(269 days)
The Straumann Immediate Temporary Abutment and associated Plastic Coping are indicated to be placed into Straumann dental implants (BL, BLT or BLX) to provide a support structure for a temporary aesthetic oral rehabilitation of partially edentulous patients with crowns. Temporary components can be used prior to the final components to maintain, stabilize and shape the soft tissue during the healing phase for up to 180 days.
The Straumann Immediate Temporary Abutment and associated Plastic Coping must be placed out of occlusion.
The Straumann Immediate Temporary Abutment and associated Plastic Copinq consist of a titanium abutment and PMMA coping for the Straumann dental implants BL, BLT and BLX. The abutments are available in a variety of gingival heights and diameters to fit individual patient situations. The PMMA coping is compatible with the subject Immediate Temporary Abutments. The Straumann Immediate Temporary Abutment and associated Plastic Coping are indicated to provide a support structure for a temporary aesthetic oral rehabilitation of partially edentulous patients with crowns. Temporary components can be used prior to the insertion of the final components to maintain, stabilize and shape the soft tissue during the healing phase for up to 180 days.
The provided text is a 510(k) summary for the Straumann® Immediate Temporary Abutments. This document primarily focuses on establishing substantial equivalence to predicate devices for regulatory clearance, rather than presenting a detailed study proving the device meets specific acceptance criteria in a quantitative performance study context.
Therefore, many of the requested sections about acceptance criteria, specific reported device performance, sample sizes, ground truth establishment, expert adjudication, MRMC studies, and standalone performance studies are not explicitly detailed in the provided text, as these are typically part of a different type of submission (e.g., a PMA or scientific publication).
However, I can extract information related to the functional characteristics and the types of testing performed to support the substantial equivalence.
Here's an attempt to answer your request based on the provided text, highlighting what is available and what is not:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state quantitative acceptance criteria or reported device performance in the format of a performance study with specific metrics (e.g., sensitivity, specificity, accuracy). Instead, it focuses on demonstrating equivalence to predicate devices through various tests.
The "acceptance criteria" here are implicitly meeting the standards of the predicate devices and relevant ISO standards. The "reported device performance" is a statement that these standards and equivalence have been met.
| Acceptance Criteria (Implicit by Equivalence/Standards) | Reported Device Performance (as stated in the document) |
|---|---|
| Biocompatibility according to ISO 10993-1:2009 | Assessed and found equivalent to predicate devices. Cytotoxicity (ISO 10993-5:2009) and Chemical Analysis (ISO 10993-18:2020) and toxicology evaluation performed for PMMA coping, concluding biocompatibility. |
| Sterilization validation according to ISO 11137 | Assessment concluded adoption into validated process for reference predicate (K192401) is appropriate. |
| High-level disinfection efficacy for PMMA coping | Validation performed on worst-case PMMA device; subject coping can adopt this validation. |
| MRI Conditional compatibility | MRI Conditional; does not introduce new material or worst-case scenario over reference device K190662. |
| Mechanical integrity/performance (implied under benchmarking with predicate) | Differences in technological characteristics (e.g., one-piece design, abutment diameter) "addressed in the performance testing provided in this submission which demonstrates equivalency in product performance." (Specific results not given in this summary). |
| Duration of Use (180 days) | Biocompatibility testing performed to support the 180-day duration of use. |
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 provide details on specific sample sizes for test sets used in the various performance tests (biocompatibility, sterilization, disinfection, or implied mechanical testing). The data provenance is not mentioned (e.g., country of origin, retrospective/prospective). These types of details are usually found in the full test reports, not typically in the 510(k) summary.
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 is not applicable to the type of device and testing described. The "ground truth" for this medical device (dental abutment) is established through adherence to engineering standards, material science, and biological safety guidelines, rather than expert clinical interpretation of data (like in imaging diagnostics).
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
Not applicable. This is typically relevant for studies involving human interpretation or subjective assessments, which is not the case for the physical and biological testing of a dental abutment.
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. MRMC studies are used for evaluating diagnostic devices, particularly those involving human interpretation (e.g., radiologists, pathologists) often assisted by AI. This device is a physical dental abutment.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. This device is a physical component, not an algorithm.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
The "ground truth" for this device is based on established engineering and material science standards (e.g., ISO for biocompatibility and sterilization), and the performance characteristics of predicate devices. For instance, the biocompatibility testing assesses the device against accepted safety limits for biological responses.
8. The sample size for the training set
Not applicable. This is not a machine learning or AI device that requires a training set.
9. How the ground truth for the training set was established
Not applicable. As above, this is not an AI/ML device.
§ 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.)