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NobelActive® implants are endosseous implants intended to be surgically placed in the upper or lower jaw bone for anchoring or supporting tooth replacements to restore patient esthetics and chewing function.

NobelActive® implants are indicated for single or multiple unit restorations in splinted applications. This can be achieved by a 2-stage or 1-stage surgical technique in combination with immediate, early or delayed loading protocols, recognizing sufficient primary stability and appropriate occlusal loading for the selected technique.

NobelActive® 3.0 implants are intended to replace a lateral incisor in the maxilla and/or a central incisor in the mandible.

NobelActive® 3.0 implants are indicated for single unit restorations only.

Nobel Biocare's NobelActive® implants are threaded, root-form dental implants intended for use in the upper and/or lower jaw to support prosthetic devices, such as artificial teeth, in order to restore patient esthetics and chewing function to partially or fully edentulous patients. They are intended for immediate loading when good primary stability is achieved and with appropriate occlusal loading.

The NobelActive® implants are available in diameters 3.0, 3.5, 4.3, 5.0, and 5.5 mm. They are available in lengths between 6.5 mm to 18 mm depending upon implant diameter.

Here's an analysis of the acceptance criteria and supporting studies for the NobelActive® dental implant, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state formal "acceptance criteria" in a quantitative sense with clear thresholds for success (e.g., "must achieve X% success rate"). Instead, it describes performance benchmarks relative to existing devices and clinical expectations for dental implants.

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

• Bench Studies:

  • Drilling protocols: 1 implant (4.3x13 mm) tested in each of two bone surrogate types.
  • Primary stability and micro-motion: Not explicitly stated, but "different implant geometries and simulated bone densities" were used with "comparator devices." The number of implants per geometry/density is not provided.
  • Provenance: Not explicitly stated, but these are non-clinical (laboratory) studies.

• Clinical Studies:

  • Study 1 (Healed Sites): 199 NobelActive® implants.
  • Study 2 (Extraction Sites): 137 NobelActive® implants.
  • Study 3 (Implant Handling): 88 implants.
  • Study 4 (Irinakis and Wiebe, 2009): 140 implants.
  • Study 5 (Demanet et al, 2011): 466 implants.
  • Data Provenance: The document does not explicitly state the country of origin. Clinical studies are inherently prospective to some extent, but the reporting here is retrospective (summarizing past studies). The "Irinakis and Wiebe (2009) conducted a prospective study" explicitly states it was prospective. The other clinical data descriptions imply retrospective analysis of existing clinical data.

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

• Bench Studies: Ground truth is based on physical measurements and engineering principles. Experts (engineers, researchers) are involved in conducting and interpreting these tests, but their specific number or dental qualifications are not specified as they relate to the "ground truth" of implant performance in a lab setting.
• Clinical Studies:
  • Bone quality classification (Lekholm and Zarb) was done "by the treating surgeon" according to standard methods, including imaging, pre-surgical investigation, and tactile sensation.
  • "Four (4) clinicians" placed implants in the implant handling study.
  • The studies mentioned clinical investigators/treating surgeons for implant placement and follow-up. Their specific qualifications (e.g., "radiologist with 10 years of experience") are not provided. However, a "treating surgeon" or "clinician" implies medical/dental professionals experienced in implantology.

4. Adjudication Method for the Test Set

The document does not describe any formal adjudication method (like 2+1 or 3+1 consensus) for the clinical outcomes or data interpretation. Clinical results are typically derived from direct observation and measurement on patients, with success/failure criteria defined within each study's protocol.

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 is for a dental implant (a physical device), not an AI/software device. Therefore, a multi-reader multi-case (MRMC) comparative effectiveness study comparing human readers with and without AI assistance is not applicable and was not conducted.

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

As noted above, this submission is for a physical medical device (dental implant). It does not involve an algorithm or AI, so the concept of standalone algorithm performance is not applicable.

7. The Type of Ground Truth Used

• Bench Studies: Physical measurements (torque, micro-motion, seating depth) in simulated environments (bone surrogates).
• Clinical Studies:
  • Clinical outcomes: Implant success/failure rates, survival rates, insertion torque values, bone quality classification by the treating surgeon. This is essentially direct clinical observation and measurement of "real-world" performance in patients.

8. The Sample Size for the Training Set

This submission pertains to a physical dental implant, not a machine learning model. Therefore, the concept of a "training set" in the context of AI/algorithms is not applicable. The clinical data described contributes to the overall evidence base for the device's performance, rather than serving as a training set for an algorithm.

