(176 days)
The CSM submerged-R Implant System is especially designed for use in dental implant surgery. According to the widely accepted clinical studies successful osseointegration between fixture and the live bone depends on surgical implantation under proper conditions, shape of fixture and surface treatment technique. Implants are intended for use in support of single or multiple-unit restorations and partial or fully edentulous mandibles and maxilla. In case of Customized Hand Milling Abutment, its wall thickness is 2mm and height is 12mm. It can be reduced into Max. 7mm. The margin of the product can be modified up to Max 20°. In case of Non-Hex Cementation Abutment, it is a bridge type. Two or more products must be used. Under part of abutment is made in order to avoid restriction in connecting work.
The CSM submerged - R implant system includes various one-stage Fixtures and two-stage Fixtures made of titanium. These implants are surgically inserted into the upper jaw and serve as a tooth root replacement providing a stable foundation for restorations. This product is a fixture and an abutment prosthetic dentistry material which are dental implant infrastructures. The connection with the abutment is inserted in bones as internal connection (the morse taper 11° and Hexagon type) method. A connection will restore mastication function of the patient who has difficulties due to damage of the natural tooth and function as a supporting the prosthetic dentistry material such as artificial tooth.
The provided text describes a 510(k) premarket notification for the "CSM submerged-R Implant System," a dental implant device. It primarily focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study proving the device meets specific acceptance criteria with performance metrics.
Based on the provided document, here's what can be extracted and what information is missing regarding acceptance criteria and a study proving their fulfillment:
The document states that the device was tested and demonstrates mechanical strength and fatigue comparable to predicate devices. However, it does not provide specific numerical acceptance criteria for these tests, nor does it detail a study with performance data against those criteria.
1. Table of Acceptance Criteria and Reported Device Performance
Acceptance Criteria and Reported Device Performance (as inferred from the document)
| Performance Metric | Acceptance Criteria (Stated/Inferred) | Reported Device Performance (Stated/Inferred) |
|---|---|---|
| Mechanical Strength | At least equivalent to the predicate devices (implied by "possess mechanical strength at least equivalent to the predicate devices") | "demonstrated that the CSM submerged-R Implant System possess mechanical strength at least equivalent to the predicate devices." (No specific numerical values provided) |
| Fatigue Performance | Meets its predefined acceptance criteria and performs in accordance with its intended use, demonstrating substantial equivalence to predicate devices. | "Fatigue testing demonstrated that there is substantial equivalence in the performance, safety and effectiveness between the CSM submerged-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." (No specific numerical values or comparison data provided, only a statement of equivalence and meeting criteria.) |
| Biocompatibility | Complies with FDA's Class II special controls guidance document (implied by design, material, surface treatment) | "made from pure titanium and the surface treatment is done with RBM." This is consistent with predicate devices and guidance. (No specific study details or results provided.) |
| Sterilization Efficacy | Effective sterilization via gamma irradiation (implied by method) | "Sterilized via gamma irradiation." (No specific study details or results provided.) |
Note: The document focuses on demonstrating substantial equivalence to a predicate device (SQ IS System, K090825) through comparison of design, materials, indications, and performance characteristics (like mechanical testing results being "equivalent"). It does not provide specific numerical acceptance criteria or detailed study results that would typically be found in a performance test report. The "predefined acceptance criteria" for fatigue testing are mentioned but not detailed.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not specified. The document mentions "mechanical testing" and "fatigue testing" but does not provide any details on the number of implants or test specimens used for these tests.
- Data Provenance: Not specified for the mechanical or fatigue testing. The document states that the testing was done "consistent with the recommendations in the FDA guidance document," implying it was conducted by the manufacturer, CSM Implant, or a contracted lab.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
Not Applicable. This document describes a medical device (dental implant), not an AI/software device that requires expert adjudication for ground truth related to diagnostic performance. The performance tests (mechanical strength, fatigue) are engineering tests, not clinical evaluations relying on expert interpretation of data.
4. Adjudication Method for the Test Set
Not Applicable. As mentioned above, this is an engineering device, not a diagnostic tool requiring image interpretation or similar expert-based adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
Not Applicable. This is not an AI/software device, and therefore, an MRMC study comparing human readers with and without AI assistance is irrelevant to this submission.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
Not Applicable. This is a physical dental implant, not an algorithm or software. The performance testing is inherent to the device itself.
7. Type of Ground Truth Used
The "ground truth" for the mechanical and fatigue testing would be the physical measurements and results obtained from standardized mechanical and fatigue tests, typically conforming to ISO or ASTM standards (e.g., ISO 14801 for dynamic fatigue testing of dental implants). The document refers to "predefined acceptance criteria" for fatigue testing, which would be based on these engineering standards and comparative data with the predicate.
8. Sample Size for the Training Set
Not Applicable. This is a physical device, not an AI model that requires a training set.
9. How the Ground Truth for the Training Set was Established
Not Applicable. As above, this is a physical device and does not have a "training set" in the context of machine learning.
§ 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.