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Preat Abutments are intended to be used in conjunction with endosseous dental implants in the maxillary or mandibular arch to provide support for single-unit or multi-unit prosthetic restorations.

All digitally designed CAD/CAM customizations for Preat Abutments are intended to be sent to a Preat validated Milling Center for manufacture or to be designed and manufactured according to a validated digital dentistry workflow. The workflow system integrates multiple components of the digital dentistry workflow: scan files from intra-oral and lab (desktop) scanners, CAD software, CAM software, milling machine and associated tooling and accessories.

Preat Abutments are compatible with the following third-party implant restorative platforms:

The purpose of this submission is to expand the use of Preat Abutments, specifically the titanium blank abutment design, to be used in a validated equipment CAD/CAM workflow where specific abutment design software, milling machines and tooling have been validated to work with the previously cleared components in K220823 and K183518.

This submission includes a titanium blank design which is compatible with sixteen (16) implant system, with a distinct connection platform, as well as varying implant diameters and implant platform diameters, for each system.

The Subject device abutments may be placed in implants located in the mandibular or maxillary arches. The Subject device abutments are compatible with implant body diameters that range from 3.0 mm to 7.0 mm and implant platform diameters which range from 2.9 to 6.0 mm.

All abutments and screws are manufactured from Ti-6Al-4V ELI alloy conforming to ASTM F136 and are provided non-sterile to the end user.

The design parameters for the CAD/CAM Titanium Blank custom abutment are:

• Minimum wall thickness – 0.5 mm to 0.9 mm (varies by implant line);
• Minimum post height for single-unit restorations (length above the abutment collar / gingival height)– 4.0 mm;
• Maximum Angle – 30°*; and
• Minimum gingival height – 0.5 mm;
• Maximum gingival height – 1.5 mm to 4.5 mm (varies by implant line).

*Astra Tech® OsseoSpeed™ Plus (OsseoSpeed™ EV) compatible are limited to 0° maximum correction angle.

The minimum and maximum abutment design parameters listed above correspond to the abutment designs used in the mechanical testing data provided in the sponsor's K220823 and K183518 device submissions.

All digitally designed CAD/CAM customizations for Preat Abutments are intended to be sent to a Preat validated Milling Center for manufacture or to be designed and manufactured according to a validated digital dentistry workflow which includes: Scan files from Intra-Oral and Desktop Scanners, CAD software, CAM software, a Milling machine and associated tooling and accessories.

The provided FDA 510(k) clearance letter pertains to "Preat Abutments," which are endosseous dental implant abutments. This type of device is mechanically tested and does not typically involve the kinds of studies (e.g., AI integration, human reader studies, clinical outcomes) that would necessitate the extensive "acceptance criteria" and "study proving device meets acceptance criteria" information you've requested.

The document describes non-clinical performance data to demonstrate substantial equivalence, focusing on engineering aspects and material compatibility, rather than clinical efficacy or diagnostic accuracy.

Therefore, many of the specific points you've asked for (e.g., sample size for test set, data provenance, number of experts for ground truth, adjudication method, MRMC study, effect size, standalone performance, ground truth for training set, training set sample size) are not applicable to this type of device and are not present in the provided FDA submission information.

Here's a breakdown based on the available information:

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

The document does not explicitly state acceptance criteria in a quantitative table format as one might find for a diagnostic AI device. Instead, it details the engineering and material performance tests conducted to demonstrate substantial equivalence to predicate devices. The "reported device performance" is described qualitatively by stating that the tests were performed and that the device is substantially equivalent.

