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LoFric® Primo™ and LoFric® Hydro-Kit™ are intended for intermittent urinary catheterization.

The LoFric® Primo™ and LoFric® Hydro-Kit™ are single-use catheters designed as intermittent pathways for drainage of the bladder. The catheters are available in a variety of lengths and configurations to accommodate individual anatomy of both male and female users. Both Nelaton (straight tip) and Tiemann (curved tip) designs are available. Each catheter is packaged along with a water packet that is to be broken immediately before use in order to soak the tubing.

The LoFric® Primo™ and LoFric® Hydro-Kit™ are urological catheters that were cleared based on substantial equivalence to predicate devices, rather than a study with specific acceptance criteria and performance metrics. Therefore, the information typically found in an AI/CAD device submission regarding detailed acceptance criteria and a study proving those criteria are met is not present. This submission relies on performance testing and biocompatibility testing as compared to existing, legally marketed predicate devices.

Here's an analysis based on the provided text, addressing the points where information is available or can be inferred:

1. Table of Acceptance Criteria and Reported Device Performance

Explanation: The "acceptance criteria" for this submission are fundamentally defined by the characteristics of the predicate devices. The new devices are deemed "substantially equivalent" if they meet these characteristics and do not raise new issues of safety or efficacy.

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

This information is not provided in the submission. The submission describes non-clinical testing data including "dimensional analysis, biocompatibility testing and modified performance testing according to ASTM F623." However, specific sample sizes for these tests, or information on test sets derived from patient data (retrospective or prospective), are not included. Given that it's a medical device (catheter) rather than a diagnostic AI/CAD system, "data provenance" in the sense of patient data doesn't directly apply in this type of submission for substantial equivalence.

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

This information is not applicable/not provided. This is a submission for a physical medical device (catheter), not an AI/CAD system requiring expert-established ground truth on clinical images or data. The "ground truth" for demonstrating equivalence largely comes from engineering specifications, material science, and performance standards (like ASTM F623) in comparison to predicate devices, not expert consensus on diagnostic interpretations.

4. Adjudication Method for the Test Set

This information is not applicable/not provided. As explained above, this is not an AI/CAD system requiring adjudication of interpretations.

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

This information is not applicable/not provided. MRMC studies are typically performed for diagnostic AI/CAD systems to evaluate the impact on human reader performance. This submission is for a physical medical device.

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

This information is not applicable/not provided. This is not an algorithm-based device.

7. The Type of Ground Truth Used

The "ground truth" for this substantial equivalence submission is essentially derived from:

• Predicate Device Characteristics: The established safety and effectiveness profiles of the legally marketed predicate devices.
• Engineering Specifications and Standards: Compliance with relevant engineering and material standards, such as ASTM F623 for performance testing.
• Biocompatibility Standards: Successful completion of biocompatibility testing to ensure safety in contact with biological tissues.

8. The Sample Size for the Training Set

This information is not applicable/not provided. This is not an AI/ML device that requires a "training set" in the computational sense. The "learning" for the manufacturer comes from established manufacturing processes and prior device iterations (e.g., K113424, K043241, K050874, which are predicate devices).

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

This information is not applicable/not provided for the same reasons as point 8.

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 cemented, screw retained or friction fit 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 Atlantis Abutment in Zirconia for Dentsply Ankylos Implant is compatible with the Dentsply Ankylos 3.5mm, 4.5mm, 5.5mm and 7.0mm Implants.

The Atlantis™ Crown Abutment in Zirconia is intended for use with an endosseous implant to function as a substructure that also serves as the final restoration, in partially or completely edentulous patients. The prosthesis is screw retained. The abutment screw is intended to secure the crown abutment to the endosseous implant.

This device is compatible with the following manufacturers' implant systems:
the Dentsply Ankylos 3.5mm, 4.5mm, 5.5mm and 7.0mm 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 on small diameter implants are intended for the anterior region of the mouth only.

The Atlantis Abutment and Atlantis™ Crown Abutment in Zirconia for Dentsply AnkylosImplant is compatible with the Dentsply Ankylos 3.5mm, 4.5mm, 5.5mm and 7.0mm 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 angulated abutments on small implants are to be used for the anterior region of the mouth 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 for cemented, screw retained or friction fit restorations. The Atlantis™ Abutment and Atlantis™ Crown Abutment in Zirconia for Dentsply Ankylos 3.5mm, 4.5mm, 5.5mm and 7.0mm Implants is made of biocompatible material, yttria-stabilized tetragonal for the zirconia polycrystals (Y-TZP) ( meets ISO Standards 6972 & 13356). Zirconia may have variation in shade. The abutment screw is made of Titanium grade Ti-6A1-4V ELI (meets ASTM Standard F-136). The zirconia abutments are placed over the implant shoulder and are mounted into the implant with a titanium screw.

