(270 days)
Noris Medical Dental Implants System is intended to replace missing tooth/teeth in either jaw for supporting prosthetic devices that may aid in restoring the patient's chewing function. The procedure can be accomplished in a one-stage or two-stage surgical operation. All implants are appropriate for immediate loading when good primary stability is achieved and with appropriate occlusal loading.
Noris Medical Zygomatic Dental Implant System is intended to be implanted in the upper jaw arch to provide support for fixed or removable prosthetic devices in patients with partially or fully edentulous maxillae.
Noris Medical Dental Implants are tapered internal hex implants, designed to enable easy insertion while supporting excellent initial stability. The variable thread design enables self-tapping, thus providing solutions for a variety of bone conditions. Noris Medical multi-design features offer a solution for immediate placement and immediate loading. The implantation procedure can be accomplished in a one-stage or twostage surgical operation for all implants type beside the Mono(Noris Medical cleared K140440) which is for one stage only. Packaging has been designed for quick identification and easy opening.
The Noris Medical Zygomatic Dental Implant is designed to provide a solution for cases of atrophic maxilla. The shape of the Noris Medical Zygomatic Dental Implant consists of sharp threads at the apical part. The platform of the Noris Medical Zygomatic Dental Implant is 3.75mm platform, with internal Hex connection. The Noris Medical Zygomatic Dental Implant is available in a large variety of lengths, from 30 mm to 57.5 mm.
Prosthetic Components for Noris Medical Zygomatic Implant: Multi unit and Vari connect 45° prosthetic system are subject of this current submission as a part of the Zyqomatic Dental Implant System.
Materials and Production: The implants and prosthetic components are manufactured from Titanium alloy complying with standard ASTM F 136 Standard Specification for Wrought Titanium-6Aluminum-4Vanadium ELI (Extra Low Interstitial) Alloy for surgical implant applications. Noris Medical employs the RBM (Resorbable Blast Media) surface treatment technology. The product is packed using materials known in the industry to be appropriate for medical device packaging and is provided with a minimum sterility assurance level of 10 ° validated in compliance with ANSI/AAMI/ISO 11137-1.
The provided document is a 510(k) summary for the Noris Medical Zygomatic Dental Implant System (K151909). It describes the device, its intended use, and claims substantial equivalence to predicate devices based on non-clinical and clinical testing.
Here's a breakdown of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state formal "acceptance criteria" as clear numerical thresholds for performance metrics. Instead, it demonstrates substantial equivalence to predicate devices through various tests and a retrospective clinical study. The "reported device performance" is primarily presented as a success rate from the clinical study.
| Performance Metric | Acceptance Criteria (Not explicitly stated as numerical criteria in this document) | Reported Device Performance |
|---|---|---|
| Non-clinical testing: | ||
| SEM and Surface analysis (EDS) | Morphology and cleanliness similar to predicate devices. | Demonstrated morphology and cleanliness of final product. |
| Sterilization validation | Compliance with ANSI/AAMI/ISO 11137-1, EN ISO 11137-2, and ANSI/AAMI ST79. | Tests conducted in compliance with specified standards. |
| Biocompatibility testing | Compliance with AAMI ANSI ISO 10993-5 and AAMI ANSI ISO 10993-11. | Tests conducted in compliance with specified standards. |
| Accelerated aging (shelf life) | 5 years shelf life validated against peel, dye, and burst tests. | 5 years shelf life substantiated. |
| Static and dynamic compression testing | Similar to predicate devices (per ISO 14801, modified for zygomatic design). | Results indicate substantial equivalence to predicate devices. |
| Clinical Study: | ||
| Success endpoint | Osseointegration following implant placement. | 96% success rate after at least 6 months follow-up. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample size for the test set (Clinical Study): 18 patients, involving a total of 29 Zygomatic implants.
- Data provenance: Retrospective clinical case studies. The study was conducted in one clinical site in Israel.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
The document does not specify the number of experts or their qualifications used to establish the ground truth for the clinical study. It mentions that patients were evaluated at a minimum of 6 months post-surgery for the success endpoint of osseointegration. Imaging (CT and panoramic radiographs) was used for evaluation.
4. Adjudication Method for the Test Set
The document does not specify an adjudication method (e.g., 2+1, 3+1). It only states that "Patients were evaluated at a minimum of 6 months post-surgery, with the success endpoint identified as osseointegration following implant placement."
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
No, an MRMC comparative effectiveness study was not done. The study described is a retrospective clinical case study of the device itself, not a comparison of human readers with and without AI assistance.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) Was Done
This question is not applicable. The device is a physical dental implant system, not an algorithm or AI system. Therefore, standalone algorithm performance is not relevant.
7. The Type of Ground Truth Used
For the clinical study, the ground truth for device success was defined as osseointegration following implant placement. This was assessed through patient evaluations at follow-up and imaging (CT and panoramic radiographs).
8. The Sample Size for the Training Set
This question is not applicable. The document describes a medical device (dental implant system), not an AI/ML algorithm that requires a training set. The clinical study described served as a validation/test set for the device's performance.
9. How the Ground Truth for the Training Set Was Established
This question is not applicable, as there is no training set for an AI/ML algorithm described.
§ 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.