(112 days)
For use when screw retention of a single or splinted prosthesis is desired, e.g., single crown, bars and bridges. Implants must be within 30° of parallelism to each other for a splinted prosthesis.
The Spline Engaging Shouldered Abutment System provides an antirotational option for single or multiple tooth prosthetic restorations. The components of this system are supplied non-sterile, for use by licensed dentists.
This document is a 510(k) summary for a medical device (dental implant abutment system). It is a regulatory submission for pre-market notification to the FDA, demonstrating substantial equivalence to a predicate device. This type of document does not contain the kind of study information requested in your prompt. Medical device 510(k) submissions primarily focus on comparing a new device to an already legally marketed one concerning technological characteristics, materials, and intended use. They are generally not accompanied by extensive clinical studies demonstrating performance against acceptance criteria in the way described in your request. Such studies are more typical for Premarket Approval (PMA) applications, which involve higher-risk devices or novel technologies.
Therefore, I cannot extract the following information from the provided text:
- Table of acceptance criteria and reported device performance: This document does not establish or report performance against specific acceptance criteria.
- Sample sized used for the test set and the data provenance: No test set is described.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
- Adjudication method: Not applicable.
- 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: This device is a mechanical dental implant component, not an AI-assisted diagnostic or therapeutic tool.
- If a standalone performance study was done: Not applicable in the sense of an algorithm's standalone performance.
- The type of ground truth used: Not applicable.
- The sample size for the training set: This device is a mechanical component, not an AI system that requires a training set.
- How the ground truth for the training set was established: Not applicable.
The document states:
- Device Trade Name: Spline Engaging Shouldered Abutment System
- Intended Use: For use when screw retention of a single or splinted prosthesis is desired, e.g., single crown, bars and bridges. Implants must be within 30° of parallelism to each other for a splinted prosthesis.
- Technological Characteristics: A modification to the shouldered abutment and associated components. Both the implant/abutment and abutment/coping interface engage the spline tines, providing anti-rotation. No change to the materials of this device.
- Comparison Analysis: The overall design of the prosthetic components are similar or identical to the predicate devices.
- Predicate Device: Sulzer Calcitek's existing Spline Dental Implant System.
This submission is purely about regulatory clearance based on substantial equivalence, not performance studies as outlined in your prompt.
§ 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.