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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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