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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 abutment to the endosseous implant.

This device is compatible with the following manufacturers' implant systems: The titanium abutments are compatible with the Keystone 3.5mm, 4.1mm and 5.0mm Keystone Implants. The zirconia abutments are compatible with the Keystone 3.5mm, 4.1mm and 5.0mm Keystone Implants.

Please note: This device may be used in an early load situation, but is dependent on the specific implant system and protocol used by the dental professional.

Highly angled abutments on small diameter implants are intended for the anterior region only.

The devices covered in this submission are abutments which are placed into the dental implant to provide support for a prosthetic restoration. The subject abutments are indicated for cemented or screw retained restorations. The Atlantis™ Abutment for Keystone Implant and abutment screw are made of Titanium grade Ti-6A1-4V ELI (meets ASTM Standard F-136) for the 3.5mm, 4.0mm, 4.1mm and 5.0mm sizes. In addition, the Atlantis™ Abutment for Keystone Implant for the 3.5mm, 4.1mm and 5.0mm sizes are also made of biocompatible material, yttria-stabilized tetragonal zirconia polycrystals (Y-TZP) and meets ISO Standards 6972 & 13356). Zirconia may have variation in shade. The titanium and zirconia abutments are placed over the implant shoulder and are mounted into the implant with a titanium screw.

The provided text describes a 510(k) premarket notification for a medical device, specifically the Atlantis™ Abutment for Keystone Implant. This type of submission focuses on demonstrating substantial equivalence to a predicate device rather than conducting a full clinical study with specific acceptance criteria and detailed performance metrics as one might find for a novel device requiring a PMA.

Therefore, the information typically requested in your prompt regarding acceptance criteria and a study proving those criteria are met is not fully applicable in the context of this 510(k) summary. The testing performed is non-clinical and aimed at demonstrating equivalence in performance characteristics to existing, legally marketed devices.

Here's an analysis based on the available information:

1. Table of acceptance criteria and the reported device performance:

Explanation: For a 510(k), "acceptance criteria" are implied by demonstrating that the new device's technological characteristics, performance, and intended use are sufficiently similar to a predicate device. The "reported device performance" is the result of non-clinical testing verifying these similarities. There aren't explicit numerical thresholds like accuracy or sensitivity for this type of device and submission.

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

• Sample size: Not explicitly stated. The document mentions "worst case scenario" implant assemblies were used for static and fatigue compression testing. The exact number of test samples is not provided.
• Data provenance: The testing was "non-clinical testing" conducted by the manufacturer, Astra Tech Inc. There is no mention of country of origin of the data or whether it was retrospective or prospective, as a clinical study was not performed.

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

• Not applicable. This was a non-clinical, engineering-based performance study, not a clinical study involving ground truth established by expert clinicians.

4. Adjudication method for the test set:

• Not applicable, as this was not a clinical study requiring expert adjudication of results.

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 an endosseous dental implant abutment, a mechanical component, not an AI-driven diagnostic tool.

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:

• For the non-clinical testing, the "ground truth" was adherence to established mechanical testing standards (e.g., ASTM, ISO referenced for materials) and the performance characteristics of the predicate device. The performance was assessed against engineering principles and the functional requirements of an abutment, rather than clinical outcomes or pathology.

8. The sample size for the training set:

• Not applicable. This is not a machine learning or AI device that requires a training set.

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

• Not applicable.

Summary of the Study Proving Device Meets Acceptance Criteria:

The study described is a "Summary of Non-clinical Testing." This testing involved:

• Study Type: Static and fatigue compression testing.
• Purpose: To demonstrate that the Atlantis Abutments are compatible with Keystone implants and perform as intended under mechanical stress.
• Methodology: Testing was conducted on "worst case scenario" implant assemblies using Atlantis angled titanium and zirconia abutments with the Keystone implant.
• Results: The test results demonstrated that the implant system supported appropriate static and fatigue test loads, indicating that the device performs as intended and is substantially equivalent in performance characteristics to the predicate device.

In the context of a 510(k) for a device like a dental abutment, the "acceptance criteria" are predominantly met through demonstrated material equivalence, functional equivalence, and successful non-clinical mechanical testing that ensures the device is as safe and effective as the predicate device. Clinical trials with human subjects, expert review, or AI performance metrics are generally not required for this type of submission.

