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BIOMET 3i Dental Implants are intended for surgical placement in the upper or lower jaw to provide a means for prosthetic attachment in single tooth restorations and in partially or fully edentulous spans with multiple single teeth utilizing delayed or immediate loading, or with a terminal or intermediary abutment for fixed or removable bridgework, and to retain overdentures.

OSSEOTITE® 2 Dental Implants are intended for immediate function on single tooth and/or multiple tooth applications when good primary stability is achieved, with appropriate occlusal loading, in order to restore chewing function.

OSSEOTITE® 2 Dental Implants are similar to predicate BIOMET 3i OSSEOTITE Implants, currently being sold worldwide. OSSEOTITE 2® Dental Implants are provided with the proprietary OSSEOTITE dual acid-etched surface which has been in commercial distribution since market clearance in 1995 and are made of Commercially Pure Titanium. Implants have a straight wall design, with an External Hex Connection. OSSEOTITE® 2 Dental Implants are offered in diameters of 3.25, 3.75, 4.0, 5.0, and 6.0 in varying lengths from 3 mm to 15 mm. Size appropriate cover screws are provided with each implant.

The provided document is a 510(k) summary for the OSSEOTITE® 2 Dental Implants. This is a special 510(k) submission, meaning it's for a modification to a previously cleared device. Therefore, the "study" described is primarily focused on demonstrating substantial equivalence to predicate devices through bench testing and referencing existing clinical data rather than conducting a de novo clinical trial for the new device.

Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:

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

The acceptance criteria for this device are based on demonstrating that the OSSEOTITE® 2 Dental Implants are substantially equivalent to legally marketed predicate devices (OSSEOTITE II MODEL XIFOSSXXX (K100724) and OSSEOTITE; OSSEOTITE NT; XP; TG Implant(s) (K063286)). This means they must share the same intended use, indications for use, technological characteristics, and principles of operation, and any differences must not raise new questions of safety or effectiveness.

The document directly compares the proposed device to its predicates across various characteristics. The "reported device performance" in this context refers to showing that these characteristics are either identical or that any modifications (specifically the abutment connection) do not negatively impact performance as demonstrated by bench testing.

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

• Test Set Sample Size: For the bench testing, the document states "All testing conducted met the acceptance criteria and evaluated the worst case scenario including 30° pre-angled abutments as compared to predicate BIOMET 3i designs." It does not specify the numerical sample size for the fatigue testing according to ISO 14801:2007. For the clinical reports cited, specific sample sizes are also not provided in this summary document.
• Data Provenance:
  • Bench Testing: The geographical origin is not specified, but it was conducted by "BIOMET 3i" implying internal company testing or contracted to a lab.
  • Clinical Data: The summary mentions two clinical reports ("Insertional Torque Force, Osseotite 2 Placement Data, Pressure Necrosis" dated September 21st, 2011, and "BIOMET 3i Insertion Torque Report" dated November 10, 2011). These reports summarize clinical projects and "implant placement experience data". The summary doesn't explicitly state if they are retrospective or prospective, nor does it specify the country of origin. However, given they are reports on existing data, they are likely retrospective analyses of clinical experience.

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)

• For the bench testing (ISO 14801:2007), ground truth is established by the standard itself and objective mechanical measurements. No human experts are involved in establishing ground truth in terms of diagnostic assessment.
• For the clinical reports, the "ground truth" relates to clinical outcomes (insertion torque, success, failure). These would have been established by the dental practitioners involved in the implant placement and follow-up. The document does not specify the number or qualifications of these experts; it only cites the reports.

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

• There is no mention of an adjudication method for either the bench testing or the clinical data in this 510(k) summary. Bench testing results are objective measurements against a standard. Clinical outcomes would typically be derived from patient records and the assessment of the treating clinicians, not through a separate adjudication panel described in this summary.

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 MRMC comparative effectiveness study was done or is relevant for this submission. This device is a dental implant, a physical product, not an AI or imaging device that would involve "human readers" or AI assistance in interpretation.

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

• Not applicable. This device is a physical dental implant, not an algorithm.

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

• For bench testing, the "ground truth" is defined by the acceptance criteria of the ISO 14801:2007 standard and the objective mechanical properties measured.
• For the clinical data cited, the ground truth is derived from clinical outcomes data (e.g., measured insertion torque values, implant success/failure at follow-up).

