(397 days)
The AnyRidge Octa 1 Implant System is intended to be surgically placed in the maxillary or mandibular arches for the purpose of providing prosthetic support for dental restorations (Crown, bridges, and overdentures) in partially or fully edentulous individuals. It is used to restore a patient's chewing function in the following situations and with the clinical protocols:
- Delayed loading.
- Immediate loading when good primary stability is achieved and with appropriate occlusal loading.
Larger implants are dedicated for the molar region.
The AnyRidge Octa 1 Fixture is a substructure of a dental implant system made of CP Ti Grade 4 with the surface treated by SLA method. The fixture offers two types: Normal Thread Type and Deep Thread Type. As the name indicates the Deep Thread Type has slightly deeper threads than the Normal Thread Type. The abutments are made of Ti-6AI-4V-ELI (ASTM F136-13) except the CCM Abutment. The CCM Abutment is made of Cobalt Chrome Molybdenum (ASTM F1537-11). Also for the Fuse Abutment, the post is covered with provisional restoration that is made of plastic (POM). The system offers various components including the AnyRidge Octa 1 Fixture, EZ Post Abutment, Angled Abutment, Milling Abutment, Octa Abutment, Multi-unit Abutment, Multi-unit Angled Abutment, Meg-Rhein Abutment, CCM Abutment, Cover Screw, Healing Abutment, Temporary Abutment, Fuse Abutment, Abutment Screw, and Multi-unit Abutment Screw, in various sizes.
The provided document is a 510(k) Premarket Notification from the FDA for the AnyRidge Octa 1 Implant System. This type of submission is for demonstrating substantial equivalence to a legally marketed predicate device, not for proving a device meets specific performance criteria through a standalone study with acceptance thresholds.
The document discusses non-clinical testing performed to support the substantial equivalence claim. 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 numerical acceptance criteria (e.g., minimum accuracy percentages, AUC values) or corresponding device performance results in the context of clinical effectiveness or diagnostic accuracy, as it is a 510(k) submission focusing on substantial equivalence to predicate devices rather than novel performance claims.
However, it mentions that fatigue tests were performed on the subject devices in accordance with ISO 14801. The acceptance criterion for this would be that the fatigue test results of the subject device are substantially equivalent to the predicate device. The document states:
- "The fatigue testing demonstrates that the results of the subject devices are substantially equivalent to the predicate device."
This indicates that the subject device met the implied acceptance criterion of demonstrating comparable mechanical durability to the predicate under the specified test conditions.
Other non-clinical tests mentioned also have implicit acceptance criteria:
- Sterilization validation testing (ISO 11137 and ISO 17665-1, 2): To verify a sterility assurance level (SAL) of 10^-6. The document states this was performed to verify SAL (10^-6), implying it met this standard.
- Shelf life validation testing (ASTM F1980): To validate a 5-year shelf life using accelerated aging. The document states "the test results validated 5 year shelf life," indicating the criterion was met.
- Surface Morphology (EDS), Surface Roughness, GC/LC Analysis, IC Analysis: These tests were done to evaluate SLA treatment. The implicit acceptance would be that the characteristics are consistent with acceptable dental implants and/or comparable to the predicate device's surface treatment.
- Endotoxin testing (USP 39 ): The testing limit is below 0.5 EU/mL. This will be conducted on every batch, implying this is the ongoing acceptance criterion for endotoxin levels.
2. Sample Size Used for the Test Set and Data Provenance
The document does not describe a "test set" in the context of patient data or a clinical study for performance evaluation. The "tests" performed are non-clinical, laboratory-based tests on the device itself. Therefore, information on sample size for patient data or data provenance (country of origin, retrospective/prospective) is not applicable or provided.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
Not applicable. This is a non-clinical 510(k) submission, not a clinical study requiring expert ground truth for a test set.
4. Adjudication Method
Not applicable. This is a non-clinical 510(k) submission.
5. Multi Reader Multi Case (MRMC) Comparative Effectiveness Study
Not applicable. This is a non-clinical 510(k) submission for a dental implant system, not a diagnostic device typically evaluated with MRMC studies with human readers and AI assistance.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
Not applicable. This product is a physical medical device (dental implant system), not an algorithm or AI system.
7. Type of Ground Truth Used
For the non-clinical tests, the "ground truth" refers to established scientific standards and regulatory guidelines.
- Mechanical Fatigue: ISO 14801, and comparison to the performance of legally marketed predicate devices.
- Sterilization: ISO 11137 and ISO 17665-1, 2.
- Shelf Life: ASTM F1980.
- Biocompatibility: Likely established through previous 510(k) submissions for the predicate devices using similar materials.
- Endotoxin: USP 39 .
8. Sample Size for the Training Set
Not applicable. This is a physical device, not an AI/algorithm-based product that requires a 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.