(190 days)
CSM Implants are intended for use in support of single or multiple-unit restorations and partial or fully edentulous mandibles and maxilla. This system is intended for delayed loading.
The CSM submerged-L Implant System includes various one-stage Fixtures and two-stage Fixtures made of titanium. These implants are surgically inserted into the upper and/or lower jawbone 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.
Here's a breakdown of the acceptance criteria and the study information for the "CSM submerged-L Implant System" based on the provided 510(k) summary:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Mechanical Strength (Fatigue Testing) | "demonstrated that the CSM submerged-L Implant System possess mechanical strength at least equivalent to the predicate devices." |
| Predefined Acceptance Criteria | "this system meets its predefined acceptance criteria" |
| Performance in Accordance with Intended Use | "and performs in accordance with its intended use." |
| Substantial Equivalence (Design, Materials, Indications, Use, Packaging, Labeling) | "substantially equivalent in design, materials, indications and intended use, packaging, labeling, and performance to the predicate device currently marketed in the U.S." |
| Safety and Effectiveness (Compared to Predicate) | "as safe and effective as the predicate device, and that the new device does not raise different questions regarding safety and effectiveness as compared to the predicate device." |
2. Sample Size Used for the Test Set and Data Provenance:
The document explicitly states that the study involved "mechanical testing" and "fatigue testing." However, it does not specify the sample size for the test set (number of implants tested) or the data provenance (e.g., country of origin of the data, retrospective or prospective). This type of information is typically detailed in a full testing report, which is usually not included in the publicly available 510(k) summary.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
This information is not applicable to this type of device and study. The "CSM submerged-L Implant System" is a physical medical device (dental implant), and its performance is evaluated through mechanical engineering tests (fatigue testing, mechanical strength), not through interpretation of data by human experts to establish "ground truth" in the way it would be for an AI algorithm interpreting medical images.
4. Adjudication Method for the Test Set:
This information is not applicable for the same reasons as point 3. Mechanical testing results are objective measurements, not subject to expert adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness study was done:
No, an MRMC comparative effectiveness study was not done. This type of study is relevant for evaluating the performance of AI algorithms that assist human readers (e.g., in radiology). The "CSM submerged-L Implant System" is a physical implant, and its performance evaluation focuses on its mechanical properties and equivalence to predicate devices.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done:
No, a standalone performance study in the context of an AI algorithm was not done. This device is a physical product, not an AI algorithm. Its "standalone performance" refers to its mechanical properties when tested independently.
7. The Type of Ground Truth Used:
The "ground truth" in this context is established through physical measurements and engineering standards, specifically:
- Mechanical strength (e.g., yield strength, ultimate tensile strength, fracture toughness)
- Fatigue life
- Dimensional accuracy
- These are compared against established benchmarks or the performance of a predicate device.
8. The Sample Size for the Training Set:
This information is not applicable. The "CSM submerged-L Implant System" is a manufactured product, not an AI model that requires a training set. The "training" for such a device involves design, material selection, and manufacturing processes, culminating in a final product that undergoes testing.
9. How the Ground Truth for the Training Set Was Established:
This information is not applicable as there is no "training set" in the context of an AI algorithm. For a physical device, the design and manufacturing process are iterative, informed by engineering principles, material science, and previous product data, rather than a specific "training set with ground truth."
§ 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.