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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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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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