(156 days)
The DenQ Sub SLA 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, screw retained, or overdenture restorations, and terminal or intermediate abutment support for fixed bridgework. This system is dedicated for one and two stage surgical procedures. This system is intended for delayed loading.
The DenQ Sub SLA 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. This implant system has internal hex connection, tapered with straight body and bone level that are similar to other commercial available products based on the intended use, technology used, the material composition employed and performance characteristics. This DenQ Sub SLA fixture of implant system is supplied sterile.
The DenQ Sub Abutments are device made of cp titanium grade 4 and titanium alloy intended for use as a Prosthetic restoration. It consists of Abutments(Healing, Solid, Cement, Angled, Temporary, Multi-unit Straight, Multi-unit Angled, Multi-unit Healing Cap, Multiunit Ti Cylinder, Multi-unit Temporary Cylinder and FreeMilling).
This document is a 510(k) Pre-market Notification for a dental implant system (DenQ Sub SLA Implant System). It aims to demonstrate substantial equivalence to previously cleared predicate devices, rather than proving the device meets acceptance criteria through clinical or comparative effectiveness studies in the typical sense of a novel AI/software device.
Therefore, many of the requested elements (like MRMC studies, number of experts for ground truth, training set information for an AI device) are not applicable to a 510(k) submission for a physical dental implant system. The "acceptance criteria" here refers to demonstrating that the device is as safe and effective as a legally marketed predicate device, primarily through non-clinical performance testing and comparison of characteristics.
Here's a breakdown of the available information relevant to your request, adapting it to the context of this specific document:
1. Table of Acceptance Criteria (as demonstrated by testing) and Reported Device Performance:
For a physical device like a dental implant, "acceptance criteria" are the relevant ISO standards and material specifications that the device must meet to be considered safe and effective and substantially equivalent to a predicate. The "reported device performance" is the demonstration that these tests were passed.
| Acceptance Criteria (Relevant Standard/Test) | Reported Device Performance (Outcome) |
|---|---|
| Gamma Sterilization Validation (ISO 11137-1, -2) | Test performed and met standards. |
| Shelf-life Validation (ISO 11607-1, -2, ASTM F1980-16, ASTM F1140-13, ASTM A F2096-11, ASTM F88/F88M-15) | Test performed and met standards. |
| BET Validation (USP ) | Test performed and met standards. |
| User Sterilization Validation (ISO 17665-1, -2) | Test performed and met standards. |
| Biocompatibility (ISO 10993-1, ISO 14971) | Test performed and met standards. |
| Fatigue Testing (ISO 14801:2016) for DenQ Sub straight type Abutment, DenQ Sub Angled Abutment, and DenQ Sub SLA Fixture | Test performed and met standards; worn compliant and similar to previously cleared primary predicate devices. |
| Shear testing (ASTM F1044) | Test performed. (Outcome not explicitly stated as "met standards" but implied by overall conclusion of substantial equivalence). |
| Tension testing (ASTM F1147) | Test performed. (Outcome not explicitly stated as "met standards" but implied). |
| Abrasion characteristics (Scratch test) | Test performed; information on protocol, load range, indenter, depth, failure event, and images provided. (Outcome implied as acceptable). |
| Surface analysis (SEM/EDS analysis per FDA guidance) | Test performed. (Outcome implied as acceptable). |
| MR Environment Safety (Magnetically induced displacement force and torque per FDA Guidance "Testing and Labeling Medical Devices for Safety in the Magnetic Resonance (MR) Environment") | Non-clinical worst-case MRI review performed using scientific rationale and published literature. (Conclusion: MR Conditional). |
2. Sample Size Used for the Test Set and Data Provenance:
This document is for a physical medical device, not an AI/software device that would typically have a "test set" of patient data. The "tests" here refer to laboratory and bench testing on the physical device components.
- Sample Size: Not specified for individual non-clinical tests (e.g., how many implants were subjected to fatigue testing). This information is typically detailed in the full test reports, which are summarized in the 510(k) submission.
- Data Provenance: Not applicable in the sense of patient data. The results are from in-vitro (laboratory) and bench testing of the devices themselves. The tests were performed "in accordance with ISO standards and US regulations." The manufacturer is located in the Republic of Korea.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
- Not applicable. This submission relies on engineering standards and laboratory measurements for its performance criteria, not expert interpretations of medical images or clinical data for ground truth.
4. Adjudication Method for the Test Set:
- Not applicable. There is no "test set" requiring adjudication in the context of this type of submission.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done (and effect size):
- No. MRMC studies are typically for diagnostic AI devices assessing human reader performance. This is a physical dental implant.
- Summary of clinical testing: "No clinical testing was performed for this submission."
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Not applicable. This is a physical device, not an algorithm.
7. The Type of Ground Truth Used:
- The "ground truth" for the device's performance is established by engineering and material standards (e.g., ISO, ASTM, USP), and the physical measurements and observations derived from in-vitro and bench testing of the device's components (e.g., fatigue resistance, material properties, sterility).
8. The Sample Size for the Training Set:
- Not applicable. This is a physical device, not an AI algorithm that requires a "training set" of data.
9. How the Ground Truth for the Training Set Was Established:
- Not applicable. As above, no training set.
§ 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.