(374 days)
A.B. DENTAL DEVICES® Dental Implants System is indicated for use in surgical and restorative applications for placement in the bone of the upper or lower jaw to provide support for prosthetic devices, such as artificial teeth, in order to restore the patient's chewing function. A.B. DENTAL DEVICES® Dental Implants System is indicated also for immediate loading when good primary stability is achieved and with appropriate occlusal loading.
Two Stage Implants: I22, I5, I55, I10.
P4 and P14 angled abutments are to be used only with standard platform implants 3.5 mm in diameter or larger.
A.B. DENTAL DEVICES® Dental Implants System consists of one and two stage endosseous form dental implants, internal hexagonal and one piece implants systems. Narrow platform implants are to be used with straight abutments only. The following components are being added:
| Implant | Platform | Diameter, mm | Length, mm |
|---|---|---|---|
| I22 | Standard | 3.75 | 8, 10, 11.5, 13, 16 |
| 4.2 | 8, 10, 11.5, 13, 16 | ||
| 4.5 | 8, 10, 11.5, 13, 16 | ||
| 5 | 8, 10, 11.5, 13, 16 | ||
| I5 | Narrow | 3.3 | 10, 11.5, 13, 16 |
| I55 | Narrow | 3.3 | 10, 11.5, 13, 16 |
| 3.5 | 8, 10, 11.5, 13, 16 | ||
| Standard | 3.75 | 8, 10, 11.5, 13, 16 | |
| 4.2 | 8, 10, 11.5, 13, 16 | ||
| 4.5 | 8, 10, 11.5, 13, 16 | ||
| 5 | 8, 10, 11.5, 13, 16 | ||
| 6 | 8, 10, 11.5, 13, 16 | ||
| I10 | Standard | 4.5 | 10, 11.5, 13, 16 |
Abutments:
- P0-14 Healing caps, 2.5 7 mm heights .
- P3-5 straight abutments, 5 mm diameter, 7 9 mm length ●
- P4 angled abutments, 15 - 25 degree angulation, standard platform, standard and long lengths
This is a 510(k) summary for a dental implant system. The document focuses on demonstrating substantial equivalence to a predicate device rather than providing extensive performance data against specific acceptance criteria for a novel AI/ML device. Therefore, much of the requested information regarding AI/ML device performance studies is not available in this document.
Here's an analysis of the provided text based on your request, highlighting what is present and what is not:
1. A table of acceptance criteria and the reported device performance
The document does not provide a table of acceptance criteria in the typical sense for an AI/ML device, as it describes a dental implant system. The performance data presented are primarily related to mechanical and biological safety, not diagnostic accuracy or effectiveness against quantifiable metrics for an AI system.
However, we can infer some "performance data" or testing performed:
| Test Performed | Reported Device Performance |
|---|---|
| Fatigue testing per ISO 14801:2007 | Performed on worst-case implant and abutment combination for standard platform implants and abutments. Engineering analysis to determine novel worst-cases. (Implication: Device withstands fatigue as per standard) |
| Cytotoxicity testing per ISO 10993-5 | Performed. (Implication: Device is biocompatible) |
| Biological risk assessment | Performed. (Implication: Risks are assessed and managed) |
| Gamma sterilization validation per ISO 11137 | Validated. (Implication: Device is sterile) |
| Steam sterilization validation per ANSI/AAMI/ISO 17665-1:2006 | Validated. (Implication: Device is sterile) |
| Packaging validation and accelerated shelf-life testing | Performed. (Implication: Packaging maintains sterility, shelf life is established) |
| LAL testing | Performed. (Implication: Device is endotoxin-free) |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided. The performance data listed (fatigue, cytotoxicity, sterilization, etc.) are standard engineering and biological tests for medical devices, not clinical studies with patient data.
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)
This information is not applicable and not provided. The "ground truth" for these tests relates to established standards and physical/chemical properties, not expert consensus on medical images or patient outcomes.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable and not provided.
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
This information is not applicable and not provided. This is a conventional dental implant, not an AI-powered device.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
This information is not applicable and not provided.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The ground truth for the performance tests (fatigue, cytotoxicity, sterilization) would be the established international standards themselves (ISO 14801, ISO 10993-5, ISO 11137, ANSI/AAMI/ISO 17665-1) and their defined pass/fail criteria. For LAL testing, it would be the absence of endotoxins as per FDA guidance.
8. The sample size for the training set
This information is not applicable and not provided. This is not an AI/ML device.
9. How the ground truth for the training set was established
This information is not applicable and not provided. This is not an AI/ML device.
§ 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.