Ask a specific question about this device

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 cement retained to the abutment. The abutment screw is intended to secure the abutment to the endosseous implant.

This device is compatible with the following manufacturers' implant systems: BioHorizons The Prodigy System™ Dental Implants 3.5mm, 4.0mm, 5.0mm and 6.0mm Implants and BioHorizons The Maestro™ System Implants RBM and HA coated 3.5mm, 4.0mm and 5.0mm Implants.

Please note: This device may be used in an early load situation, but is dependent on the specific implant system and protocol used by the dental professional.

Highly angled abutments (i.e. 30 degrees) on implants with diameters less than 4 mm are intended for the anterior region of the mouth and are not intended for the posterior region due to limited strength of the implant.

The devices covered in this submission are abutments which are placed into the dental implant to provide support for a prosthetic restoration. The subject abutments are indicated for cemented restorations.

The Atlantis™ Abutments in Zirconia for BioHorizons Implant and abutment screws are made from biocompatible vttria-stabilized tetragonal zirconia polycrystals (Y-TZP) and meets ISO Standards 6972 & 13356. The abutment screws are made from titanium grade Ti-6A1-V ELI and meets ASTM Standard F-136. The abutment is placed over the implant shoulder and is mounted into the implant with a screw. The abutments are compatible with BioHorizons Prodigy System™ 3.5mm, 4.0mm, 5.0mm and 6.0mm Implants and BioHorizons The Maestro™ System Implants RBM and HA coated 3.5mm, 4.0mm and 5.0mm Implants.

The provided text is a 510(k) summary for a pre-market notification of a dental implant abutment. It does not contain any information about acceptance criteria or a study that proves the device meets specific performance criteria.

The document focuses on establishing substantial equivalence to a predicate device, as required for 510(k) submissions. This typically involves demonstrating that the new device has the same intended use, technological characteristics (materials, design), and performs similarly to a legally marketed device, often through a comparison of engineering specifications and materials rather than extensive clinical efficacy studies with specific performance metrics.

Therefore, I cannot fulfill your request for details on acceptance criteria and a study to prove they are met from the provided input. The document explicitly states:

• "The Atlantis™ Abutments in Zirconia for BioHorizons Implants are substantially equivalent in intended use, material, design and performance to the Atlantis Abutments for Zimmer Interface cleared under K053373 and BioHorizons Prodigy System™ Dental Implants cleared under K042429."

This highlights that the basis for approval is substantial equivalence, not a standalone study demonstrating performance against a set of predefined acceptance criteria for the new device itself.

To answer your specific points based on the absence of information:

1. A table of acceptance criteria and the reported device performance: This information is not provided 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): No test set or related performance data is described in the document.
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, as no test set or ground truth establishment is described.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable, as no test set or adjudication is 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: This document pertains to a dental abutment, not an AI-assisted diagnostic tool, so an MRMC study is not relevant and not mentioned.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable, as this is a physical medical device, not a software algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable, as no performance study requiring ground truth is described.
8. The sample size for the training set: Not applicable, as no algorithm training is described.
9. How the ground truth for the training set was established: Not applicable, as no algorithm training is described.

Ask a specific question about this device

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 cement retained to the abutment. The abutment screw is intended to secure the abutment to the endosseous implant.

This device is compatible with the following manufacturers' implant systems: BioHorizons The Prodigy System™ Dental Implants 3.5mm, 4.0mm, 5.0mm and 6.0mm Implants.

Please note: This device may be used in an early load situation, but is dependent on the specific implant system and protocol used by the dental professional.

Highly angled abutments (i.e. 30 degrees) on implants with diameters less than 4 mm are intended for the anterior region of the mouth and are not intended for the posterior region due to limited strength of the implant.

The devices covered in this submission are abutments which are placed into the dental implant to provide support for a prosthetic restoration. The subject abutments are indicated for cemented restorations.

The Atlantis™ Abutments for BioHorizons Implant and abutment screws are made from Titanium grade Ti-6A1-4V ELI (Meets ASTM Standard F-136). The abutment is placed over the implant shoulder and is mounted into the implant with a screw. The abutments are compatible with BioHorizons Prodigy System™ 3.5mm, 4.0mm, 5.0mm and 6.0mm Implants and BioHorizons

This submission, K073258, is for the Atlantis Abutment for BioHorizons Implant. It's a pre-market notification (510(k)) that claims substantial equivalence to previously cleared devices, not an AI/ML device, and therefore does not have the acceptance criteria or study details requested in the prompt. The document details the device's name, description, intended use, and the basis for substantial equivalence to predicate devices, but does not contain any information about acceptance criteria, device performance metrics, sample sizes, expert ground truth, adjudication methods, MRMC studies, standalone performance, or training set details as it is not an AI/ML product.

