(182 days)
Selected Brånemark System® implant products (those identified in the preceding section, "Device Name") are intended to be placed in the upper or lower jaw to support prosthetic devices, such as artificial teeth, and to restore a patient's chewing function. This may be accomplished using either a two stage surgical procedure or a single stage surqical procedure.
If a single stage surgical procedure is used, these implants may be loaded immediately following insertion - PROVIDED - at least four implants are placed, and are splinted with a bar. These implants must be placed predominantly in the anterior mandible (between the mental foramina) where good initial stability of the implants, with or without bi-cortical anchoragel can most often be obtained.
Brånemark System® dental implants are threaded, root-form implants fabricated from ASTM grade 1 "commercially pure" titanium. They are available in diameters of 3.75 mm and 4.0 mm, and are available in lengths ranging from 10 mm to 21 mm. Research studies have demonstrated that titanium is biocompatible.
The provided text is a 510(k) summary for Nobel Biocare's Brånemark System® Implants, seeking clearance for an immediate loading indication. This document details the device, its intended use, and a comparison to predicate devices, but does not contain any information about specific acceptance criteria or a study proving the device meets those criteria, as typically understood for AI/ML or diagnostic devices.
The 510(k) process for medical devices primarily focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving performance against specific quantitative acceptance criteria in the way a clinical trial for a drug or an AI diagnostic algorithm would.
Therefore, many of the requested items (e.g., sample size for test set, number of experts for ground truth, MRMC studies, standalone performance) are not applicable or cannot be extracted from this type of regulatory submission. The document explicitly states "We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent...".
Here's a breakdown of what can and cannot be answered based on the provided text:
1. A table of acceptance criteria and the reported device performance
- Not applicable/Not provided. This document is a 510(k) summary for substantial equivalence, not a performance study against specific acceptance criteria. The "performance" assessment is based on demonstrating equivalence to predicate devices already cleared for immediate loading.
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not specified in this document | Substantially equivalent to predicate devices for immediate loading indication. |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not applicable/Not provided. This document does not present results from a clinical test set with specific sample sizes. The regulatory submission relies on comparison to predicate devices and existing biocompatibility data for titanium.
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/Not provided. Ground truth establishment, typically for diagnostic accuracy or outcome prediction, is not described in this 510(k) summary.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable/Not provided. No test set or adjudication method is mentioned.
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/Not provided. MRMC studies are typically for evaluating the impact of AI algorithms on human reader performance, which is not the subject of this 510(k) for dental implants.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable/Not provided. This document is not about an algorithm, but a physical dental implant.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not applicable/Not provided. This document does not refer to ground truth data in the context of device performance metrics. The implicit "ground truth" for the immediate loading indication is likely established clinical practice and safety/efficacy data already accepted for the predicate devices.
8. The sample size for the training set
- Not applicable/Not provided. This is not an AI/ML device that requires a training set.
9. How the ground truth for the training set was established
- Not applicable/Not provided. This is not an AI/ML device.
Summary of Device Acceptance (based on 510(k) Substantial Equivalence):
The device (Brånemark System® Implants with immediate loading indication) achieved acceptance through the FDA's 510(k) clearance process by demonstrating substantial equivalence to legally marketed predicate devices, specifically the Straumann ITI Implant (K984104) and the Sargon Cylindro-Blade Implant (K930071), both of which already had an immediate load indication.
The key aspects considered for substantial equivalence, as detailed in the comparison table, included:
- Intended Use: Functionally the same (support prosthetic devices, restore chewing function).
- Indication: Immediate Load.
- Design: Threaded, root-form implants (similar to Straumann ITI Implant, different but accepted from Sargon).
- Placement Method: Single stage surgery.
- Material: Commercially pure titanium (similar to Straumann, different but accepted from Sargon's titanium alloy).
- Coating: None.
- Dimensions: Within acceptable ranges relative to predicate devices.
The FDA concluded that the device is substantially equivalent to the predicate devices for the stated indications for use (immediate loading under specific conditions: at least four implants placed, splinted with a bar, predominantly in the anterior mandible, with good initial stability). This substantial equivalence determination allowed the device to be marketed.
§ 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.