Search Results

The OsseOne Dental Implant System implants are endosseous implants intended to be surgically placed in the upper or lower jaw arches to provide support for prosthetic devices, such as an artificial tooth, in order to restore patient's esthetics and chewing function. OsseOne Dental implants are intended for single or multiple unit restorations on splinted or non-splinted applications. OsseOne Dental implants are intended for immediate loading when good primary stability is achieved, and with appropriate occlusive loading. These implants can also be used for loading after a conventional healing period.

The OsseOne Dental Implant System contains 1 design of internal hex implant and a multipurpose indexed hex abutment as described below as well as 3 designs of conical implant with NP and RP platforms and abutments corresponding to both platforms. All devices are made from ASTM F136 Ti-6AL-4V ELI unless otherwise noted. The implants have a grit blasted and acid etched surface. Conical abutments need to match the implant platform of narrow or regular. No abutments are intended to be modified by the user other than the multipurpose indexed abutments & tapered multipurpose abutments which can be reduced in height to a minimum of 6mm above the platform. Multipurpose indexed abutments & tapered multi-purpose abutments are not intended for angular correction and are not intended to be cast.

OsseoMax Hex implants are tapered internal hex implants with evenly spaced large threads the length of the implant. OsseoMax Hex comes in 4.6, and 5.4 mm diameter with lengths of 8, 10mm. OsseoMax Hex are only restored using hex ball attachments or Denture Lock hex cleared in K182293.

Tapered Multipurpose Indexed Hex Abutments have a 3.75mm platform diameter with a total height of 10.98mm. Height above the platform is 7.58mm. Tapered Multipurpose Indexed Hex Abutments are to be used with internal hex implant designs cleared in K182293 and are not to be used with OsseoMax Hex.

OsseoCone implants are slightly tapered conical implants with evenly spaced sharp edge threads with microthreads in between them as well as microgrooves in the collar. OsseoCone comes in NP (3.5mm), and RP (4.3, 5.0, and 5.5mm) in lengths of 8.5, 10, 11.5, 13 and 15mm.

OsseoCone Plus implants are very slightly tapered conical implants with more tightly spaced flat edge threads at the top and wider spaced sharp edge threads in the lower tapered section. OsseoCone Plus comes in 3.5 (NP), 4.3 (RP), 5.0 (RP) and, 5.5 (RP) mm diameter with lengths of 8, 10, 11.5, 13, and 16 mm (no 5.5 x 16mm).

OsseoMax Conical implants tapered conical implants with evenly spaced large threads the length of the implant. OsseoMax Conical comes in 4.6 and 5.4 RP diameter with lengths of 8, 10mm. OsseoMax Conical are only restored using Conical ball attachments or Conical Denture Lock.

Conical healing caps come in NP and RP (3.75 and 4.5 mm diameter) with cuff heights (also height above gingiva) of 2,3,4,5 mm. Total heights are 7.32, 8.32, 9.32, 20.32 mm and 7.47, 8.47, 9.47, 10.47mm. NP and RP conical cover screws are also available. A healing cap for multi-units is available.

Conical straight abutments in 4.5mm diameter come in NP and RP with heights above gingiva of 7.7, 10.7 and 6.1, 8.3mm. Total heights are 11.85, 15.9mm and 10.6, 13mm.

Conical anatomic abutments in 4.5mm diameter come in NP and RP with gingival heights of 1,2,3 mm. Height above the platform is 7.5mm. Total heights are 11.8, 12.6, 13.6mm for both NP and RP versions.

Conical angled anatomic abutments in 5mm diameter come in 15° and 25° NP with shoulder cuff heights of 1,2,3 mm and total heights of 10.7, 12.2, 13.7 mm. Height above platform is 7.6mm.

Conical angled anatomic abutments in 5mm diameter come in 15° and 25° RP with shoulder cuff heights of 1,2,3,4 mm and total heights of 11, 12, 13, 14 mm. Height above platform is 8.4mm.

Multipurpose Indexed Conical abutment comes in NP, RP, and RP Wide with platform diameters of 4.2, 4.2 and 4.7 mm Total heights are 11.69, 11.33 and 11.33 mm. Height above platform is 8.29, 7.93, 7.93mm. Multipurpose Indexed Conical abutments are to be used with the conical implants listed above but are not to be used with OsseoMax Conical Implants.

