(301 days)
Noris Medical Ltd 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 surgical operation. All implants are appropriate for immediate loading when good primary stability is achieved and with appropriate occlusal loading.
Mono implants are specifically indicated for replacing maxillary lateral incisors and mandibular central and lateral incisors. They are used for immediate, non-occlusal provisionalization in single-tooth restorations. Multiple-unit restorations should be splinted together and may be used immediately when clinically appropriate.
The Noris Medical Dental Implants System consists of one or two stage endosseous form dental implants, internal hexagonal and one piece implants system Abutments and Superstructures are used in conjunction with an endosseous dental implant fixture to aid in prosthetic rehabilitation. The implantation procedure can be accomplished in a one-stage or two-stage surgical operation for all implants type beside the Mono which is for one stage only. The system includes Tuff Implants, Tuff TT Implants, Onyx Implants, and Mono Implants, all made of titanium alloy Ti 6Al 4V ELI. The system also includes prosthetic components such as healing caps, cemented restorations (straight and angular abutments), screw retained restorations (Multi unit, Esthetic screw abutments), removable restorations (Vari connect abutments, Ball attachments, Flat attachments), and accessories. The implants and prosthetic components are manufactured from Titanium alloy (Ti 6Al 4V ELI) and employ the SLA (Sandblasted, Large grit, Acid etched) surface treatment technology.
The Noris Medical Dental Implants System is a device intended to replace missing teeth, and the information provided is a 510(k) Summary submitted to the FDA to demonstrate substantial equivalence to legally marketed predicate devices, rather than a study proving the device meets specific acceptance criteria in a clinical setting.
Therefore, many of the requested categories related to clinical study design, acceptance criteria tables with performance, sample sizes for test/training sets, expert involvement, and ground truth establishment cannot be fully addressed from the provided document as it focuses on demonstrating equivalence through non-clinical testing and comparison with predicates.
Here's what can be extracted and inferred from the document regarding the device's assessment:
1. Table of Acceptance Criteria and Reported Device Performance:
The document does not present a formal table of acceptance criteria with reported device performance in the way a clinical study would. Instead, it relies on demonstrating substantial equivalence to predicate devices by comparing technical characteristics (like material, dimensions, design) and performing non-clinical tests (sterilization, aging, fatigue). The "acceptance criteria" are implicitly met if the device's technical characteristics and non-clinical test results are comparable to or meet the standards expected of the predicate devices.
The "performance" is reported as:
- Sterilization: Achieved an SAL of $10^{-6}$ in compliance with ANSI/AAMI/ISO 11137-1:06 and EN ISO 11137-2:12.
- Shelf Life: Substantiated a 5-year shelf life through accelerated aging per ASTM-F-1980:07, followed by peel, dye, and burst tests on packaging.
- Mechanical Performance: Static and dynamic compression performance testing was conducted per ISO 14801:07 ("Dentistry-Implants-Dynamic fatigue test for Endosseous Dental implants") using a worst-case scenario. The results are stated to "indicate that the Noris Medical Dental Implants System is substantial equivalent to the predicate devices."
2. Sample Size Used for the Test Set and Data Provenance:
- Test Set Sample Size: Not applicable in the context of a clinical test set. The non-clinical tests (SEM, surface analysis, sterilization validation, accelerated aging, static/dynamic compression) would have involved specific numbers of device units or components, but these numbers are not disclosed in the summary.
- Data Provenance: The tests were conducted by Noris Medical, Ltd. (Israel). The document does not specify the country of origin for the test data directly, but given the submitter's location in Israel, it's highly probable the testing occurred there or through contracted labs. The studies were non-clinical (laboratory/in-vitro), not retrospective or prospective patient studies.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
Not applicable. This device underwent non-clinical performance testing and comparative analysis against predicate devices, not evaluation involving expert-established ground truth for a clinical test set.
4. Adjudication Method for the Test Set:
Not applicable. There was no clinical test set requiring adjudication in the context of this 510(k) submission.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:
No. A MRMC study was not done. The submission explicitly states: "No clinical studies were performed."
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done:
Not applicable. This is a medical device (dental implant system), not an algorithm or AI-driven system.
7. Type of Ground Truth Used:
The "ground truth" for the assessment of this medical device is based on engineering standards, material specifications, and performance characteristics of legally marketed predicate devices.
- Engineering Standards: ASTM F136 (for titanium alloy), ANSI/AAMI/ISO 11137-1:06 and EN ISO 11137-2:12 (for sterilization), ASTM-F-1980:07 (for accelerated aging), and ISO 14801:07 (for dynamic fatigue).
- Predicate Device Characteristics: Comparison of materials, dimensions, design, intended use, and indications for use with the identified predicate devices (MIS K040807, MIS K080162, A.B. dental K112440, A.B. dental K132125, Nobel Biocare K061477).
8. Sample Size for the Training Set:
Not applicable. This is a medical device, not a machine learning model, so there is no "training set."
9. How the Ground Truth for the Training Set was Established:
Not applicable.
§ 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.