Search Results
Found 2 results
510(k) Data Aggregation
(156 days)
The NB 1 SA 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. NB 1 SA Implant System is dedicated for two stage surgical procedures and for immediate loading when there is good primary stability and an appropriate occlusal load. Also, implants with diameters larger than 5mm are indicated for molar regions.
The NB 1 SA Implant System is composed of ARUM NB 1 SA Fixture, ARUM NB Cover Screw, ARUM NB Healing Abutment, ARUM Cemented Abutment (Hex, Non-Hex), and Abutment screw. ARUM NB 1 SA Fixture is a thread type implant body made of TI CP4 according to ASTM F67 which will be placed in the alveolar bone to replace the function of the missing tooth. The surface of the fixture is treated with SLA (Sandblasted with Large grit and Acid-etching). The fixture is placed in the anterior or posterior site of maxillary or mandibular jawbone considering bone quality and bone quantity and it is connected with dental prostheses.
The document provided is a 510(k) Premarket Notification for the NB 1 SA Implant System. It primarily focuses on demonstrating substantial equivalence to predicate devices based on technological characteristics and non-clinical test data, rather than reporting on a specific study that evaluates device performance against acceptance criteria in a clinical setting.
Therefore, many of the requested details about acceptance criteria, device performance, sample sizes for test and training sets, ground truth establishment, and MRMC studies are not present in this document. The information provided heavily relies on non-clinical tests to support the substantial equivalence claim.
Here's an attempt to answer the questions based only on the provided text, indicating when information is not available:
1. A table of acceptance criteria and the reported device performance
Based on the provided text, the acceptance criteria are largely linked to meeting the requirements of specific ISO and ASTM standards for non-clinical testing. The "reported device performance" is that the results of these tests "met the criteria of the standards and demonstrated the substantial equivalence with the predicate device."
| Test Type | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| For Devices Delivered Sterile (Fixture & Cover Screw) | ||
| Gamma Sterilization Validation Test | Sterility Assurance Level (SAL) of 10^-6 (according to ISO 11137-1:2006) | Met the criteria of ISO 11137-1:2006; SAL of 10^-6 validated. |
| Shelf-Life Test | Equivalence to predicate devices (according to ASTM F1980) | Met the criteria of ASTM F1980; worst-case construct tested, results demonstrated equivalence to predicate. Shelf life for devices provided sterile is 5 years. |
| Biocompatibility Testing | Compliance with ISO 10993-1:2009, -3:2014, -5:2009, -6:2007, -10:2010, -11:2006 (for fixtures) | Met the criteria of the standards and demonstrated substantial equivalence with the predicate device. Performed according to ISO 10993-1:2009 and FDA guidance. |
| LAL Endotoxin Testing | Compliance with AAMI / ANSI ST72:2011/(R)2016 | Met the criteria of the standards and demonstrated substantial equivalence with the predicate device. |
| Non-Pyrogenic Claim (NB 1 SA Fixture) | Not applicable | Devices will not be marketed as non-pyrogenic. |
| For TiN Coating Abutments | ||
| Biocompatibility Testing | Compliance with ISO 10993-1:2009, -5:2009, -10:2010 | Met the criteria of the standards and demonstrated substantial equivalence with the predicate device. Performed according to ISO 10993-1:2009 and FDA guidance. |
| For Devices Delivered Non-Sterilized (Abutments) | ||
| End User Sterilization Validation Test | Compliance with ANSI/AAMI ST79, ISO 17665-1,-2, ISO 11737-1,-2, ISO 11138-1 and FDA guidance | Recommended sterilization validated according to ISO 17665-1 and ISO 17665-2 and applicable FDA guidance. Worst-case construct tested, results demonstrated equivalence to predicate device. |
| Biocompatibility Testing (Ti-6Al-4V ELI) | Compliance with ISO 10993-1:2009, -3:2014, -5:2009, -6:2007, -10:2010, -11:2006 | Met the criteria of the standards and demonstrated substantial equivalence with the predicate device. Performed according to ISO 10993-1:2009 and FDA guidance. |
| Surface Modification Information (Fixtures) | Provided (roughness, composition, SEM with SLA) | Surface modification information such as surface roughness, surface composition analysis, and SEM imaging with SLA (Sandblasted with Large-grit and Acid-etching) for fixtures was provided. (Results not explicitly detailed as acceptance criteria). |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size for Test Set: Not specified in the document. The testing described is primarily non-clinical (sterilization, shelf-life, biocompatibility, LAL endotoxin, material characteristics).