Conical ball attachments come in 3.5mm diameter for NP and 5.0mm diameter for RP with cuff heights of 1,2,3,4,5,6 mm. Total heights are 9.5, 10.5, 11.5, 12.5, 13.5, 14.5mm and 9.45, 10.45, 11.45, 12.45, 13.45, 14.45mm. Height above the platform is 3.47, 4.47, 5.47, 6.47, 7.47, 8.47mm and 4, 5, 6, 7, 8, 9mm.The ball attachments snap into a stainless steel housing which has a polyamide or polyether retention cap. The Retention Caps come in the colors yellow, pink and clear which represent 0.5, 0.9, and 1.3 kg retention levels. The retention caps allow implants to be within 14° of vertical and still snap into place. The housing and retention caps were cleared in K182293.

Conical Denture Lock attachments come in 3.5mm diameter for NP and 5.0mm diameter for RP with cuff heights of 1,2,3,4 mm. Total heights are 8.95, 9.95, 10.95, 11.95mm and 8.7, 9.7, 10.7, 11.7mm. Height above the gingiva is 2.3, 3.3, 4.3, 5.3mm. The Denture Lock attachments snap into a Ti6AL4V ELI housing which has a polyamide, polyether or polyoxymethylene retention cap. The Retention Caps come in the colors yellow, pink, clear, purple which represent 0.6, 0.8, 1.0, 1.5 kg retention levels. The retention caps allow implants to be within 20° of vertical and still snap into place. The housing and retention caps were cleared in K182293.

Conical straight multi-units in NP and RP are 4.8mm in diameter with cuff heights of 1,2,3,4,5 mm. Height above platform is 3.6, 4.6, 5.6, 6.6, 7.6mm. Total heights are 9.1, 10.1, 11.1, 12.1, 13.1mm and 9.25, 10.25, 11.25, 12.25, 13.25mm.

Conical NP and RP Angled Multi-Units are 4.8mm in diameter and come in 17° and 30° with cuff heights of 1, or 2 mm. Cone height above platform 2.15mm. NP total heights are 6.35, 7.35mm and 6.85, 7.85mm. RP total heights are 6.75, 7.11mm and 7.15, 8.15mm.

Conical abutment screws in NP & RP are used with conical abutments including angled multi-units.

The provided FDA 510(k) clearance letter and summary for the "OsseOne Dental Implant System" does not contain information typically found in an AI/software as a medical device (SaMD) submission regarding acceptance criteria, study design, and performance metrics for an AI-powered diagnostic device.

This document describes a dental implant system, which is a physical device used in surgery, not a software or AI-driven diagnostic tool. Therefore, the questions related to AI performance, human reader improvement with AI, ground truth establishment for AI models, and training/test set sizes for AI are not applicable to this submission.

The "Testing Summary" section primarily discusses non-clinical physical performance and biocompatibility testing for the dental implant components.

Here's a breakdown of the relevant information found in the document, framed as closely as possible to your request for acceptance criteria and study details, acknowledging the nature of the device:

OsseOne Dental Implant System - Acceptance Criteria and Study Overview

This FDA 510(k) clearance pertains to a physical medical device, the OsseOne Dental Implant System, and not an AI or software-based diagnostic tool. Therefore, the acceptance criteria and study details focus on the mechanical and biological aspects of the implant system rather than AI performance metrics.

1. Table of Acceptance Criteria and Reported Device Performance

The document does not present explicit "acceptance criteria" in a quantitative performance table typical for AI/diagnostic devices. Instead, it states that the device was tested to demonstrate safety and effectiveness for its intended use, primarily through non-clinical laboratory testing. The reported performance is summarized qualitatively.

2. Sample Size for Test Set and Data Provenance

For this physical device, there isn't a "test set" of patient data in the way an AI diagnostic device would have. The "samples" refer to the physical implant components tested in various laboratory conditions.

• Sample Size for Testing: Not explicitly stated as a number of implants/abutments for each test. The summary mentions "Dynamic fatigue testing according to ISO 14801 was conducted," "Biocompatibility testing...was done," "Steam sterilization validation was conducted," etc. ISO standards typically prescribe minimum sample sizes for such tests.
• Data Provenance: Not applicable in terms of retrospective/prospective patient data or country of origin for patients. The data provenance is from laboratory testing performed by the manufacturer or contract labs.

3. Number of Experts and Qualifications for Ground Truth

Not applicable. "Ground truth" in the context of an FDA 510(k) for a physical device like a dental implant is established through adherence to recognized international standards (e.g., ISO, ASTM), material specifications, and validated engineering principles. There are no "experts establishing ground truth" on a test set of cases in the diagnostic sense. The experts are the engineers, material scientists, and microbiologists who perform and interpret the laboratory tests according to established protocols.

