(336 days)
This product is designed for use in the placement of the "Dual Integrator" Dental Implant (K944225).
The Parallel Pin is used to insure correct vertical placement of the implant. The Depth Gauge is used to measure the depth of surgical site, while the Surgical Ratchet is used to screw the "Dual Integrator" Dental Implant into the surgical site.
These products along with the "Dual Integrator" Dental Implant make up the total system of tooth replacement by Implant Integration Systems.
The "Dual Integrator" Parallel Pin, Depth Gage, and Surgical Ratchet are all intended to be used with the Implant Integration Systems "Dual Integrator" Dental Implant (K944225).
This document describes the "Dual Integrator" Parallel Pin, Depth Gage, and Surgical Ratchet, which are dental implant accessories, and their intended use with the "Dual Integrator" Dental Implant (K944225).
However, the provided text does not contain any information regarding acceptance criteria or a study proving the device meets acceptance criteria. It is a 510(k) summary and FDA clearance letter, which focuses on demonstrating substantial equivalence to previously marketed devices rather than presenting performance metrics from a specific study.
Therefore, I cannot fulfill your request for:
- A table of acceptance criteria and the reported device performance: This information is not present.
- Sample size used for the test set and the data provenance: Not available.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not available.
- Adjudication method for the test set: Not available.
- 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 document is about mechanical dental instruments and predates common AI applications in medical devices. No such study is mentioned or implied.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable, as this is a mechanical device, not an algorithm.
- The type of ground truth used: Not available.
- The sample size for the training set: Not applicable, as this is a mechanical device, not a machine learning algorithm.
- How the ground truth for the training set was established: Not applicable.
The document primarily focuses on:
- Device Description: The "Dual Integrator" Parallel Pin, Depth Gage, and Surgical Ratchet are described as being made of stainless steel and similar in design, composition, and function to other predicate devices.
- Intended Use: Used for the placement of the "Dual Integrator" Dental Implant. Specific functions are outlined: Parallel Pin for vertical placement, Depth Gauge for depth measurement, and Surgical Ratchet for screwing in the implant.
- Substantial Equivalence: The FDA clearance confirms that the device is substantially equivalent to legally marketed predicate devices (e.g., Minimatic Implant Tech. BC 1208, Impla-Med, Inc. Stainless Steel Instruments). This demonstrates that the device meets safety and effectiveness requirements by virtue of being comparable to devices already on the market, but it does not detail specific performance studies with acceptance criteria for the new device itself.
§ 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.