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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.

Ask a specific question about this device