(135 days)
NobelSpeedy® Groovy implants are endosseous implants intended to be surgically placed in the upper or lower jaw bone for anchoring or supporting tooth replacements to restore patient esthetics and chewing function.
NobelSpeedy® Groovy implants are indicated for single or multiple unit restorations in splinted applications. This can be achieved by a 2-stage or 1-stage surgical technique in combination with immediate, early or delayed loading protocols, recognizing sufficient primary stability and appropriate occlusal loading for the selected technique. Implants allow also for bi-cortical anchorage in cases of reduced bone density.
NobelSpeedy® Groovy implants 20, 22, 25 mm when placed in the maxilla are only indicated for multiple unit restorations in splinted applications that utilize at least two implants.
NobelSpeedy® Groovy implants are threaded, root-form dental implants intended for use in the upper and/or lower jaw to support prosthetic devices, such as artificial teeth, in order to restore patient esthetics and chewing function to partially or fully edentulous patients. They are intended for immediate loading when good primary stability is achieved and with appropriate occlusal loading.
The NobelSpeedy® Groovy implants (20 mm, 22 mm, and 25 mm) share the same design characteristics as the existing NobelSpeedy® implants but are longer than the existing range of NobelSpeedy® implants. All NobelSpeedy® implants are made of commercial pure titanium.
The provided document is a 510(k) premarket notification for a medical device called "NobelSpeedy® Groovy" dental implants. It describes the device, its intended use, comparison to predicate devices, and performance data from various studies.
Here's an analysis of the acceptance criteria and the study that proves the device meets the acceptance criteria, based on the information provided in the document:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state "acceptance criteria" in the traditional sense of numerical thresholds for performance metrics. Instead, it demonstrates substantial equivalence to predicate devices through various tests and clinical studies. The core acceptance criterion for a 510(k) submission is to demonstrate that the new device is as safe and effective as a legally marketed predicate device.
The reported device performance is compared to the predicate devices and general expectations for dental implants (e.g., successful osseointegration, stable marginal bone levels, no significant complications).
| Category | Acceptance Criterion (Implicit) | Reported Device Performance |
|---|---|---|
| Substantial Equivalence | Device is as safe and effective as the predicate device(s). | Demonstrated through: |
- Similar design characteristics (single lead thread, tapered apex, external hex connection, materials, surface).
- Same intended use.
- Satisfactory performance in various tests and clinical studies, showing no new concerns for safety or effectiveness compared to predicate. |
| Sterilization | Validation of gamma irradiation process in accordance with established standards. | "Validation of the gamma irradiation process was previously conducted for the predicate device. There has been no change to the manufacturing or sterilization processes since then; therefore, additional validation is not required." (Implies the existing validation is sufficient for the subject device). |
| Shelf-Life | Product remains sterile throughout the duration of the labeled expiry according to ISO 11607-1 and 1SO 11607-2. | "Real-time and accelerated aging studies were conducted in accordance with ISO 11607-1 and 1SO 11607-2 and support that the product remains sterile throughout the duration of the labeled expiry." |
| Biocompatibility | Device material and manufacturing processes are biologically safe, similar to the predicate. | "Biocompatibility testing on the NobelSpeedy Groovy implants was previously conducted. As the material of construction and manufacturing processes are the same as the predicate device, no additional testing is required to support the biological safety of the subject devices." (Implies the previous testing is sufficient). |
| Magnetic Resonance (MR) Safety | Safe for patients in an MR environment, satisfying FDA guidance and relevant ASTM/IEC standards. | "MR testing sufficient to ensure the safety of the patient was conducted to satisfy the requirements described in the 'FDA Guidance: Establishing Safety and Compatibility of Passive Implants in the Magnetic Resonance (MR) Environment' and ASTM F2052, ASTM F2119, ASTM F2182, ASTM F2213, ASTM F2503, and IEC 60601-2-33." (No specific results provided, but states requirements were satisfied). |
| Biomechanical Performance | Insertion, removal, yield, and maximum torque characteristics are acceptable and comparable to predicate devices (implied). | "A comparative torque study was conducted on the subject devices in accordance with ISO 13498:2011. The purpose of the study was to evaluate insertion and removal torque during implant placement and removal as well as the yield and maximum torque of the implants." (No specific results provided, but states a study was done according to standard). |
| Clinical Performance (Survival Rate) | High survival rate, comparable to established dental implant success rates. | - Agliardi et al. (2014): 100% survival rate over a mean follow-up of 50 months. - Malo et al. (2013): 100% survival rate over a mean follow-up of 14 months. |
| Clinical Performance (Bone Remodeling / Soft Tissue) | Stable marginal bone levels and favorable soft tissue results, within the usual range for dental implants. | - Agliardi et al. (2014): "stable marginal bone levels and favorable soft tissue results." - Malo et al. (2013): "bone level change was -0.85 (+ 0.45) mm at 1 year, being in the usual range." |
| Clinical Performance (Complications) | Low incidence of biological and mechanical complications. | - Agliardi et al. (2014): "No biological and mechanical complications occurred." - Malo et al. (2013): "One mechanical complication (i.e. abutment loosening) occurred that could be fixed." |
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 references two investigator-initiated clinical studies:
- Agliardi et al. (2014):
- Sample Size: 10 humans (patients).
- Data Provenance: Prospective, single arm study. Country of origin not specified, but the journal is "The Journal of Craniofacial Surgery." Based on author names and journal, likely European (e.g., Italy where Agliardi is active).
- Malo et al. (2013):
- Sample Size: 16 humans (patients).
- Data Provenance: Prospective, single arm study. Country of origin not specified, but the journal is "Clinical Implant Dentistry and Related Research Journal." Similar to above, often international with European or North American contributors.
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)
The document does not provide details on the number or qualifications of experts used to establish "ground truth" in the context of these clinical studies. Clinical studies typically rely on the treating clinicians and researchers to assess outcomes (e.g., survival, bone levels, complications). There's no mention of an independent panel of experts reviewing cases for a separate "ground truth" determination.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
The document does not describe any specific adjudication method (like 2+1 or 3+1) for the clinical studies. These were single-arm prospective studies, meaning outcomes were assessed by the study investigators.
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, the document describes studies about the performance of a dental implant device itself, not an AI or imaging diagnostic tool. Therefore, an MRMC comparative effectiveness study involving human readers with or without AI assistance is not applicable and was not conducted.
6. If a standalone (i.e., algorithm only without human-in-the loop performance) was done
No, this pertains to a physical dental implant, not an algorithm or AI system. Standalone algorithm performance is not relevant to this submission.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
For the clinical studies referenced, the "ground truth" was based on clinical outcomes data observed and reported by the study investigators. This includes:
- Implant survival (presence/absence of implant).
- Radiographic assessment of marginal bone remodeling.
- Clinical assessment of soft tissue health.
- Occurrence of biological and mechanical complications.
8. The sample size for the training set
The document does not describe a "training set" in the context of machine learning or AI. This is a premarket notification for a physical medical device. The "training" in the context of device development would refer to engineering design, material science, and manufacturing processes, rather than a data-driven training set.
9. How the ground truth for the training set was established
As there is no "training set" in the AI/machine learning sense for this device submission, this question is not applicable. The device's design and manufacturing are based on established engineering principles, materials science, and prior knowledge from predicate devices and general dental implant literature.
§ 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.