8. The sample size for the training set

• This is a special 510(k) for a physical medical device, not a machine learning or AI algorithm. Therefore, the concept of a "training set" in the context of AI is not applicable. The device's design and manufacturing rely on established engineering principles and prior predicate devices.

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

• As the concept of a "training set" for an AI algorithm is not applicable here, there is no ground truth established for a training set. The device's safety and effectiveness are established through comparison to predicates and bench testing against industry standards.

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BIOMET 3i Dental Abutments are intended for use as accessories to endosseous dental implants to support a prosthetic device in a partially or completely edentulous patient. A dental abutment is intended for use to support single and multiple tooth prosthesis, in the mandible or maxilla. The prosthesis can be screw retained or cement retained to the abutment.

BIOMET 3i Encode Patient Specific Abutment for Nobel Replace Connection can be compared to current Encode Patient Specific abutments. The change to this device is only to the connection that is intended to interface which is identical to the interface found on the Nobel Replace HA Coated Implant. This feature does not modify the intended functionality of the implant/abutment system. This device is also intended for dental laboratories to provide limited design input to match the anatomical requirements of the patient. Maximum angulation for the abutment is limited to 15°.

The provided document (K110565) describes a traditional 510(k) premarket notification for a medical device called "BIOMET 3i Encode Patient Specific Abutment for Nobel Replace Connection." This document focuses on demonstrating substantial equivalence to predicate devices rather than providing detailed acceptance criteria and a standalone study for novel performance claims.

Based on the information provided, here's what can be extracted and what is not present:

1. Table of acceptance criteria and reported device performance:

The document states: "Performance testing was conducted as per Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Abutments. Performance testing was based on a comparison between proposed and predicate implant/abutment systems. The results were equal or better than established acceptance criteria, where predicate testing was used as a baseline."

This indicates that acceptance criteria were established and met, but the specific numerical criteria and the quantitative reported device performance are not detailed in this summary. Instead, it refers to a "comparison between proposed and predicate implant/abutment systems" and implies meeting established baselines.

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

This information is not provided in the document. The document mentions "Performance testing was conducted," but it doesn't specify the number of samples used for this testing or the origin of any data (e.g., country of origin, retrospective/prospective).

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 for this type of device submission. This device is a mechanical abutment, not an AI/software device that requires expert ground truth for interpretation or diagnosis. The performance evaluation would involve engineering and material testing, not clinical expert review for diagnostic accuracy.

4. Adjudication method for the test set:

This information is not applicable and not provided. As above, this is a mechanical device, not an AI/software product requiring adjudication of interpretations.

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

This information is not applicable and not provided. An MRMC study is relevant for diagnostic imaging or AI systems where human readers interpret cases. This device is a physical dental abutment.

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

This information is not applicable and not provided. This device is a physical product, not an algorithm, so "standalone performance" in the context of AI is not relevant.

7. The type of ground truth used:

For this device, the "ground truth" would be established through engineering and materials testing standards (e.g., fatigue testing, static load testing, dimensional accuracy measurements) as per the "Class II Special Controls Guidance Document." It relies on objective, measurable physical properties and mechanical performance, not expert consensus, pathology, or outcomes data in the usual sense for diagnostic devices. The acceptance criteria themselves serve as the definition of acceptable "truth" for performance.

8. The sample size for the training set:

This information is not applicable and not provided. This is a physical device, not an AI model, so there is no "training set."

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

This information is not applicable and not provided. There is no "training set" for this physical device.

In summary:

The provided document describes a 510(k) submission for a dental abutment, demonstrating substantial equivalence to predicate devices primarily through performance testing based on established guidance documents. It does not contain the detailed information typically found in AI/software device submissions regarding acceptance criteria, sample sizes for test/training sets, expert ground truth establishment, or human-in-the-loop studies. The "study" here refers to engineering performance testing against regulatory guidance and predicate device baselines, not a clinical study with human readers or AI algorithms.

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BIOMET 3i Dental Implants are intended for surgical placement in either jaw and used for anchoring or supporting single- and multiple-unit prostheses. BIOMET 3i Dental Implants can be immediately loaded when primary stability and proper occlusion have been established.

Full OSSEOTITE® Certain® II Dental Implants are substantially equivalent to BIOMET 3i's OSSEOTITE® Dental Implants which have been previously cleared in K063286 and K063341. The device is an endosseous dental implant made of Commercially Pure Titanium. It is available in various lengths and diameters with a straight-walled implant body, Incremental Cutting Edge (I.C.E.) with apical taper, and a Full OSSEOTITE® surface. It has an Internal Hexagon Connection for mating with BIOMET 3i Certain® Restorative Components. The implants are packaged in a sterile tray with a cover screw and sterilized by Gamma Irradiation with a shelf life of 5 years.