The provided document is a 510(k) summary for a medical device (dental abutments) and does not contain information related to AI/ML device acceptance criteria or studies as typically found in submissions for AI-powered diagnostics or medical image analysis.

The document describes the "Atlantis™ Abutment and Atlantis™ Crown Abutment in Zirconia for Dentsply Ankylos Implant" and its substantial equivalence to a predicate device. The "study" mentioned is non-clinical testing to demonstrate performance characteristics, not a clinical trial or AI/ML performance study.

Therefore, most of the requested information (acceptance criteria for AI, sample sizes for test/training sets, ground truth establishment, expert qualifications, adjudication methods, MRMC studies, standalone performance) is not applicable to this type of device submission.

Here's a breakdown of the relevant information from the document:

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't provide explicit "acceptance criteria" in the format of thresholds for metrics like sensitivity, specificity, or F1-score as you would see for an AI/ML device. Instead, the acceptance is based on demonstrating substantial equivalence to an already legally marketed predicate device (K#101004). The performance is demonstrated through non-clinical mechanical testing, ensuring the device can withstand intended forces.

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

• Test Set Sample Size: Not explicitly stated as a "test set" in the context of clinical or AI/ML performance evaluation. The "worst case scenario" implant assemblies used for static and fatigue testing would constitute the "test set" for the mechanical performance. The exact number of samples for these mechanical tests is not provided in this summary.
• Data Provenance: The mechanical testing would have been conducted in a laboratory setting, likely by the manufacturer or a contracted lab. Country of origin of the data is not specified but is presumed to be relevant to the manufacturer (Astra Tech Inc., Waltham, Massachusetts, USA). This is retrospective in the sense that the test results are reported after the tests were conducted prior to submission.

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

• Not applicable. Ground truth in the context of AI/ML evaluation (e.g., expert consensus on medical images) is not relevant for this mechanical device submission. The "ground truth" for mechanical testing is established by engineering standards and measurements.

4. Adjudication method for the test set:

• Not applicable. Adjudication methods like 2+1 or 3+1 are used for establishing ground truth from multiple human reviewers, which is not relevant here. Mechanical test results are typically objective measurements against predefined engineering specifications.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done:

• No. This is a mechanical device, not an AI/ML diagnostic.

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

• No. This is a physical medical device, not an algorithm.

7. The type of ground truth used:

• For the mechanical performance component, the "ground truth" is derived from established engineering standards and material properties, along with the results of static and fatigue compression testing measured against performance specifications that demonstrate the device "performs as intended."

8. The sample size for the training set:

• Not applicable. There is no AI/ML component or "training set" in this submission.

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

• Not applicable.

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 endentulous 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 and zirconia abutments are compatible with the 3.8mm, 4.5mm, 5.5mm, and 6.5mm Keystone Genesis Tapered and Straight Implants.

The Atlantis™ Crown Abutment in Zirconia is intended for use with an endosseous implant to function as a substructure that also serves as the final restoration, in partially or completely edentulous patients. The prosthesis is screw retained. The abutment screw is intended to secure the crown abutment to the endosseous implant.

This device is compatible with the following manufacturers' implant systems:

the 3.8mm, 4.5mm, 5.5mm, and 6.5mm Keystone Genesis Tapered and Straight 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 of the mouth only.

The devices covered in this submission are abutments which are placed into the dental implant to provide support for a prosthetic restoration. The titanium and zirconia abutments are indicated for cemented or screw retained restorations. The crown abutment in zirconia is indicated for screw retained restorations. The titanium Atlantis™ Abutment for Keystone Genesis Implant and abutment screw are made of Titanium grade Ti-6A1-4V ELI (meets ASTM Standard F-136) for the 3.8mm, 4.5mm, 5.5mm and 6.5mm sizes. In addition, the zircoina Atlantis™ Abutment for Keystone Genesis Implant and the Atlantis™ Crown Abutment in Zirconia for the 3.8mm. 4.5mm. 5.5mm and 6.5mm sizes are made of biocompatible material, yttriastabilized 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.

This document describes a 510(k) premarket notification for the Atlantis™ Abutment and Atlantis™ Crown Abutment in Zirconia for Keystone Genesis Implant. This is a medical device submission, and therefore, the information provided is focused on demonstrating substantial equivalence to a predicate device rather than presenting a study to prove performance against specific acceptance criteria for a novel device.