The device is an endosseous dental implant abutment made from Titanium grade Ti-6A1-4V ELI, intended to support prosthetic reconstructions in partially or completely edentulous patients.

Since this request is about an AI/ML device and the provided document describes a dental implant abutment, it does not contain the information required to answer the specific questions posed.

Ask a specific question about this device

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 cement retained to the abutment. The abutment screw is intended to secure the abutment to the endosseous implant.

This device is compatible with the following manufacturers' implant systems: 3i Osseotite NT® Certain™ and 3i Osseotite® Certain™ (parallel Walled) 3.25mm diameter implants.

Please note: This device may be used in an early load situation, but is dependent on the specific implant system and protocol used by the dental professional.

Also, highly angled abutments (i.e. 30 degrees) on implants with diameters less than 4 mm are intended for the anterior region of the mouth and are not intended for the posterior region due to limited strength of the implant.

The devices covered in this submission are abutments which are placed into the dental implant to provide support for a prosthetic restoration. The subject abutments are indicated for cemented restorations.

The Atlantis™ Abutments in Zirconia for 3i Certain MicroMini Implant is made of biocompatible material, yttria-stabilized tetragonal zirconia polycrystals (Y-TZP) and meets ISO Standards 6972 & 13356). The abutment screws are made from titanium grade Ti-6A1-V ELI and meets ASTM Standard F-136. The abutment is placed over the implant shoulder and is mounted into the implant with a screw. The abutments are compatible with the 3i Osseotite NT® Certain™ and 3i Osseotite® Certain™ (parallel Walled) 3.25mm diameter implants.

Here's an analysis of the provided text regarding acceptance criteria and study data:

Based on the provided text, this document is a 510(k) summary for a dental abutment, not a study report for a novel AI/software device. Therefore, most of the requested information regarding acceptance criteria for device performance, sample sizes for test/training sets, expert ground truth, MRMC studies, or standalone performance of an algorithm is not applicable or cannot be extracted from this type of document.

The primary purpose of a 510(k) submission is to demonstrate substantial equivalence to a legally marketed predicate device, not typically to present detailed performance studies against specific acceptance criteria in the manner one would for a new diagnostic or AI-powered solution.

Here's what can be inferred or explicitly stated from the provided text, addressing the points where information is available:

1. Table of Acceptance Criteria and Reported Device Performance

• Not Applicable. This document does not present acceptance criteria in terms of performance metrics (e.g., accuracy, sensitivity, specificity) for an AI or software device, nor does it report device performance against such metrics. The "performance" mentioned relates to the physical and material characteristics of the abutment, demonstrating equivalence to predicates.

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

• Not Applicable. No "test set" in the context of an AI/software performance study is mentioned. The submission is about a physical dental abutment.

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

• Not Applicable. Ground truth, in the context of an AI/software study, is not established or discussed here for a test set.

4. Adjudication Method for the Test Set

• Not Applicable. Adjudication methods are not relevant to this submission.

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. No MRMC study was conducted or is mentioned, as this is a physical medical device, not an AI/software diagnostic tool requiring human reader improvement assessments.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

• Not Applicable. This device is a physical abutment, not an algorithm.

7. The Type of Ground Truth Used

• Not Applicable. "Ground truth" in the context of performance evaluation for an AI model is not applicable here. The "ground truth" for this device would relate to its physical and material properties meeting established standards and being equivalent to predicates.

8. The Sample Size for the Training Set

• Not Applicable. There is no training set mentioned, as this is not an AI/machine learning device.

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

• Not Applicable. No training set, no ground truth establishment for a training set.

Summary of Relevant Information from the Provided Text:

The document describes a dental abutment and focuses on demonstrating substantial equivalence to previously cleared predicate devices.

