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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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The Elos Accurate® Hybrid Base™ is intended for attaching to dental implants in order to provide basis for single or multiple tooth prosthetic restorations. The Hybrid Base™ is used as an interface between a dental implant and a zirconia superstructure and will be attached to the implant using a prosthetic screw and attached to the zirconia superstructure by cementing. The Elos Accurate® Hybrid Base™ is compatible with the implant systems listed in table 1:

| Implant Platform compatibility | Platform diameter
[mm] | Implant Body diameter
[mm] |
|--------------------------------|---------------------------|--------------------------------|
| Zimmer Screw-vent 3.5 | Ø3.5 | Ø3.7/Ø4.1 |
| Zimmer Screw-vent 4.5 | Ø4.5 | Ø4.7 |
| Zimmer Screw-vent 5.7 | Ø5.7 | Ø6.0 |
| Biomet 3i Certain 3.4 | Ø3.4 | Ø3.25 |
| Biomet 3i Certain 4.1 | Ø4.1 | Ø4 |
| Biomet 3i Certain 5.0 | Ø5 | Ø5 |
| Biomet 3i Certain 6.0 | Ø6 | Ø6 |
| Straumann Standard RN | Ø4.8 | Ø3.3/Ø4.1/Ø4.8 |
| Straumann Standard WN | Ø6.5 | Ø4.8 |
| Neodent GM | Ø3.5/Ø4.5/Ø5.5/Ø 6.5 | Ø3.5/Ø3.75/Ø4/Ø4.3/Ø 5/Ø 6/Ø 7 |
| Hiossen ET Mini | Ø3.2/Ø3.5 | Ø3.2/Ø3.5 |
| Hiossen ET Regular | Ø4/Ø4.5/Ø5/ Ø5.5/Ø6/Ø7 | Ø4/Ø4.5/Ø5/ Ø5.5/Ø6/Ø7 |

The zirconia superstructures for use with the Elos Accurate® Hybrid Base™ are either intended to be sent and manufactured at an FDA registered Elos Medtech approved milling facility or to be designed and manufactured according to digital dentistry workflow system integrates multiple components of the digital dentistry workflow: scan files from Intra-Oral Scanners, CAD software, CAM software, ceramic material, milling machine and associated tooling and accessories.

The Elos Accurate® Hybrid Base™ is intended for attaching to dental implants in order to provide basis for single or multiple tooth prosthetic restorations. The Hybrid Base™ is used as an interface between a dental implant and a zirconia superstructure and will be attached to the implant using the included prosthetic screw and attached to the zirconia superstructure by cementing. The Elos Accurate® Hybrid Base™ is a two-piece abutment composed of the Hybrid Base as the bottomhalf and the zirconia superstructure as the top-half, which when assembled comprises the final finished medical device.

The Elos Accurate® Hybrid Base™ consists of a pre-manufactured prosthetic component in Titanium alloy per ASTM F136, as well as supporting digital library file for 510(k) cleared design software (3Shape Abutment Designer™ Software, K151455) which facilitates the design of a patient specific zirconia superstructure by the laboratory/clinician. The Elos Accurate® Hybrid Base™ fits directly to an endosseous dental implant. The laboratory designed superstructure is manufactured from 510(k) cleared Zirconia (Lava Plus, K011394) according to digital dentistry workflow. For all Elos Accurate® Hybrid Base™ models the zirconia superstructure must be designed according to following limits:

• 1. Minimum wall thickness 0.5 mm
• 2. Minimum post height 4.0 mm (for single unit restorations)
• 3. Maximum gingival height 5.0 mm (min. GH of 0.5mm)
• 4. Maximum angulation 20°

The laboratory designed superstructure is attached to the Elos Accurate® Hybrid Base by use of 510(k) cleared cement (Multilink Hybrid Abutment, K130436 or Panavia V5, K150704) and the final prosthetic restoration is attached to the implant using a Prosthetic screw.

The Elos Accurate® Hybrid Bas has a gold-colored anodized surface to increase the esthetics of the dental restoration - the same surface as in predicate device K201860.

Some of the prosthetic screws are uncoated and two screws are Medicarb coated, identical to the Medicarb coating in predicate device K201860. The subject uncoated screws are compatible with implant platforms Zimmer Screw-vent, Biomet 3i, Neodent GM and Straumann Standard RN and WN. The subject Medicarb coated screws are compatible with the implant platforms Hiossen ET Mini and ET Regular. The purpose of the coating is to lower friction in the thread connection and the screw seat connection.

The Elos Accurate® Hybrid Base™ is delivered non-sterile and the final restoration and corresponding screw is intended to be sterilized at the dental clinic before it is placed in the patient.

The Elos Accurate® Hybrid Base™ is a dental device intended for attaching to dental implants to provide a basis for single or multiple tooth prosthetic restorations. It acts as an interface between a dental implant and a zirconia superstructure.

Here's a breakdown of the acceptance criteria and supporting studies:

1. Table of Acceptance Criteria and Reported Device Performance:

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

   • Fatigue Testing: "fatigue testing was performed on the subject devices per ISO 14801." The exact number of samples tested per device type is not specified but implied to be sufficient for ISO 14801 compliance.
   • Engineering and Dimensional Analysis: Performed on "original manufactures' components (abutments, implants & abutment screws)." The number of components is not specified.
   • Digital Dentistry Workflow Validation/Design Limitation Test: "The digital dentistry workflow validation was completed on selected models of subject product line" and "A design limitation test is performed...". Number of models/tests not specified.
   • Biocompatibility (Cytotoxicity): A cytotoxicity test was performed on "a complete restoration produced via the described validated workflow." Exact number of samples not specified.
   • Data Provenance: Not explicitly stated, but the testing appears to be conducted by or for the manufacturer (Elos Medtech Pinol A/S). No information is given about the country of origin of the data or if it was retrospective or prospective in the context of clinical studies (as this is a non-clinical submission).

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

   • This submission focuses on non-clinical testing and substantial equivalence to predicate devices based on engineering and performance standards. There is no mention of "experts" establishing ground truth in the context of diagnostic performance or clinical outcomes. The "ground truth" for the engineering and material properties would be established by validated test methods and established standards (e.g., ISO 14801, ISO 10993).

4. Adjudication Method for the Test Set:

   • Not applicable. This is a non-clinical submission based on engineering tests and standards, not a clinical study requiring adjudication of diagnostic results.

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 study was mentioned or performed. This device is a dental implant component, not an AI-assisted diagnostic tool.

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

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

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

   • The "ground truth" in this context refers to established engineering standards, material properties, and performance requirements for dental implant abutments. This includes:
     • ISO 14801: "Dentistry – Implants – Dynamic fatigue test for endosseous dental implants" for fatigue testing.
     • ISO 17665-1 & ISO 17665-2: For sterilization validation.
     • ISO 10993-1 & ISO 10993-5: For biocompatibility (cytotoxicity).
     • Engineering and dimensional analysis: Based on specifications of original manufacturers' components.

8. The sample size for the training set:

   • Not applicable. This device is not an AI/machine learning product and does not have a "training set." The closest analogy could be the design and manufacturing parameters used to create the device, which are based on established engineering principles and prior device knowledge.

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

   • Not applicable, as there is no "training set" for this type of medical device. The design and manufacturing are based on established engineering principles and validation against performance standards.

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