This document describes the 510(k) summary for the Full OSSEOTITE® Certain® II Dental Implant, focusing on its substantial equivalence to predicate devices rather than a study with a traditional AI-specific acceptance criteria framework. Therefore, many of the typical categories for AI/ML performance studies (like sample size for test sets, expert ground truth, MRMC studies, or training set details) are not directly applicable or reported in this type of submission.

Here's an analysis of the provided text based on your request, with a focus on what can be extracted and what is not applicable:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for this device are primarily based on design verification testing, ensuring proper device functioning and substantial equivalence to legally marketed predicate devices. The performance is demonstrated by meeting these engineering and material standards, rather than statistical performance metrics for diagnostic accuracy.

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

• Sample Size: The document does not specify a "test set" in the context of clinical or data-driven validation. The testing performed is "design verification testing," likely involving a set number of implants for mechanical and material property assessments, as per engineering and regulatory standards (e.g., ISO, ASTM, or specific FDA guidance for dental implants). However, the exact sample sizes for these engineering tests are not provided in this 510(k) summary.
• Data Provenance: Not applicable in the context of clinical data for AI/ML. The "data" here refers to engineering test results and manufacturing specifications.

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

• This is not applicable as the device is not an AI/ML diagnostic or assistive tool requiring expert-labeled ground truth from medical images or clinical data. The "ground truth" for device performance is based on established engineering standards and regulatory guidance for dental implants.

4. Adjudication Method for the Test Set

• Not applicable for this type of device submission. Adjudication methods are typically relevant for clinical studies where human reviewers assess diagnostic outputs, which is not the case here.

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

• No, an MRMC study was not done. This type of study is relevant for evaluating the impact of AI on human reader performance for diagnostic tasks, which is not the purpose of a dental implant submission.

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

• No, a standalone performance study in the context of an algorithm is not applicable. This device is a physical dental implant, not a software algorithm. Its performance is assessed through physical and material property tests.

7. The Type of Ground Truth Used

• The "ground truth" here is based on engineering standards, material specifications, and regulatory guidance documents (specifically, the "FDA Guidance Document - Special Control Class II Root-Form Dental Implants (May 2004)"). This includes established benchmarks for mechanical strength, biocompatibility, and dimensions of dental implants.

8. The Sample Size for the Training Set

• Not applicable. This device is a physical product, not a machine learning model, so there is no "training set."

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

• Not applicable, as there is no training set for a machine learning model.

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Encode® Patient Specific Dental Abutments made from oral scans provided from 3M ESPE Lava Chair Scanner and the 3M Lava COS (2.0) software are intended for use as an accessory to endosseous dental implants to support a prosthetic device in a partially or edentulous patient. Encode® Patient Specific Dental Abutments are intended for use to support single and multiple tooth prostheses, in the mandible or maxilla. The prostheses can be screw or cement retained to the abutment.

Patient Specific Dental Abutments are Encode® designed specifically for a patient using a CAD/CAM system. The abutments are designed from a threedimensional intra-oral optical scan or resin model scan and then machined/milled according to the parameters created in a digital file which are derived from the scan. The abutments are manufactured from titanium alloy (Ti 6Al-4V ELI) or biocompatible Zirconia TZP. The abutment design is limited according to BIOMET 3i Specifications, as follows:

The provided text focuses on the 510(k) summary for the Encode® Patient Specific Dental Abutments, particularly the addition of oral scan data input. It describes the device, its intended use, and its equivalence to previously cleared devices.

Based on the information provided, here's a breakdown of the acceptance criteria and the study that proves the device meets them:

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

Reported Device Performance: The document states, "The abutments are manufactured from titanium alloy (Ti 6Al-4V ELI) or biocompatible Zirconia TZP. The abutment design is limited according to BIOMET 3i Specifications, as follows:" and then lists the specifications provided in the table above. This indicates that the device's performance aligns with these specified design parameters.

The "Performance Data" section further states: "Validation performed on scanning equipment and software to ensure accuracy of scanning models to produce the intended design as cleared in K032263 & K052648." This implies that the device successfully produced abutments within the specified design parameters when using the new oral scan input.

