(70 days)
The Xpeed AnyRidge Internal Implant System is intended to be surgically placed in the maxillary or mandibular molar areas for the purpose 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. Smaller implants (less than Ø6.0 mm) are dedicated for immediate loading when good primary stability is achieved and with appropriate occlusal loading. Larger implants are dedicated for the molar region and are indicated for delayed loading.
The Xpeed AnyRidge Internal Implant System is especially designed for use in dental implant surgery. It consists of machined titanium, screw-form, root-form endosseous dental implant. The Xpeed AnyRidge Internal Implant System contains two types of fixtures, Normal ridge type and low ridge type, various abutments and instruments. This system is made from CP Titanium, Gr. 4 and Ti-6Al-4V, ELI, and the surface treatment is done with S.L.A (Sand-blasted, Large grit, Acid-etched). The implants are used to replace missing teeth in various situations ranging from a single missing tooth to the completely edentulous individual. The wide ranges of size are provided to be in conformance with each patient, or to cover up in case of due to deficiency in implant operation. The system is used as two stage, root-form dental implants, associated with abutment systems, which provide the clinician with the screw (for UCLA abutments) and cement (for solid abutments) retained restoration for multimount options. This system has 4.0, 4.4, 4.9, 5.4, 5.9mm diameters for normal ridge and 6.4, 6.9, 7.4, 7.9, 8.4mm diameters for low ridge fixtures. In addition, this system has 7.7, 9.2, 10.7, 12.2, 14.2, 17.2mm lengths for normal ridge and 7.9, 9.4, 10.9, 12.4, 14.4mm lengths for low ridge fixtures. Fixtures, the prosthetics, and the surgical instruments are produced and packaged separately. All included devices in the system are covered by this submission.
The provided documentation does not describe a study involving a device that analyzes data or requires acceptance criteria based on performance metrics such as accuracy, sensitivity, or specificity. Instead, it describes a dental implant system (Xpeed AnyRidge Internal Implant System) and its substantial equivalence to predicate devices.
The "acceptance criteria" in this context refer to the successful demonstration of substantial equivalence to legally marketed predicate devices, primarily through non-clinical testing of the physical and material properties of the implant, rather than an AI/software-based performance evaluation.
Therefore, the requested information regarding sample sizes, data provenance, expert ground truth, MRMC studies, standalone performance, and training set details for AI model evaluation is not applicable to this 510(k) submission.
Here's a breakdown of what is available based on the provided text:
1. A table of acceptance criteria and the reported device performance:
The acceptance criteria are not in the form of performance metrics like those for AI devices (e.g., sensitivity, specificity). Instead, the "acceptance criteria" are implied by the demonstration of substantial equivalence through non-clinical testing.
| Acceptance Criteria (Implied by Substantial Equivalence to Predicate Devices) | Reported Device Performance (Non-Clinical Test Data) |
|---|---|
| Maintain appearance consistent with predicate devices. | Appearance tests were performed. |
| Maintain dimensions consistent with predicate devices. | Dimension tests were performed. |
| Maintain packaging integrity. | Packing tests were performed. |
| Exhibit acceptable extraction properties (material safety). | Extraction tests were performed. |
| Maintain sterility. | Sterility tests were performed. |
| Ensure modifications (surface treatment, new instruments, design changes) do not affect safety and effectiveness. | All performed non-clinical tests (Appearance, Dimension, Packing, Extraction, Sterility) aimed to prove that modifications do not affect safety and effectiveness. |
| Material properties (CP Titanium, Gr.4 and Ti-6Al-4V, ELI) match predicate. | Device is made from CP Titanium, Gr. 4 and Ti-6Al-4V, ELI. |
| Sterilization method (Gamma sterilization) matches predicate. | Device uses Gamma sterilization. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Not Applicable. This device is a physical dental implant, not a data-driven device that requires a "test set" in the computational sense. The "tests" mentioned are non-clinical material and physical property tests.
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. This is not a diagnostic device requiring expert interpretation for ground truth.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not Applicable. This is not a diagnostic device requiring adjudication.
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:
- No. This is a physical dental implant, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- No. This is a physical dental implant, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- Not Applicable (in the context of AI evaluation). The "ground truth" for this device's safety and effectiveness is established through adherence to recognized standards and successful non-clinical testing of its physical and material properties, demonstrating equivalence to already approved devices. The 'truth' is about engineering specifications and material compatibility, not diagnostic accuracy.
8. The sample size for the training set:
- Not Applicable. This is a physical dental implant, not a machine learning model.
9. How the ground truth for the training set was established:
- Not Applicable. This is a physical dental implant, not a machine learning model.
§ 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.