Here's an analysis based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

For this type of 510(k) submission, the "acceptance criteria" are typically defined by demonstrating that the new device is "substantially equivalent" to legally marketed predicate devices. This equivalence is primarily shown through comparisons of technological characteristics, intended use, and performance characteristics. The acceptance criteria aren't explicitly numerical thresholds as one might see for a diagnostic AI.

Here's a table based on the provided "Substantial Equivalence Summary" (Table 1):

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

• Sample Size: The document mentions "worst case scenario" implant assemblies were tested, but it does not specify the numerical sample size used for the static and fatigue compression testing.
• Data Provenance: The testing was conducted as part of the premarket submission by Astra Tech Inc. It is internal testing to demonstrate the device's compatibility and performance. The document does not specify the country of origin of the data further than implying it's internal to the manufacturer's R&D process. It is prospective data generated specifically for this submission.

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

This information is not applicable and not provided in the context of this 510(k) submission. For medical devices like dental abutments, "ground truth" is typically established through direct physical and mechanical testing (e.g., material properties, static and fatigue strength) against engineering standards and comparison to predicate devices, rather than expert consensus on observational data.

4. Adjudication method for the test set

This information is not applicable and not provided. Adjudication methods like 2+1 or 3+1 are used in studies where human readers evaluate cases (e.g., medical images) and their interpretations need to be reconciled. This submission focuses on physical performance 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

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This type of study is relevant for AI-powered diagnostic or assistive devices where human performance with and without AI assistance is being compared. The device in question is a physical dental abutment, not an AI diagnostic tool.

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

No, a standalone performance evaluation of an algorithm was not done. This device is a physical product, not a software algorithm.

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

The "ground truth" for the performance of the Atlantis™ Abutment and Atlantis™ Crown Abutment is established through physical and mechanical testing (static and fatigue compression testing) designed to simulate the in-vivo environment and demonstrate that the device performs as intended and is comparable to previously cleared predicate devices. The "truth" is based on meeting engineering specifications and demonstrating mechanical integrity under specified loads.

8. The sample size for the training set

This information is not applicable and not provided. There is no "training set" in the context of developing and validating a physical dental abutment. Training sets are used for machine learning algorithms.

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

This information is not applicable and not provided for the same reason as in point 8.

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 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 Atlantis Abutment in Zirconia for Astra Tech Osseospeed Implant is compatible with the Astra Tech Osseospeed Plus 3.6mm and 4.2mm 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 of the mouth 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 in Zirconia for Astra Tech Osseospeed Plus Implant for the Astra Tech Osseospeed Plus 3.6mm and 4.2mm Implants is made of biocompatible material, yttria-stabilized tetragonal for the zirconia polycrystals (Y-TZP) ( meets ISO Standards 6972 & 13356). Zirconia may have variation in shade. The abutment screw is made of Titanium grade Ti-6A1-4V ELI (meets ASTM Standard F-136). The zirconia abutments are placed over the implant shoulder and are mounted into the implant with a titanium screw.

This is not an AI/ML device and therefore no AI/ML specific information can be extracted.

The document describes the Atlantis™ Abutment in Zirconia for Astra Tech Osseospeed Plus Implant.

1. Table of Acceptance Criteria and Reported Device Performance:

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

The document states that "Static and fatigue compression testing was conducted on 'worst case scenario' implant assemblies." However, it does not specify the exact sample size (number of assemblies tested) or the data provenance (e.g., country of origin, retrospective or prospective).

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

This information is not applicable as the study described is a non-clinical, mechanical testing study, not a study evaluating human interpretation or diagnosis. Therefore, no experts were needed to establish ground truth in this context.

4. Adjudication Method for the Test Set:

This information is not applicable for the same reason as point 3.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done:

No, a Multi Reader Multi Case (MRMC) comparative effectiveness study was not done. The study was non-clinical mechanical testing of an implant abutment.

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

This information is not applicable as the device is a physical medical device (dental abutment), not an algorithm or AI system.

7. The Type of Ground Truth Used:

The ground truth for the non-clinical testing was based on engineering standards and expected mechanical performance limits for dental implant systems, as detailed in ISO Standards 6972 & 13356 and ASTM Standard F-136. The "appropriate static and fatigue test loads" represent the ground truth for mechanical integrity.

8. The Sample Size for the Training Set:

This information is not applicable as the device is a physical medical device and does not involve AI/ML a training set.

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

This information is not applicable for the same reason as point 8.

Ask a specific question about this device

The Atlantis Crown Abutment in Zirconia is intended for use with an endosseus implant to function as a substructure that also serves as the final restoration, in a partially or completely edentulous patient. The prosthesis is screw retained. The abutment screw is intended to secure the crown abutment to the endosseous implant.

