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510(k) Data Aggregation
(149 days)
IS-III HActive Fixture
The IS-III HActive Fixture 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, and to restore the patient's chewing function. It is intended for immediate loading when good primary stability is achieved and with appropriate occlusal loading.
IS-III HActive Fixture is composed of fixtures and cover screw. Fixtures are thread type implants made of titanium alloy which will be placed in the alveolar bone to replace the function of the missing tooth. It is made of Titanium Alloy based on ASTM F136. Surface treatment is HA Coating. This device has connection between the upper prosthesis and the internal hex. Surface is treated with RBM (Resorbable Blasting Media) using Hydroxyapatite powder. Residues are removed through a washing procedure after Plasma-spray with Hydroxyapatite and formation of the HA coating. It is only part to be implanted into bone, and to provide connection of prosthetic devices or other components of a dental implant set with human body (mandibular or maxillary bone). The diameters are 3.5/4.0/4.5/5.0/6.0/7.0mm and the lengths are 7.3/ 8.5/10.0/ 11.5/13.0/15.0mm. (Do not offer 3.5 x 7.3mm implant, 6.0 x 15mm implant, or 7.0 x 15mm implant). Cover Screw intended to protect the inside of the implant during osseointegration. It is made of titanium alloy according to ASTM F136. The surface treatment of the cover Screw is anodizing or non-anodizing. The purpose of anodizing is to distinguish the sizes with the naked eyes for convenience. The diameter of cover screw is 3.45/3.6mm. IS-III HActive Fixture is enclosed with Cover Screw in a packing. IS-III HActive Fixture and Cover Screw can be packed separately for convenience.
The provided text describes the submission of a new dental implant device (IS-III HActive Fixture) to the FDA for substantial equivalence to existing predicate devices. It does not contain information about acceptance criteria or a study proving the device meets specific performance criteria in the way a diagnostic AI/ML device submission would.
The document focuses on demonstrating that the new device is as safe and effective as previously approved devices by comparing their characteristics (intended use, materials, design, etc.) and presenting results from non-clinical testing. This type of submission (510(k)) does not typically include clinical studies with acceptance criteria for device performance as would be seen for AI/ML-driven diagnostics.
Therefore, most of the requested information cannot be extracted from this document, as it pertains to a different type of device and regulatory submission.
However, I can extract the following relevant information:
1. A table of acceptance criteria and the reported device performance:
This document does not provide a formal table of acceptance criteria and reported device performance in the context of diagnostic accuracy (e.g., sensitivity, specificity, AUC). Instead, it refers to meeting criteria of various engineering and biocompatibility standards.
| Acceptance Criteria Category | Specific Standard/Test | Reported Performance (Summary) |
|---|---|---|
| Biocompatibility | ISO 10993-1:2009, ISO 10993-3:2014, ISO 10993-.5:2009, ISO 10993-6:2007, ISO 10993-10:2010 and ISO 10993-11:2006 | Device is biocompatible and substantially equivalent. |
| Mechanical Performance | Bench testing (visual, dimension, compressive loads, fatigue, adaptation accuracy, torque tests) | Met the criteria of the standards and demonstrated substantial equivalence. |
| Fatigue Life | ISO 14801:2016 (worst-case scenario) and "Guidance for Industry and Staff - Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Implant Abutments" | Performed with angled abutment of predicate device; results met criteria. |
| Sterilization | ISO 11137-1:2006, ISO 11137-2:2013, and ISO 11137-3:2006 | Met the criteria of the standards. |
| Shelf Life | ASTM F1980 | Met the criteria of the standards. |
| Endotoxin Levels | ANSI/AAMI ST72:2011, USP , and USP | Met the criteria of the standards. |
| Coating Adhesion | Comparative SEM surface evaluation | Demonstrated HA coating adhesion. |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Not applicable. The document describes non-clinical bench testing and biocompatibility assessments, not a diagnostic test on a test set of human 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)
Not applicable. Ground truth for diagnostic performance is not established in this type of submission. Performance is based on material properties and mechanical integrity.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable.
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
Not applicable. This is not an AI/ML device.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. This is not an AI/ML device.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
For the non-clinical testing, the "ground truth" or reference was based on established industry standards (ISO, ASTM, ANSI/AAMI, USP) and FDA guidance documents for mechanical, material, and biological properties of medical devices.
8. The sample size for the training set
Not applicable. This is not an AI/ML device.
9. How the ground truth for the training set was established
Not applicable.
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