- Data Provenance: Not explicitly stated as "country of origin for data." The submitter is Arumdentistry Co., Ltd. from Daejeon, Republic of Korea. The testing itself is non-clinical and conducted in vitro or ex vivo (e.g., material testing, microbial inactivation). The document does not describe human subject data.
- Retrospective or Prospective: Not applicable as the described tests are non-clinical hardware tests.
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. The ground truth for the non-clinical tests is established by the specified international standards and guidelines (e.g., ISO, ASTM, AAMI/ANSI). No human expert "ground truth" derived from clinical data is described.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. The described tests are non-clinical and do not involve adjudication by experts in the context of diagnostic interpretation.
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
No MRMC comparative effectiveness study is mentioned. The device is an endosseous dental implant system, not an AI-powered diagnostic tool for human readers.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
This section is not applicable to the device described. The NB 1 SA Implant System is a physical dental implant.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the non-clinical tests, the "ground truth" is defined by the technical specifications and performance requirements established in the referenced international standards (e.g., SAL of 10^-6 for sterility, specific material properties, successful validation of sterilization cycles, biocompatibility under ISO guidelines, etc.). No clinical ground truth (like pathology or outcomes data) is discussed for this 510(k).
8. The sample size for the training set
Not applicable. This document describes non-clinical testing of a physical medical device, not a machine learning algorithm that requires training data.
9. How the ground truth for the training set was established
Not applicable, as no training set is mentioned or relevant to the device described.
Ask a specific question about this device
(586 days)
The LOTA SLA Dental Implant System and LOTA HA Dental Implant System are 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. The LOTA SLA Dental Implant System and LOTA HA Dental Implant System are for single and two stage surgical procedures. These systems are intended for delayed loading.
The LOTA SLA Dental Implant system and LOTA HA Dental Implant System are dental implant systems made of Titanium 6AL 4V ELI alloy, which confirms to ASTM F136, intended to be surgically placed in the bone of the upper or lower jaw arches for loading after a conventional healing period. The implants may be used to replace one or more missing teeth. All diameters are available with all lengths. The implants are used with the following abutments. The Shouldered Abutments and the Shouldered Hex Abutments have internal connection structure, and they adopt locking taper connection. They restore fixed crown and bridge restorations. The Shouldered Removal Abutment uses screw and locking taper connection to be connected with the fixture. It has the same intended use as the other abutments. All the abutments are not intended for angulation.
This document is a 510(k) premarket notification for the LOTA SLA Dental Implant System and LOTA HA Dental Implant System. It primarily focuses on demonstrating substantial equivalence to previously cleared devices rather than presenting a study that proves the device meets specific performance acceptance criteria for a new and innovative AI/software functionality.
Therefore, many of the requested items (e.g., sample size for training/test sets, expert adjudication methods, MRMC studies, standalone performance, ground truth for AI, effect size of human reader improvement with AI) are not applicable or extractable from this document as it pertains to a medical device (dental implant system), not an AI/Software as a Medical Device (SaMD).
However, I can extract information related to the non-clinical testing performed to establish substantial equivalence for this physical device.
