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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 mandible or maxilla. The prosthesis can be cemented or screw retained to 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 attachment-retained by friction fit to the abutment screw is intended to secure the ATLANTIS® Conus Abutment to the endosseous implant.

The ATLANTIS® Healing Abutment can be used with an endosseous implant for temporary use during soft tissue healing after one-stage or two-stage surgeries. The abutment screw is intended to secure the ATLANTIS® Healing Abutment to the endosseous implant.

ATLANTIS® Abutment is compatible with MIS Conical Connection implant from MIS Implant System.

ATLANTIS® products are compatible with the implants shown in the table below.

Implant Diameter V3: Ø3.30 mm C1: Ø3.30 mm C1: Ø3.75,4.2 mm, V3: Ø3.90,4.3,5.0 mm C1: Ø5.0 mm

The proposed ATLANTIS® Abutments for MIS Conical Connection Implant are endosseous dental implant abutments.

The proposed devices are compatible with:

• MIS V3 conical connection narrow and standard dental implant diameters Ø3.3, 3.9, 4.3 and a. 5.0 mm (K163349)
• b. MIS C1 narrow, standard and wide platform conical connection implant diameters Ø3.3, 3.75, 4.2, and 5.0 (K172505, K112162)

Refer to Table 5.1 for the implants the proposed ATLANTIS® Abutments for MIS Conical Connection Implant are compatible with.

| Table 5.1 Implant systems which proposed ATLANTIS® Abutments for MIS Conical Connection

The abutments are available in four (4) designs:

• ATLANTIS® Abutment for MIS Conical Connection Implant, a.
• ATLANTIS® Crown Abutment for MIS Conical Connection Implant, b.
• ATLANTIS® Conus Abutment (Custom or Overdenture) for MIS Conical Connection C. Implant
• d. ATLANTIS® Healing Abutment for MIS Conical Connection Implant

The materials composition of the proposed devices are described below in Table 5.2.

The maximum abutment height is 15 mm above implant interface and the minimum abutment height is 4 mm above the trans-mucosal collar. The abutments are provided straight and up to 30° of angulation.

All proposed abutments are patient-specific abutments fabricated using CAD/CAM technology by Dentsply Sirona Implants. 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® Abutments for MIS Conical Connection Implant can be fabricated as a conventional abutment for prosthesis attachment (ATLANTIS® Abutment for MIS Conical Connection Implant or ATLANTIS® Conus Abutment for MIS Conical Connection Implant), fabricated as a single tooth final restoration onto which porcelain is added ATLANTIS® Crown Abutment for MIS Conical Connection Implant) or fabricated with a short core for soft tissue healing (ATLANTIS® Healing Abutment).

This document describes the Dentsply Sirona ATLANTIS® Abutment for MIS Conical Connection Implants and its substantial equivalence to predicate devices, based on non-clinical performance data. There is no information provided about an AI/ML device in this document, so the questions regarding AI/ML device performance are not applicable.

Here's an analysis based on the provided text, focusing on the mechanical and material aspects of the device, and addressing the questions where applicable:

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

The document does not explicitly state "acceptance criteria" in a quantitative manner with reported performance metrics to directly compare. Instead, it relies on demonstrating substantial equivalence to predicate devices through various tests and comparisons. The performance is assessed against established standards and predicate device characteristics.

However, based on the non-clinical performance data section, we can infer some criteria and the types of performance reported:

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

The document does not explicitly state the sample size for the "test set" in terms of number of abutments or implants used, nor does it specify the country of origin or whether the data was retrospective or prospective for the non-clinical tests. It refers to "fatigue testing" and "geometric compatibility analysis," which are bench tests.

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 question is not applicable as the document describes a dental abutment, not an AI/ML device requiring expert ground truth for interpretation of images or other data. The "ground truth" for this device would be its physical and mechanical properties, assessed through engineering and materials testing, not expert review.

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

Not applicable. Adjudication methods like 2+1 or 3+1 typically refer to expert review processes for clinical or image interpretation studies, which are not relevant to the non-clinical bench testing described for this dental abutment.

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 document is about a dental implant abutment, not an AI-assisted diagnostic or therapeutic device. There are no human readers or AI involved in its function.

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

Not applicable. This is not an algorithm or AI device.

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

The "ground truth" for this device's performance relies on established engineering standards and material properties, and comparison to legally marketed predicate devices' performance.

