(224 days)
Southern Implants Dental Implants are intended for both one- and two-stage surgical procedures in the following situations and with the following clinical protocols:
- replacing single and multiple missing teeth in the mandible and maxilla,
- immediate placement in extraction sites and in situations with a partially or completely healed alveolar ridge,
- . immediate loading in all indications, except in single tooth situations on implants shorter than 8mm or in soft bone (type IV) where implant stability may be difficult to obtain and immediate loading may not be appropriate.
The intended use for 3.0 Deep Conical implants is limited to replacement of maxillary lateral incisors and mandibular incisors
The Deep Conical (DC Implant) has a deep conical connection system. The implants are available in Cylindrical, Tapered, Deep Conical 12º Co-Axis Cylindrical, and Deep Conical 12º Co-Axis Tapered configurations with various lengths and diameters. The implants have a moderately roughened surface, are non-roughened around the coronal region, and have an external thread and microthreads at the coronal end. The Co-Axis Implants are compatible only with straight abutments. The submission also includes various abutments (Cover Screw, Healing Abutments, Overdenture Abutments, Temporary Cylinders, Cosmetic Abutments, Gold Cylinders, Compact Conical Abutments, Passive Abutments, Titanium Abutments, Angled abutments) designed for use with the Deep Conical Implants.
The provided text is a 510(k) Summary for a medical device (Deep Conical (DC) Implants and Accessories) and does not describe an AI/ML powered device. Therefore, it does not include acceptance criteria, performance studies, or details regarding AI model development such as training/test set sizes, ground truth establishment, or expert involvement.
The document focuses on demonstrating substantial equivalence to predicate devices through technical characteristics and non-clinical testing.
Here's an overview of the non-clinical testing performed, but please note that this is not a performance study for an AI/ML device:
Non-clinical Testing and Performance Testing (for a dental implant device, not AI/ML):
- Fatigue testing: In accordance with ISO 14801, to prove sufficient strength. Reported as substantially equivalent to predicate devices.
- Comparative surface area, pullout strength and bone to implant contact analyses: For implants less than 7mm in length. Reported as substantially equivalent to predicate devices.
- Placement torque testing: To show sufficient strength to withstand placement torque. Reported as substantially equivalent to predicate devices.
- Sterilization method validation: Gamma radiation (for sterile devices) validated per ISO 11137; moist heat (for end-user sterilized devices) validated per ISO 17665-1 and ISO 17665-2.
- Packaging validation: In accordance with ISO 11607, with accelerated aging per ASTM-F-1980 to substantiate 5 years shelf life.
- Biocompatibility: The device is manufactured from the same material using the same method as the applicant's predicates, has the same intended use, and patient contact type and duration. It is reported as biocompatible in accordance with ISO 10993-1.
Absence of AI/ML Specific Information:
The document explicitly states: "No clinical studies were conducted." This further confirms the lack of any study that would typically be associated with evaluating the performance of an AI/ML device.
Therefore, the requested information regarding acceptance criteria and performance studies for an AI/ML device cannot be extracted from this document as it pertains to a different type of medical device (dental implants) and its regulatory pathway (510(k) for substantial equivalence).
§ 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.