(16 days)
The NobelActive 3.0mm implant is indicated for use in the treatment of missing maxillary lateral incisors or the mandibular central and lateral incisors to support prosthetic devices, such as artificial teeth, in order to restore chewing function in partially edentulous patients. The NobelActive 3.0 implants may be put into immediate function provided that stability requirements detailed in the manual are satisfied.
The NobelActive 3.0 Angled Abutment is an angled abutment intended to be used with the Nobel Biocare NobelActive 3.0 implant system. The abutments are made of titanium vanadium alloy.
The provided text describes a 510(k) premarket notification for the NobelActive 3.0 Angled Abutment. This submission primarily relies on non-clinical testing to demonstrate substantial equivalence to a predicate device. It does not involve a study of an AI/ML powered medical device with acceptance criteria in the traditional sense of evaluating algorithmic performance.
Here's an analysis of why the requested information cannot be fully provided based on the given text, followed by the information that can be extracted:
- No AI/ML Component: The device described is a dental implant abutment, a physical medical device made of titanium vanadium alloy. There is no mention of any artificial intelligence or machine learning component.
- No "Acceptance Criteria" for Algorithmic Performance: The "acceptance criteria" here refer to satisfying the requirements of the FDA guidance for dental implants/abutments, specifically fatigue testing. These are not performance metrics for an algorithm (e.g., sensitivity, specificity).
- No "Study that proves the device meets the acceptance criteria" in terms of algorithmic performance: The "study" mentioned is non-clinical fatigue testing, not a clinical or standalone study of an algorithm.
- No Ground Truth, Experts, or Adjudication for Algorithms: These concepts are entirely irrelevant to a physical dental device.
Information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (from FDA Guidance) | Reported Device Performance (from Non-Clinical Testing) |
|---|---|
| Withstand anticipated forces (as per FDA guidance: "Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Implant Abutments") | "The testing indicates that the device is strong enough to withstand the anticipated forces." |
2. Sample sized 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: Not explicitly stated. The document mentions "non-clinical testing consisted of performance of fatigue testing," but does not provide details on the number of samples tested.
- Data Provenance: Not applicable in the context of device performance data location; it's a non-clinical, laboratory-based test.
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 relates to interpretation of data for ground truth establishment. For a physical device, performance is typically measured through engineering tests, not expert interpretation of data.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. No expert adjudication process is described for non-clinical fatigue testing.
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. This is a physical dental device, not an AI/ML powered device, so no MRMC study with AI assistance was performed.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- No. This is a physical dental device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not applicable. For this type of device, "ground truth" would be the measured physical properties and performance characteristics against established engineering standards and safety requirements. The "ground truth" for meeting acceptance criteria is the successful completion of the fatigue testing described in the FDA guidance document.
8. The sample size for the training set
- Not applicable. No training set for an algorithm is mentioned or relevant.
9. How the ground truth for the training set was established
- Not applicable. No training set or associated ground truth establishment is mentioned or relevant.
§ 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.)