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

Since this is not an AI/ML device, there is no "training set" and thus no ground truth established for one. The clinical studies mentioned contribute to demonstrating the device's safety and effectiveness for its intended use.

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Nobel Biocare's NobelActive implants are endosseous implants intended to be surgically placed in the bone of the upper or lower jaw arches to provide support for prosthetic devices, such as an artificial tooth, in order to restore patient esthetics and chewing function. Nobel Biocare's NobelActive implants are indicated for single or multiple unit restorations in splinted or non-splinted applications. Nobel Biocare's NobelActive implants are intended for immediate loading when good primary stability is achieved and with appropriate occlusal loading.

Nobel Biocare's NobelActive Wide Platform (WP) implants are threaded, root-form dental implants intended for use in the upper and/or lower jaw to support prosthetic devices, such as artificial teeth, in order to restore patient esthetics and chewing function to partially or fully edentulous patients. They are intended for immediate loading when good primary stability is achieved and with appropriate occlusal loading.

The NobelActive Wide Platform (WP) implants share the same basic design principles as the existing NobelActive Internal Connection Implant. The Wide Platform (WP) implants are a bigger diameter implant extending the range of the existing NobelActive platforms. The Wide Platform is made of commercial pure titanium, is 5.5 mm in diameter, and available in lengths from 6.5 mm to 12.5 mm.

Healing and temporary abutments in both titanium/vanadium alloy and PEEK and definitive abutments made of titanium/vanadium alloy are available for the new WP platform. Titanium abutments may also be designed and made individually to fit the individual requirements for each patient using NobelBiocare's NobelProcera system.

The provided text describes a 510(k) submission for the Nobel Biocare NobelActive Wide Platform (WP) implant, seeking substantial equivalence to predicate devices. The submission focuses on technological characteristics and MR conditional testing, and explicitly states that no clinical data was necessary. As such, the requested information regarding acceptance criteria, study details, and ground truth establishment for an AI/algorithm-based device is not applicable to this submission.

Therefore, many of the requested fields cannot be filled.

Acceptance Criteria and Reported Device Performance

Study Details

1. Sample size used for the test set and the data provenance: Not applicable. The submission explicitly states, "Nobel Biocare utilizes an ISO 14971 Risk Management System. The NobelActive Wide Platform (WP) was subjected to this system which determined that no clinical test data was necessary to support the decision of safety and effectiveness excluding the MRI Safety and compatibility."
2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable, as no clinical test data was necessary.
3. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable, as no clinical test data was necessary.
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: Not applicable. This is not an AI/algorithm-based device, and no MRMC study was conducted.
5. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable. This is not an AI/algorithm-based device.
6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable, as no clinical test data was necessary. The determination of substantial equivalence was based on technological characteristics and MR conditional testing results.
7. The sample size for the training set: Not applicable, as this is not an AI/algorithm-based device and no training set was used.
8. How the ground truth for the training set was established: Not applicable, as this is not an AI/algorithm-based device.

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The NobelActive 3.0mm implant is indicated for use in the treatment of missing maxillary lateral incisors or the mandibular central and lateral incisors to support prosthetic devices, such as artificial teeth, in order to restore chewing function in partially edentulous patients. The NobelActive 3.0 implants may be put into immediate function provided that stability requirements detailed in the manual are satisfied.

The NobelActive 3.0 GoldAdapt Abutment is an abutment intended to be used with the Nobel Biocare NobelActive 3.0 implant system. The abutments are made of a gold alloy.

The provided text describes a 510(k) submission for a dental abutment. This type of submission focuses on demonstrating "substantial equivalence" to a legally marketed predicate device, rather than proving efficacy through clinical or standalone performance studies with specific acceptance criteria as you've outlined for AI/software devices.

Therefore, many of the requested categories (acceptance criteria, sample size, ground truth, experts, MRMC, standalone performance, training set) are not applicable to this document. The "device performance" in this context refers to non-clinical fatigue testing to ensure the device's mechanical strength is adequate and comparable to predicates.

Here's a breakdown based on the provided text, indicating where information is not available or not applicable for a traditional AI/software device evaluation:

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

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

• Sample Size: Not specified. This typically refers to the number of physical abutments subjected to fatigue testing.
• Data Provenance: Not applicable in the context of clinical data for this type of device. The testing is non-clinical/mechanical.

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. This is a non-clinical, mechanical device. "Ground truth" would refer to the physical properties and performance measured during fatigue testing, not expert interpretation.

