

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

• Sample Size for Test Set: Not specified in terms of number of devices, but "representative worst-case test samples" were constructed for dynamic fatigue testing.
• Data Provenance: The tests are non-clinical, conducted in a laboratory setting. There is no patient data provenance (e.g., country of origin, retrospective/prospective) because no clinical study was performed.

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

Not applicable as no clinical ground truth was established for this submission. The "ground truth" for non-clinical tests is adherence to established international standards (ISO, ANSI/AAMI).

4. Adjudication Method for the Test Set

Not applicable as no clinical ground truth requiring adjudication was established.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No, an MRMC study was not done. The submission explicitly states "No human clinical study was performed to support substantial equivalence."

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

Not applicable. This device is a physical dental suprastructure, not a software algorithm.

7. The Type of Ground Truth Used

For the non-clinical tests, the "ground truth" is based on:

• Established International Standards: ISO 14801:2007 for dynamic fatigue, ISO 22674:2006 and ISO 9693:1999 for material properties, and ISO 17665-1:2006, ISO 17665-2:2009, and ANSI/AAMI ST79:2010 for sterilization.
• Comparative Data: Comparison to results of equivalent testing on legally marketed predicate dental abutments and published in vitro data regarding maximum bite and chewing forces.

8. The Sample Size for the Training Set

Not applicable. No training set was used as this device is not an AI/ML algorithm or a device requiring a training phase based on a dataset.

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

Not applicable as no training set was used.

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MTM® Clear Aligner In-Office is indicated for the treatment of anterior tooth malocclusions in patients with permanent dentition (i.e. all second molars). Utilizing a series of incremental minor tooth movements (torque, tipping, rotation and bodily movement), MTM® Clear Aligner sequentially positions teeth by way of continuous gentle force.

MTM® Clear Aligner In-Office is a system of plastic aligners fabricated in the dental professional's office that are modified with thermoplier accessories to create force points and spaces necessary for tooth movement by way of continuous gentle force. Commercially available auxiliaries such as hooks and orthodontic elastics may also be used in order to create the desired tooth movement. As the aligner is positioned on any particular tooth, the presence of the force points loads the polymeric shell material. The stored energy thus imparted into the elastomeric material of the aligner slowly dissipates over time as the bone underlying the tooth physiologically responds to the forces. After each desired incremental tooth movement has occurred, the aligner can be modified to increase the size of the force points or a new aligner may be fabricated. Each aligner moves the patient's teeth in small increments from their original state.

This document describes the acceptance criteria and the study conducted to prove that the MTM® Clear Aligner In-Office device meets these criteria.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for the MTM® Clear Aligner In-Office were based on its ability to achieve incremental minor tooth movements, as stated in its Indications for Use. The clinical study aimed to demonstrate this capability.

2. Sample Size and Data Provenance for the Test Set

• Sample Size: The document lists the number of cases successfully treated for each type of tooth movement: 5 for Torque, 7 for Tipping, 14 for Rotation, and 11 for Bodily Movement. The total number of unique patients or overall cases included in the study is not explicitly stated but is implicitly the sum of cases across all movement types if each case represented a unique patient with a primary movement type, or possibly a smaller number if a single patient experienced multiple types of movements. Without further detail, it's difficult to ascertain the exact total number of individuals.
• Data Provenance: The study was a "prospective open-label safety and effectiveness study." The country of origin for the data is not specified.

3. Number of Experts and Qualifications for Ground Truth Establishment (Test Set)

• Number of Experts: The document does not specify the number of experts explicitly. However, it mentions that the study included a "pretreatment period for establishing baseline root integrity and tooth position and to develop a treatment plan." This implies that dental professionals (likely orthodontists or dentists) were involved in assessing the initial state and planning the treatment for each patient.
• Qualifications of Experts: The specific qualifications of these experts are not detailed, but it can be inferred that they were dental practitioners responsible for treatment planning and monitoring.