• Fatigue Resistance: Ground truth would be defined by the specified load cycles and failure criteria outlined in ISO 14801.
• Geometric Compatibility: Ground truth is the precise dimensional specifications of the OEM implant bodies, OEM abutments, and OEM screws.
• Sterilization: Ground truth is the successful validation according to ISO 17665-1.
• Biocompatibility: Ground truth is the conformity of materials to ASTM F136 and the established biocompatibility of the predicate device (K172225) using identical materials and processes.
• Design Specifications: Ground truth lies in the adherence to predefined maximums and minimums for angulation, height, and width.

8. The sample size for the training set

Not applicable as this is not an AI/ML device.

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

Not applicable as this is not an AI/ML device.

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MIS Conical Connection Implants are 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 a patient's chewing 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.

The conical connection dental implants are self tapping, root-form, two piece screw type dental implants, indicated for use in surgical and restorative applications for placement in the upper or lower jaw to provide support for prosthetic devices such as artificial teeth, in order to restore the patient chewing function. The conical connection dental implants are provided in 3.75, 4.2 and 5.0 mm diameters and with the following lengths:

0 3.75mm diameter: 8mm, 10mm, 11.5mm, 13mm and 16mm

0 4.2mm diameter: 8mm, 10mm, 11.5mm, 13mm and 16mm

o 5.0mm diameter: 8mm, 10mm, 11.5mm, 13mm and 16mm

The implants surface is sand blasted and acid etched.

The conical connection dental implants are two piece devices whereas the implant is to be used in combination with cover screws, healing caps, abutments and superstructures.

The conical connection dental implants are made of Ti6AL4V ELI complying with standard ASTM F 136-08- Standard Specification for Wrought Titanium-6Aluminum-4Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant. The conical connection dental implants were modified to integrate a new type of connection, internal conical connection of 6 degrees with an anti-rotation index of six positions, ensuring a more definite seal and a more stable connection.

This looks like information from a 510(k) premarket notification for a medical device, specifically dental implants. This type of submission is for demonstrating "substantial equivalence" to a predicate device, rather than proving safety and efficacy through clinical trials that would typically involve acceptance criteria and detailed performance studies like those common for PMAs or de novo submissions.

Therefore, many of the requested categories (like "acceptance criteria," "sample size for test set," "number of experts," "adjudication method," "MRMC study," "standalone performance," "type of ground truth," and "sample size for training set") are not applicable in the context of this 510(k) submission.

The document focuses on comparing the new device to a legally marketed predicate device based on technological characteristics and non-clinical performance (like fatigue testing), with a brief mention of a preliminary clinical evaluation for stability.

Here's a breakdown of the available information:

1. Table of acceptance criteria and the reported device performance

Not applicable in the typical sense for a 510(k) submission. The "acceptance criteria" here is "substantial equivalence" to the predicate device. The performance is demonstrated through a comparison of technological characteristics and non-clinical testing.

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 for Test Set:
  • Non-clinical (Fatigue Test): Not explicitly stated. Typically, fatigue tests follow ISO or ASTM standards, which specify sample sizes (e.g., 5-10 samples per group).
  • Clinical Evaluation: "case studies" - the specific number of cases is not stated, but "case studies" typically implies a small number.
• Data Provenance: Not specified for the non-clinical or preliminary clinical evaluation. Israel, where the company is located, is the likely origin for the internal testing.
• Retrospective or Prospective:
  • Non-clinical: Likely prospective (tests conducted specifically for this submission).
  • Clinical Evaluation: "preliminary clinical evaluation, based on case studies with six months follow up" suggests prospective observation of a small number of patients post-implantation.

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. For a device like this, the "ground truth" for the non-clinical fatigue test is measured physical parameters, not expert consensus on images. The preliminary clinical evaluation likely involved clinical observations made by the treating clinicians, not multiple independent experts establishing a "ground truth" for a test set in the same way as, for example, a diagnostic AI device.

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

Not applicable. No expert adjudication method is described for either the non-clinical or preliminary clinical evaluation.

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

Not applicable. This device is not an AI diagnostic device.

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

Not applicable. This device is not an AI diagnostic device/algorithm.

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

• Non-clinical Fatigue Test: The ground truth is the physical measurement of fatigue properties (e.g., cycles to failure, maximum load) according to established engineering standards.
• Preliminary Clinical Evaluation: The "good stability" observation would be based on clinical outcomes and examinations by the treating clinician over the six-month follow-up period.

8. The sample size for the training set

Not applicable. This is not an AI device that requires a training set.

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

Not applicable. This is not an AI device that requires a training set.

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