(117 days)
SLActive implants are for single-stage or two-stage surgical procedures. SLActive implants are intended for immediate placement and function on single-tooth and/or multiple tooth applications when good primary stability is achieved and with appropriate occlusal loading, to restore chewing function. Multiple tooth applications may be rigidly splinted. In the case of edentulous patients, 4 or more implants must be used in immediately loaded cases.
The Straumann solid screw dental implants are of various diameters and lengths with an anchorage surface that is grit blasted and acid etched and modified as described in K033984. No changes to overall implant design or dimensions were made. This submission involved additional studies to support the benefits of the SLActive implant surface.
This is an interesting case where the provided text is a 510(k) summary for a dental implant, which is a medical device. However, 510(k) summaries, especially from 2006, often do not contain detailed information about specific acceptance criteria and the results of studies in the way one might expect for a diagnostic AI device. They primarily focus on demonstrating substantial equivalence to a predicate device.
Based on the provided text, the device in question is the "Straumann Dental Implant System®" with the "SLActive implant surface." The submission focuses on the benefits of this new surface.
Here's an analysis based on the provided text, highlighting the absence of some requested information due to the nature of the 510(k) submission:
1. Table of Acceptance Criteria and Reported Device Performance
It is important to note that the provided 510(k) summary from 2006 does not explicitly state specific quantitative acceptance criteria or corresponding reported device performance metrics in a table format, as one would typically find for a diagnostic AI device aiming for performance targets like sensitivity, specificity, or AUC.
Instead, the "acceptance criteria" can be inferred from the basis for substantial equivalence, which focuses on demonstrating improved performance compared to the existing SLA surface and equivalence to the predicate device in other aspects.
| Acceptance Criteria (Inferred) | Reported Device Performance (as stated in the 510(k) Summary) |
|---|---|
| Criterion 1: Equivalence in Intended Use, Material, and Design | "The subject dental implants are identical to the currently marketed Straumann dental implants in intended use, material and design." |
| Criterion 2: Equivalence in Indications for Use | "The subject SLActive dental implants have the same indications for use as the currently marketed Straumann dental implants." |
| Criterion 3: Demonstrated Benefit of SLActive Surface (Physiological Response) | "The subject device with the modified SLActive surface demonstrates increased osteoblast activity and increased angiogenesis within the first several days after placement when compared to the SLA implant surface in animal studies." (This is a qualitative statement of improved biological response). |
| Criterion 4: Demonstrated Benefit of SLActive Surface (Clinical Performance - Early Stability) | "The SLActive surface has faster implant secondary stability in the early healing period of 2 to 4 weeks after implant placement when compared to the SLA surface." (This is a qualitative statement of improved clinical outcome. Specific quantitative metrics like a mean difference in stability index or time to stability are not provided in this summary, but would have been in the full submission). |
| Criterion 5: Specific Use Cases for Immediate Loading (as per Indications for Use) | "SLActive implants are intended for immediate placement and function on single-tooth and/or multiple tooth applications when good primary stability is achieved and with appropriate occlusal loading, to restore chewing function. Multiple tooth applications may be rigidly splinted. In the case of edentulous patients, 4 or more implants must be used in immediately loaded cases." (These are constraints/conditions for safe and effective use, rather than performance metrics, but demonstrate meeting specific clinical application requirements). |
2. Sample Size Used for the Test Set and Data Provenance
The summary states: "The subject device with the modified SLActive surface demonstrates increased osteoblast activity and increased angiogenesis within the first several days after placement when compared to the SLA implant surface in animal studies."
- Sample Size for Test Set: The sample size for the animal studies is not specified in this 510(k) summary.
- Data Provenance (Country of Origin, Retrospective/Prospective): The summary indicates "animal studies." The country of origin and whether the studies were retrospective or prospective are not specified.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
This information is not applicable and therefore not provided in the 510(k) summary for this type of device. The "ground truth" for an implant's biological performance in animal studies would be derived from histological analysis, biomechanical testing, and other laboratory-based assessments, not typically expert panel consensus on interpretations of images.
4. Adjudication Method for the Test Set
This is not applicable and therefore not provided. Adjudication methods like 2+1 or 3+1 are typically used in clinical imaging studies where human readers are assessing diagnostic output. The animal studies described would involve objective measurements and histological analysis.
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, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic AI devices that assist human readers. The SLActive implant is a physical medical device, not an AI diagnostic tool.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
- No, a standalone performance study as described (for an algorithm) was not done. This concept is also not applicable to a dental implant product. The "standalone" performance here refers to the implant's biological and mechanical performance.
7. The Type of Ground Truth Used
Based on the description of the studies ("increased osteoblast activity and increased angiogenesis... in animal studies," "faster implant secondary stability"), the ground truth would be established through a combination of:
- Pathology/Histology: For observing osteoblast activity and angiogenesis.
- Biomechanical Testing/Measurement of Stability: For assessing implant secondary stability.
- Physiological Outcome Data: Direct measurement of biological responses in animal models.
8. The Sample Size for the Training Set
- Not applicable/Not provided. This device is a physical implant, not an AI algorithm that requires a training set. The "studies" mentioned are performance evaluations, not algorithm training.
9. How the Ground Truth for the Training Set was Established
- Not applicable/Not provided for the same reasons as point 8.
§ 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.