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

The document does not explicitly state the sample size used for the test set or the data provenance (country of origin, retrospective/prospective). It generally refers to "validation performed on scanning equipment and software."

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)

The document does not specify the number of experts used or their qualifications for establishing ground truth.

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

The document does not describe any adjudication method used for a test set.

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

A multi-reader multi-case (MRMC) comparative effectiveness study was not conducted or reported. This device is a dental abutment, not an AI-assisted diagnostic tool for human readers. The validation focuses on the accuracy of the CAD/CAM system and oral scanner to produce the intended physical device.

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

This is not a software algorithm that performs a diagnostic task. The "algorithm" here is the CAD/CAM software that designs the dental abutment based on scan data. The performance validation was for the overall system (scanner + software + manufacturing) to produce a physical device that meets pre-defined design specifications. It is a "standalone" performance verification in the sense that the system itself, from input scan to manufactured abutment, was validated to ensure it produces the desired physical outcome.

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

The ground truth for this device appears to be the established design specifications and physical characteristics of the dental abutments as cleared in the predicate devices K032263 & K052648. The "Performance Data" section indicates that "Validation performed on scanning equipment and software to ensure accuracy of scanning models to produce the intended design as cleared in K032263 & K052648." This suggests the ground truth is the "intended design"—meaning the established, accepted dimensions and shapes of the predicate abutments.

8. The sample size for the training set

The document does not mention a specific "training set" or its sample size. The focus is on the integration and validation of a new input method (oral scans) for an existing CAD/CAM system, rather than training a novel AI algorithm.

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

Since no training set is explicitly mentioned for an AI algorithm (as this is not an AI diagnostic device), the concept of ground truth establishment for a training set does not directly apply in the usual sense. The closest equivalent is that the CAD/CAM system's design parameters and the physical characteristics of the manufactured abutments are based on established dental engineering principles and the specifications of the predicate devices.

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Encode® Patient Specific Dental Abutments made from oral scans provided from Sirona CEREC AC Scanner System and inLab Software v3.65 are intended for use as an accessory to endosseous dental implants to support a prosthetic device in a partially or edentulous patient. Encode® Patient Specific Dental Abutments are intended for use to support single and multiple tooth prostheses, in the mandible or maxilla. The prostheses can be screw or cement retained to the abutment.

Encode® Patient Specific Dental Abutments are designed specifically for a patient using a CAD/CAM system. The abutments are designed from a threedimensional intra-oral optical scan or resin model scan and then machined/milled according to the parameters created in a digital file which are derived from the scan. The abutments are manufactured from titanium alloy (Ti 6Al-4V ELI) or biocompatible Zirconia TZP. The abutment design is limited according to BIOMET 3i Specifications, as follows:

The provided text is a 510(k) summary for a medical device (Encode® Patient Specific Dental Abutments). It describes the device, its intended use, and claims substantial equivalence to predicate devices. However, it does not contain the detailed study information about acceptance criteria, device performance metrics, sample sizes, ground truth establishment, expert qualifications, or MRMC studies that you've requested.

The "Performance Data" section merely states: "Validation performed on scanning equipment and software to ensure accuracy of scanning models to produce the intended design as cleared in K032263 & K052648." This is a high-level statement and does not provide specific acceptance criteria or quantitative performance results.

The "Equivalence Data" section emphasizes that the new option of oral scans has the "same intended use and indications, principles of operation, and technological characteristics" as previously cleared devices and that "Validation data demonstrates that the modified process results in a finished device that is just as safe and effective as Encode® Patient Specific Dental Abutments that are currently cleared under K032263 & K052648." Again, this is a qualitative statement of equivalence, not a detailed report of a study proving specific acceptance criteria are met.

Therefore, I cannot populate the table or answer the specific questions based on the provided text. The document focuses on demonstrating substantial equivalence rather than presenting a performance study with detailed acceptance criteria and results.

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BIOMET 3i Patient Specific Dental Abutments (Encode®) Designed Using Cadent iTero Scanner and inLab Software v3.5are intended for use as an accessory to endosseous dental implants to support a prosthetic device in a partially or edentulous patient. These are intended for use to support single and multiple tooth prostheses, in the mandible or maxilla. The prostheses can be screw or cement retained to the abutment.

