(231 days)
The 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 AnyRidge Internal Implant System is especially designed for use in dental implant surgery. It consists of machined titanium, screw-form, rootform endosseous dental implant. The 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 pure titanium and the surface treatment is done with R.B.M. 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 multi-mount 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, 14.20, 17.20mm lengths for normal ridge and 7.9, 9.4, 10.9, 12.4, 14.4mm lengths for low ridge fixtures.
The provided text describes a 510(k) premarket notification for the AnyRidge Internal Implant System, which is a dental implant system. This type of submission relies on demonstrating substantial equivalence to a legally marketed predicate device, rather than providing extensive clinical study data that would be typical for novel devices or AI/ML-driven diagnostics.
Therefore, the acceptance criteria and study information typically requested for AI/ML devices or novel medical devices with performance claims are largely not applicable in this context. The focus of this 510(k) is on demonstrating that the new device is as safe and effective as existing, legally marketed devices.
Here's a breakdown based on the provided document, addressing the requested points where applicable, and noting where information is not present:
1. A table of acceptance criteria and the reported device performance
For a 510(k) based on substantial equivalence for a dental implant system, the "acceptance criteria" are primarily related to meeting established standards and being comparable to predicate devices in terms of design, materials, intended use, and performance where tested (e.g., fatigue). There are no specific quantitative performance metrics (like sensitivity/specificity for a diagnostic AI) provided in this document as acceptance criteria.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Material: CP4 Titanium | AnyRidge System: CP4 Titanium and its alloy |
| Sterilization: Gamma sterilization | AnyRidge System: Gamma sterilization |
| Design: Complies with FDA's Class II special controls guidance document for root-form endosseous dental implants and abutments | AnyRidge System: Designed, manufactured, and tested in compliance with FDA's Class II special controls guidance document. Internal Hex connection. |
| Indication for Use: Mandible and Maxilla Endosseous Dental Implant & Accessories | AnyRidge System: Mandible and Maxilla Endosseous Dental Implant & Accessories |
| Fatigue Testing: Successful according to ISO 14801 standard | AnyRidge System: Fatigue testing performed successfully in accordance with ISO 14801 standard. |
| Substantial Equivalence: No new questions of safety or effectiveness compared to predicate devices. | The document concludes that the AnyRidge Internal Implant System performs "well or better than predicate device" based on provided information. |
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 / not provided: This type of information (test set sample size, provenance related to clinical data for performance evaluation in the AI/ML sense) is not relevant for a 510(k) submission for a dental implant based on substantial equivalence. The "test set" here refers to the physical device's non-clinical testing (fatigue). The non-clinical test data for fatigue testing doesn't specify a "sample size" in the context of clinical or diagnostic data, but rather the number of samples tested for the engineering evaluation. No information on data provenance relating to patient populations is provided.
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 / not provided: The device is a physical dental implant. There's no "ground truth" to be established by experts in the context of a diagnostic AI/ML device. The "truth" for fatigue testing is whether the implant withstands certain loads according to the ISO standard.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable / not provided: No adjudication method is described as there is no diagnostic or interpretive data requiring expert consensus.
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: This device is a dental implant, not a diagnostic AI or imaging system, so MRMC studies are not relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable: This device is a physical medical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not applicable (for AI/ML context): For the non-clinical fatigue testing, the "ground truth" is adherence to the ISO 14801 standard for dental implants. This involves objective engineering measurements of material strength and durability, not clinical outcomes or expert consensus on a diagnosis.
8. The sample size for the training set
- Not applicable: This device is not an AI/ML algorithm that requires a training set.
9. How the ground truth for the training set was established
- Not applicable: This device is not an AI/ML algorithm that requires a 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.