• Device: Atlantis™ Abutment in Zirconia for 3i Certain MicroMini Implant.
• Intended Use: To provide support for a prosthetic reconstruction in partially or completely edentulous patients, supporting single and multiple tooth prostheses in the mandible or maxilla. The prosthesis can be cement retained.
• Material: Yttria-stabilized tetragonal zirconia polycrystals (Y-TZP) for the abutment, titanium grade Ti-6Al-V ELI for the screws.
• Standards Met: ISO Standards 6972 & 13356 for the Y-TZP material, ASTM Standard F-136 for the titanium screws.
• Basis for Equivalence: Intended use, material, design, and performance are substantially equivalent to predicate devices: K062069, K063734 (both Atlantis Abutments), and K014235 (3i Certain Implant System).

The "performance" aspect is demonstrated by the device's compatibility with existing implant systems and its material properties meeting specified ISO and ASTM standards, which are implicitly the "acceptance criteria" for its physical characteristics and safety/effectiveness in the context of substantial equivalence. This differs significantly from the performance metrics and studies typically associated with AI/software medical devices.

Ask a specific question about this device

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 cement retained to the abutment. The abutment screw is intended to secure the abutment to the endosseous implant. This device is compatible with the following manufacturers' implant systems: Astra Tech Systems OsseoSpeed™ Implants 3.5 mm, 4.0mm, 4.5 mm and 5.0 mm diameters. Please note: This device may be used in an early load situation, but is dependent on the specific implant system and protocol used by the dental professional. Also, highly angled abutments (i.e. 30 degrees) on implants with diameters less than 4 mm are intended for the anterior region of the mouth and are not intended for the posterior region due to limited strength of the implant.

The devices covered in this submission are abutments which are placed into the dental implant to provide support for a prosthetic restoration. The subject abutments are indicated for cemented restorations. The Atlantis™ Abutments in Zirconia for Astra Implants is made of biocompatible material, yttria-stabilized tetragonal zirconia polycrystals (Y-TZP) and meets ISO Standards 6972 & 13356). The abutment screws are made from titanium grade Ti-6A1-V ELI and meets ASTM Standard F-136. The abutment is placed over the implant shoulder and is mounted into the implant with a screw. The abutments are compatible with the Astra Tech OsseoSpeed™ implants 3.5 mm, 4.0 mm, 4.5 mm and 5.0 mm diameters.

This 510(k) premarket notification for the Atlantis™ Abutment in Zirconia for Astra Implants does not include a study proving device performance against acceptance criteria in the way typically seen for diagnostic or AI-driven devices.

Instead, this submission is a claim of substantial equivalence to previously cleared predicate devices based on material, design, and intended use. The "acceptance criteria" here relate more to meeting established standards for biocompatibility and mechanical properties rather than performance in a clinical or diagnostic setting.

Here's an breakdown based on the provided text, highlighting what is (and isn't) present:

Acceptance Criteria and Device Performance (Based on provided text)

Further Information Based on the Document:

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

   • N/A. No "test set" in the context of performance data (e.g., clinical outcomes, diagnostic accuracy) is described. The submission relies on a comparison to predicate devices, material standards, and intended use.

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

   • N/A. No ground truth establishment by experts for a test set is described.

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

   • N/A. No adjudication method for a test set is described.

4. 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 device is a dental implant abutment, not a diagnostic imaging device or an AI-driven tool for human readers. Therefore, an MRMC study is not applicable.

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

   • N/A. This is a physical medical device (dental abutment), not an algorithm or AI system.

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

   • N/A. For this type of 510(k) submission, the "ground truth" is largely established by adherence to recognized material standards (ISO, ASTM) and the established performance/safety profile of the predicate devices. There is no "ground truth" in the sense of clinical outcomes or pathology data specifically collected for this submission to prove its performance.

7. The sample size for the training set:

   • N/A. This is a physical medical device, not a machine learning model. There is no training set mentioned or implied.

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

   • N/A. As above, no training set is relevant here.

Summary of the Study/Evaluation described in the document:

The document describes a substantial equivalence claim rather than a "study" in the traditional sense of a clinical trial or performance evaluation against specific metrics. The "study" implicitly performed by the manufacturer, and reviewed by the FDA, involved:

• Comparison to Predicate Devices: The Atlantis™ Abutment in Zirconia for Astra Implants was compared to three predicate devices (K070833, K053384, K024111) to demonstrate equivalence in intended use, material, design, and performance. This is the primary method of evaluation for this 510(k)
• Material Characterization: The biocompatibility and composition of the materials (Y-TZP and Ti-6A1-V ELI) were likely verified against established international standards (ISO 6972, ISO 13356, ASTM F-136).
• Design Specifications: The design would have been reviewed to ensure it met specifications compatible with the Astra Tech OsseoSpeed™ implants and to verify that any design changes from predicate devices did not raise new questions of safety or effectiveness. This would include considerations for angled abutments and implant diameters.

