(82 days)
"O" Company's Titanium CP Endosseous Implant is intended to be surgically placed in the bone of the upper of lower jaw arches providing support for prosthetic devices resulting in the restoration of the patient's chewing function.
A cylinder shaped commercially pure titanium dental implant with external threads and a Hydroxylapatite Coating.
The provided text is a 510(k) premarket notification for a medical device called the "O" Butment HS Implant, a type of dental implant. It focuses on demonstrating substantial equivalence to previously marketed devices rather than presenting a study for meeting specific acceptance criteria for performance.
Therefore, most of the requested information regarding acceptance criteria, performance studies, sample sizes, expert ground truth, adjudication methods, and MRMC studies is not available in the provided document. The document describes a regulatory process for market clearance, not an evaluation of device performance against pre-defined acceptance criteria through a clinical or non-clinical study designed for that purpose.
Here's a breakdown based on the information that is available:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not provided | Not provided |
| (No specific performance metrics or acceptance thresholds are mentioned in the document.) | The document states that "physical integrity of the implant has not been compromised by the modifications" based on stress analysis, but quantitative performance against specific criteria is not given. |
2. Sample Size Used for the Test Set and Data Provenance:
- Not applicable / Not provided. No test set in the sense of patient data or clinical images was used for performance evaluation against acceptance criteria. The "test" mentioned relates to non-clinical stress analysis.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
- Not applicable / Not provided. No ground truth established by experts is mentioned, as there was no test set of clinical cases.
4. Adjudication Method for the Test Set:
- Not applicable / Not provided.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:
- No. An MRMC study was not done. The submission focuses on substantial equivalence based on design, materials, and non-clinical testing.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not applicable. This device is a physical dental implant, not an algorithm.
7. The Type of Ground Truth Used:
- Not applicable / Not provided. The evaluation was based on design comparison and non-clinical engineering stress analysis, not clinical ground truth.
8. The Sample Size for the Training Set:
- Not applicable / Not provided. This is not a machine learning device; therefore, no training set is relevant.
9. How the Ground Truth for the Training Set was Established:
- Not applicable / Not provided.
Summary of Relevant Information from the Document:
- Non-clinical tests: Lateral and vertical stress analysis performed by Rocky Mountain Testing.
- Finding: "It has been determined that the physical integrity of the implant has not been compromised by the modifications."
- Basis for Substantial Equivalence: Design, function, labeling, material composition, and intended use compared to predicate devices ("O" Butment ES Implant and Screw-Vent Implant).
§ 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.