This device is compatible with the following manufacturers' implant systems:

Astra Tech Microthread ST 3.5mm, 4.0mm, 4.5mm 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 on small diameter implants are intended for the anterior region of the mouth only.

The device covered in this submission is a single restorative component for dental implants that integrates all aspects of the coping and abutment functionalities. The device has a crown shape exterior which allows the porcelain to be applied directly to the surface of the screw retained abutment and provides support for the described prosthetic restoration. The Atlantis Crown Abutment in Zirconia design is different than an Atlantis Abutment for cement-retained restoration in that the basis for its individualized design is the final crown.

The subject crown abutment is indicated for screw retained restorations. The Atlantis™ Crown Abutment in Zirconia is made of biocompatible material, yttria-stabilized tetragonal zirconia polycrystals (Y-TZP) and meets ISO Standards 6972 & 13356. Zirconia may have variation in shade. The abutment screw is made of Titanium grade Ti-6A1-4V ELI and complies with ASTM Standard F-136. The zirconia screw retained abutments are placed over the implant shoulder and are mounted into the implant with the titanium screw.

This document describes a 510(k) premarket notification for the "Atlantis™ Crown Abutment in Zirconia," a dental implant component. The information provided outlines the device's administrative details, intended use, device description, and its equivalence to a previously marketed device. The primary study described is a non-clinical test.

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

Acceptance Criteria and Device Performance Study

The acceptance criteria for the Atlantis™ Crown Abutment in Zirconia are based on demonstrating substantial equivalence to a predicate device (Atlantis™ Abutment for Astra Implants cleared under K071946) and performance as intended under specific testing conditions.

1. Table of Acceptance Criteria and Reported Device Performance

• Predicate Device: Titanium Alloy (screw) and Biocompatible ceramic material (abutment). |
  | - Performance Characteristics (functionality) | - Atlantis™ Crown Abutment in Zirconia: Allows the prosthesis to be screw-retained to the endosseous implant.
• Predicate Device: Allows the prosthesis to be cemented or screw-retained to abutment; abutment screw secures abutment to the endosseous implant. (Note: The new device is specifically screw-retained, a subset of the predicate's capability regarding connection to the abutment, but both secure to the implant via screw) |
  | - Intended Use | - Atlantis™ Crown Abutment in Zirconia: Intended for use with an endosseous implant as a substructure functioning as the final, screw-retained restoration in partially/completely edentulous patients. Abutment screw secures to the implant.
• Predicate Device: Intended for use with an endosseous implant to support a prosthetic device in partially/completely edentulous patients, supporting single or multiple tooth prosthesis in mandible or maxilla. |
  | Performance as Intended (Non-clinical Testing): | |
  | - Withstand Static Compression | "Test results demonstrate that the Atlantis Crown Abutment is compatible with the Astra implants and the implant system supported appropriate static... test loads demonstrating that the implant system performs as intended." |
  | - Withstand Fatigue Compression | "Test results demonstrate that the Atlantis Crown Abutment is compatible with the Astra implants and the implant system supported appropriate... fatigue test loads demonstrating that the implant system performs as intended." |
  | - Compatibility with Astra Implants | "Test results demonstrate that the Atlantis Crown Abutment is compatible with the Astra implants..." |

2. Sample Size for the Test Set and Data Provenance

The study referenced is a non-clinical bench test. The text states:

• "Static and fatigue compression testing was conducted on "worst case scenario" implant assemblies for the Atlantis angled zirconia crown abutments with the Astra implant."
• Sample Size: The exact number of "worst case scenario" implant assemblies tested is not specified in the provided text.
• Data Provenance: The testing appears to be conducted by the manufacturer, Astra Tech Inc., as part of their premarket notification. This is a pre-clinical/bench test, not human patient data, so concepts like "country of origin of data" or "retrospective/prospective" in the typical clinical sense are not applicable.

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

This was a non-clinical bench test involving physical components and engineering analyses. Therefore, no human "experts" were used to establish ground truth in the context of clinical interpretation or diagnosis. The "ground truth" was established by the physical testing conditions and engineering standards/methods relevant to static and fatigue compression testing of dental implant systems.

4. Adjudication Method for the Test Set

Not applicable. As a non-clinical bench test without human assessors making judgments, there was no need for an adjudication method.

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

No, an MRMC comparative effectiveness study was not done. This device is a physical dental implant component, not an imaging or diagnostic device that would involve human readers interpreting cases.

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

This refers to an AI/algorithm performance. No, this is not applicable as the device is a physical dental implant substructure, not an algorithm.