4. Adjudication Method for Test Set

Not applicable. This concept pertains to resolving discrepancies in expert interpretations of diagnostic data, which is not relevant for physical device performance testing.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

Not applicable. This type of study is specific to evaluating the clinical effectiveness of AI-assisted diagnostic tools by comparing human reader performance with and without AI assistance. The OsseOne Dental Implant System is a physical implant, not a diagnostic aid.

6. Standalone Performance (Algorithm Only)

Not applicable. There is no AI algorithm in this device. The system is a physical dental implant.

7. Type of Ground Truth Used

For this physical medical device, the "ground truth" is established through:

• Engineering Standards: Conformance to mechanical test standards (e.g., ISO 14801 for fatigue).
• Biocompatibility Standards: Conformance to biological safety standards (e.g., ISO 10993 for cytotoxicity, sensitization, irritation).
• Material Specifications: Verification that components meet specified material requirements (e.g., ASTM F136 Ti-6AL-4V ELI).
• Sterilization Validation: Demonstrated effectiveness of sterilization processes (e.g., ISO 17665-1, ISO 11137-2).

8. Sample Size for the Training Set

Not applicable. There is no training set as this is not an AI/machine learning device. The design and manufacturing processes are validated through engineering and biological testing, not through training on data.

9. How the Ground Truth for the Training Set Was Established

Not applicable, as there is no training set.

Ask a specific question about this device

OsseOne Dental Implants are endosseous implants intended to be surgically placed in the upper or lower jaw arches to provide support for prosthetic devices, such as an artificial tooth, in order to restore patients and chewing function. Osse one implants are intended for single or multiple unit restorations on splinted applications. OsseoPlus and OsseoLock are intended for immediate loading when good primary stability is achieved, and with appropriate occlusive loading. These implants can also be used for loading after a conventional healing period. OsseoLock 3.3 implants are intended to replace a lateral incisor in the maxilla and/or a central incisor in the mandible. Mandibular central and lateral incisors must be splinted if using two or more 3.3 implants adjacent to one another.

OsseOne Dental Implant System is an internal hex implant system with two models of implant, OsseoLock which is a cylindrical implant and OsseoPlus which is a spiral implant. OsseoLock comes in 3.3, 3.7, 4.2, 5.0, and 6.0 diameter. OsseoPlus comes in diameters of 3.5, 3.75, 4.2, 5.0 and 6.0. The implants come in lengths of 8, 10, 11.5, 13 and 16. OsseoLock 5.0 and 6.0 diameter implants do not come in 16mm length. Both straight and angled abutments are available. The implants have a grit blasted and acid etched surface. Standard abutments, standard narrow abutments, standard shoulder abutments, standard wide shoulder abutments, multi-unit abutments, denture lock abutments, overdenture abutments, angled overdenture abutments, ball attachments, healing caps (3.8, 4.6, 5.5, and 6.3 mm diameter), UCLA in 4.5mm diameter and standard 15° and 25° abutments are included in the system.

The provided text describes the OsseOne Dental Implant System and its equivalence to a predicate device, the SpiralTech Dental Implant System. It does not contain information about an AI/ML-driven device or study parameters related to AI/ML device performance. Therefore, I cannot extract the requested information regarding acceptance criteria and study details for an AI/ML device.

The document discusses the following types of testing for the OsseOne Dental Implant System:

• Dynamic fatigue testing (ISO 14801): To determine abutment strength.
• Surface analysis: According to FDA guidance.
• Sterilization validation: For implants (ISO 11137-1 and ISO 11137-2) and abutments (ISO 17665-1 and ISO 17665-2).
• Package integrity testing and accelerated aging: According to ASTM F1929-12, ASTM F 1980-07(2011), ASTM D 4332-13, ASTM D 999-08, ASTM D4169-09, ASTM D5276-98(2009), and ASTM F 3039-13.
• Materials testing: ASTM F136.
• Endotoxin testing: USP 161.
• Cytotoxicity testing: ISO 10993-5.

The study presented is a substantial equivalence comparison study where the OsseOne Dental Implant System is compared to the SpiralTech Dental Implant System.

Acceptance Criteria and Reported Device Performance (Table):

Missing Information (as per your request for AI/ML devices):

The provided text does not contain any of the following details, as the device is not an AI/ML device:

• Sample size used for the test set and data provenance (e.g. country of origin of the data, retrospective or prospective)
• Number of experts used to establish the ground truth for the test set and the qualifications of those experts
• Adjudication method (e.g. 2+1, 3+1, none) for the test set
• If a multi-reader multi-case (MRMC) comparative effectiveness study was done, or the effect size of how much human readers improve with AI vs without AI assistance
• If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
• The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
• The sample size for the training set
• How the ground truth for the training set was established

Ask a specific question about this device