(113 days)
The CSM Internal-R Implant System is indicated 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. This system is intended for delayed loading.
The CSM Internal-R Implant System is intended for use in partial or fully edentulous mandibles and maxillae, in support of single or multiple-unit restorations. The CSM Internal-R Implant system contains two types of fixtures, straight and tapered type based on the shape of the fixture. This system is made from titanium (Ti-6AI-4V ELI) and the surface treatment is done with Resorbable hydroxyapatite Blast Medium.
This document describes CSM Internal-R Implant System, a dental implant device. The provided text is a 510(k) summary, which focuses on demonstrating substantial equivalence to predicate devices rather than proving specific performance criteria through diagnostic study. Therefore, most of the requested information regarding diagnostic study elements (like expert panels, adjudication, standalone performance, training sets, etc.) is not applicable or not available in this type of submission.
Here's a breakdown of the requested information based on the provided text:
1. A table of acceptance criteria and the reported device performance
The submission does not outline specific, quantified acceptance criteria in the typical sense of a diagnostic performance study (e.g., minimum sensitivity, specificity). Instead, the acceptance criterion for this 510(k) submission is "substantial equivalence" to predicate devices, particularly in mechanical strength and fatigue resistance.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Mechanical Strength: At least equivalent to predicate devices | "mechanical testing of the implants demonstrated that the CSM Internal-R Implant System possess mechanical strength at least equivalent to the predicate devices." |
| Fatigue Resistance: Meets predefined acceptance criteria | "fatigue testing demonstrated that there is substantial equivalence in the performance, safety and effectiveness between the CSM Internal-R Implant System and the referenced predicate devices. Fatigue testing also demonstrated that this system meets its predefined acceptance criteria and performs in accordance with its intended use." (Specific numerical acceptance criteria for fatigue are not provided in this summary but are stated to have been met.) |
| General Equivalence: Same intended use, technological characteristics, safety, and effectiveness as predicate devices. | "The CSM Internal-R Implant System, as designed and manufactured, is as safe and effective as the predicate devices and therefore is determined to be substantially equivalent to the referenced predicate devices." |
| "The CSM Internal-R Implant System has a substantially equivalent intended use as the identified predicates... The system is similar to other commercially available products based on the intended use, the technology used, the claims, the material composition employed and performance characteristics." |
2. Sample size used for the test set and the data provenance
Not Applicable (N/A): This is a 510(k) submission for a physical medical device (dental implant), not an AI/diagnostic software. The "test set" here refers to the physical implants subjected to mechanical and fatigue testing, not a diagnostic dataset of patient cases. The specific number of implants tested is not detailed in the summary, nor is the provenance of such "data" in the sense of patient information. The tests were non-clinical (laboratory-based).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
N/A: Ground truth in this context would likely be established by engineering standards and validated physical measurements, not clinical expert consensus. There were no clinical experts involved in establishing "ground truth" for mechanical testing in the way they would be for a diagnostic study.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
N/A: Adjudication methods are relevant for resolving discrepancies in expert interpretations of diagnostic data. This is not applicable to the mechanical testing performed 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
N/A: This submission is for a physical dental implant, not AI software. No MRMC study was conducted.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
N/A: This is not an AI algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
For the mechanical and fatigue testing, the "ground truth" would be established by:
- Engineering Standards: Compliance with industry standards (e.g., ISO standards for dental implants, ASTM standards for materials).
- Physical Measurements: Objective measurements of mechanical properties (e.g., ultimate tensile strength, fatigue life cycles) against predefined specifications.
8. The sample size for the training set
N/A: There is no "training set" in the context of a physical device's mechanical testing in the way it's used for AI models.
9. How the ground truth for the training set was established
N/A: As there's no training set, this question is 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.