(353 days)
The Stella is intended to be surgically placed in the upper or lower jawbone to provide support for prosthetic devices, such as artificial teeth, restoring the patient's chewing capabilities. The Stella is intended for delayed loading and immediate loading is possible when good primary stability is achieved and with appropriate occlusal loading. The Stella Abutment is intended to be connected to the dental implant to retain the overdenture or partial denture.
Stella is a dental implant fixture that is implanted in the jawbone to support and maintain prosthetic restoration teeth or dentures in case of partial or total loss of teeth as a material for dental surgery. The fixture is made of titanium (ASTM F67, Grade 4), and the retention area is surface treated by spraying with Al2O3 (alumina) powder and then pickling to roughen the surface. The system incudes Healing Abutment, Simple Abutment, Duo Abutment, Contour Abutment, Angled Abutment, and Temporary Abutment.
The provided text describes the regulatory clearance for the "Stella" dental implant system. It does not contain information about acceptance criteria or a study demonstrating the device meets performance criteria in the context of AI/ML or diagnostic applications. The document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device rather than presenting performance data against specific acceptance criteria for a novel AI/ML algorithm.
Therefore, most of the requested information regarding acceptance criteria, device performance, sample sizes, ground truth, expert opinions, and MRMC studies for an AI/ML device is not present in the provided document.
However, I can extract the non-clinical testing performed to support the substantial equivalence claim for the Stella dental implant system.
Here's the relevant information that is available:
1. A table of acceptance criteria and the reported device performance:
This information is not provided in the context of an AI/ML device's diagnostic performance. The document only lists types of non-clinical tests performed for physical characteristics of the dental implant system, and states that the "Stella" has "similar fatigue testing results to the predicate devices in the market" without providing specific acceptance criteria or quantitative results for these comparisons.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
Not applicable to this document. The document describes a medical device (dental implant), not a diagnostic algorithm.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):
Not applicable to this document.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
Not applicable to this document.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
Not applicable to this document.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable to this document.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
Not applicable to this document. The "ground truth" for a physical device like a dental implant would be engineering specifications and material properties, validated through physical testing, not expert consensus on images or pathology.
8. The sample size for the training set:
Not applicable to this document, as it does not describe an AI/ML algorithm.
9. How the ground truth for the training set was established:
Not applicable to this document.
Summary of Non-Clinical Testing (as described in the document for the physical device Stella, not an AI/ML component):
The document highlights the following non-clinical tests performed to support substantial equivalence of the Stella dental implant system:
| Test Type | Basis for Performance Claim |
|---|---|
| Fatigue Test | Performed in accordance with ISO 14801. The document states "similar fatigue testing results to the predicate devices in the market" and that "it was confirmed that there was no strength problem through the fatigue test on the fixture diameter 3.7mm." (No specific acceptance criteria or quantitative results are provided in this summary, but the test was done.) |
| SLA Surface Treatment | Evaluated under previous 510(k)s (K123155 and K160106) for SHINHUNG MST CO., LTD.'s Luna Dental Implant System. The subject device "Stella" is stated to be made of the same material and goes through the same manufacturing processes, implying similar surface characteristics to already cleared devices. |
| Biocompatibility | Evaluated under a previous 510(k) (K123155) for SHINHUNG MST CO., LTD.'s Luna Dental Implant System. The "Stella" is stated to be made of the same material (Pure Titanium Gr 4, ASTM F67) and process, with the safety of raw materials (including TiN coating where applicable) being demonstrated through the previously approved Luna system. |
| Shelf Life | Evaluated under a previous 510(k) (K123155). |
| Sterilization | Evaluated under a previous 510(k) (K123155) for both Gamma radiation and Moist Heat Methods. The Stella implant fixture and cover screw are radiation sterile. Abutments and other components are user sterile. |
| Packaging | Evaluated under a previous 510(k) (K123155). |
| Endotoxin/LAL Testing | Will be conducted on every batch of the subject device. (This is an ongoing quality control measure, not a pre-market test result presented here). |
| MRI Review | A non-clinical worst-case MRI review was conducted using scientific evidence and published literature (e.g., Woods et al., 2019). Titanium Grade 4 was assessed according to ASTM F2052 (magnetic induced displacement force), ASTM F2213 (magnetic induced torque), ASTM F2182 (RF induction heating), and ASTM F2119 (image artifact). This addresses parameters per FDA guidance "Testing and Labeling Medical Devices for Safety in the Magnetic Resonance (MR) Environment." |
§ 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.