• This implies the device met the standards of ISO 14801, demonstrating mechanical integrity comparable to predicates. (Specific pass/fail values or results are not provided in this summary, but would have been in the full submission). |
  | | - Compression fatigue testing according to ISO 14801. | |
  | Software Validation | - Restrictions to prevent design outside stated design parameters. | - "Software verification included testing of restrictions that prevent design of components outside of the stated design parameters." |
  | | - Abutment design library limitations are locked and unmodifiable. | - "The abutment design library was validated to demonstrate that the established design limitations and specifications are locked and cannot be modified by the user." |
  | | - CAM restriction zones avoid damage/modification of connection geometry and are locked. | - "Validation testing of the CAM restriction zones was conducted, including verification to show avoidance of damage or modifications of the connection geometry, and locking of restriction zones from user editing in the CAM software." |
  | Biocompatibility | - Conforms to ISO 10993-1 and ISO 10993-5. | - "Biocompatibility has been demonstrated through the sponsor's K220823 device testing according to ISO 10993-1, and ISO 10993-5." (Leveraged from predicate). |
  | Sterilization | - Conforms to ISO 17665-1 and ISO 14937. | - "Sterilization validation was demonstrated through and leveraged from the sponsor's K220823 device testing according to ISO 17665-1 and ISO 14937." (Leveraged from predicate). |
  | MR Safety | - Assessment of magnetically induced displacement force and torque. | - "Non-clinical worst-case MRI review was performed... using scientific rationale and published literature... Rationale addressed parameters per the FDA guidance 'Testing and Labeling Medical Devices for Safety in the Magnetic Resonance (MR) Environment,' including magnetically induced displacement force and torque." (Indicating an assessment was made to show safety, though specific results are not detailed). |
  | Material Composition | - Ti-6Al-4V ELI alloy conforming to ASTM F136. | - "All abutments and screws are manufactured from Ti-6Al-4V ELI alloy conforming to ASTM F136." |
  | Design Parameters (for CAD/CAM customizations) | - Minimum wall thickness: 0.5 mm to 0.9 mm (varies).
• Minimum post height single-unit: 4.0 mm.
• Maximum Angle: 30° (0° for some Astra Tech models).
• Minimum gingival height: 0.5 mm.
• Maximum gingival height: 1.5 mm to 4.5 mm (varies). | - The device is designed to these parameters, and software validation ensures these are maintained. |

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 for Test Set: The document mentions "worst-case constructs" for mechanical testing, but does not specify a numerical sample size. For software, it refers to "testing of restrictions" and "validation testing," without numerical samples. Biocompatibility and sterilization data are leveraged from previous submissions (K220823).
• Data Provenance: Not specified in terms of country of origin. The data is non-clinical/bench testing.

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 device is an implant abutment, not a diagnostic device requiring expert interpretation of medical images or data to establish ground truth. The "ground truth" here is adherence to engineering standards and material properties.

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

• Not applicable. As above, this is not a diagnostic study requiring expert adjudication.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

• Not applicable. This is not a diagnostic device involving AI and human readers.

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

• Not applicable. This device is a dental implant component, not an algorithm. The software mentioned is for design and manufacturing control, not for standalone diagnostic performance.

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

• The "ground truth" for this device's performance is adherence to recognized international standards (e.g., ISO 14801 for mechanical testing, ISO 10993 for biocompatibility, ISO 17665-1 and ISO 14937 for sterilization), material specifications (e.g., ASTM F136 for Ti-6Al-4V ELI alloy), and internal design parameters and software validation criteria.

8. The sample size for the training set

• Not applicable. This is not a machine learning/AI device requiring a training set.

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

• Not applicable.

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Preat Abutments are intended to be used in conjunction with endosseous dental implants in the maxillary or mandbular arch to provide support for single-unit or multi-unit prosthetic restorations. The Titanium Base abutments consists of two major parts. Specifically, the titanium base and the mesostructured components make up a two-piece abutment.

All digitally designed custom abutments, superstructures, and/or hybrid crowns for use with Titanium Blanks are to be sent to a Preat validated milling center for manufacture.

Preat Abutments were previously cleared under K183518. The purpose of this submission is to obtain marketing clearance for additional compatible implant systems under the Preat Abutments device name. This submission for Preat Abutments is a dental implant abutment system that includes nine (9) abutment designs compatible with five (5) OEM implant systems. The Subject device abutment platform diameters range from 2.9 mm to 5.4 mm, and the corresponding compatible implant body diameters also range from 3.0 mm to 7.0 mm. The Subject device includes the following abutment designs: temporary engaging, multi-unit straight, multi-unit angled 17°, multi-unit angled 30°, engaging titanium base, titanium blank and healing abutments. The system also includes corresponding abutment screws.

All abutments and screws are manufactured from Ti-6Al-4V ELI alloy conforming to ASTM F136 and are provided non-sterile to the end user. All digitally designed custom abutments for use with Titanium Base (superstructures) or Titanium Blank are to be sent to a Preat validated milling center for manufacture. All superstructures are to be manufactured from zirconia conforming to ISO 13356. Digitally designed CAD/CAM abutments must have a 0.5 mm minimum gingival height dimension.