7. The Type of Ground Truth Used

The "ground truth" for the non-clinical testing was based on:

• Engineering Standards and Specifications: The test loads applied, and the definition of failure or performance within the static and fatigue compression tests, would be based on established engineering principles and potentially relevant ISO or ASTM standards for dental implant components.
• Predicate Device Equivalence: A significant part of the "ground truth" for regulatory clearance was the demonstration of substantial equivalence to the previously cleared predicate device (K071946) in terms of materials, intended use, and performance characteristics.

8. The Sample Size for the Training Set

Not applicable. This is a physical device, and therefore there is no "training set" in the context of machine learning or algorithms.

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

Not applicable, as there is no training set for this type of device.

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 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 Camlog 3.3mm, 4.3mm, 5.0mm and 6.0mm Root-Line, Cylinder-Line, Cylinder Line TPS, Screw-Line, Promote and Promote Plus K-Series Implants.

The zirconia abutments are compatible with the Camlog 3.8mm. 5.0mm and 6.0mm Root-Line, Cylinder-Line, Cylinder Line TPS, Screw-Line, Promote and Promote Plus K-Series 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 Camlog Implant and abutment screw are made of Titanium grade Ti-6A1-4V ELI (meets ASTM Standard F-136) for the 3.3mm. 3.8mm. 4.3mm. 5.0mm and 6.0mm sizes. In addition. the Atlantis™ Abutment for Camlog Implant for the 3.8mm. 4.3mm. 5.0mm and 6.0mm 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.

Here's a breakdown of the acceptance criteria and study information based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria:
The document implicitly defines acceptance criteria through the successful performance of "worst case scenario" implant assemblies under static and fatigue compression testing. The overarching acceptance criterion is that the implant system (Atlantis Abutments with Camlog implants) must perform as intended under these loads. "As intended" implies demonstrating mechanical integrity and stability comparable to or better than the predicate devices.

Reported Device Performance:

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

• Sample Size for Test Set: The document does not explicitly state the exact number of samples (implant assemblies) used for static and fatigue compression testing. It refers to "worst case scenario" implant assemblies without specifying the quantity.
• Data Provenance: This was a non-clinical bench testing study, not involving human subjects. Therefore, data provenance in terms of country of origin or retrospective/prospective human data is not applicable. The tests were conducted to evaluate the mechanical performance of the device.

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

• Not Applicable. This was a non-clinical bench testing study assessing mechanical performance against engineering standards and established methods for dental implant testing (static and fatigue compression). Ground truth was established through validated testing protocols and measurements, not expert human assessment.

4. Adjudication Method

• Not Applicable. As this was a non-clinical bench testing study, there was no need for human adjudication of results. The outcomes are objective measurements of mechanical load bearing and fatigue resistance.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

• No. An MRMC comparative effectiveness study is designed for evaluating human reader performance with and without AI assistance, typically in image interpretation or diagnostic tasks. This submission is for a dental implant abutment, and the testing involved mechanical performance, not diagnostic review.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study Was Done

• Yes, in essence. The testing described is a "standalone" evaluation of the device's mechanical performance in a laboratory setting. The "device" here is the Atlantis™ Abutment and its interaction with the Camlog implant system. The performance evaluated (static and fatigue strength) is inherent to the device itself, without human intervention during the actual performance measurement. There is no "algorithm" in the context of an AI device.

7. The Type of Ground Truth Used

• Engineering Standards and Bench Test Results: The "ground truth" for this device's performance is established by its ability to meet accepted industry standards for static and fatigue strength of dental implant components. The test results (load sustained, cycles to failure) serve as the objective ground truth, demonstrating the device's mechanical properties. It's not pathology, expert consensus, or outcomes data in the biological sense, but rather a mechanical performance assessment.

8. The Sample Size for the Training Set

• Not Applicable. This device is a physical medical device (dental implant abutment), not an AI/machine learning algorithm. Therefore, there is no "training set" in the context of algorithm development.

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

• Not Applicable. As there is no training set for an algorithm, this question is not relevant to this device's 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 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 Atlantis Abutment in Zirconia is compatible with the Astra Tech Osseospeed TX Profile 4.5, 5.0 and 5.0 S 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 angulated abutments on small implants are intended for the anterior region of the mouth 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 in Zirconia for Osseospeed TX Profile Implant for the Astra Tech Osseospeed Profile 4.5, 5.0 and 5.0 S Implants is made of biocompatible material, yttria-stabilized tetragonal for the zirconia polycrystals (Y-TZP) ( meets SO Standards 6972 & 1356). Zircomia may have variation in shade. The abutment serew is made of Titanium grade Ti-6A1-4V ELI (meets ASTM Standard F-136). The zirconia abutments are placed over the implant shoulder and are mounted into the implant with a titanium screw.

