(129 days)
Intended for surgical placement in the maxillary and/or mandibular arch to support crowns, bridges, or overdentures in edentulous or partially edentulous patients.
The Uniplant Dental Implant System is composed of a solid titanium alloy root-form implant and a solid conical abutment, with associated instruments. The implant is a screw-type, two-stage design, incorporating a titanium cover screw that seals the internal bore of the implant from the physiologic environment during healing. The implant is available in three diameters (3.4, 4.1 and 5.1 mm) and three implanted lengths (10 mm, 12 mm and 14 mm). The system includes surgical instruments such as drills, insertion modules and try-ins. The system includes a solid conical abutment that is intended to the implant by engaging the threaded shaft of the abutment in the internal threaded bore of the implant. The abutment includes a cylindrical transmucosal portion and a tapered, grooved coronal portion, with an internal hex socket at the coronal end to facilitate attachment to the implant. A prosthesis may be fabricated by means of standard crown and bridge techniques for attachment to the abutment.
The provided text is a 510(k) summary for the Uniplant Dental Implant System from 2001. This type of regulatory submission typically focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting new clinical study data with specific acceptance criteria and performance metrics.
Therefore, the information you've requested regarding acceptance criteria, device performance, sample sizes, ground truth establishment, expert adjudication, and MRMC studies is not present in the provided document. The 510(k) process for this device relies on demonstrating similarity to existing devices for which safety and effectiveness have already been established.
However, I can extract the information related to substantial equivalence, which is the core of this document.
Here's a breakdown of the available information based on your request, highlighting what is not applicable (N/A) given the nature of a 510(k) submission for this type of device:
1. A table of acceptance criteria and the reported device performance
- Acceptance Criteria: N/A. This document does not define specific performance acceptance criteria for the Uniplant Dental Implant System in the way a clinical study would with primary endpoints (e.g., success rates, failure rates, stability metrics). Instead, it demonstrates that the device's characteristics are comparable to predicate devices.
- Reported Device Performance: N/A. The document does not report specific device performance data from clinical trials with numerical outcomes. It asserts equivalency in design and materials.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- N/A. No clinical test set or data provenance is mentioned. The submission is based on a comparison to existing devices and their known characteristics.
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)
- N/A. No test set requiring expert ground truth establishment is described.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- N/A. No test set requiring adjudication is described.
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
- N/A. This is a medical device (dental implant), not an AI-driven diagnostic tool. Therefore, an MRMC study is not relevant here.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- N/A. Not an AI algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- N/A. No specific ground truth is established for this device. The basis for approval is substantial equivalence to predicate devices, whose safety and effectiveness are established through their existing market history and previous regulatory clearances.
8. The sample size for the training set
- N/A. Not an AI algorithm.
9. How the ground truth for the training set was established
- N/A. Not an AI algorithm.
Summary Table of Substantial Equivalence (as provided in the document):
This table demonstrates the basis for regulatory acceptance, which is equivalence to previously approved devices, rather than a clinical study's acceptance criteria.
| Characteristic | Uniplant Dental Implant System (Subject Device) | Predicate Devices (Examples given in the table) |
|---|---|---|
| INTENDED USE | ||
| Surgical placement in the maxillary and/or mandibular arch to support crowns, bridges, or overdentures in edentulous or partially edentulous patients | YES | YES |
| DESIGN | ||
| Body shape | cylindrical | cylindrical ("O" Company, Simpler), tapered (Steri-Oss) |
| Surface design | threaded | threaded |
| Single-stage or two-stage design | two-stage | two-stage ("O" Company, Steri-Oss), single-stage or two-stage (Simpler) |
| Method of abutment attachment to implant | threaded connection | threaded connection ("O" Company, Simpler), screw (Steri-Oss) |
| Available diameters, mm | 3.4, 4.1, 5.1 | 3.25, 4.0 ("O" Company, Simpler), 6.0, 5.0, 4.3 (Steri-Oss) |
| Available lengths, mm | 10, 12, 14 | 8, 10, 12, 14, 16 ("O" Company), 10, 13, 16 (Steri-Oss), 8, 10, 13, 15 (Simpler) |
| Solid abutment for cemented restorations | YES | YES |
| MATERIALS | ||
| Implant body | Ti-6Al-4V | CP Ti ("O" Company, Steri-Oss), Ti-6Al-4V (Simpler) |
| Abutment | Ti-6Al-4V | Ti-6Al-4V ("O" Company, Simpler), Ti alloy (Steri-Oss) |
| Surface characteristics / coating | RBM or HA | Machined or HA ("O" Company), HA (Steri-Oss), Grit blasted or HA (Simpler) |
Study Proving Device Meets Acceptance Criteria:
The document describes a substantial equivalence review rather than a specific clinical study to prove the device meets pre-defined acceptance criteria for performance.
- Study Type: Substantial Equivalence Comparison.
- Methodology: The manufacturer compared the Uniplant Dental Implant System to three established predicate devices (products from "O" Company, Steri-Oss Replace, and Simpler Implant System) that had already demonstrated safety and effectiveness and were legally marketed. The comparison was based on:
- Intended Use: All devices shared the same intended use for surgical placement to support crowns, bridges, or overdentures in edentulous or partially edentulous patients.
- Design and Functional Characteristics: Similarities in root-form threaded design, two-stage configuration, and abutment attachment methods were highlighted. Variations in dimensions (diameters, lengths) were noted, but within the scope of predicate devices.
- Material Composition: Comparison of implant and abutment materials (Ti-6Al-4V, CP Ti) and surface treatments (HA coating, RBM treatment) to those of the predicate devices, emphasizing the widespread and biocompatible nature of these materials. The HA coating's characteristics were also compared to vendor master files and FDA Guidance Document suggestions for crystallinity, purity, and mechanical properties.
- Conclusion of the Review: The FDA's letter (K011574) states, "We have reviewed your Section 510(k) notification... and we have determined the device... is substantially equivalent to legally marketed predicate devices." This determination signifies that based on the provided comparison, the device is considered as safe and effective as the predicate devices, without requiring new clinical performance data.
§ 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.