The FDA's review and clearance signify their agreement that the provided information supports the claim of substantial equivalence, meaning the device is as safe and effective as the legally marketed predicate devices.

Ask a specific question about this device

The Atlantis Abutment is intended for use as an accessory to 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 cement retained to the abutment. The abutment screw is intended to secure the abutment to the endosseous implant.

The Atlantis Abutment for Astra Implant is compatible with Astra's OsseoSpeed™ 3.5(S) mm, 4.0(S) mm Internal Hex Implants.

Please note: This device may be used in an early load situation, but is dependent on the specific implant system and protocol used by the dental professional. Highly angled abutments (i.e. 30 degrees) on implants with diameters less than 4 mm are intended for the anterior region of the mouth and are not intended for the posterior region due to limited strength of the implant.

The devices covered in this submission are abutments which are placed into the dental implant to provide support for a prosthetic restoration. The subject abutments are indicated for cemented restorations.

The Atlantis™ Abutments for Astra Implant and abutment screws are made from Titanium grade Ti-6A1-4V ELI (Meets ASTM Standard F-136). The abutment is placed over the implant shoulder and is mounted into the implant with a screw. The abutments are compatible with Astra's 3.5 S mm, 4.0 S mm OsseoSpeed™ Implants.

The provided text is a 510(k) summary for a dental device, the Atlantis™ Abutment for Astra Implant. It primarily focuses on demonstrating substantial equivalence to existing predicate devices, rather than presenting a performance study with detailed acceptance criteria and a comprehensive study report.

Therefore, many of the requested sections regarding performance criteria, study design, and ground truth establishment cannot be found in this document. The purpose of a 510(k) is often to show that a new device is as safe and effective as a legally marketed one, which can be done through comparison of materials, intended use, and design, without necessarily requiring a new, extensive clinical performance study if the differences are minor.

Here's an analysis of the information that is available in the provided text, and where the requested information is missing:

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

• Acceptance Criteria: Not explicitly stated in terms of quantitative performance metrics for a study. The "basis for substantial equivalence" is the primary "acceptance criterion" in this context.
• Reported Device Performance: No specific performance metrics (e.g., success rates, longevity, strength) are reported for the device in a formal study within this document. The document states that the device is "substantially equivalent in intended use, material, design and performance" to predicate devices.

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 does not describe a performance study with a test set. It's a regulatory submission focused on substantial equivalence.

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. No test set or ground truth establishment by experts is described in this document.

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

• Not Applicable. This document does not describe a performance study requiring adjudication.

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

• Not Applicable. This device is a dental abutment, not an AI-powered diagnostic tool. MRMC studies are not relevant here.

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

• Not Applicable. This device is a physical dental component, not an algorithm.

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

• Not Applicable. No explicit performance study requiring ground truth is described. The "ground truth" for this 510(k) is the established safety and effectiveness of the predicate devices.

8. The sample size for the training set

• Not Applicable. This document does not describe the development of an algorithm requiring a training set.

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

• Not Applicable. No training set or ground truth establishment for a training set is described.

Summary from the Document:

The K070833 submission for the Atlantis™ Abutment for Astra Implant establishes its substantial equivalence to existing, legally marketed predicate devices rather than providing a new, independent performance study against specific acceptance criteria. The claim of equivalence is based on the device's intended use, material (Titanium grade Ti-6Al-4V ELI), design, and performance being similar to:

• Atlantis Abutment for 3i MicroMini (K062069)
• Atlantis Abutment for Astra Fixture (K053384)
• Astra Tech MicroThread™ OsseoSpeed™ (K024111)
• Astra Tech Implants-Dental System Fixture MicroMacro (No 510(k) number provided in table, but referenced)

This type of 510(k) filing relies on the FDA's prior determination of safety and effectiveness for the predicate devices.

Ask a specific question about this device

The Atlantis Abutment is intended for use as an accessory to 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 cement retained to the abutment. The abutment screw is intended to secure the abutment to the endosseous implant.