Here's an analysis of the provided text regarding the acceptance criteria and study for the Astra Tech Atlantis™ Abutment in Zirconia for Osseospeed TX Profile Implant:

This summary does not contain the level of detail requested for many of your points, specifically for a typical AI/ML medical device submission. This document is a 510(k) summary for a dental abutment, which is a traditionally regulated medical device, not an AI/ML device. Therefore, many of the questions regarding AI/ML study design (e.g., sample sizes for test/training sets, data provenance, expert ground truth, MRMC studies) are not applicable or the information is not present in this type of submission.

The primary method of demonstrating substantial equivalence for this device is based on comparison to predicate devices and non-clinical engineering testing, rather than a clinical study evaluating diagnostic or prognostic performance of an algorithm.

Acceptance Criteria and Reported Device Performance

1. Table of Acceptance Criteria and Reported Device Performance

Since this is a non-AI/ML device, there are no "acceptance criteria" in the sense of performance metrics like sensitivity, specificity, or AUC against a ground truth. Instead, the acceptance is based on meeting engineering performance standards and demonstrating substantial equivalence to predicate devices. The study performed was focused on mechanical integrity.

Study Details (Based on available information)

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

• Sample Size: Not specified. The document states "Static and fatigue compression testing was conducted on 'worst case scenario' implant systems using Atlantis angled zirconia abutments with the Astra Tech Osseospeed TX Profile implant." This implies a limited number of physical samples were tested, not a large patient data set.
• Data Provenance: Not applicable in the context of patient data. This was laboratory-based mechanical testing.

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

• Not applicable. Ground truth for mechanical testing is based on engineering specifications and physical measurements, not expert human interpretation.

4. Adjudication method for the test set:

• Not applicable. This was mechanical testing, not a study requiring adjudication of expert interpretations.

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 study was not done. This is not an AI/ML device.

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 mechanical testing, the "ground truth" (or reference standard) would be the established engineering standards and specifications for static and fatigue loads on dental implant abutments.

8. The sample size for the training set:

• Not applicable. This device does not involve an AI/ML algorithm or a "training set" in that context.

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

• Not applicable.

Summary of the "Study" and Conclusions from the Document:

The core of the "study" described in this 510(k) summary is non-clinical bench testing.

• Study Design: Static and fatigue compression testing was performed on "worst case scenario" configurations of the Atlantis Abutment in Zirconia integrated with the Astra Tech Osseospeed TX Profile implant system.
• Purpose: To demonstrate the mechanical compatibility and integrity of the new abutment with the specified implant system, and ultimately to support substantial equivalence to predicate devices.
• Results: The tests showed that the implant system (with the new abutments) "supported appropriate static and fatigue test loads demonstrating that the implant system performs as intended."
• Conclusion for Substantial Equivalence: Based on the similarities in material, design principles, performance characteristics, and the successful non-clinical testing, the device was deemed substantially equivalent to the predicate devices (Astra Tech's Osseospeed TX Profile System K080156 and the Atlantis Abutment in Zirconia for Astra Implant K071946).

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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 cement 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 Dentsply 3.5mm, 4.5mm, 5.5mm and 7.0mm Ankylos 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 or screw retained restorations. The Atlantis™ Abutment for Dentsply Ankylos Implant and abutment screw are made from Titanium grade Ti-6A 1-4V ELI (meets ASTM Standard F-136) for the 3.5mm, 4.5mm, 5.5mm, and 7.0mm sizes. The titanium abutments are placed over the implant shoulder and are mounted into the implant with a titanium screw.

Here's an analysis of the provided text regarding the acceptance criteria and study for the Atlantis™ Abutment for Dentsply Ankylos Implant:

This document is a 510(k) Summary, which typically focuses on demonstrating substantial equivalence to a predicate device rather than presenting detailed performance studies against specific acceptance criteria for a new device's efficacy. In this case, the device is an implant abutment, which is a component of a dental implant system. The "performance" discussed primarily relates to its compatibility and functional equivalence to existing, legally marketed components.

Based on the provided text, a formal study with quantitative acceptance criteria as one might expect for a diagnostic AI device is not presented. Instead, the submission relies on demonstrating substantial equivalence to predicate devices.

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

1. Table of Acceptance Criteria and Reported Device Performance

Given that this is a 510(k) submission for substantial equivalence for a physical medical device (dental abutment), the "acceptance criteria" are not framed in terms of metrics like sensitivity, specificity, or accuracy that would be typical for an AI/diagnostic study. Instead, the acceptance criteria are met by demonstrating the device is:

• Substantially equivalent in intended use, material, design, and performance to the predicate devices.
• Able to perform the same functions as the predicate devices.
• Made of the same material as the predicate device.