Encode® Abutments are designed specifically for a patient in a CAD/CAM system. The abutments are designed from a three-dimensional intra-oral optical scan or resin model scan and then machined/milled according to the parameters created in a digital file which is derived from the scan. The abutments are manufactured from titanium alloy or ceramic.

The provided text is a 510(k) summary for a medical device and does not contain the detailed information required to answer all parts of the request. The document specifically states that "Validation performed on scanning equipment and software to ensure accuracy of scanning models to produce the intended design as cleared in K032263 & K052648." However, it does not provide specific acceptance criteria, study methodologies, sample sizes, ground truth details, or effectiveness study results in the format requested.

Therefore, the following information can be extracted based on the limitations of the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

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

• Sample Size: Not specified. The document only mentions "Validation performed on scanning equipment and software."
• Data Provenance: Not specified (e.g., country of origin, retrospective or prospective).

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

• Not specified. The document does not describe the establishment of a ground truth by experts for the validation.

4. Adjudication method for the test set:

• Not specified.

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 MRMC comparative effectiveness study is mentioned. This device is an accessory to dental implants (abutments) designed using CAD/CAM, not an AI-based diagnostic tool for human readers.

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

• The performance validated relates to the accuracy of the CAD/CAM system (scanner and software) in producing the intended design. While the process is largely automated (algorithm only in terms of design generation post-scan), specific standalone algorithm performance metrics are not provided. The phrase "algorithm only" in the context of an "AI" evaluation is not applicable here as it is a CAD/CAM design and manufacturing process, not an AI diagnostic algorithm.

7. The type of ground truth used:

• The ground truth explicitly mentioned is "the intended design as cleared in K032263 & K052648." This implies a comparison to a predefined standard or previously cleared designs/specifications, likely through dimensional accuracy measurements or similar engineering validation methods, rather than clinical outcomes or pathology.

8. The sample size for the training set:

• Not applicable. This is not a machine learning model that undergoes a "training" phase in the conventional sense. The "training" here would refer to the historical data or engineering principles used to develop the CAD/CAM software, which is not detailed.

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

• Not applicable for the reasons mentioned in point 8. The "ground truth" for the CAD/CAM software development would be based on engineering specifications, dental anatomy, and functional requirements for abutments, but the document does not elaborate on this.

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The 3i Patient-Specific CAM StructSURE® Precision Milled Bars are intended for use as an accessory to endosseous dental implants to support a prosthetic device in a partially or edentulous patient.

All CAM StructSURE® Precision Milled Bars (Dolder, Primary, Hader, Hybrid and Copy Milled) are designed to match an individual patient. The bars are designed from a three-dimensional optical and/or digital scanner system that scans the casting of a patient's impression and then machined using a CAD/CAM software system. The bars are milled from either titanium alloy or CP titanium.

The provided text describes a 510(k) premarket notification for BIOMET 3i Patient Specific CAM StructSURE Bars, focusing on the change from using Delcam and 3Shape scanning and milling systems to the Renishaw system.

Here's an analysis based on your requested information:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state acceptance criteria in the form of numerical performance metrics. Instead, it describes "Validation performed on scanning equipment and software to ensure accuracy of scanning 3D models and performed Install Qualification." The reported "device performance" is an assertion of substantial equivalence based on this validation.

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

The document does not specify a distinct "test set" sample size or data provenance (e.g., country of origin, retrospective/prospective). The validation appears to be a general process for the new Renishaw system rather than a study on a specific cohort of patient data.

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

This information is not provided. The study focuses on equipment and software validation, not on clinical outcomes assessed by human experts.

4. Adjudication Method for the Test Set

This information is not applicable and not provided, as the validation described does not involve expert adjudication of clinical cases.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No, an MRMC comparative effectiveness study was not done. The submission is for a material and process change (new scanning/milling system), not an AI-assisted diagnostic tool that would typically involve human reader performance evaluation.

6. Standalone (Algorithm Only) Performance Study

Yes, in a sense. The "validation performed on scanning equipment and software to ensure accuracy of scanning 3D models" can be considered a standalone performance assessment of the Renishaw system's ability to accurately capture 3D models, independent of human interaction beyond operating the equipment. No specific metrics are given, but the statement implies this standalone assessment was successful.

7. Type of Ground Truth Used

The ground truth for the validation appears to be based on physical measurements and technical specifications of the 3D models produced by the scanning and milling systems, as well as the functional verification of the installation. For example, comparing the scanned 3D model to the physical casting, or comparing the milled bar to the CAD design. It's not based on expert consensus, pathology, or outcomes data in a clinical sense.