4. Adjudication Method for the Test Set

The document does not describe a formal adjudication method (e.g., 2+1, 3+1) for establishing the ground truth or evaluating the outcomes of the test set. The study design focused on documenting "progression of the case" and establishing "final tooth position and root integrity," which suggests that the clinical outcomes were assessed directly by the participating practitioners as part of the prospective study.

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

No Multi-Reader Multi-Case (MRMC) comparative effectiveness study was mentioned. The study focused on the performance of the device itself rather than comparing human readers with and without AI assistance.

6. Standalone Performance (Algorithm Only)

This device is an in-office system of physical aligners and accessories, not an AI algorithm. Therefore, the concept of "standalone (algorithm only without human-in-the-loop performance)" is not applicable. The device inherently requires human intervention (dental professional's fabrication, modification, and patient's wear).

7. Type of Ground Truth Used

The ground truth used was based on clinical outcomes assessed by dental professionals. This included:

• Pre-treatment establishment of "baseline root integrity and tooth position."
• Documentation of "progression of the case" during treatment.
• Post-treatment establishment of "final tooth position and root integrity" to determine the "magnitude of total tooth movement."
• Monitoring for "adverse events, including root resorption."

8. Sample Size for the Training Set

The document does not mention a "training set" in the context of machine learning or AI. The MTM® Clear Aligner In-Office system is a physical medical device, not a software algorithm that requires a training dataset.

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

As there is no mention of a training set for an AI/ML algorithm, this question is not applicable.

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5% Sodium Fluoride Varnish is indicated for sealing of dentinal tubules for the treatment of hypersensitive teeth, sensitive root surfaces and for cavity preparations.

5% Sodium Fluoride Varnish is a fluoride varnish which is applied to tooth surfaces for sealing dentinal tubules and treatment of hypersensitive teeth. The varnish is applied in a thin layer over the tooth with an applicator brush, and moisture from saliva cures the varnish for adhesion to the tooth surface.

The provided document describes the 510(k) summary for "5% Sodium Fluoride Varnish." This is a medical device application for a product that is not software-based or AI-driven. Therefore, many of the requested categories in the prompt, such as "sample sizes for the test set," "number of experts used to establish ground truth," "adjudication method," "MRMC study," "standalone performance," and "training set details," are not applicable.

The document focuses on demonstrating the substantial equivalence of the 5% Sodium Fluoride Varnish to a predicate device (Fluoride Varnish K031932) through non-clinical performance data and biocompatibility testing. No clinical performance data was considered necessary due to the low-risk nature of the device and commonality of materials.

Here's a breakdown of the available information:

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)

• Sample Size: Not specified. The document states "non-clinical performance data included testing for tubule occlusion, viscosity, retention on the tooth surface, fluoride release and fluoride content." For biocompatibility, it states "Biocompatibility testing was performed according to ISO 10993-1:2009." Specific sample sizes for these tests are not provided in the summary.
• Data Provenance: Not specified, but generally, tests supporting a 510(k) submission are conducted in a controlled lab environment. This is considered a "bench test" or in vitro data.

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 device is a fluoride varnish, and its performance is evaluated through physical, chemical, and biological testing (biocompatibility), not through expert interpretation of data like medical images.

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

• Not applicable. There is no human interpretation or ground truth establishment requiring adjudication for this type of device testing.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

• Not applicable. This is not an AI-assisted diagnostic or interpretative device; it's a topical dental product.

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

• Not applicable. There is no algorithm or AI component to this device.

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

• The "ground truth" for this device's performance is established by the results of standardized in vitro bench tests that measure physical properties (viscosity, fluoride content/release, retention) and biological interaction (tubule occlusion efficacy, biocompatibility). These are objective measurements against established scientific standards.

8. The sample size for the training set

• Not applicable. There is no training set as this is not a machine learning or AI device.

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

• Not applicable. There is no training set.

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