This device is compatible with the 3i Osseotite™ NT Certain™ (tapered wall) Implants with 4.0mm, 5.0mm and 6.0mm diameters.

Please note: This device may be used in an early load situation, but is dependent on the specific implant system and protocol used by the dental professional.

Also, highly angled abutments (i.e. 30 degrees) on implants with diameters less than 4 mm are intended for the anterior region of the mouth and are not intended for the posterior region due to limited strength of the implant.

The devices covered in this submission are abutments which are placed into the dental implant to provide support for a prosthetic restoration. The subject abutments are indicated for cemented restorations.

The Atlantis™ Abutments in Zirconia for 3i Certain Interface is made of biocompatible material, yttria-stabilized tetragonal zirconia polycrystals (Y-TZP) and meets ISO Standards (6972 & 13356). The abutment screw is made from Titanium grade Ti-6A1-4V ELI (Meets ASTM Standard F-136). The abutment is placed over the implant shoulder and is mounted into the implant with a screw. The abutments are compatible with 3i Osseotite NT® Certain™ Implants (tapered wall) with 4.0 mm (RP), 5.0 mm (WP) and 6.0 mm (WP) diameters.

The provided text focuses on regulatory approval (510(k) submission) for a dental abutment. It describes the device, its intended use, and claims substantial equivalence to legally marketed predicate devices. However, it does not contain information about specific performance acceptance criteria or a study that directly proves the device meets those criteria, as typically found in a clinical or performance study report.

The document states the device "meets ISO Standards (6972 & 13356)" for its material (yttria-stabilized tetragonal zirconia polycrystals - Y-TZP) and its abutment screw material "Meets ASTM Standard F-136" (Titanium grade Ti-6A1-4V ELI). These are material specifications, not performance criteria for the assembled device.

Therefore, I cannot fulfill your request for:

1. A table of acceptance criteria and the reported device performance: This information is not present in the provided text.
2. Sample size used for the test set and the data provenance: No performance testing data is provided.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: No ground truth establishment/expert review is mentioned as part of a performance study.
4. Adjudication method for the test set: Not applicable as no performance test data is provided.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done: No MRMC study is mentioned.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable as the device is a physical dental abutment, not an AI algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable as no performance test data is provided.
8. The sample size for the training set: Not applicable as no AI/algorithm training is involved.
9. How the ground truth for the training set was established: Not applicable as no AI/algorithm training is involved.

The document is a regulatory submission demonstrating substantial equivalence, relying on the fact that the new device has similar materials, design, and intended use as devices already on the market, which are presumed to be safe and effective. It does not include a detailed performance study with acceptance criteria.

Ask a specific question about this device

The Atlantis Abutment is intended for use as an accessory to 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 cement retained to the abutment. The abutment screw is intended to secure the abutment to the endosseous implant.

The Atlantis Abutment for 3i Certain MicroMini Implant is compatible with 3i Osseotite NT® Certain and Parallel Walled Implants both with 3.25 mm diameters.

Please note: This device may be used in an early load situation, but is dependent on the specific implant system and protocol used by the dental professional. Highly angled abutments (i.e. 30 degrees) on implants with diameters less than 4 mm are intended for the anterior region of the mouth and are not intended for the posterior region due to limited strength of the implant fixture.

The devices covered in this submission are abutments which are placed into the dental implant to provide support for a prosthetic restoration. The subject abutments are indicated for cemented restorations.

The Atlantis™ Abutments for 3i Certain™ MicroMini Implant and abutment screws are made from Titanium grade Ti-6A1-4V ELI (Meets ASTM Standard F-136). The abutment is placed over the implant shoulder and is mounted into the implant with a screw. The abutments are compatible with 3i Osseotite NT® Certain™ and Parallel Walled Implants both with a 3.25mm diameter.

The provided text is a 510(k) summary for a medical device, specifically a dental implant abutment. It describes the device, its intended use, and its claim of substantial equivalence to predicate devices. However, this document does not contain any information about acceptance criteria or a study proving that the device meets such criteria.

The 510(k) process for this type of device (Class II, dental implant abutment) primarily focuses on demonstrating substantial equivalence to a predicate device already on the market, rather than requiring extensive clinical trials with acceptance criteria based on performance metrics like accuracy, sensitivity, or specificity.

