(90 days)
The intended use for this device is to serve as temporary support for provisional prosthetic devices during the healing phase of permanent endosseous dental implants.
Nobel Biocare's "Immediate Provisional Implant" is designed to provide temporary support for prosthetic devices during the healing phase of permanent root form implants.
Nobel Biocare's threaded titanium "Immediate Provisional Implant" is available in widths of 2.8 millimeters and 3.2 millimeters, and lengths ranging from 14 millimeters to 22 millimeters.
The provided document is a 510(k) premarket notification for a medical device and thus does not include extensive details about acceptance criteria or detailed study results in the way a peer-reviewed publication or a full clinical study report might. It primarily focuses on demonstrating substantial equivalence to predicate devices.
However, based on the limited information available in the document, here's what can be extracted and inferred regarding the clinical study:
1. Table of Acceptance Criteria and Reported Device Performance:
The document does not explicitly state quantitative acceptance criteria (e.g., "95% success rate"). Instead, it describes a qualitative success based on the intended use.
| Acceptance Criterion (Inferred from Intended Use) | Reported Device Performance |
|---|---|
| Provide temporary support for provisional prosthetic devices during the healing phase of permanent endosseous dental implants. | Successfully provided support for provisional prosthetic devices while simultaneously protecting the permanent implants from premature loading during their healing period. |
| Protect permanent implants from premature loading during their healing period. | Successfully protected the permanent implants from premature loading during their healing period. |
| Not affect the success of the permanent implants. | Did not affect the success of the permanent implants. |
| Not affect the success of the associated permanent implant-supported restorations. | Did not affect the success of the associated permanent implant-supported restorations. |
2. Sample Size Used for the Test Set and Data Provenance:
- The document states: "In a clinical trial, Nobel Biocare's 'Immediate Provisional Implant' successfully provided support..."
- Sample Size: Not specified.
- Data Provenance: Not specified, but generally, clinical trials submitted for U.S. FDA 510(k) clearance are conducted in the U.S. or internationally following recognized clinical practice guidelines. The document itself is from a U.S. company to the U.S. FDA, suggesting the study would likely be relevant to the U.S. context. It is a prospective study as it's a "clinical trial."
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications:
- Number of Experts: Not specified.
- Qualifications of Experts: Not specified. In dental implant studies, typically the "ground truth" (e.g., successful healing, absence of premature loading, success of permanent implants) would be assessed by the treating dentists/surgeons and potentially independent evaluators, who are typically experienced clinicians.
4. Adjudication Method for the Test Set:
- Not specified.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
- No, a MRMC comparative effectiveness study is not mentioned or implied. The study described is a clinical trial evaluating the performance of the device itself, not a comparison of human readers with and without AI assistance.
6. Standalone (Algorithm Only) Performance:
- Not applicable. This device is a physical dental implant, not a software algorithm. Therefore, no standalone algorithm performance study was done.
7. Type of Ground Truth Used:
- The ground truth was based on clinical outcomes as observed in the "clinical trial." This includes the successful temporary support, protection of permanent implants, and the ultimate success of the permanent implants and restorations.
8. Sample Size for the Training Set:
- Not applicable. This is a physical device, not an AI algorithm that requires a training set.
9. How the Ground Truth for the Training Set Was Established:
- Not applicable. As above, this is a physical device, and thus no training set or ground truth for a training set was required or established in the context of AI/algorithm development.
Summary of Limitations from the Document:
It's important to reiterate that 510(k) summaries are concise and do not contain the full details of clinical trials. The lack of specificity regarding sample sizes, expert qualifications, and detailed statistical results is typical for this type of submission, which primarily aims to demonstrate substantial equivalence rather than provide exhaustive scientific evidence of efficacy and safety as would be found in a Premarket Approval (PMA) application or a peer-reviewed publication.
§ 872.3640 Endosseous dental implant.
(a)
Identification. An endosseous dental implant is a prescription device made of a material such as titanium or titanium alloy that is intended to be surgically placed in the bone of the upper or lower jaw arches to provide support for prosthetic devices, such as artificial teeth, in order to restore a patient's chewing function.(b)
Classification. (1) Class II (special controls). The device is classified as class II if it is a root-form endosseous dental implant. The root-form endosseous dental implant is characterized by four geometrically distinct types: Basket, screw, solid cylinder, and hollow cylinder. 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.)(2)
Classification. Class II (special controls). The device is classified as class II if it is a blade-form endosseous dental implant. The special controls for this device are:(i) The design characteristics of the device must ensure that the geometry and material composition are consistent with the intended use;
(ii) Mechanical performance (fatigue) testing under simulated physiological conditions to demonstrate maximum load (endurance limit) when the device is subjected to compressive and shear loads;
(iii) Corrosion testing under simulated physiological conditions to demonstrate corrosion potential of each metal or alloy, couple potential for an assembled dissimilar metal implant system, and corrosion rate for an assembled dissimilar metal implant system;
(iv) The device must be demonstrated to be biocompatible;
(v) Sterility testing must demonstrate the sterility of the device;
(vi) Performance testing to evaluate the compatibility of the device in a magnetic resonance (MR) environment;
(vii) Labeling must include a clear description of the technological features, how the device should be used in patients, detailed surgical protocol and restoration procedures, relevant precautions and warnings based on the clinical use of the device, and qualifications and training requirements for device users including technicians and clinicians;
(viii) Patient labeling must contain a description of how the device works, how the device is placed, how the patient needs to care for the implant, possible adverse events and how to report any complications; and
(ix) Documented clinical experience must demonstrate safe and effective use and capture any adverse events observed during clinical use.