(84 days)
BTI Dental Implant Tiny® 3.0 are intended to be used to restore missing teeth in partially or fully edentulous patients and/or the fixation of overdentures to restore or enhance the chewing capacity of patients.
These implants shall be used only to replace maxillary lateral incisors and mandibular lateral and central incisors.
Immediate loading is recommended when there is good primary stability and an appropriate occlusal load.
The BTI Dental Implant Tiny® Ø3.0 is a self tapping, threaded, root- form dental implant intended for restoring missing teeth in partially or fully edentulous patients to restore the chewing capacity of patients. It is made of titanium and offers a variety of sizes including diameter: 3.0mm and lengths: 11.5, 13, 15mm
The provided text is a 510(k) summary for the BTI Dental Implant Tiny® Ø3.0. This document primarily focuses on demonstrating substantial equivalence to predicate devices, which is a regulatory pathway for medical devices. It does not contain information about acceptance criteria or a study proving the device meets specific performance criteria in the way you've outlined for an AI/software device evaluation.
Dental implants, like the one described, are typically evaluated through:
- Mechanical Testing: To ensure strength, fatigue resistance, and fracture toughness. Standards like ISO 14801 (Fatigue Test for Endosseous Dental Implants) are common.
- Biocompatibility Testing: To ensure the material is safe for implantation. Based on ISO 10993.
- Animal Studies or Clinical Performance Data: Especially for new designs or materials, to demonstrate osseointegration and long-term success.
The 510(k) summary only mentions "Technological Aspects: A comparison of the device features, intended use and other information demonstrate that the BTI Dental Implant Tiny® Ø3.0 substantially equivalent to the predicate devices." This implies that the device's performance is assumed to be similar to its predicate devices, which have already gone through their own testing and regulatory approval processes.
Therefore, I cannot fill in the table or answer most of your questions as the requested information (acceptance criteria, specific performance studies, sample sizes for test/training sets, ground truth establishment, expert adjudication, MRMC studies, or standalone studies) is not present in the provided text.
The closest I can get is extracting the intended use and device description, but these are not "acceptance criteria" in the sense of a quantitative performance metric.
Here's what I can extract from the provided text, acknowledging that it doesn't align with your request for AI/software-specific evaluation:
1. Table of (Implied) Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria (Implied by Substantial Equivalence to Predicates) | Reported Device Performance (Implied by Substantial Equivalence and Device Description) |
|---|---|
| Material: Biocompatible and suitable for long-term implantation, as demonstrated by predicate devices. | Made of titanium. Assumed to meet biocompatibility requirements due to substantial equivalence. |
| Form/Design: Root-form, threaded, and self-tapping, with specific dimensions comparable to predicate devices. | Self-tapping, threaded, root-form dental implant. Diameter: 3.0mm, Lengths: 11.5, 13, 15mm. |
| Intended Use: Capable of restoring missing teeth and/or fixing overdentures in partially or fully edentulous patients, specifically for maxillary lateral incisors and mandibular lateral and central incisors, with suitability for immediate loading under good primary stability and appropriate occlusal load. | Intended to be used to restore missing teeth in partially or fully edentulous patients and/or the fixation of overdentures. Specifically for maxillary lateral incisors and mandibular lateral and central incisors. Immediate loading recommended under specific conditions. |
The following questions cannot be answered from the provided text as they pertain to a different type of device evaluation (e.g., AI/software performance) than what is presented in a dental implant 510(k) summary based on substantial equivalence:
2. Sample size used for the test set and the data provenance: Not applicable/Not provided. The 510(k) relies on substantial equivalence to predicate devices, not a test set in the AI sense.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable/Not provided.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable/Not provided.
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/Not provided, as this is not an AI-assisted device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable/Not provided, as this is not an AI algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable/Not provided in the context of device performance testing for substantial equivalence. Clinical outcomes data for predicate devices would implicitly support their safety and effectiveness.
8. The sample size for the training set: Not applicable/Not provided.
9. How the ground truth for the training set was established: Not applicable/Not provided.
In summary, the provided document is a regulatory submission for a dental implant, detailing its intended use and features to demonstrate substantial equivalence to existing devices. It does not include the detailed performance study information with acceptance criteria, sample sizes, and ground truth establishment that would be found in submissions for AI/software-based medical devices.
§ 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.