(154 days)
The OSI O-ball Abutment implant is a self-tapping titanium threaded screw indicated for long term intra-bony fixation of upper and lower dentures in edentulous cases. These devices will permit immediate splinting and ability and short-term fixation of failing crown and bridge installations, for full or partial edentulism. They can be used in the anterior regions of the maxillary and mandibular arches and are indicated for immediate loading when there is good primary stability and appropriate occlusal load.
The JUELL OSI O-Ball Abutment Dental Implant is available with a gingival collar in four diameters: 3.0mm, 3.5mm, 4.0mm and 4.5mm. The JUELL OSI O-Ball Abutment Dental Implant is available in thread lengths ranging from 10mm to 18mm. The implant is manufactured from ASTM F136 Ti6Al4V. The threaded surface is blasted with particulate media to increase the surface area.
The provided FDA 510(k) summary for the Juell OSI O-ball Abutment Dental Implant focuses on establishing Substantial Equivalence to legally marketed predicate devices, rather than performing a rigorous study to prove the device meets specific acceptance criteria with quantifiable metrics.
Therefore, many of the requested sections (e.g., sample size for test/training sets, number of experts for ground truth, adjudication methods, MRMC studies) are not applicable or cannot be extracted from this document as these types of studies are not typically required for 510(k) clearances focused on substantial equivalence through material and design comparison and existing test standards.
Here's a breakdown of the information that can be extracted, and where the requested information is not applicable:
Acceptance Criteria and Device Performance for Juell OSI O-ball Abutment Dental Implant (K110348)1
The primary "acceptance criterion" for this 510(k) clearance is Substantial Equivalence to existing predicate devices, particularly regarding materials, design, indications for use, and successful fatigue testing.
The study presented is a comparison to predicate devices and demonstration of compliance with an industry standard for mechanical performance.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implicit for Substantial Equivalence) | Reported Device Performance (Juell OSI O-ball) |
|---|---|
| Material Equivalence (to Predicate) | Manufactured from ASTM F136 Ti6Al4V. |
| Design Equivalence (to Predicate) | O-ball implant head shape. Available in 3.0mm, 3.5mm, 4.0mm, 4.5mm diameters; 10mm-18mm thread lengths. "Designs are similar." |
| Indications for Use Equivalence (to Predicate) | "Indications for use is similar to those of the predicate devices." (See detailed description in the document). |
| Fatigue Performance (Modified ISO 14801) | "Tested to modified ISO 14801 successfully." |
| Surface Treatment Equivalence | "Blasted and clean" (compared to "Sandblasted and acid etched" and "Blasted and etched" for predicates). |
| Sterilization | Delivered sterile. |
2. Sample Size for Test Set and Data Provenance
- Sample Size for Test Set: Not explicitly stated for fatigue testing. Fatigue testing according to ISO 14801 typically involves multiple samples (e.g., 10-20 per condition) to establish a statistically significant endurance limit, but the exact number is not provided in this summary.
- Data Provenance: The fatigue testing was conducted by or for Juell Dental. The country of origin of the data is not specified, but the company is based in Ardmore, OK, USA. The testing is prospective for the device being submitted.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
Not applicable. This type of submission relies on engineering standards (ISO 14801) and comparison to predicate devices, not on expert-established ground truth for a test set in the clinical or diagnostic sense.
4. Adjudication Method for the Test Set
Not applicable. There was no clinical or diagnostic "test set" requiring adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No. An MRMC study is not relevant for this type of device (dental implant) and submission, which focuses on mechanical performance and substantial equivalence.
6. Standalone Performance Study (Algorithm Only)
Not applicable. This device is a physical medical device (dental implant), not a software algorithm.
7. Type of Ground Truth Used
The "ground truth" for the fatigue test was established by the ISO 14801 standard, which defines how dental implants should be subjected to cyclic loading to assess their durability. The outcome is whether the device successfully met the standard's criteria (i.e., did not fracture within a specified number of cycles at a given load).
8. Sample Size for the Training Set
Not applicable. There is no "training set" in the context of this device. The device design and materials are based on established engineering principles and comparison to existing, already "trained" (i.e., clinically proven) predicate devices.
9. How the Ground Truth for the Training Set Was Established
Not applicable. As there's no training set, there's no ground truth establishment for it.
§ 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.