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

• Not Applicable. This is a non-clinical, mechanical device. Adjudication methods are typically used for expert review of clinical cases.

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. The document explicitly states: "No clinical testing was performed." MRMC studies apply to AI-assisted diagnostic tools involving human readers.

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

• Not Applicable. This is a physical, non-AI dental abutment.

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

• Not Applicable. The "ground truth" for this device's performance is determined by the physical results of fatigue testing, measured against established engineering standards (e.g., ability to withstand anticipated forces, as outlined in FDA guidance for dental implants).

8. The sample size for the training set

• Not Applicable. This is a non-AI, physical medical device. There is no training set as would be found in machine learning.

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

• Not Applicable. This is a non-AI, physical medical device. There is no training set or ground truth establishment relevant to AI/software development.

Summary of the Study that Proves the Device Meets Acceptance Criteria:

The study that proves the device meets its (implicit) acceptance criteria is a non-clinical fatigue testing study.

• Methodology: The testing was conducted "in accordance with the FDA guidance Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Implant Abutments." This guidance outlines the specific mechanical tests and acceptance criteria for demonstrating the durability and strength of such devices.
• Results: The testing indicated "that the device is strong enough to withstand the anticipated forces."
• Conclusion: Based on this non-clinical data, the device was deemed "substantially equivalent" to predicate devices, satisfying the requirements for 510(k) clearance by demonstrating comparable safety and effectiveness, particularly in terms of mechanical integrity.

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Nobel Biocare's NobelActive implants are endosseous implant intended to be surgically placed in the bone of the upper or lower jaw arches to provide support for prosthetic devices, such as an artificial tooth, in order to restore patient esthetics and chewing function. Nobel Biocare's NobelActive implants are indicated for single or multiple unit restorations in splinted or nonsplinted applications. Nobel Biocare's NobelActive implants may be placed immediately and put into immediate function provided that initial stability requirements detailed in the manual are satisfied.

NobelActive 8.5 mm & 18.0 mm implants are threaded, root-form dental implants intended for use in the upper and/or lower jaw to support prosthetic devices, such as artificial teeth, in order to restore patient esthetics and chewing function to partially or fully edentulous patients.

NobelActive Internal Connection Implants are similar to predicate NobelActive Internal Connection Implants. The NobelActive 8.5 mm and 18.0 mm implants differ from the predicate device in length.

This document describes the NobelActive 8.5 mm & 18.0 mm dental implants and their substantial equivalence to a predicate device. However, this submission does not contain information about acceptance criteria or a study proving that a device meets acceptance criteria in the context of an AI/ML medical device.

The provided text is a 510(k) summary for a dental implant, which is a physical medical device. It focuses on device description, indications for use, and a demonstration of substantial equivalence to an existing predicate device based on differences in length for the new models.

Therefore, I cannot provide the requested information about acceptance criteria, device performance, sample sizes for test/training sets, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth establishment, as these details are not present in the provided documentation for this type of medical device submission.

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NobelActive Zirconia Abutment is a pre-manufactured prosthetic component directly connected to the endosseous dental implant and is intended for use as an aid in prosthetic rehabilitation in the anterior region.

NobelActive Zirconia Abutments are artificial tooth abutments designed to fit and function on the NobelActive Implants. It is an internal hexagonal design similar to the previous SFB (renamed NobelActive) Abutments. The material of construction is the same as the previous Esthetic Zirconia Abutments. The NobelActive Zirconia Abutments differ from the predicate device in trade name and material of construction.

This document is a 510(k) summary for a dental abutment, which is a physical device, not an AI/ML algorithm. Therefore, the questions regarding acceptance criteria, study data, sample sizes, ground truth establishment, expert involvement, and comparative effectiveness studies for AI performance are not applicable.

The document describes the NobelActive Zirconia Abutment, a pre-manufactured prosthetic component intended for use in dental rehabilitation.

Here's the relevant information from the provided text, re-contextualized for a physical medical device:

Device Description:

• Device Name: NobelActive Zirconia Abutment
• Purpose: Artificial tooth abutment designed to fit and function on NobelActive Implants.
• Design: Internal hexagonal design, similar to previous SFB (renamed NobelActive) Abutments.
• Material: Same as previous Esthetic Zirconia Abutments.
• Distinguishing Features (from predicate): Differs in trade name and material of construction from the predicate device.

Indications for Use:

• "NobelActive Zirconia Abutment is a pre-manufactured prosthetic component directly connected to the endosseous dental implant and is intended for use as an aid in prosthetic rehabilitation in the anterior region."