Summary of Acceptance Criteria and Proving the Device Meets Them (Based on the Provided Document which is for a Physical Medical Device - Dental Implant System)
This 510(k) submission establishes substantial equivalence for the LOTA SLA Dental Implant System and LOTA HA Dental Implant System to legally marketed predicate devices. The "acceptance criteria" here are not about software performance metrics but rather about demonstrating that the new device shares fundamental scientific technology, materials, design, and performance characteristics with existing devices, and that any differences do not raise new questions of safety or effectiveness. The "study" largely refers to non-clinical testing and comparison to predicates.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria (Demonstrated) | Reported Device Performance / Assessment |
|---|---|---|
| Intended Use | The device is used in partially or fully edentulous mandibles and maxillae, in support of single or multiple-unit restorations including cemented, screw-retained, or overdenture restorations, and terminal or intermediate abutment support for fixed bridgework, for single and two-stage surgical procedures, intended for delayed loading. | Demonstrated Equivalence: The subject device (LOTA SLA/HA Dental Implant System) has the same indications for use as the primary predicate device (KJ Submerged System, K103810). |
| Fundamental Scientific Technology | The device should employ similar principles and mechanisms as legally marketed devices. | Demonstrated Equivalence: The subject device and the predicate device (KJ Submerged System, K103810) have the same fundamental scientific technology. |
| Materials | Biocompatibility and mechanical properties of materials (Titanium 6AL 4V ELI alloy, ASTM F136). | Demonstrated Equivalence: The subject and predicate devices employ the same materials (Titanium 6AL 4V ELI alloy, ASTM F136). |
| Design | Similar design elements (Implant Type: Bone Level, Connection Type: Internal Locking Taper, Neck Design: Straight walled neck, Body Design: Tapered) and dimensional ranges (diameters, lengths). | Demonstrated Similarity/Mitigation: The subject and predicate devices have very similar in design. Differences identified (fixture thread design, fixture size, abutment design) were addressed by identifying reference devices with similar features and size ranges (Bicon Implants K092035, J2a/J2c Dental Implant System K150060, MegaGen AnyRidge® Implant System K170044) to demonstrate these changes do not raise new concerns. |
| Surface Treatment | The SLA treatment should not introduce new safety concerns (e.g., biocompatibility, residual contaminants). | Mitigation/Equivalence: The SLA treatment is a difference from the primary predicate's RBM Treatment/HA Coating. This was addressed by identifying a reference device made by the same company (J2A SLA Dental Implant System, K161923) that goes through the same manufacturing processes and has the same material/surface treatment. Additionally, SEM analysis was performed to validate no residual contaminants remained on the implants. |
| Sterilization & Shelf Life | The device must be adequately sterilized and maintain sterility and integrity over its shelf life. | Testing Performed: Sterilization validation testing was conducted in accordance with ISO 11137-1 and 11137-2 (Gamma sterilization). Shelf life validation tests were performed in accordance with ASTM F1980-7, ASTM F88, ISO 11607, and ISO 11737-2. The results support substantial equivalence. |
| Endotoxins | Endotoxin levels must be within acceptable limits for lot release. | Testing Performed: Endotoxin testing for lot release was evaluated in accordance with USP 39 , confirming the endotoxin limit is 0.5 EU/mL. |
| Risk Management | Risks associated with modifications must be identified and mitigated. | Risk Analysis Conducted: Risk analysis was conducted according to ISO 14971 to evaluate the effect of the modifications. The activities/tests listed above (identification of reference devices, sterilization/shelf-life validation, endotoxin testing, SEM analysis) were performed based on this analysis to mitigate identified potential risks. |
Regarding AI/Software specific criteria (not applicable for this document):
The provided document is a 510(k) premarket notification for a physical medical device (dental implants). It is not for a software or AI device. Therefore, the specific questions related to AI/Software performance, test sets, ground truth establishment by experts, MRMC studies, or standalone algorithm performance are not detailed or relevant in this context.
If this were an AI/Software as a Medical Device (SaMD) submission, these sections would be crucial. Since it's for a physical implant, the "acceptance criteria" are based on material properties, design, manufacturing processes, intended use equivalence to predicates, and standard biological and physical testing.
Ask a specific question about this device
Page 1 of 1