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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 Dental Abutments and Overdenture Bars are intended for use as an accessory to endosseous dental implants to support a prosthetic device in a partially or edentulous patient. It is intend 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.

The 3i Patient-Specific Dental Abutments are designed to match an individual patient. Since each 3i Patient-Specific Dental Abutment is manufactured to match a particular patient according to the doctor's requirements, a specific device description is not possible. However, the 3i Patient-Specific Dental Abutments are designed in keeping with the general descriptions presented in Section G, unless otherwise specifically requested by the doctor.

Here's an analysis of the provided information, focusing on the acceptance criteria and the study details as requested. It's important to note that the provided text is a 510(k) summary for a dental abutment, which is a physical device, not a software or AI-driven system. Therefore, many of the typical AI/software study criteria (like experts, ground truth, training sets, MRMC studies) are not applicable here.

1. Table of Acceptance Criteria and Reported Device Performance

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

This information is not applicable to this type of device submission. The 510(k) for a physical dental abutment relies on demonstrating equivalence to a predicate device, often through design comparison, material testing, and sometimes bench testing, rather than a clinical "test set" with patient data in the way an AI/software device would. The document does not specify any sample sizes for tests.

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

This information is not applicable. The concept of "ground truth" established by experts for a test set is relevant to diagnostic or interpretive AI systems, not a physical dental abutment.

4. Adjudication Method for the Test Set

This information is not applicable. Adjudication methods are used in studies involving human interpretation or decision-making, especially in AI-assisted diagnostics, which is not the case here.

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. This type of study is relevant for evaluating the impact of an AI system on human reader performance, which does not apply to 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. The device is a physical dental abutment; there is no AI algorithm to evaluate in a standalone capacity.

7. The Type of Ground Truth Used

This information is not applicable in the context of this device. For a physical device, "ground truth" might refer to engineering specifications, material properties, or functional benchmarks, which are evaluated through design review and potentially bench testing, rather than expert consensus on data interpretation.

8. The Sample Size for the Training Set

This information is not applicable. Training sets are used for machine learning models, which are not relevant to this physical medical device.

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

This information is not applicable. As there is no training set for an AI model, the method of establishing ground truth for it is irrelevant.

Summary of Device Acceptance & Study Information (based on provided text):

The acceptance of the "3i Patient-Specific Dental Abutments" is primarily based on demonstrating substantial equivalence to an already legally marketed predicate device (3i Patient-Specific Dental Abutments, K032263). The study performed, implicitly, is a comparison of the new device's design, materials, and intended use against the predicate device to show that it raises no new questions of safety or effectiveness.

The document states: "The 3i Patient-Specific Dental Abutments contain features Technological and functions which are similar to the currently available 3i Characteristics Patient-Specific Dental Abutments [K032263]." and explicitly concludes: "The 3i Patient-Specific Dental Abutments are substantially equivalent to the legally marketed 3i Patient-Specific Dental Abutments."

This means the "study" for acceptance was a comparison study against a predicate device, focusing on design, materials, and intended use to establish substantial equivalence, rather than a clinical trial with a "test set" for performance metrics commonly associated with diagnostic or AI devices. The FDA's decision is based on agreement that the new device is as safe and effective as the predicate.

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