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510(k) Data Aggregation
(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." |
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(30 days)
The Luna Dental Implant System 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, and to restore the patient's chewing function.
The Luna Dental Implant System - Healing Abutment is to be connected to the implant and is to heal gingiva before setting abutment on the implant in the oral cavity. It is made of commercially pure titanium alloy Gr4. It offers narrow and regular platform types, and the narrow type has anodizing surface treatment in purple to be distinguished from the regular type.
The provided text is a 510(k) summary for the Luna Dental Implant System - Healing Abutment, a medical device. This document focuses on demonstrating substantial equivalence to previously cleared predicate devices rather than providing detailed acceptance criteria and performance data from a clinical or non-clinical study designed to prove the device meets specific performance metrics.
Therefore, the document does not contain the information requested in your prompt regarding acceptance criteria, device performance, sample sizes, expert involvement, adjudication methods, MRMC studies, standalone performance, or ground truth establishment relevant to proving device performance against specific criteria.
The 510(k) summary explicitly states its basis for substantial equivalence:
"The Luna Dental Implant System - Healing Abutment is substantially equivalent to its predicate device (K123155) in terms of indications for use, raw material, and design. The differences are in body design and size range. The design change does not raise a question in substantial equivalence since the change is not significant. We have identified a reference device that encompass the size range of the subject device. Based on the information submitted here in we conclude that the subject device is substantially equivalent to the predicate devices."
The "Non-Clinical Testing" section merely states: "Risk analysis was conducted according to ISO14971 to evaluate the effect of the modification. The risk assessment did not show that the device changes affected biocompatibility, sterilization, and shelf life such that the testing in the prior (predicate) file is still applicable." This indicates that no new performance testing was conducted or deemed necessary to demonstrate the modified device meets specific acceptance criteria, as its equivalence to the predicate implies it meets the same criteria the predicate device did.
In summary, this 510(k) document is a declaration of substantial equivalence, not a report of a study designed to establish acceptance criteria for a novel device and prove its performance against those criteria.
Since the requested information (acceptance criteria, performance data, sample sizes, expert details, etc.) is not present in the provided text, I cannot complete the table or answer the specific questions about the study from this document.
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