Therefore, I cannot fulfill your request for the following information based on the provided text, as it is not present in the document:

• A table of acceptance criteria and the reported device performance
• Sample size used for the test set and the data provenance
• Number of experts used to establish the ground truth for the test set and their qualifications
• Adjudication method for the test set
• If a multi-reader multi-case (MRMC) comparative effectiveness study was done, or its effect size
• If a standalone (algorithm only) performance study was done
• The type of ground truth used
• The sample size for the training set
• How the ground truth for the training set was established

The document focuses on:

• Device Name: Atlantis™ Abutment for 3i Certain™ MicroMini Implant
• Manufacturer: Atlantis Components Inc.
• Intended Use: To support a prosthetic reconstruction in partially or completely edentulous patients, supporting single and multiple tooth prosthesis in the mandible or maxilla, with the prosthesis being cement-retained. The abutment screw secures the abutment to the endosseous implant.
• Materials: Titanium grade Ti-6Al-4V ELI (Meets ASTM Standard F-136).
• Compatibility: Compatible with 3i Osseotite NT® Certain™ and Parallel Walled Implants (3.25mm diameter).
• Predicate Devices: Atlantis Abutment and Abutment Screw (K981858), Atlantis Abutment for 3i Certain Implant (K051011), and 3i Osseotite NT Dental Implants (K014235).
• Basis for Substantial Equivalence: Claimed equivalence in intended use, material, design, and performance to the listed predicate devices.

The FDA's letter (pages 2-3) confirms the review of the premarket notification and the determination of substantial equivalence, allowing the device to be marketed. This regulatory pathway does not typically require the detailed performance study information you requested, which is more common for diagnostic AI/ML devices or novel high-risk devices.

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The Atlantis Abutment is intended for use as an accessory to an endosseous implant to support a prosthetic reconstruction 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 cement retained to the abutment. The abutment screw is intended to secure the abutment to the endosseous implant.

The Atlantis Abutment for 3i MicroMini Implant is compatible with the 3i: Osseotite NT® Certain and Parallel Walled Implants both with 3.25mm diameter; Nobel Biocare: Mk III 3.3mm, Threaded HL Series 3.3mm, HL Immediate Impression 3.25mm, Cylindrical HL Series 3.25mm; BioHorizons: Maestro™ 3.5mm; Lifecore: Self-tapping 3.75mm, Threaded 3.3mm, Cylinder 3.4mm, Titanium 3.3mm; Sterngold: Implamed Hex Screw 3.3mm, 3.75mm, 4.0mm and 5.0mm, Hex Cylinder 3.3mm; Innova: Endopore® External 3.5mm and Entegra™ External 3.25mm.

Please note: This device may be used in an early load situation, but is dependent on the specific implant system and protocol used by the dental professional. Highly angled abutments (i.e. 30 degrees) on implants with diameters less than 4 mm are intended for the anterior region of the mouth and are not intended for the posterior region due to limited strength of the implant.

The devices covered in this submission are abutments which are placed into the dental implant to provide support for a prosthetic restoration. The subject abutments are indicated for cemented restorations. The Atlantis™ Abutments for 31 MicroMini Implant and abutment screws are made I ne Atlantis - 110 am 2012 (Meets ASTM Standard F-136). The abutment is placed over the implant shoulder and is mounted into the implant with a screw. The placed over the mipatible with 3i Ossectite NT® Certain™ Implant 3.25mm and Parallel abulled Implant 3.25mm; Nobel Biocare Mk III 3.3mm, Threaded HL Series 3.3mm, HL Wared Impression 3.25mm, Cylindrical HL Series 3.25mm; BioHorizons Maestro™ 1.5mm; Lifecore Self-tapping 3.75mm, Threaded 3.3mm, Cylinder 3.4mm, Titanium 3.3mm; Sterngold Implamed Hex Screw 3.3mm, 3.75mm, 4.0mm and 5.0mm; Innova Endopore® external 3.5mm and Entegra™ External 3.25mm.

Here's a breakdown of the acceptance criteria and study information for the Atlantis™ Abutment for 3i MicroMini Implant, based on the provided text, recognizing that this is a 510(k) summary and not a full study report.