8. Sample Size for the Training Set

This information is not provided. The document describes a CAD/CAM system, which would involve training data for its algorithms, but details on the size and nature of this training data are not included in this summary.

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

This information is not provided. For CAD/CAM systems, ground truth for training would typically involve precise 3D models, either physical or digitally generated, used to teach the system how to accurately interpret scans and generate designs.

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BIOMET 3i Low Profile Abutments are intended for use as accessories to endosseous dental implants to support a prosthetic device in a partially or completely edentulous patient. A dental abutment is intended for use to support single and multiple tooth prosthesis, in the mandible or maxilla. The prosthesis is screw retained to the abutment.

Not Found

This appears to be a 510(k) premarket notification for a dental abutment, which is a mechanical component, not a device that processes or analyzes data. Therefore, the concepts of "acceptance criteria" and "study that proves the device meets the acceptance criteria" in the context of software or AI/ML performance are not directly applicable in the way you've framed them for a data-driven device.

The information provided describes the regulatory submission for a physical medical device (Low Profile Abutment). The "acceptance criteria" for a physical device like this typically pertain to engineering specifications, material properties, biocompatibility, mechanical strength, and manufacturing quality, often demonstrated through laboratory testing, simulations, and adherence to recognized standards.

Here's why your specific questions about AI/ML performance, sample sizes for test/training sets, expert adjudication, and MRMC studies don't apply to this document:

• No AI/ML Component: The submission focuses on the mechanical function of a dental abutment (supporting a prosthetic device). There's no mention of any software, AI, or machine learning algorithms involved in its function or its regulatory review.
• Physical Device, Not Data-Driven: The "device" in question is a physical object implanted in a patient's mouth. Its performance is assessed through its physical properties and how it interacts with other physical components (implants, prostheses), not through data analysis or diagnostic interpretation.
• Regulatory Pathway: The document identifies this as a "Traditional 510(k) Pre-market Notification." This pathway assesses substantial equivalence to a predicate device, primarily focusing on similar technological characteristics and indications for use, often supported by design specifications, material testing, and sometimes bench or animal testing, rather than clinical studies of diagnostic accuracy.

Therefore, I cannot extract the requested information from the provided text because it describes a physical medical device submission, not an AI/ML-powered or data-driven device.

If you have a document related to an AI/ML or software device, I would be happy to analyze it against your criteria.

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The CAM StructSURE® Precision Milled Bars are intended for use as an accessory to an endosseous dental implant to support a prosthetic device in a partially or edentulous patient. It is intended for use to support multiple tooth prostheses in the mandible or maxilla. The prostheses can be screw retained.

All CAM StructSURE® Precision Milled Bars (Dolder, Primary, Hader, Hybrid and Copy Milled) are designed to match an individual patient. The bars are designed from a three-dimensional optical and/or digital scanner system that scans the casting of a patient's impression and then is machined using a CADCAM software system. The bars are milled from titanium alloy or CP titanium.

CAM StructSURE® Precision Milled Bars:
CSHxx CAM StructSURE Hader Bar: 2-10 implants
CSPxx CAM StructSURE Primary Bar: 2-10 implants
CSDxx CAM StructSURE Dolder Bar: 2-10 implants
CSCMxx CAM StructSURE Copy Milled Bar: 4-10 implants
CSIYxx CAM StructSURE Hybrid Bar: 4-10 implants

The provided document is a 510(k) summary for a dental device (CAM StructSURE® Precision Milled Bars). It focuses on demonstrating substantial equivalence to a predicate device rather than presenting a performance study with detailed acceptance criteria and results as typically found for complex AI/diagnostic devices.

Therefore, much of the requested information regarding acceptance criteria, study design elements (sample size, ground truth, experts, adjudication, MRMC, standalone), and training set details are not applicable or available within this specific document. This document is a regulatory submission for a medical device approval that is not based on a statistical study with specific performance outcomes.

Here's an analysis based on the provided text, highlighting where information is not present:

1. Table of Acceptance Criteria and Reported Device Performance

Not applicable in this context. This 510(k) submission for the CAM StructSURE® Precision Milled Bars focuses on demonstrating "substantial equivalence" to a legally marketed predicate device (K034035 3i Patient Specific Overdenture Bars) rather than meeting specific quantifiable performance metrics through a clinical trial or performance study with acceptance criteria.