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

No specific "test set" in the context of an AI study is mentioned. The submission relies on a comparison of characteristics and intended use to existing, legally marketed predicate devices (Dentsply Ankylos C/X Dental Implant System K083805 and Astra Tech Inc. Atlantis™ Abutment K093780). There is no mention of data provenance (e.g., country of origin, retrospective/prospective) for a performance study.

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

Not applicable. The document describes a physical medical device (dental abutment), not an AI or diagnostic device that would require expert-established ground truth for a test set.

4. Adjudication Method for the Test Set

Not applicable. There is no human-reviewed test set or 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

Not applicable. This is a filing for a physical medical device, not an AI or diagnostic software subject to MRMC studies.

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

Not applicable. This is a filing for a physical medical device, not an AI algorithm.

7. The Type of Ground Truth Used

Not applicable. The "ground truth" for a physical device like a dental abutment would be its physical properties, material composition, manufacturing tolerances, and functional performance (e.g., torque strength, fatigue resistance), typically evaluated through engineering tests, not a "ground truth" as understood in AI/diagnostic studies. The document mentions ASTM Standard F-136 for material, which provides a standard specification for titanium alloy for surgical implants, serving as a form of "ground truth" for material properties.

8. The Sample Size for the Training Set

Not applicable. There is no training set mentioned, as this is not an AI or machine learning device.

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

Not applicable. There is no training set or associated ground truth establishment process 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 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 Dentsply 3.0mm, 3.8mm, 4.5mm and 5.5mm XiVE® S Plus Implants.

The titanium and zirconia abutments are compatible with the Dentsply 3.4mm, 3.8mm, 4.5mm, 5.5mm and 6.5mm Frialit® Plus Implants.

The zirconia abutments are compatible with Dentsply 3.4mm, 4.5mm and 5.5mm XiVE® S Plus 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 or screw retained restorations. The Atlantis™ Abutment for Dentsply Implant and abutment screw are made from Titanium grade Ti-6A1-4V ELI (meets ASTM Standard F-136) for the 3.0mm, 3.4mm, 3.8mm, 4.5mm, 5.5mm and 6.5mm sizes. In addition, the Atlantis™ Abutment for Dentsply Implant for the 3.4mm, 3.8mm, 5.5mm and 6.5mm sizes, also are made of the biocompatible material, yttria-stabilized tetragonal zirconia polycrystals (Y -TZP) (meets ISO Standards 6072 & 13356). Zirconia may have a variation in shade. The titanium and the zirconium abutments are placed over the implant shoulder and are mounted into the implant with a titanium screw.

The provided text is a 510(k) summary for the Atlantis™ Abutment for Dentsply Implant. It describes the device, its intended use, and claims substantial equivalence to predicate devices. However, it does not contain information about acceptance criteria or a study proving the device meets those criteria, as typically understood in the context of performance metrics like sensitivity, specificity, accuracy, or reader studies for AI/medical imaging devices.

The document primarily focuses on establishing substantial equivalence based on material, design, and intended use to previously cleared devices. It does not present a clinical performance study with defined acceptance criteria and reported device performance in the way requested.

Therefore, many of the requested fields cannot be populated from the provided text.

Here's a breakdown based on what can be inferred or determined to be absent from the document:

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

• Not applicable / Not provided. The document establishes substantial equivalence based on materials, design, and intended use, not on specific performance metrics with acceptance criteria like sensitivity, specificity, etc.

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 / Not provided. No specific test set data is mentioned for performance evaluation.

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 / Not provided. No ground truth establishment is described for a performance test.

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

• Not applicable / Not provided. No adjudication method 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

• Not applicable / Not provided. This device is a dental abutment, not an AI or imaging device that would typically undergo MRMC studies.

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

• Not applicable / Not provided. This is a physical medical device, not an algorithm.

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

• Not applicable / Not provided. No performance-related ground truth is discussed.

8. The sample size for the training set

• Not applicable / Not provided. This is not an AI/machine learning device that uses training sets.

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

• Not applicable / Not provided. This is not an AI/machine learning device.