The Titanium Base abutment is composed of two-piece abutment that is a titanium base at the bottom and a zirconia superstructure (CAD/CAM patient specific superstructure) at the top. The zirconia superstructure is straight only and is not to be designed to provide an angle or divergence correction.

For the Titanium Base abutment, the design parameters for the CAD/CAM zirconia superstructure are: Minimum wall thickness - 0.5 mm; Minimum post height for single-unit restorations – 4.0 mm; Maximum gingival height – 5.0 mm; and All zirconia superstructures are for straight abutments only. The design parameters for the CAD/CAM Titanium Blank custom abutment are:

Minimum wall thickness – 0.5 mm to 0.9 mm (varies by implant line); Minimum post height for single-unit restoration – 4.0 mm; Maximum Angle - 30°*; and Minimum gingival height - 0.5 mm; Maximum gingival height – 2.0 mm to 4.5 mm (varies by implant line). * Astra Tech® OsseoSpeed™ Plus (OsseoSpeed™ EV) compatible are limited to 0° maximum correction angle.

The provided document describes the Preat Abutments and their substantial equivalence to predicate devices, based on non-clinical performance data. It does not contain information about studies involving human readers, ground truth establishment for a test or training set, or specific details on sample sizes for a test set in the context of AI/algorithm performance.

Here's the information that can be extracted relevant to acceptance criteria and device performance based on the provided text:

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

The document describes non-clinical performance data used to demonstrate substantial equivalence, focusing on mechanical testing and material properties. The acceptance criteria are implicitly met by comparing the subject device to predicate and reference devices, and by conforming to relevant ISO standards where applicable.

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 detail specific sample sizes for the mechanical testing ("worst-case constructs"). The data provenance is not explicitly stated in terms of country of origin, nor is it described as retrospective or prospective in the context of test sets. The studies are non-clinical (laboratory testing).

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):

This information is not applicable. The studies described are non-clinical performance and material conformance tests, not diagnostic studies or those requiring expert interpretation of results to establish ground truth in the way medical imaging algorithms might.

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

This information is not applicable. Adjudication methods typically apply to human interpretation of data, often in clinical studies or when establishing ground truth for AI algorithms, which is not the nature of the studies 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:

This information is not applicable. An MRMC comparative effectiveness study is used for diagnostic AI devices involving human readers. This document describes non-clinical performance testing for dental abutments, which is a physical device, not an AI algorithm.

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, not an algorithm.

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

The concept of "ground truth" as typically used in the context of evaluating diagnostic algorithms (e.g., expert consensus, pathology) is not applicable here. For the non-clinical tests, the "ground truth" or reference for performance is the compliance with specified ISO and ASTM standards and the performance of the predicate/reference devices through comparative testing. For example:

• Mechanical Testing: The "ground truth" would be the passing criteria defined by ISO 14801.
• Material Conformance: The "ground truth" would be the specifications in ASTM F136 and ISO 13356.
• Biocompatibility & Sterilization: The "ground truth" would be the specifications in ISO 10993-1, ISO 10993-5, ISO 17665-1, and ISO 14937.

8. The sample size for the training set:

This information is not applicable. There is no AI algorithm being described, and therefore no training set.

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

This information is not applicable for the same reason as above.

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Preat Abutments are intended to be used in conjunction with endosseous dental implants in the maxillary or mandibular arch to provide support for single-unit or multi-unit prosthetic restorations. The Titanium Base abutments consists of two major parts. Specifically, the titanium base and mesostructured components make up a two-piece abutment.

All digitally designed custom abutments, superstructures, and/or hybrid crowns for use with Titanium Blank are to be sent to a Preat validated milling center for manufacture.

Preat Abutments is a dental implant abutment system that includes ten (10) abutment designs compatible with twelve (12) OEM implant systems. The subject device abutment platform diameters range from 3.0 mm to 6.5 mm, and the corresponding compatible implant body diameters also range from 3.0 mm to 6.5 mm. The subject device includes the following abutment designs: temporary, esthetic angled 15°, multi unit straight, multi-unit angled 17°, ball (Clix Ball and O-Ring), titanium base, and titanium blank. The system also includes corresponding abutment screws.

