(147 days)
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:
| Compatible Third-Party Implant Systems | Implant Body Diameter (mm) | Implant Platform Diameter (mm) |
|---|---|---|
| 3i OSSEOTITE® Certain® | 3.25 | 3.4 |
| 4.0 | 4.1 | |
| 5.0 | 5.0 | |
| 6.0 | 6.0 | |
| Astra Tech OsseoSpeed™ | 3.0 | 3.0 |
| 3.5, 4.0 | 3.5/4.0 | |
| 4.5, 5.0 | 4.5/5.0 | |
| Astra Tech OsseoSpeed™ Plus (OsseoSpeed™ EV) | 3.0 (3.0S) | 3.0 |
| 3.6 (3.6S) | 3.6 | |
| 4.2 (4.2C, 4.2S) | 4.2 | |
| 4.8 (4.8C, 4.8S) | 4.8 | |
| 5.4 (5.4S) | 5.4 | |
| BioHorizons® Tapered Internal | 3.0 | 3.0 |
| 3.5 | 3.5 | |
| 4.0 | 4.5 | |
| HIOSSEN ET III | 3.5 | Mini |
| 4.0, 4.5, 5.0, 6.0, 7.0 | Regular | |
| Implant Direct Legacy | 3.2 | 3.0 |
| 3.7, 4.2 | 3.5 | |
| 4.7, 5.2 | 4.5 | |
| 5.7, 7.0 | 5.7 | |
| Keystone PrimaConnex™ | 3.5 | 3.5 (SD) |
| 4.1 | 4.1 (RD) | |
| 5.0 | 5.0 (WD) | |
| MegaGen AnyRidge | 3.5, 4.0, 4.5, 5.0, 5.5 | 3.5 |
| Neodent® GM™ Helix | 3.5, 3.75, 4.0, 4.3, 5.0, 6.0, 7.0 | 3.0 |
| Neoss | 3.5, 4.0, 4.5, 5.0, 5.5 | 4.1 |
| Nobel Biocare™ NobelActive® | 3.0 | 3.0 |
| 3.5 | NP | |
| 4.3, 5.0 | RP | |
| Nobel Biocare™ NobelReplace® | 3.5 | NP |
| 4.0, 4.3, 5.0 | RP | |
| 5.0 | WP | |
| 6.0 | 6.0 | |
| Straumann™ BLX | 3.75, 4.0, 4.5 (RB) | RB |
| 5.0, 5.5, 6.5 (WB) | WB | |
| Straumann® Bone Level | 3.3 | NC |
| 4.1, 4.8 | RC | |
| Straumann® Tissue Level | 3.3, 4.1, 4.8 | RN |
| 4.8, 6.5 | WN | |
| Zimmer Screw-Vent®/ Tapered Screw-Vent® | 3.3, 3.7, 4.1 | 3.5 |
| 4.7 | 4.5 | |
| 6.0 | 5.7 |
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.
| Category | Acceptance Criteria (Inferred/Stated) | Reported Device Performance (as per document) |
|---|---|---|
| Mechanical Performance | - Static compression testing according to ISO 14801. | - "Worst-case constructs were subjected to static compression and compression fatigue testing." |
- 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.
§ 872.3630 Endosseous dental implant abutment.
(a)
Identification. An endosseous dental implant abutment is a premanufactured prosthetic component directly connected to the endosseous dental implant and is intended for use as an aid in prosthetic rehabilitation.(b)
Classification. Class II (special controls). The guidance document entitled “Class II Special Controls Guidance Document: Root-Form Endosseous Dental Implants and Endosseous Dental Implant Abutments” will serve as the special control. (See § 872.1(e) for the availability of this guidance document.)