(98 days)
The NobelProcera Ti Abutments are premanufactured prosthetic components directly connected to endosseous dental implants and are intended for use as an aid in prosthetic rehabilitation.
Nobel Biocare's NobelProcera Ti Abutment is an endosseous dental implant abutment. The Nobel Biocare's NobelProcera Ti Abutment attaches directly to endosseous dental implants and provides a platform for restoration.
Nobel Biocare's NobelProcera Ti Abutments are designed and made individually to fit the individual requirements for each patient. The NobelProcera Ti Abutments are made entirely of titanium or titanium/vanadium alloy.
The provided text is a 510(k) summary for the NobelProcera Ti Abutment. This type of regulatory submission is for demonstrating substantial equivalence to a predicate device, not for proving a device meets specific acceptance criteria through a clinical study or performance testing that would typically generate the kind of data requested in the prompt.
The document discusses device description, indications for use, and a comparison with legally marketed predicate devices to establish substantial equivalence. It does not contain information on acceptance criteria for device performance, nor does it detail a study performed to meet such criteria. Therefore, most of the requested fields cannot be extracted from this document.
Here's a breakdown of what can be extracted and what information is missing:
1. A table of acceptance criteria and the reported device performance:
- Missing. The document does not specify any acceptance criteria for device performance or provide reported performance metrics. The 510(k) process for this type of device (dental implant abutment) relies on demonstrating substantial equivalence to previously cleared devices, often through mechanical testing, biocompatibility, and material equivalence, rather than clinical performance metrics found in the prompt's context (like sensitivity, specificity, or reader improvement with AI).
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Missing. No test set or study data of this nature is mentioned.
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):
- Missing. This information is relevant for studies involving human interpretation or expert-driven evaluations, which are not detailed here.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Missing. Similar to the above, this would be relevant for expert-based evaluations, which are not 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:
- Missing. This type of study (MRMC, AI assistance) is not applicable to an endosseous dental implant abutment and is not mentioned in the document.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Missing. Not applicable to this device type.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- Missing. No "ground truth" as typically defined in diagnostic performance studies is applicable or mentioned. The device's safety and effectiveness are established through reference to predicate devices and material/design specifications.
8. The sample size for the training set:
- Missing. No training set for an algorithm is mentioned.
9. How the ground truth for the training set was established:
- Missing. Not applicable.
Summary based on the provided document:
The provided 510(k) summary for the NobelProcera Ti Abutment focuses on demonstrating substantial equivalence to predicate devices already on the market. It confirms the device's indications for use and its material composition. The document does not contain any information about acceptance criteria or performance studies (like those involving AI, human readers, or diagnostic metrics) as typically discussed for software as a medical device or diagnostic imaging devices. The type of information requested (e.g., sample sizes, expert qualifications, adjudication methods, MRMC studies) is not usually found in a 510(k) for a mechanical dental prosthetic component like an abutment.
§ 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.)