(266 days)
Inclusive® Mini Implants are self-tapping threaded titanium screws indicated for long-term applications. Inclusive® Mini Implants may also be used for provisional applications. These devices will allow immediate loading and long-term stabilization of dentures and provisional stabilization of dentures while standard implants heal. To be used for immediate loading only in the presence of primary stability and appropriate occlusal loading.
Prismatik Dentalcraft, Inc.'s Inclusive® Mini Implant is a one-piece, root-form, screw-type, endosseous dental implant. These self-tapping, threaded implants are manufactured from Ti6Al-4V ELI, titanium alloy for surgical implant applications (ASTM F136). The Mini Implant will be available in 9 sizes: 2.2mm, 2.5mm, and 3.0mm diameters in 10mm, 13mm, and 15mm thread lengths. The implant body has a thread design for bone compression and the surface is blasted and etched to facilitate osseointegration. The 3.0mm implant has microthreads at the intra-osseous collar to preserve crestal bone. The Mini Implants have a transgingival collar 2mm in height and an O-Ball design prosthetic head.
The provided 510(k) summary for the Inclusive® Mini Implant does not contain specific acceptance criteria with quantifiable metrics or detailed study results that prove the device meets such criteria.
Instead, it relies on demonstrating substantial equivalence to predicate devices and states that the device was subjected to verification and validation studies in accordance with FDA guidance.
Here's an analysis of the information provided, specifically addressing your numbered points:
1. A table of acceptance criteria and the reported device performance
No explicit acceptance criteria with specific numerical targets (e.g., "fatigue strength must exceed X Newtons") or corresponding reported device performance values are provided in this document. The document states: "The Inclusive® Mini Implants were subjected to verification and validation studies... The results of the testing demonstrate the Inclusive® Mini Implants are safe and effective for use." However, it does not present a table outlining these results against predefined criteria.
The types of testing mentioned are:
- Static and fatigue strength
- Sterilization validation
- Bioburden
- Shelf life validation
- Packaging integrity
- Cytotoxicity
- Independent clinician evaluations
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided in the document. The summary only broadly mentions "verification and validation studies" and "independent clinician evaluations" without detailing sample sizes, study designs (retrospective/prospective), or data provenance.
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)
This information is not provided. The document mentions "independent clinician evaluations," but does not specify the number or qualifications of these clinicians, nor how their evaluations established a "ground truth."
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is 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
There is no indication of an MRMC comparative effectiveness study, and this device is a physical dental implant, not an AI-assisted diagnostic tool. Therefore, the concept of "improving human readers with AI" is not applicable here.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
This question is not applicable as the device is a physical implant, not an algorithm or software device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
Given the nature of the device (a dental implant), the "ground truth" for its performance would typically be established through biomechanical testing (static and fatigue strength), biological assessments (cytotoxicity, osseointegration inferred from material properties and surface treatment), and clinical outcomes (though outcomes data is not detailed here for this specific submission). The document mentions "independent clinician evaluations," which would relate to clinical performance or usability, but the specific metrics or "ground truth" derived from these are not detailed.
8. The sample size for the training set
This question is not applicable as this is a physical medical device, not an AI/ML algorithm that requires a training set.
9. How the ground truth for the training set was established
This question is not applicable as this is a physical medical device.
Summary of what is present:
The 510(k) summary focuses on demonstrating substantial equivalence to predicate devices by comparing their materials, physical dimensions (diameters, lengths), prosthetic head designs, and intended indications for use. It lists various tests performed (static/fatigue strength, sterilization, bioburden, shelf life, packaging, cytotoxicity, clinician evaluations) in accordance with FDA guidance for root-form endosseous dental implants. However, it does not provide the quantitative results of these tests or explicit acceptance criteria. The claim of safety and effectiveness relies on these tests confirming the device's performance is comparable to legally marketed predicates.
§ 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.