Important Note: The provided document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device rather than presenting a novel clinical trial for device-specific performance criteria. Therefore, explicit "acceptance criteria" and "device performance" in the typical sense of a clinical study with statistical endpoints are not present. Instead, the "acceptance criteria" are implied by the claim of substantial equivalence in "intended use, material, design and performance" to the predicate devices. The "reported device performance" is essentially the statement that it meets these equivalence criteria.

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: The document does not specify a separate "test set" sample size in the context of a clinical performance study. This is a 510(k) submission, primarily relying on comparison to predicate devices and (implied) bench testing rather than a new clinical trial.
• Data Provenance: Not applicable in the context of a clinical test set. The data provenance supporting the substantial equivalence would come from the manufacturer's internal testing (mechanical, material characterization) and comparison to the known characteristics of the predicate devices. There is no mention of country of origin for clinical data as no clinical study demonstrating new performance data is described for this specific device.

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

• Number of Experts: Not applicable. There is no mention of experts establishing ground truth for a clinical test set in this 510(k) summary. The "ground truth" for substantial equivalence is based on engineering principles, material science, and regulatory comparison.

4. Adjudication Method for the Test Set

• Adjudication method is not applicable as there is no described clinical test set involving human assessment requiring adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and its effect size.

• No, an MRMC comparative effectiveness study was not done. This document pertains to a dental implant abutment, where performance is typically assessed through mechanical testing and equivalence to existing devices, not through human reader interpretation of images or data that would necessitate an MRMC study.

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

• Not applicable. This device is a passive mechanical component (an abutment for a dental implant), not an algorithm or AI system.

7. The type of ground truth used

• The "ground truth" for this 510(k) submission is the established performance and safety profiles of the predicate devices (Atlantis Abutments K981858 and 3i Osseotite NT Dental Implant System K014235). The applicant aims to demonstrate that the new device's material, design, intended use, and performance are equivalent to these legally marketed devices. This would typically be supported by:
  • Mechanical Testing Data: (Implied) to show comparable strength, fatigue resistance, and fit.
  • Material Characterization: (Stated: Ti 6Al 4V ELI, ASTM F-136 compliance).
  • Design Specifications: Showing compatibility with target implant systems.

8. The Sample Size for the Training Set

• Not applicable. This submission describes a physical device, not an AI/ML algorithm that requires a training set.

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

• Not applicable. As there is no training set for an AI/ML algorithm, no ground truth establishment for such a set is relevant.

Ask a specific question about this device

The Atlantis Abutment is intended for use as an accessory to 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 cement retained to the abutment. The abutment screw is intended to secure the abutment to the endosseous implant.

This device is compatible with the following manufacturers' implant systems: Nobel Biocare, Zimmer Dental, 3i, Lifecore, Sterngold, Innova and BioHorizons.

Please note: This device may be used in an early load situation, but is dependent on the specific implant system and protocol used by the dental professional.

Also, highly angled abutments (i.e. 30 degrees) on implants with diameters less than 4 mm are intended for the anterior region of the mouth and are not intended for the posterior region due to limited strength of the implant.

The devices covered in this submission are abutments which are placed into the dental implant to provide support for a prosthetic restoration. The subject abutments are indicated for cemented restorations.

The Atlantis™ Abutments in Zirconia for Nobel Replace is made of biocompatible material, yttria-stabilized tetragonal zirconia polycrystals (Y-TZP) and meets ISO Standards 6972 & 13356). The abutment screw is made from titanium grade Ti-6A1-V ELI and meets ASTM Standard F-136. The abutment is placed over the implant shoulder and is mounted into the implant with a screw. The abutments are compatible with Nobel Replace® Select Straight, Replace Select Straight One Stage, Replace Select Tapered and Replace Select Tapered One Stage for the 4.3 mm (RP), 5.0 mm (WP) and 6.0 mm (WP) Implants.

The provided text describes a 510(k) premarket notification for a dental implant abutment and does not contain information about acceptance criteria, device performance metrics, or study results in the context of AI/ML-based medical devices. The document focuses on establishing substantial equivalence to predicate devices based on intended use, materials, design, and performance, rather than presenting a performance study against predefined acceptance criteria.

Therefore, I cannot extract the requested information (acceptance criteria table, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, or training set details) from the provided text. This document is a regulatory submission for a physical medical device, not a software-as-a-medical-device (SaMD) or AI-powered diagnostic tool, which typically would involve such performance study details.

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