(105 days)
SS System is intended for use in partially or fully edentulous mandibles and maxillae, in support of single or multiple-unit restorations including; cemented retained, screw retained, or overdenture restorations, and terminal or intermediate abutment support for fixed bridgework. SS System is for one stage surgical procedures. It is not for immediate load.
The SS system is a dental implant system made of titanium metal intended to be surgically placed in the bone of the upper or lower jaw arches.
The provided text describes a 510(k) summary for the "SS System" dental implant. This type of submission is for demonstrating substantial equivalence to a predicate device, not typically for reporting on new clinical studies that establish acceptance criteria and device performance in the way an AI/software device would.
Therefore, many of the requested sections related to acceptance criteria, ground truth, sample sizes for testing sets, and human reader performance with AI assistance are not applicable to this document as it pertains to a physical medical device (a dental implant) that underwent safety and performance validations rather than an AI/software device.
Here's an analysis based on the information provided:
1. A table of acceptance criteria and the reported device performance
The document does not specify quantitative acceptance criteria or a direct performance table in the context of a new functional study. Instead, it relies on demonstrating substantial equivalence to a predicate device. The "performance" is implicitly tied to meeting the safety and effectiveness profile of the predicate device.
| Acceptance Criteria (Implicit) | Reported Device Performance (Summary) |
|---|---|
| Similar Material | "SS System has similar material..." |
| Similar Indication for Use | "...indication for use..." |
| Similar Design | "...design..." |
| Similar Technological Char. | "...and technological characteristics as the predicate device." |
| Safety Profile | "Safety tests including biocompatibility have been performed to ensure the devices comply with the applicable International and US regulations." |
| Substantial Equivalence | "SS System is safe and effective and substantially equivalent to the predicate device as described herein." |
2. Sample size used for the test set and the data provenance
Not applicable for this type of submission. The safety and performance validations mentioned likely refer to bench testing, material characterization, and biocompatibility tests rather than clinical studies with a "test set" in the context of an AI/software device. No specific sample sizes for such tests or data provenance are detailed.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. Ground truth, in the context of expert consensus, is typically associated with AI/software performance evaluation. For a physical dental implant, safety and performance are evaluated through engineering tests, material science, and biocompatibility assessments, not by experts establishing a "ground truth" on images or data.
4. Adjudication method for the test set
Not applicable. This concept is relevant for clinical or observational studies where expert review is needed to establish ground truth or assess outcomes, often with multiple readers and an adjudication process for discrepancies. This is not described for a dental implant.
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 specifically for AI-assisted diagnostic or decision-support systems. The SS System is a physical dental implant, not an AI product.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This also pertains to AI/software performance.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
As noted, the concept of "ground truth" in the context of expert consensus or pathology isn't precisely defined for a physical implant in this submission. The "ground truth" for the implant's safety and performance is established through compliance with recognized standards, material specifications, biocompatibility testing, and comparison to the predicate device's known history of safe and effective use.
8. The sample size for the training set
Not applicable. There is no "training set" for a physical dental implant device in the context of this 510(k) submission.
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.