Regulatory Information:

• 510(k) Number: K072129
• Applicant: Nobel Biocare USA LLC
• Predicate Devices: SFB & CFB Angled Abutments (K062749) and Esthetic Zirconia Abutment (K031719)
• Classification: Class II, Endosseous Dental Implant Abutment (21 CFR 872.3630)

Study Information (as pertains to a physical device submission):

For physical medical devices like this, the "study" typically refers to demonstrating substantial equivalence to a predicate device through material characterization, mechanical testing, and biocompatibility assessments, rather than clinical performance studies with large patient cohorts and complex statistical analyses as would be common for new drugs or AI algorithms. The 510(k) process primarily relies on demonstrating that the new device is as safe and effective as a legally marketed predicate device.

The provided text does not contain details about specific acceptance criteria or a study proving the device meets those criteria in the format requested for AI/ML algorithms (i.e., performance metrics, sample sizes for test/training, ground truth, expert opinions, etc.). Instead, the FDA's acceptance is based on the demonstration of substantial equivalence to existing predicate devices.

The submission would have included:

• Comparison to Predicate: A comparison of the new device's technological characteristics (design, materials, indications for use) to the predicate devices.
• Performance Data: This would typically include bench testing for mechanical properties (e.g., strength, fatigue, torque, fracture resistance) of the abutment and its connection to the implant, material characterization (e.g., chemical composition, microstructure), and possibly biocompatibility data. This data would be compared against established standards or performance levels of the predicate devices.
• No "acceptance criteria table" or "reported device performance" in the AI/ML sense is present. The "performance" is implicitly deemed acceptable if it meets the criteria for substantial equivalence, ensuring it performs as intended and is as safe and effective as the predicates.

Without further documentation (e.g., the full 510(k) submission, which would detail the specific tests and their results), it's impossible to provide the granular "acceptance criteria" and "study data" in the AI/ML context.

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NobelActive Multi Unit Abutment is a pre-manufactured prosthetic component directly connected to the endosseous dental implant and is intended for use as an aid in prosthetic rehabilitation.

NobelActive Multi Unit Abulments are artificial tooth abutments designed to fit and function on the NobelActive Implants. It is an internal hexagonal design similar to the previous SFB (renamed NobelActive) Abutments. The material of construction is the same as the previous SFB Abutments. The NobelActive Multi Unit Abutments differ from the predicate device in trade name and design.

This document is a 510(k) summary for the NobelActive Multi Unit Abutment. It is a premarket notification for a medical device and therefore does not contain acceptance criteria for device performance in the context of a study, nor does it present the results of a study to demonstrate such performance or discuss any AI components.

The document focuses on:

• Legal Information: Submission details, classification names, trade names, and legally marketed predicate devices.
• Device Description: Material and design differences/similarities to predicate devices.
• Indications for Use: The intended purpose of the device (prosthetic rehabilitation).
• FDA Correspondence: Official letter from the FDA determining substantial equivalence to predicate devices, allowing the device to be marketed.

Therefore, I cannot extract the requested information (acceptance criteria, device performance, study details, sample sizes, ground truth, expert information, MRMC studies, or standalone algorithm performance) from the provided text. This type of information is typically found in clinical trial reports, validation studies, or performance testing summaries, which are not part of this 510(k) summary.

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Nobel Biocare's NobelActive implants are endosseous implant intended to be surgically placed in the bone of the upper or lower jaw arches to provide support for prosthetic devices, such as an artificial tooth, in order to restore patient esthetics and chewing function. Nobel Biocare's NobelActive implants are indicated for single or multiple unit restorations in splinted or non-splinted applications. Nobel Biocare's NobelActive implants may be placed immediately and put into immediate function provided that initial stability requirements detailed in the manual are satisfied.

NobelActive Internal Connection Implants are threaded, root-form dental implants intended for use in the upper and/or lower jaw to support prosthetic devices, such as artificial teeth, in order to restore patient esthetics and chewing function to partially or fully edentulous patients.

NobelActive Internal Connection Implants are similar to predicate SFB implants. The NobelActive Internal Connection Implants differ from the predicate device in trade name and implant/abutment connection.

I am sorry, but the provided text, K071370, focuses on the regulatory clearance of a dental implant, the NobelActive Internal Connection Implant. It describes the device, its indications for use, and confirms its substantial equivalence to a predicate device.

However, the document does not contain any information regarding clinical studies, device performance data, acceptance criteria, ground truth establishment, sample sizes for testing or training, or expert qualifications as requested in your prompt.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them based on the provided input.

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