(431 days)
ARDS dental implants are indicated for use in surgical and restorative applications for placement in the bone of the upper and lower jaw to provide support for prosthetic devices in order to restore the patient's chewing function. ARDS dental implants are indicated for two-stage surgery.
ARDS implants are made from Titanium alloy. The ARDS implants geometrical shape is characterized by altering drilling profile, with double thread at the upper part that change to one thread at the lower part, which increases its surface, and as a result, increases in the preliminary contact surface with the bone. The ARDS dental implants are : S type: Internal hex implants, length 10/13 mm, diameter 3.75/4.5 mm, with double thread at the upper part that goes over in a single thread at the lower part. S implant types are supplied sterile in a double vial system, inside a plastic box which includes the covering screw and the Instructions For Use. The abutments are for single use only and supplied non-sterile. The tools are reusable and supplied non-sterile, they must be sterilized by autoclave before use.
The documents provided are FDA 510(k) clearance letters and related summaries for "ARDS Dental Implants." These documents establish that the device is "substantially equivalent" to a legally marketed predicate device.
It is important to note that 510(k) clearance usually signifies a device is as safe and effective as a predicate device, but it does not typically involve specific acceptance criteria, comprehensive clinical studies, or performance metrics in the same way a PMA (Pre-Market Approval) or a more rigorous clinical trial for a novel device would. The focus of a 510(k) is on substantial equivalence.
Therefore, based solely on the provided text, a detailed table of acceptance criteria and reported device performance, information on sample sizes for test sets, expert adjudication methods, MRMC studies, standalone performance, and detailed ground truth establishment methods as you've requested cannot be fully provided in the manner normally associated with studies proving discrete performance metrics for AI/ML devices.
The information available primarily discusses the device's classification, intended use, and comparison to a predicate device.
However, I can extract and infer some points based on the provided text:
1. A table of acceptance criteria and the reported device performance
The documents do not provide a table of quantitative acceptance criteria or specific device performance metrics in terms of accuracy, sensitivity, specificity, etc., because this is a 510(k) summary for a dental implant, not an AI/ML device. The "performance" being assessed here is the substantial equivalence to a predicate device in terms of design, materials, and intended use.
| Acceptance Criterion (Implied by 510(k)) | Reported Device Performance (Implied by 510(k) Clearance) |
|---|---|
| Substantial Equivalence to Predicate Device (Alpha Bio Dental Implant System K063364) | ARDS Dental Implants are "substantially equivalent" in technology and intended use. Differences (proprietary in nature) do not raise additional safety or efficacy concerns. |
| Intended Use | Indicated for use in surgical and restorative applications for placement in the bone of the upper and lower jaw to provide support for prosthetic devices in order to restore the patient's chewing function and indicated for two-stage surgery. |
| Materials | Made from Titanium alloy. |
| Sterility & Reusability of Components | S implant types are supplied sterile. Abutments are for single use only and supplied non-sterile. Tools are reusable and supplied non-sterile, requiring sterilization by autoclave before use. |
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. The clearance is based on comparison to a predicate device, not on a clinical test set in the traditional sense for evaluating an AI/ML diagnostic or prognostic device's performance metrics. The "testing results" mentioned in point 6 of K071803 refer to tests related to the proprietary differences and ensuring they don't impact safety/efficacy relative to the predicate, likely involving bench testing, material properties, and possibly limited in vitro or in vivo studies, but not a large-scale clinical test set for performance metrics.
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 where expert ground truth is established for a test set.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable.
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 is a physical dental implant, not an AI/ML diagnostic or assistive device for human readers.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
The "ground truth" for this 510(k) clearance is primarily the established safety and effectiveness of the predicate device (Alpha Bio Dental Implant System, K063364) and the demonstration that the ARDS Dental Implants are substantially equivalent to it. This involves:
- Physical and mechanical characteristic comparison (materials, geometry, dimensions).
- Intended use comparison.
- "Testing results" (mentioned in section 6 of K071803 summary) which likely refer to engineering, biocompatibility, and perhaps mechanical fatigue tests to support that the "proprietary" differences do not raise new safety or effectiveness concerns compared to the predicate.
8. The sample size for the training set
Not applicable. This is not an AI/ML device that uses 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.