Summary of what the document does provide:

The document focuses on demonstrating substantial equivalence to predicate devices by comparing:

• Intended Use: The Atlantis™ Abutment is intended for use with an endosseous implant to support a prosthetic device in partially or completely edentulous patients, supporting single and multiple tooth prostheses in the mandible or maxilla, with cement or screw-retained options. This aligns with the predicate devices.
• Materials: The abutments are made from Titanium grade Ti-6A1-4V ELI (ASTM Standard F-136) and yttria-stabilized tetragonal zirconia polycrystals (Y-TZP) (ISO Standards 6072 & 13356). These materials are commonly used in dental implants and are present in equivalent forms in the predicate devices.
• Design: The device functions as an abutment placed into a dental implant to support a prosthetic restoration. Compatibility with specific Dentsply implant systems is detailed. The design is considered substantially equivalent to the predicate devices.
• Performance (as implied by equivalence studies, not specific metrics): The document implies that because the materials, design, and intended use are substantially equivalent to legally marketed predicate devices, its performance is also considered equivalent. This typically involves non-clinical bench testing (e.g., mechanical strength, fatigue, biocompatibility) rather than clinical performance metrics in the context of this type of device. While the 510(k) summary doesn't detail these tests, such data would typically be part of the full 510(k) submission to demonstrate the performance equivalence to the predicate.

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:

The titanium and zirconia abutments are compatible with the Nobel Biocare's NobelActive Implants: NP 3.3mm, RP 4.3mm and 5.0 mm sizes

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™ Abutment for Nobel Biocare Active Implant and abutment screw are made from Titanium grade Ti-6A1-4V ELI (meets ASTM Standard F-136) for the 3.5mm, 4.3mm and 5.0mm sizes. In addition, the Atlantis™ Abutment for Nobel Biocare Active Implant for the 3.5mm, 4.3mm and 5.0mm sizes, also are made of the biocompatible material, yttria-stabilized tetragonal zirconia polycrystals (Y-TZP) (meets ISO Standards 6072 & 13356). Zirconia may have a variation in shade. The titanium and the zirconium abutments are placed over the implant shoulder and are mounted into the implant with a titanium screw.

The provided text is a 510(k) premarket notification for a dental abutment. The primary purpose of this type of submission is to demonstrate substantial equivalence to a legally marketed predicate device, rather than to establish safety and effectiveness through clinical trials with detailed acceptance criteria and performance studies for a novel device.

Therefore, the document does not contain the kind of detailed information requested in your prompt regarding acceptance criteria, specific device performance metrics, sample sizes for test sets, expert ground truth establishment, or clinical study designs (like MRMC or standalone performance). The "study" proving the device meets acceptance criteria is fundamentally a demonstration of equivalence to the predicate, primarily through material and design specifications and intended use.

Here's an analysis based on the information provided, explaining why certain sections of your request cannot be fulfilled:

1. Table of Acceptance Criteria and Reported Device Performance:

• Acceptance Criteria: Not explicitly stated in terms of quantitative performance metrics for the device itself (e.g., specific force resistance values, wear rates, etc.). The "acceptance criteria" for this submission are fundamentally demonstrating that the Atlantis™ Abutment for Nobel Active Implant has the same intended use, material, and design characteristics as the predicate devices, and performs similarly in terms of its intended function as an endosseous dental implant abutment.
• Reported Device Performance: No specific quantitative performance data (e.g., stress testing results, fatigue life in cycles) is reported in this summary. The performance is implied to be "substantially equivalent" to the predicate.

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

• Sample Size: Not applicable in the context of this 510(k) summary. This document does not describe a clinical performance study with a "test set" of patients or images. Instead, it relies on demonstrating substantial equivalence to pre-existing, legally marketed devices.
• Data Provenance: Not applicable. There is no patient data (retrospective or prospective) described in this submission.

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

• Not applicable. There is no "test set" requiring expert ground truth in this type of submission.

4. Adjudication method for the test set:

• Not applicable. There is no patient-level or image-level test set that would require 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 medical device for tooth restoration, not an AI-powered diagnostic or assistive tool for human readers.

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

• Not applicable. This is a physical medical device (an abutment), not an algorithm or AI system.

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

• Not applicable. The "ground truth" for this submission is the established safety and effectiveness of the predicate devices, based on their prior marketing clearance and use. The new device demonstrates conformance to established engineering specifications and biocompatibility standards rather than clinical ground truth from patient outcomes.

8. The sample size for the training set:

• Not applicable. This is not an AI/machine learning device.

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

• Not applicable. This is not an AI/machine learning device.

In summary: K093483 is a 510(k) premarket notification for a dental abutment. The "study" demonstrating that it meets "acceptance criteria" is the comprehensive technical and regulatory documentation showing its substantial equivalence to previously cleared predicate devices (K071370 and K072129) in terms of intended use, materials, and design. It is not a clinical trial with performance metrics typically associated with novel or AI-driven diagnostic devices.

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