(266 days)
The Highness Implant System is designed to be surgically placed in the maxillary or mandibular arches for the purpose of providing prosthetic support for dental restorations (crowns, bridges, and overdentures) in partially or fully edentulous individuals. It is used to the restore the patient's chewing function. Implants with diameter less than ø5.5mm are intended for immediate loading when good primary stability is achieved and with appropriate occlusal loading. Larger implants are dedicated to the molar region and are indicated for delayed loading.
The Multi-Unit Abutments are intended for multi-unit restorations only and can be used up to 25 degrees when connecting cylinder.
The Highness Implant System is a titanium-metal dental implant designed to be surgically placed in the bone of the upper or lower jaw to support prosthetic devices, such as artificial teeth, and to restore the patient's chewing function.
The Highness Implant System consists of fixtures and abutments.
The fixture is made of pure titanium metal and is supplied sterile (gamma irradiated). The surface is SLA, sandblasted (using 425-180-micron MCD apatitic abrasive, which is a granular, multi-phase calcium phosphate composed primarily of hydroxyapatite and tricalcium phosphate), large grit, acid-etched (solution of hydrochloric acid and nitric acid), treated.
The abutments are made of Ti-6Al-4V ELI titanium alloy (ASTM F136). It consists of a Cemented Abutment, Angled Abutment, Solid Abutment, Temporary Abutment, and Multi-Unit Abutment Screw & Abutment Screw, which are intended for use as an aid in single- or multiple-unit prosthetic restorations, and the Multi-Unit Abutment and Multi-Angled Abutment, which are intended for use only as aids in multiple-unit prosthetic restorations. In addition, Cover Screws and Healing Abutments are prefabricated prosthetic components that connect directly to endosseous dental implants and are indicated as temporary components to allow for soft tissue healing. All abutments are supplied non-sterile and individually packaged in FDA cleared wraps and/or pouches. The abutments should be sterilized prior to use by the end-user. And temporary abutments are intended to be used 6 months.
The abutments are compatible with both HS - I and HS - VII implant bodies.
This document, K240383, is a 510(k) Premarket Notification for the Highness Implant System. It primarily focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting a study proving the device meets specific acceptance criteria related to clinical performance or AI/software.
Based on the provided text, there is no information about acceptance criteria or a study that proves the device meets such criteria in the context of clinical effectiveness, AI performance, or human reader improvement. This document is a regulatory submission for a medical device (dental implants) and, as explicitly stated in Section X, it does not include data from clinical tests.
Therefore, I cannot provide answers to most of your requested points as they pertain to clinical studies, AI performance, or multi-reader multi-case studies, which are not present in this regulatory submission.
However, I can extract information related to non-clinical testing which demonstrates the device meets certain performance standards (acceptance criteria) for the device itself, not for an AI component or clinical outcomes.
Here's what can be extracted from the document regarding non-clinical performance:
1. A table of acceptance criteria and the reported device performance
The document provides performance data in relation to industry standards and guidance, which serve as the acceptance criteria for these non-clinical tests.
| Acceptance Criterion (Standard / Guidance) | Reported Device Performance |
|---|---|
| Fatigue: ISO 14801:2016 and FDA guidance on "Root-form Endosseous Dental Implants and Endosseous Dental Abutments – Class II Special Controls Guidance Document" (specifically, ability to withstand 5,000,000 cycles without failure under equivalent loading to primary predicate). | The test articles (Highness Implant System) were able to withstand 5,000,000 cycles without failure under substantially equivalent loading to the cited primary predicate device (K182448). |
| SLA Surface Treatment: Removal of particles/chemicals, no elements other than titanium on surface. | Cleaning validation and SEM/EDS (Scanning Electron Microscopy/Energy Dispersive X-ray Spectroscopy) analysis were performed. The SEM/EDS analysis confirms that no elements other than titanium were found on the surface of the implant. |
| Biocompatibility: ISO 10993-1:2018, ISO 7405:2018, ISO 10993-5:2019/2009, and FDA guidance. | The device fulfilled all required testing per specified ISO standards and FDA guidance. Cytotoxicity testing was conducted as per ISO 10993-5. (No specific numerical performance metric is given beyond "fulfilled all testing" and "was conducted," implying successful completion against the standard's criteria). |
| Sterilization (Non-sterile abutments): ISO 17665-1:2006, ISO/TS 17665-2:2009. | Demonstrated a Sterility Assurance Level (SAL) of 10^-6. |
| Sterilization (Sterile implants/fixtures): ISO 11137-1:2006, -2:2013, -3:2017. | Gamma sterilization validation was performed in accordance with these standards. (No specific numerical performance metric is given beyond "was performed," implying successful validation). |
| Shelf Life (Sterile implants/fixtures packaging): ISO 11607-1:2019, -2:2019, ASTM F1980-21. | Sterile barrier testing confirms the stability and effectiveness of the packaging for a shelf life of 5 years by evaluating changes due to accelerated aging. (Implies satisfactory performance against these standards). |
| Bacterial Endotoxin Testing (Sterile implants): ANSI/AAMI ST72:2019. | Performed at a test limit of 20 EU/device. (Implies meeting the limit, as no negative result is stated). |
| MRI Safety (Non-clinical worst-case review): FDA guidance "Testing and Labeling Medical Devices for Safety in the Magnetic Resonance (MR) Environment." | Reviewed using scientific rationale and published literature. The rationale addressed parameters including magnetically induced displacement force and torque based on all compatible components and material composition. (Implies satisfactory addressing of these safety concerns through a non-clinical review). |
Points that cannot be addressed from the document:
- 2. Sample sized used for the test set and the data provenance: Not applicable for non-clinical tests in the context of user evaluation or clinical effectiveness. The numbers of devices tested for fatigue, biocompatibility, and sterilization validation are not specified, only that the tests were performed "in accordance with" standards. Data provenance (country, retrospective/prospective) is typically for clinical data, which is absent.
- 3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable, as this refers to establishing ground truth for perception/interpretation tasks, or clinical endpoints, neither of which are part of this 510(k) submission.
- 4. Adjudication method: 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, as there's no AI component or clinical study.
- 6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable, no algorithm.
- 7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable for non-clinical material and mechanical tests. The "ground truth" here is the physical and material properties meeting specified engineering and biological standards.
- 8. The sample size for the training set: Not applicable, no AI/training set.
- 9. How the ground truth for the training set was established: Not applicable, no AI/training set.
§ 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.