(171 days)
Surgikor's Dental Implant System is indicated for use in surgical and restorative applications for placement in the bone of the upper or lower jaw to provide support for prosthetic devices, such as artificial teeth, in order to restore the patient's chewing function. The Dental Implant System is indicated also for immediate loading when good primary stability is achieved and with appropriate occlusal loading.
Surgikor Abutment Blanks and Abutments are intended to be used in conjunction with Surgikor endosseous dental implants in the maxillary or mandibular arch to provide support for single-unit or multi-unit prosthetic restorations.
All digitally designed abutments for use with Surgikor Abutment Blanks are intended to be sent to a Surgikor validated milling center for manufacture.
The Surgikor Fixation One implant is an alternative version of the 4.3 and 5.0 mm diameter Fixation implants that uses the regular platform used by the 3.5mm Fixation implants. The Surgikor abutment blanks and abutments consist of hexagonal and conical abutments made from abutment blanks, an additional hexagonal healing cap, and multi-unit abutments for conical RP and WP. Surgikor implants and abutments are made from Ti6AL4V ELI.
Fixation One is a root form implant that is appropriate for both immediate load applications and insertion into fresh extraction sockets. Fixation One is offered with a conical connection in regular platform. The Fixation One regular platform implant is available in 4.3, and 5.0 mm diameter and has available lengths of 8.5, 10, 11.5, 13, 15, and 18 mm.
Healing cap for internal hex in 3.75mm x 7mm in standard emergence.
Multi-Unit Abutment in conical RP and WP are available in heights of 1.5, 2.5, and 3.5 mm. An angled multi-unit of either 17° (2.5 or 3.5 mm) or 30° (3.5 or 4.5 mm) is available for conical connections of regular and wide platform. Multi-unit abutments are intended for multiple unit restorations only. Angled multi-units use RP and WP conical multi-unit screws.
Surgikor Blank Abutments are designed for fabrication of a customized all titanium alloy abutment by CAD-CAM processes. Surgikor Blank Abutments have an engaging implant connection. Abutments made from Surgikor Blank Abutments use internal hex abutment screws and RP & WP conical abutment screws from K182615.
The design parameters for customized abutments fabricated from Titanium Blank Abutments are: Minimum wall thickness – 0.4 mm Minimum post height for single-unit restorations (length above the abutment collar / gingival height)— 4.0 mm Minimum gingival height - 0.5 mm Maximum gingival height – 6.7 mm Maximum angulation - 25° (in relation to the long axis of the implant)
All abutment blanks are made of titanium alloy conforming to ASTM F136. Abutments made from the blanks are only for use with Surgikor dental implants of the implant/abutment interface on the package label and are not to be used with other dental implant designs. This includes Versatile Hex 3.5mm and larger, Immediate Hex 3.75mm and larger, and Solution Fixation & Fixation One conical 3.5mm and larger.
There are 3 models of abutment blank: internal hex, conical RP and conical WP.
Minimum diameter at abutment/implant interface: Versatile Hex 3.5mm Immediate Hex 3.75mm Solution 3.5mm Fixation 3.5mm Fixation One 4.3mm
Maximum length of abutment from abutment/implant interface: Versatile and Immediate Hex 13.00mm Solution 9.5mm Fixation and Fixation One 9mm
The provided text is a 510(k) Premarket Notification from the FDA regarding the Surgikor Fixation One, Abutment Blanks, and Abutments. This document focuses on demonstrating substantial equivalence to previously cleared predicate devices, not on proving that a device meets specific acceptance criteria through a clinical or performance study involving an AI algorithm or human readers.
Therefore, I cannot provide the requested information about acceptance criteria and a study proving device performance in the context of an AI/human-in-the-loop system because:
- The document is for a dental implant system (physical medical devices), not an AI algorithm or software. The "device" in question (Surgikor Fixation One, Abutment Blanks, and Abutments) is a set of physical components used in dental implant procedures, made from Ti6AL4V ELI material.
- The "study" discussed is a demonstration of substantial equivalence. This involves comparing the new device's indications for use, materials, design, principles of operation, and sterilization to legally marketed predicate devices. It does not involve performance metrics like sensitivity, specificity, or human improvement with AI assistance.
- There is no mention of algorithms, AI, human readers, or image analysis. The testing summary mentions cytotoxicity, steam sterilization, gamma irradiation validation, LAL testing, shelf-life, surface assessment, bench testing, and an MRI environment review, all related to the physical properties and safety of the dental implants.
The document does not contain any of the information required to populate the fields related to acceptance criteria for an AI-powered diagnostic device.
Summary of why the requested information cannot be extracted from the provided text:
The document describes a 510(k) submission for mechanical dental implants and abutments. It focuses on demonstrating "substantial equivalence" to existing predicate devices, rather than presenting a performance study of an AI-driven system or a system involving human interpretation of data. Therefore, details such as algorithm performance, sample sizes for AI training/testing sets, expert qualifications for ground truth, adjudication methods, MRMC studies, standalone AI performance, or ground truth establishment for AI models are not present.
§ 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.