All abutments and screws are manufactured from Ti-6Al-4V alloy conforming to ASTM F136 and are provided non-sterile to the end user. All digitally designed custom abutments, superstructures, and/or hybrid crowns for use with Titanium Base or Titanium Blank are to be sent to a Preat validated milling center for manufacture. All superstructures are to be manufactured from zirconia conforming to ISO 13356.

The Titanium Base abutment is composed of two-piece abutment that is a titanium base at the bottom and a zirconia superstructure (CAD/CAM patient specific superstructure) at the top. The zirconia superstructure is straight only and is not to be designed to provide an angle or divergence correction.

For the Titanium Base abutment, the design parameters for the CAD/CAM zirconia superstructure are: Minimum wall thickness - 0.5 mm; Minimum post height for single-unit restorations - 4.0 mm; Maximum gingival height - 5.0 mm; and All zirconia superstructures are for straight abutments only.

The design parameters for the CAD/CAM Titanium Blank custom abutment are: Minimum wall thickness - 0.5 mm; Minimum post height for single-unit restoration - 4.0 mm; Maximum Angle - 30°; and Maximum gingival height - 1.5 mm to 2.65 mm (varies by implant line).

The provided document is a 510(k) Premarket Notification for dental implant abutments. It focuses on demonstrating substantial equivalence to previously cleared devices rather than providing detailed performance data from a clinical or standalone study. Therefore, most of the requested information regarding acceptance criteria for an AI/device performance study, sample sizes for test/training sets, expert qualifications, and ground truth establishment is not available in this document.

The document details the technical and material characteristics of the Preat Abutments and compares them to predicate devices to argue for their equivalence. It includes non-clinical performance data related to mechanical testing, sterilization, and biocompatibility, but not data related to an AI's diagnostic performance or human reader improvement with AI assistance.

Here's an attempt to answer the questions based on the provided text, indicating when the information is not present:

Analysis of Device Performance and Acceptance Criteria (Based on Substantial Equivalence)

This 510(k) submission for Preat Abutments relies on demonstrating substantial equivalence to existing legally marketed predicate devices. The "acceptance criteria" here are implicitly related to meeting the performance characteristics and safety profiles of these predicates, rather than specific statistical thresholds for a new diagnostic algorithm's accuracy or efficacy. The "study" proving acceptance is primarily the non-clinical testing performed and the comparison to predicate devices.

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size for Test Set: Not applicable in the context of an AI/diagnostic performance study. For the mechanical testing, the document states "worst-case constructs were subjected to static compression fatigue testing," but does not specify the number of samples or "test set" size.
• Data Provenance: Not applicable for location (country of origin), as this is a physical device testing submission. The data is from laboratory testing (mechanical, biocompatibility, sterilization validation). The testing is prospective in nature, as it was conducted specifically for this submission.

3. Number of Experts Used to Establish Ground Truth and Qualifications

• Not applicable. There is no "ground truth" established by experts in the context of a diagnostic performance study. The ground truth for mechanical and material properties is based on established engineering standards and test methods (e.g., ISO 14801, ISO 10993, ISO 17665).

4. Adjudication Method for the Test Set

• Not applicable. No human-based adjudication was performed for a diagnostic test set.

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

• No. This is not a submission for a diagnostic AI device, so an MRMC comparative effectiveness study was not performed.
• Effect Size: Not applicable.

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

• No. This is not an AI algorithm submission. The "standalone" performance here relates to the physical device's mechanical and material properties, which were tested in a laboratory setting as described under "Performance Data."

7. The Type of Ground Truth Used

• For physical device performance: The "ground truth" is defined by international standards (e.g., ISO 14801 for mechanical testing, ISO 10993 for biocompatibility, ISO 17665 for sterilization) and engineering specifications derived from predicate device performance and design. It's not clinical outcomes data or expert consensus in the diagnostic sense.

8. The Sample Size for the Training Set

• Not applicable. There is no "training set" as this is not an AI/machine learning device.

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

• Not applicable. There is no "training set." The understanding of predicate device performance and design parameters, which inform the design and testing of the subject device, is derived from existing regulatory clearances and documented technical specifications of those predicate devices.

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