(164 days)
The Rescue Internal Implant System is intended to be surgically placed in the maxillary or mandibular molar areas for the purpose providing prosthetic support for dental restorations (Crown, These implants are bridges, and overdentures) in partially or fully edentulous individuals. These implants can be used where smaller implants have failed.
Rescue Internal Implant System consists of machined titanium, screw-form, root-form endosseous dental implants. It is intended to be surgically placed in the maxillary or mandibular molar areas for the purpose of providing prosthetic support for dental restorations (Crown, bridges, and overdentures) in partially or fully edentulous individuals. These implants can be used where smaller implants have failed.
Rescue Internal Implant System is an integrated system of endosseous dental implants which designed to support prosthetic devices for partially or fully edentulous patients. Rescue Internal Implant Fixture Systems consist of two-stage, root-form dental implants, associated with abutment systems, and the instruments.
This document is a 510(k) Premarket Notification Summary for the Rescue Internal Implant System, which is a dental implant device. It does not contain information about acceptance criteria or a study proving the device meets performance criteria in the way a medical device utilizing an algorithm or AI would.
The document primarily focuses on establishing "substantial equivalence" of the new Rescue Internal Implant System components to previously cleared predicate devices (Rescue Internal Implant System K063216 and BIOCON Dental Implants K010185 and K050712). Substantial equivalence in this context means that the device is as safe and effective as a legally marketed device.
Here's why the requested information cannot be extracted from this document:
- Type of Device: This is a physical, endosseous dental implant system, not a software or AI-driven diagnostic or treatment device. The performance of such devices is typically assessed through aspects like material biocompatibility, mechanical strength, and clinical outcomes over time, rather than metrics like sensitivity, specificity, or predictive accuracy.
- Regulatory Pathway: A 510(k) submission primarily demonstrates substantial equivalence to a predicate device. It doesn't typically require a clinical study demonstrating performance against specific acceptance criteria for algorithm performance.
- Lack of Performance Data: The document states, "FDA has not established a performance standard applicable to endosseous implants. The materials in the Rescue Internal Implant System meet applicable standards." This indicates that the regulatory pathway for this physical device does not require a study with performance metrics as would be expected for a device using an algorithm. The "standards" referred to are likely material and manufacturing standards, not performance metrics related to diagnostic accuracy.
Therefore, I cannot provide the requested information because the provided text describes a physical medical device (dental implant) approved through the 510(k) pathway by demonstrating substantial equivalence, and not a device that would typically have acceptance criteria and a study design focused on algorithm performance, such as sensitivity/specificity, sample sizes for test/training sets, expert ground truth, or MRMC studies.
§ 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.