(253 days)
The SM Dental implant system is an endosseous dental implant that is indicated to use for surgical placement in the upper and lower jaw arches, to provide a root form means for single or multiple units' prosthetic appliance attachment to restore a patient's chewing function. The SM Dental implant system is intended for immediate placement and function on singletooth and/or multiple tooth applications when good primary stability is achieved and with appropriate occlusal loading, to restore chewing function. Multiple tooth applications may be rigidly splinted. In the case of edentulous patients 4 or more implants must be used.
SM® Implant System is a root-form threaded dental implant made of Grade 3 and Grade 4 titanium. The implant is produced by machining process, followed by grit blasting and cleaning. It is available in diameters 3.8, 4.5 and 5.3mm, and lengths from 8mm to 14mm. It is placed via one or two stage surgery and the functional loading can be from immediate to delay.
The provided text describes a 510(k) summary for the SM® Internal/External Implant Systems. This document is a premarket notification to the FDA to demonstrate that the device is substantially equivalent to a legally marketed predicate device. The information presented is typical for a medical device submission seeking regulatory clearance, focusing on comparison to existing devices rather than a detailed performance study with acceptance criteria and statistical analysis in the way modern AI/ML device submissions require.
Therefore, many of the requested elements for a performance study evaluating an AI/ML device will not be present in this document, as it pertains to a dental implant system.
Here's an analysis based on the information provided:
1. Table of Acceptance Criteria and Reported Device Performance
| Criterion Type | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Intended Use | "The SM Dental implant system is an endosseous dental implant that is indicated to use for surgical placement in the upper and lower jaw arches, to provide a root form means for single or multiple units' prosthetic appliance attachment to restore a patient's chewing function. The SM Dental implant system is intended for immediate placement and function on singletooth and/or multiple tooth applications when good primary stability is achieved and with appropriate occlusal loading, to restore chewing function. Multiple tooth applications may be rigidly splinted. In the case of edentulous patients 4 or more implants must be used." (Identical to predicate device's intended use.) | The submission states, "Identical to predicate devices" under the "Intended Use" comparison. This implies that the device meets the functional requirements for its intended use, as demonstrated by the predicate device's established performance. The "Performance" section explicitly states, "Laboratory testing was conducted to determine device functionality and conformance to design input requirements." This general statement indicates that the device's functional performance aligns with its design. However, specific quantitative performance metrics against pre-defined acceptance thresholds in a table format are not provided in this summary. |
| Material | Commercially pure titanium GR. 3 and GR.4 (ASTM-F-67) | Commercially pure titanium GR. 3 and GR.4 (ASTM-F-67) |
| Design | Morse Taper with Thread | Morse Taper with Thread |
| Screw Threads | YES | YES |
| Implant Thread | 3.8, 4.5, and 5.3 mm | 3.8, 4.5, and 5.3 mm |
| Collar Height | 1.8 mm | 1.8 mm |
| Lengths (External) | 8-14 mm | 8-14 mm |
| Surface Treatment | Machined | Machined |
| Sterilization | Gamma sterilized | YES |
| Attachments | Screw-retained, Cemented, Overdenture restoration, Instruments (surgical and restorative) supported | YES (for all listed attachment types) |
2. Sample Size Used for the Test Set and Data Provenance
This document does not describe a "test set" in the context of an AI/ML device validation. The "Performance" section generically states, "Laboratory testing was conducted to determine device functionality and conformance to design input requirements." This likely refers to mechanical, material, and biocompatibility testing inherent to dental implants, not a data-driven validation. No specific sample sizes for such tests are provided in this summary, nor is the provenance of any "data" specified. It is a physical device, and testing would involve physical specimens, not a data set.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. This is not an AI/ML device requiring expert-established ground truth for a test set.
4. Adjudication Method for the Test Set
Not applicable. This is not an AI/ML device with a test set requiring expert adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size
Not applicable. This document pertains to a physical dental implant, not an AI-assisted diagnostic tool that would typically undergo an MRMC study.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
Not applicable. This is not an AI algorithm.
7. The Type of Ground Truth Used
The concept of "ground truth" as used in AI/ML validation (e.g., pathology, outcomes data) is not applicable here. For this physical device, the "ground truth" would be established by validated engineering standards (e.g., ASTM-F-67 for materials), mechanical testing benchmarks (e.g., fatigue strength, torque), and biocompatibility assessments, which are not detailed in this summary. The submission focuses on demonstrating "substantial equivalence" to a predicate device based on identical materials, similar design, and intended use.
8. The Sample Size for the Training Set
Not applicable. This is not an AI/ML device, and therefore, there is no "training set."
9. How the Ground Truth for the Training Set Was Established
Not applicable. As there is no training set for an AI/ML model, there's no ground truth establishment for it.
Summary of the Study and Device Performance:
The provided 510(k) summary for the SM® Internal/External Implant Systems describes a submission to the FDA seeking clearance for a dental implant. The primary method for proving the device meets acceptance criteria is through demonstration of substantial equivalence to a previously cleared predicate device (SM® Implant System, K061797).
The study that supports the device meeting its acceptance criteria is not a "study" in the sense of a clinical trial or AI/ML validation. Instead, it relies on a comparison of technological characteristics and intended use to the predicate device, along with "Laboratory testing... to determine device functionality and conformance to design input requirements."
The acceptance criteria are implicitly met by showing that:
- The Intended Use is "Identical to predicate devices."
- The Material (Commercially pure titanium GR. 3 and GR.4 (ASTM-F-67)) is identical.
- The Technological Characteristics such as design (Morse Taper with Thread), screw threads (YES), implant thread diameter (3.8, 4.5, and 5.3 mm), collar height (1.8 mm), lengths (8-14 mm), surface treatment (Machined), and sterilization (Gamma sterilized) are identical to or within the established parameters of the predicate device.
- The types of Attachments supported are also identical.
The "reported device performance" is the direct correspondence and equivalency of these characteristics to the predicate device. The FDA's letter of clearance (K070569) signifies that the agency has reviewed this comparative information and determined the device is "substantially equivalent" to the predicate, thus deeming its performance acceptable for market entry based on the predicate's established safety and effectiveness. Specific quantitative results from the "laboratory testing" are not detailed in this summary.
§ 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.