(23 days)
The HU II / HS II Fixture System is indicated for use in partially or fully edentulous mandibles and maxillae, in support of single or multiple-unit restorations including; cemented retained, screw retained, or overdenture restorations, and terminal or intermediate abutment support for fixed bridgework.
The HU II / HS II Fixture System is for one and two stage surgical procedures. It is not for immediate load.
The HU II / HS II Fixture System is a dental implant made of titanium metal intended to be surgically placed in the bone of the upper or lower jaw arches.
The provided text is a 510(k) summary for a dental implant system (HU II / HS II Fixture System). This type of submission is for demonstrating substantial equivalence to a legally marketed predicate device, not for proving a device meets specific acceptance criteria through a study with the detailed structure you've requested.
The document states that "The HU II /HS II Fixture System has been subjected to safety, performance, and product validations prior to release. Safety tests including biocompatibility have been performed to ensure the devices comply with the applicable International and US regulations." However, it does not provide specific acceptance criteria or detailed study information in the way that would typically be presented for an AI/ML medical device's performance evaluation.
Therefore, I cannot extract the information to fill out your table and answer your specific questions in the context of an AI/ML device study.
Here's why and what the document does provide:
- Substantial Equivalence: This 510(k) focuses on demonstrating that the HU II / HS II Fixture System is "substantially equivalent" to existing predicate devices (The US System, K062030, and The SS System, K062051). This means proving it has similar materials, indications for use, design, and technological characteristics, and that it doesn't raise new questions of safety or effectiveness.
- Safety and Performance Validations: The document broadly states that safety, performance, and product validations were performed, including biocompatibility. However, it does not detail:
- Specific acceptance criteria (e.g., a target accuracy, sensitivity, specificity).
- The methodology of these validations (e.g., what specific tests were done, what data was used).
- The results of these validations in a quantitative manner.
In summary, the provided text does not contain the information required to populate your table or answer your questions about acceptance criteria, study details, sample sizes, ground truth, experts, or MRMC studies, as it pertains to the performance evaluation of an AI/ML device. This document describes a traditional medical device (dental implant) approval process, not an AI/ML product.
§ 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.