(144 days)
The HS II Short 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 HS II Short Fixture System is for single and two stage surgical procedures. It is not for immediate load.
The HS II Short 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.
This report describes a 510(k) premarket notification for the "HS II Short Fixture System," a dental implant device. The provided text mainly focuses on demonstrating substantial equivalence to predicate devices, rather than presenting a study specifically designed to assess its performance against predefined acceptance criteria for a new AI/medical device.
Therefore, the requested information regarding acceptance criteria and performance against those criteria, especially in the context of an AI device, cannot be extracted from this document. The document confirms the device's material, indications for use, and technological characteristics are similar to the predicate devices, leading to a conclusion of substantial equivalence.
However, based on the provided text, here's a breakdown of what can be inferred and what cannot:
1. Table of Acceptance Criteria and Reported Device Performance:
Not applicable in this context. The document is a 510(k) summary for a legacy medical device (dental implant). It does not present acceptance criteria or reported performance metrics in the way an AI/software device would, such as sensitivity, specificity, accuracy, or AUC. The "performance" assessment here is focused on demonstrating that the new device is "substantially equivalent" to existing, legally marketed predicate devices.
2. Sample Size Used for the Test Set and Data Provenance:
Not applicable. This document describes a dental implant, not an AI or software device that would typically use test sets of data for performance evaluation. Product testing for a device like this would involve mechanical, biological, and material properties testing, not data-driven performance assessments against a ground truth dataset.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts:
Not applicable. As above, there is no "test set" in the context of AI or diagnostic imaging for this device. The regulatory submission relies on comparison to predicate devices and established standards for dental implants.
4. Adjudication Method for the Test Set:
Not applicable. No test set requiring expert adjudication is discussed in this 510(k) summary.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance:
Not applicable. This document pertains to a physical dental implant, not an AI-powered diagnostic or assistive tool. Therefore, an MRMC study related to readers improving with AI assistance is not relevant or described.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:
Not applicable. This is a physical medical device, not an algorithm.
7. The Type of Ground Truth Used:
Not applicable. No "ground truth" (in the sense of a definitive diagnosis or outcome for data evaluation) is discussed here. The "truth" for this device's approval lies in its material composition, design, and functional equivalence to legally marketed predicates.
8. The Sample Size for the Training Set:
Not applicable. There is no training set mentioned, as this is not an AI/machine learning device.
9. How the Ground Truth for the Training Set Was Established:
Not applicable. As there is no training set, there is no ground truth establishment for it.
In summary, the provided 510(k) summary for the "HS II Short Fixture System" is exclusively focused on demonstrating substantial equivalence to predicate dental implants through a comparison of their materials, design, indications for use, and technological characteristics. It is not a study about an AI/software device and therefore does not contain information about acceptance criteria, performance metrics, sample sizes, expert ground truth establishment, or human-AI interaction studies typically associated with such devices.
§ 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.