The "conclusion" states: "Appropriate verification and validation activities were performed to provide assurance that CAM StructSURE® Precision Milled Bars remain substantially equivalent to the predicate and the modifications have not changed the intended use, altered the fundamental scientific technology or the safety and effectiveness of the device." This indicates general design control and validation rather than a study against a specific performance benchmark.

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

Not applicable. The document does not describe a "test set" in the context of a statistical study for device performance. It refers to "verification and validation activities" but provides no details on sample size, data origin, or retrospective/prospective nature.

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

Not applicable. No "ground truth" or expert review process is described for performance evaluation of this device as it is not a diagnostic or AI-driven device.

4. Adjudication method for the test set

Not applicable. No "test set" or 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. This device is not an AI-assisted diagnostic tool, and therefore, an MRMC study is not relevant.

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

Not applicable. This device is a physical dental overdenture bar, not an algorithm.

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

Not applicable. The concept of "ground truth" as it applies to performance studies for AI/diagnostic devices is not relevant here. The substantial equivalence is based on comparison to a predicate device and adherence to design controls.

8. The sample size for the training set

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

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

Not applicable. Since there is no training set mentioned, the establishment of ground truth for it is also not applicable.

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BIOMET 31 Certain® Contoured Margin Ceramic Abutments are intended for use as an cessory to endosseous dental implants to support a prosthetic device in a partially or contains patient. The Certain® Contoured Margin Ceramic Abutments are intended for use support single and multiple tooth prostheses, in the mandible or maxilla. The prosthesis is ment retained to the abutment.

The BIOMET 3i Certain® Contoured Margin Ceramic Abutment design consists of The BIOME I 37 Certains Contoured in buttent screw. These devices worldwords ffferent abutments $125, thanimi insort and all about - 11.00 as 1000 as 1000 and and propriate reatures and 311 with internal connections.

This 510(k) premarket notification is for a dental abutment, a mechanical device rather than an AI-powered one. Therefore, the questions regarding acceptance criteria, study details, ground truth, and training sets, which are typically relevant for AI/ML device submissions, do not apply here.

The document focuses on demonstrating substantial equivalence to existing legally marketed predicate devices, as per the FDA's 510(k) pathway for medical devices that are not significantly new in technology or intended use.

Here's why the AI-specific questions are not applicable and what this document does provide:

• No AI/ML Component: The device is a "Certain® Contoured Margin Ceramic Abutment," described as an accessory to endosseous dental implants. It's a physical component, not software with an algorithm.
• No Device Performance Metrics (in the AI/ML sense): For mechanical devices like this, "performance" would typically refer to mechanical strength, biocompatibility, fit, etc., tested through benchmarks, fatigue tests, material characterization, or preclinical studies. The document states "minor technological differences between the proposed devices components and their predicate devices raise no new issues of safety or effectiveness," implying that standard tests were likely performed to confirm no degradation in these mechanical properties compared to the predicate, but specific performance metrics are not listed in this summary.
• "Study" for 510(k) Substantial Equivalence: The "study" in this context is the comparison made by Biomet 3i to its own predicate device (BIOMET 3i Dental Ceramic Abutment) and a competitor's (Zimmer® Contour Ceramic Abutment). This comparison aims to show that the new device has the same intended use, indications, and technological characteristics, with no new issues of safety or effectiveness. This is a regulatory comparison, not a clinical trial or algorithm performance study.

Information provided in the document (relevant to a physical device submission):

• Device Name: Certain® Contoured Margin Ceramic Abutment
• Intended Use/Indications for Use: To support a prosthetic device in partially or completely edentulous patients, for single and multiple tooth prostheses in the mandible or maxilla, with the prosthesis cement-retained to the abutment.
• Technological Characteristics: Described largely by its composition (Zirconium oxide material), connections (internal and external), and screw type.
• Predicate Devices: BIOMET 3i Dental Ceramic Abutment and Zimmer® Contour Ceramic Abutment.
• Substantial Equivalence Claim: The device has the "same general intended uses, indications, technological characteristics," and that "minor technological differences... raise no new issues of safety or effectiveness."

To answer the user's request for acceptance criteria and study information, I would have to state that these concepts as they relate to AI/ML devices are not applicable to the provided 510(k) summary for this mechanical dental component. The "acceptance criteria" here is simply satisfying the FDA's requirements for demonstrating substantial equivalence, and the "study" is the comparison against predicates.

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