(478 days)
The OneQ-SL Implant System is indicated for use in partially or fully edentulous mandibles and maxillae, in support of single or multiple-unit restorations including; cemented retained, or overdenture restorations, and terminal or intermediate abutment support for fixed bridgework. This system is intended for delayed loading.
The OneQ-SL Implant 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 OneQ-SL Implant system includes the i-Clean OneQ Fixtures which are Internal Octa-connected, non-submerged fixtures. The fixture is made of CP Titanium Grade 4. The surface is treated by Sand -blasting (Large grit) and acid etching method (SLA). The Fixtures are supplied sterile.
This document describes a 510(k) premarket notification for the OneQ-SL Implant System, a dental implant device. Therefore, the information typically requested in your prompt regarding acceptance criteria and study details for an AI/CADe device will not be present. This document does not describe a study that uses AI for diagnostic or screening purposes. Instead, it describes non-clinical testing performed to establish substantial equivalence to a predicate device.
Here's the breakdown of why I cannot answer your prompt with the given document:
- No AI/CADe device: The OneQ-SL Implant System is a physical dental implant, not an AI or CADe (Computer-Aided Detection) device. The document details its material, design, and intended use as a surgically placed implant.
- Substantial Equivalence Study: The document is a 510(k) summary, which aims to demonstrate that a new device is "substantially equivalent" to a legally marketed predicate device. This is a common regulatory pathway for medical devices that are not high-risk and do not introduce novel technology.
- Non-Clinical Testing: The "study" mentioned here refers to non-clinical tests (packaging, sterilization, fatigue, cytotoxicity) to confirm the device meets certain standards and safety requirements, not to evaluate diagnostic accuracy or human reader performance.
Therefore, the following points from your request cannot be addressed by this document:
- A table of acceptance criteria and the reported device performance.
- Sample sized used for the test set and the data provenance.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts.
- Adjudication method.
- If a multi reader multi case (MRMC) comparative effectiveness study was done.
- If a standalone performance was done.
- The type of ground truth used.
- The sample size for the training set.
- How the ground truth for the training set was established.
Summary of available information (related to non-clinical testing for substantial equivalence):
The document states that the OneQ-SL Implant System underwent the following non-clinical tests to evaluate its performance and demonstrate substantial equivalence to the predicate device (K120847, ET/SS Implant System manufactured by Osstem Implant Co., Ltd.):
- Packaging Test: Performed in accordance with ISO11607-1:2006 and ISO11607-2:2006.
- Sterilization Validation Test: Performed in accordance with ISO11137-1:2006 and ISO11137-2:2013.
- Fatigue Test: Performed in accordance with ISO14801:2007.
- Cytotoxicity Test: Performed according to ISO 10993-5:2009.
Acceptance Criteria and Reported Device Performance (Non-Clinical):
| Acceptance Criteria / Standard | Reported Device Performance |
|---|---|
| Packaging: ISO11607-1:2006 and ISO11607-2:2006 | "The result of the above tests have met the standard, and proved the substantial equivalence with the predicate device." (Specific numerical results are not provided in this summary document) |
| Sterilization Validation: ISO11137-1:2006 and ISO11137-2:2013 | "The result of the above tests have met the standard, and proved the substantial equivalence with the predicate device." (Specific numerical results are not provided in this summary document) |
| Fatigue: ISO14801:2007 | "The result of the above tests have met the standard, and proved the substantial equivalence with the predicate device." (Specific numerical results are not provided in this summary document) |
| Cytotoxicity: ISO 10993-5:2009 | "The result of the above tests have met the standard, and proved the substantial equivalence with the predicate device." (Specific numerical results are not provided in this summary document) |
Ground Truth for Non-Clinical Tests: For these non-clinical tests, "ground truth" is established by the methods and requirements specified in the respective ISO standards. For example, for the fatigue test, the ground truth would be resistance to a certain number of cycles at a defined load without failure. For cytotoxicity, it would be the absence of toxic effects as per the ISO standard for biological evaluation of medical devices.
Clinical Testing: The document explicitly states: "No additional clinical testing was performed for this submission." This further confirms that this is not an AI/CADe study involving human readers or diagnostic accuracy.
§ 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.